Intellia Therapeutics Presents Positive Pooled Phase 1/2 Data of Lonvoguran Ziclumeran (lonvo-z) in Patients with Hereditary Angioedema




Intellia Therapeutics Presents Positive Pooled Phase 1/2 Data of Lonvoguran Ziclumeran (lonvo-z) in Patients with Hereditary Angioedema

• Deep, stable and durable reductions in kallikrein observed 
• Among 32 patients who received a 50 mg dose of lonvo-z as of data cutoff:
  • 31 (97%) were attack-free and long-term prophylaxis (LTP)-free
  • 24 (75%) were attack-free and LTP-free for at least seven months (up to 32 months)
  • Among the 11 patients who originally received a 50 mg dose in Phase 2, 10 were attack-free and LTP-free
• Continue to observe a well-tolerated safety profile with up to three years of patient follow-up and no new long-term risks identified

CAMBRIDGE, Mass., Nov. 08, 2025 (GLOBE NEWSWIRE) — Intellia Therapeutics, Inc. (NASDAQ: NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today presented positive clinical data from a pooled analysis of all patients who received a 50 milligram (mg) dose of lonvo-z in the company’s ongoing Phase 1/2 clinical trial in patients with hereditary angioedema (HAE). These results were shared in an oral presentation today at the American College of Allergy, Asthma & Immunology (ACAAI) 2025 Annual Scientific Meeting in Orlando, Florida.

“Today’s data further support our belief that lonvo-z could completely redefine the HAE treatment landscape,” said Intellia President and Chief Executive Officer John Leonard, M.D. “With up to three years of follow-up, the vast majority of patients who received a one-time 50 mg dose of lonvo-z – including 10 of our original 11 patients who received this dose in Phase 2 – were both attack-free and LTP-free as of the data cutoff. We are looking forward to our approaching topline readout from our Phase 3 HAELO clinical trial by mid-2026.”

“Hereditary angioedema is a condition with significant burden that is marked by the unpredictable nature of when the next attack could occur, the painful and often prolonged swellings themselves as well as the need for lifelong treatment,” said Dr. Danny Cohn, M.D., Ph.D., Internist, Department of Vascular Medicine, Amsterdam University Medical Center. “The data presented today offer hope that lonvo-z could significantly reduce or remove those burdens for many patients via a one-time treatment. I am eagerly awaiting results from the ongoing HAELO Phase 3 clinical trial.”

Pooled Phase 1/2 Analysis
Intellia’s global Phase 1/2 clinical trial is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of lonvo-z in adults with HAE Types I or II. Today’s presentation was based on a pooled analysis of all 32 patients who have received a one-time 50 mg treatment of lonvo-z via intravenous infusion in the Phase 1/2 trial. Of the 32 patients, 15 had initially received the 50 mg dose at study Day 1 (four in Phase 1 and 11 in Phase 2) and 17 were treated after unblinding of the Phase 2 clinical trial for the primary analysis (11 had originally received a 25 mg dose of lonvo-z, which was determined to be a suboptimal dose, and six had previously received placebo). The data cut-off for the analysis was August 29, 2025.

Deep, stable and durable reductions in plasma kallikrein were observed in all patients, with a mean reduction of 89% at month 24. Among the 32 patients, 31 (97%) were both attack-free and LTP-free as of the data cutoff, with 24 (75%) being attack-free and LTP-free for at least seven months (up to 32 months for patients with the longest follow-up). Of the 11 patients who initially received the 50 mg dose of lonvo-z in Phase 2, 10 were attack-free and LTP-free (nine for 7-32 months and one for <6 months). The one patient who was not attack-free and LTP-free as of the data cutoff had a 59% reduction from baseline in their monthly attack rate.

Safety
After a 50 mg dose, a well-tolerated safety profile was observed for up to three years of follow-up with no long-term risks identified. The most frequent treatment-emergent adverse events (TEAEs) within 28 days of infusion were infusion-related reactions, fatigue and headache. The most frequent TEAEs reported ≥28 days after infusion up to long-term follow-up (LTFU) were nasopharyngitis, upper respiratory tract infection, back pain, arthralgia and COVID-19. A single Grade 2 AST elevation was reported among all patients who received a 50 mg dose of lonvo-z. This event had an onset at Day 1 and spontaneously resolved by Day 4 in a patient previously treated with lonvo-z 25 mg. Safety of the 50 mg dose after patients received the suboptimal dose (25 mg) was consistent with the overall clinical trial population. There were no clinically significant shifts in liver enzymes or coagulation parameters. One serious adverse event (SAE), a pulmonary embolism, was observed in a patient with multiple risk factors one year after the infusion, and the event resolved without sequelae. In LTFU (n=17), there were no SAEs or TEAEs reported with 50 mg of lonvo-z, as of the data cutoff.

A one-time 50 mg treatment of lonvo-z is being further evaluated in patients with HAE in the ongoing global Phase 3 HAELO clinical trial that completed enrollment in September 2025.

The ACAAI data presentation will be available on the Scientific Publications & Presentations section of intelliatx.com.

About the Lonvoguran Ziclumeran (lonvo-z, formerly known as NTLA-2002) Clinical Program
Intellia’s ongoing Phase 1/2 clinical trial is evaluating the safety and efficacy of lonvo-z in adults with Type I or Type II hereditary angioedema (HAE). The Phase 1 portion is an international, open-label trial designed to identify the dose level of lonvo-z selected for further evaluation in the Phase 2 portion of the trial. Enrollment in both portions of the Phase 1/2 trial is complete. Intellia completed enrollment in the global Phase 3, randomized, double-blind, placebo-controlled HAELO clinical trial in September of 2025. Visit clinicaltrials.gov (NCT05120830) for more details.

About Lonvo-z
Based on Nobel Prize-winning CRISPR/Cas9 technology, lonvo-z has the potential to become the first one-time treatment for hereditary angioedema (HAE). Lonvo-z is an investigational in vivo CRISPR-based gene editing therapy that is currently being investigated in HAELO, a Phase 3 clinical trial in HAE, and is designed to prevent HAE attacks by inactivating the kallikrein B1 (KLKB1) gene, which encodes for prekallikrein, the kallikrein precursor protein. Interim Phase 1/2 clinical data showed dramatic reductions in attack rate, as well as consistent, deep and durable reductions in kallikrein levels. Lonvo-z has received five notable regulatory designations, including Orphan Drug and RMAT Designation by the U.S. Food and Drug Administration (FDA), the Innovation Passport by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), Priority Medicines (PRIME) Designation by the European Medicines Agency, as well as Orphan Drug Designation (ODD) by the European Commission.

About Intellia Therapeutics
Intellia Therapeutics, Inc. (NASDAQ:NTLA) is a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies. Since its inception, Intellia has focused on leveraging gene editing technology to develop novel, first-in-class medicines that address important unmet medical needs and advance the treatment paradigm for patients. Intellia’s deep scientific, technical and clinical development experience, along with its people, is helping set the standard for a new class of medicine. To harness the full potential of gene editing, Intellia continues to expand the capabilities of its CRISPR-based platform with novel editing and delivery technologies. Learn more at intelliatx.com and follow us @intelliatx.

Forward-Looking Statements
This press release contains “forward-looking statements” of Intellia Therapeutics, Inc. (“Intellia” or the “Company”) within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Intellia’s beliefs and expectations concerning: the safety, efficacy, success and advancement of its clinical programs for lonvoguran ziclumeran or “lonvo-z” (f/k/a NTLA-2002) for hereditary angioedema (“HAE”), including the ability to successfully complete its global Phase 3 HAELO study and to present a topline data readout from the HAELO study by mid-2026; and lonvo-z’s potential to significantly reduce or remove burdens for patients with HAE and to become the first one-time treatment for HAE.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to Intellia’s ability to protect and maintain its intellectual property position; risks related to Intellia’s relationship with third parties, including its contract manufacturers, licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; risks related to Intellia’s ability to protect and maintain its intellectual property position; risks related to valid third party intellectual property; risks related to Intellia’s relationship with third parties, including its licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; uncertainties related to regulatory agencies’ evaluation of regulatory filings and other information related to our product candidates, including lonvo-z; uncertainties related to the authorization, initiation and conduct of studies and other development requirements for our product candidates, including uncertainties related to regulatory approvals to conduct clinical trials, including our ability to complete the Phase 3 HAELO study for HAE, present a topline data readout from the HAELO study by mid-2026, and generate data to support lonvo-z’s potential to significantly reduce or remove burdens for patients with HAE via a one-time treatment; the risk that any one or more of Intellia’s product candidates, including lonvo-z, will not be successfully developed and commercialized; and the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies for the same product candidate or Intellia’s other product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Intellia’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Intellia’s most recent annual report of Form 10-K and quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Intellia’s other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intellia undertakes no duty to update this information unless required by law.

Intellia Contacts:
Investors:
Jason Fredette
Vice President, Investor Relations and Corporate Communications
Intellia Therapeutics, Inc.
jason.fredette@intelliatx.com

Media:
Matt Crenson
Ten Bridge Communications
mcrenson@tenbridgecommunications.com

Clinical Data Demonstrating Efficacy of Sotagliflozin in Preserved Ejection Fraction Heart Failure (HFpEF) without Diabetes Presented at American Heart Association (AHA) Annual Scientific Sessions 2025




Clinical Data Demonstrating Efficacy of Sotagliflozin in Preserved Ejection Fraction Heart Failure (HFpEF) without Diabetes Presented at American Heart Association (AHA) Annual Scientific Sessions 2025

Oral presentation highlights sotagliflozin’s unique benefits to HFpEF patients in significantly improving cardiac and physical performance, and quality of life

THE WOODLANDS, Texas, Nov. 08, 2025 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that new sotagliflozin clinical data was presented at the AHA Annual Scientific Sessions 2025. The data highlighted benefits observed from sotagliflozin treatment in heart failure patients with preserved ejection fraction (HFpEF), and without diabetes, across a range of measures, including cardiac structure and function, quality of life and functional capacity.

Conducted under the direction of Dr. Juan J Badimon, PhD, FACC, FAHA, director, Atherothrombosis Research Unit, professor of Medicine/Cardiology at Mount Sinai Medical Center in New York City, “SOTA P CARDIA: A Randomized Trial of Sotagliflozin in HFpEF Patients without Diabetes” was a prospective, randomized, double-blind, placebo-controlled trial that exclusively enrolled patients with HFpEF, the most rapidly increasing form of heart failure.

The objective of the study was to compare treatment with sotagliflozin to placebo on a number of cardiac functional and structural measures, such as left ventricular mass, diastolic function, standard six-minute walk test, and KCCQ. The study enrolled 88 participants who were racially diverse and 70 percent female. Patients were treated with sotagliflozin or placebo for six months, and comparisons were made between groups during and after completion of treatment.

Treatment with sotagliflozin resulted in statistically significant improvements in left ventricular mass, diastolic function, capacity for a six-minute walk test, and KCCQ measurements. In addition, though peak VO₂ improvement did not achieve statistical significance, there was a notable improvement after treatment with sotagliflozin.

“The benefits observed with sotagliflozin treatment in the study include significant improvements in cardiac structure and function, symptom relief and, most importantly, quality of life and functional capacity,” said Dr. Badimon. “Although sotagliflozin was approved more than two years ago for heart failure patients with or without diabetes, our study is the first to demonstrate important clinical benefits for patients with preserved ejection fraction without diabetes.”

According to the American College of Cardiology, nearly 6.7 million Americans have heart failure, more than half with preserved ejection fraction. This condition often leads to frequent hospitalizations and has a one-year risk of death of roughly 25 percent.

“When you combine these study results with previously reported data on reductions among patients treated with sotagliflozin in the risks for MACE and rehospitalization following previous hospitalization for acute heart failure events, the potential for sotagliflozin to be considered a different class of medication starts to come into focus,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer.

Click here and search for “SOTA P CARDIA” to access the study abstract.

About Sotagliflozin 
Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. Sotagliflozin is also currently under investigation for another cardiac condition, hypertrophic cardiomyopathy (HCM). 

About Lexicon Pharmaceuticals    
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, HCM, obesity, metabolism and other indications.  For additional information, please visit www.lexpharma.com.

Safe Harbor Statement    
This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of sotagliflozin and its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.    

For Investor and Media Inquiries:   

Lisa DeFrancesco    
Lexicon Pharmaceuticals, Inc.   
lexinvest@lexpharma.com  

Telitacicept Achieved Primary Endpoint of Reducing Proteinuria in Stage A of a Phase 3 Clinical Study for IgA Nephropathy in China




Telitacicept Achieved Primary Endpoint of Reducing Proteinuria in Stage A of a Phase 3 Clinical Study for IgA Nephropathy in China

Treatment with telitacicept for 39 weeks resulted in a rapid, clinically meaningful, and statistically significant reduction in proteinuria, with a favorable safety profile

Telitacicept demonstrated a 55% reduction in 24-hour urine protein-to-creatinine ratio (24h-UPCR) at 39 weeks compared with placebo; statistically significant benefits also achieved across all key secondary endpoints

Data presented as late-breaking oral presentation at American Society of Nephrology’s Kidney Week 2025

BOSTON, Nov. 08, 2025 (GLOBE NEWSWIRE) — Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that the primary endpoint was achieved in Stage A of a Phase 3 clinical study in China evaluating telitacicept in adults with IgA nephropathy (IgAN). In addition, statistically significant benefits were achieved across all secondary endpoints in the study, which was conducted by RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), Vor Bio’s collaborator.

“Telitacicept delivered statistically significant deep, sustained, and clinically meaningful reductions in proteinuria with stabilization of kidney function and a favorable safety profile. An objective endpoint like 24h-UPCR validates the therapeutic effect of dual BAFF/APRIL inhibition. These findings, alongside the strong pharmacodynamic evidence of telitacicept’s dual B-cell pathway inhibition, demonstrate its potential to deliver disease-modifying effects in IgAN,” said Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of the Board. “With this Phase 3 success in IgAN, telitacicept has provided additional clinical evidence supporting its mechanism in yet another indication, reinforcing our confidence in its potential as a foundational therapy for B-cell mediated diseases.”

This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial in China that enrolled 318 adult patients with IgAN at high risk of progression who had received stable standard therapy. Patients were randomized (1:1) to telitacicept (240 mg) or placebo, subcutaneously once weekly.

Primary Endpoint Achieved
In Stage A of the Phase 3 study, telitacicept achieved the primary endpoint of reducing proteinuria, demonstrating a significant reduction in 24h-UPCRvs. Placebo at 39 weeks compared to placebo (-58.9% vs. -8.8%, p<0.0001), 24h-UPCR is an objective and internally recognized regulatory marker for assessing disease activity in IgAN.

Statistically Significant Benefits Across all key Secondary Endpoints
Key secondary endpoints evaluated preservation of kidney function—measured by change in estimated glomerular filtration rate (eGFR), the proportion of patients with a ≥30% decline in eGFR, and remission rates defined by achievement of UPCR threshold <0.8 g/g. Additional endpoints included resolution of hematuria and changes in pharmacodynamic markers such as B-cell counts and serum immunoglobulins.

Treatment with telitacicept achieved statistically significant improvements across all key secondary endpoints at Week 39. Compared with placebo, telitacicept stabilized kidney function (GMR of eGFR relative to baseline, showed stabilization in the telitacicept group (-0.10) in contrast to a decline in the placebo group (-0.77)) and reduced the risk of eGFR decline ≥ 30% (6.3% in the telitacicept group vs. 27.0% in the placebo group). 61% of patients on telitacicept vs.19.5% of patients on placebo achieved 24h-UPCR <0.8 g/g, 42.1% of patients on telitacicept vs. 7.5% of patients on placebo achieved <0.5 g/g, and 24.5% of patients on telitacicept vs. 0.6% of patients on placebo achieved <0.3 g/g, thresholds linked to low risk of disease progression.

Favorable Safety Profile
Telitacicept demonstrated a favorable and well-tolerated safety profile. While overall treatment-emergent adverse events were more frequent with telitacicept (89.3% vs. 78.6%), most were mild or moderate, and serious adverse events occurred less often with telitacicept than with placebo (2.5% vs. 8.2%). No apparent unexpected safety findings were noted.

RemeGen announced that a Biologics License Application (BLA) has been submitted to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China for IgAN, which if approved would become telitacicept’s fifth approved indication in China.

About Vor Bio

Vor Bio is a clinical-stage biotechnology company transforming the treatment of autoimmune diseases. The Company is focused on rapidly advancing telitacicept, a novel dual-target fusion protein, through Phase 3 clinical development and potential commercialization to address serious autoantibody-driven conditions worldwide. For more information visit www.vorbio.com.

About Telitacicept

Telitacicept is a novel, investigational recombinant fusion protein designed to treat autoimmune diseases by selectively inhibiting BLyS (BAFF) and APRIL – two cytokines essential to B cell and plasma cell survival. This dual-target mechanism reduces autoreactive B cells and autoantibody production, key drivers of autoimmune pathology.

Telitacicept is approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG). A global Phase 3 clinical trial in gMG is currently underway across the United States, Europe, South America, and Asia-Pacific to support potential approval in the United States, Europe, and Japan.

About IgAN Nephropathy

IgA nephropathy (IgAN) is one of the most common primary glomerular diseases worldwide and a leading cause of chronic kidney disease (CKD) and end-stage renal disease (ESRD). It is characterized by IgA-containing immune complex deposition in the kidney, leading to inflammation, proteinuria, hypertension, and progressive loss of renal function. Up to 40% of patients progress to ESRD within 20 years of diagnosis, underscoring the significant unmet need for effective therapies. Current treatment approaches, including optimized blood pressure control, renin-angiotensin system blockade, and SGLT2 inhibitors, primarily slow disease progression but do not address the underlying immunopathology.

The prevailing scientific consensus is that overproduction of galactose-deficient IgA1 (Gd-IgA1) is a central driver of IgAN. BAFF and APRIL, two cytokines critical to B-cell survival and function, promote the production of Gd-IgA1 and its pathogenic antibodies.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “aim,” “anticipate,” “can,” “continue,” “could,” “design,” “enable,” “expect,” “initiate,” “intend,” “may,” “on-track,” “ongoing,” “plan,” “potential,” “should,” “target,” “update,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include Vor Bio’s statements regarding the potential of telitacicept in various indications, including IgAN; telitacicept’s potential as a foundational therapy for B-cell mediated diseases worldwide; the timing of presentation of clinical data; Vor Bio’s development and commercialization plans for telitacicept; and other statements that are not historical fact.

Vor Bio may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including the data for our product candidates may not be sufficient for obtaining regulatory approval to commercialize products; we may not be able to execute our business plans, including meeting our planned clinical and regulatory milestones and timelines, and possible limitations of financial and other resources. These and other risks are described in greater detail under the caption “Risk Factors” included in Vor Bio’s most recent annual or quarterly report and in other reports it has filed or may file with the Securities and Exchange Commission. The results of the clinical trial described in this press release is based on information reported by RemeGen; Vor Bio has not independently verified this data.

Any forward-looking statements contained in this press release speak only as of the date hereof, and Vor Bio expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law.

Media & Investor Contacts:
Carl Mauch
cmauch@vorbio.com

Sarah Spencer
investors@vorbio.com

Monte Rosa Therapeutics Presents Preclinical Data at AHA Scientific Sessions 2025 on the Potential of MRT-8102, a NEK7-directed Molecular Glue Degrader, to Treat Cardiovascular and Cardiometabolic Diseases




Monte Rosa Therapeutics Presents Preclinical Data at AHA Scientific Sessions 2025 on the Potential of MRT-8102, a NEK7-directed Molecular Glue Degrader, to Treat Cardiovascular and Cardiometabolic Diseases

Data support NEK7 as a potential novel and differentiated therapeutic approach to modulate the NLRP3 inflammasome in multiple cardiovascular and cardiometabolic diseases, including pericarditis and atherosclerosis

Initial data from a Phase 1 study of MRT-8102 in healthy volunteers and elevated CVD-risk subjects on track for first half of 2026

Poster presentation on November 8 at 10:30 a.m. CST

BOSTON, Nov. 08, 2025 (GLOBE NEWSWIRE) — Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced the company will present preclinical data on the potential of MRT-8102, a first-in-class, NEK7-directed MGD for inflammatory diseases driven by the NLRP3 inflammasome, at the American Heart Association’s Scientific Sessions 2025, held November 7-10 in New Orleans, LA.

“These promising findings reinforce our belief in the highly differentiated profile of MRT-8102, the only clinical-stage degrader targeting NEK7, as a potential treatment for cardiovascular and cardiometabolic diseases such as pericarditis, atherosclerosis, and others,” said Sharon Townson, Ph.D., Chief Scientific Officer of Monte Rosa Therapeutics. “By modulating the NLRP3/IL-1/IL-6 pathway upstream of other approaches, MRT-8102 potently inhibited pyroptotic cell death and inhibited the release of multiple inflammatory cytokines. Furthermore, MRT-8102 has the potential to block cholesterol crystal-induced cardiovascular inflammation characterized by pyroptosis and cytokine release that leads to atherosclerotic plaque pathogenesis. We are encouraged by the growing interest in targeting the NLRP3/NEK7 inflammasome to treat cardiovascular disease, and we believe we have a unique approach to achieve this. We continue to enroll our Phase 1 study of MRT-8102 and look forward to presenting initial data in healthy volunteers and elevated CVD-risk subjects in the first half of 2026.”

The poster, entitled, “Selective Degradation of NIMA-related kinase 7 (NEK7) via a Molecular Glue Degrader Inhibits IL-1 Downstream of NLRP3 Inflammasome Activation: A Novel Therapeutic Approach for Cardiovascular Inflammation” (Poster Number #Sa4063), will be displayed on Saturday, November 8, 2025 from 10:30 to 11:30 a.m. CST in a poster session entitled, “Novel Cellular Stress Sensors in Cardiovascular Pathology: Metabolic, Mechanical, and Immune Interactions.” The poster will be presented by Daric Wible, Ph.D., Senior Scientist II, Biology, Monte Rosa Therapeutics.

Summary of key findings:

• MRT-8102 is a selective, potent, and durable NEK7 degrader. Activation of the NLRP3 inflammasome critically depends on NEK7.
• Administration of MRT-8102 led to inhibition of NLRP3 inflammasome in vitro and in vivo and subsequently inhibited production of multiple inflammatory cytokines.
• In in vitro assays, MRT-8102 inhibited pyroptotic membrane permeabilization in stimulated human monocyte-derived macrophages (hMDM), unlike anti-IL-1 and anti-IL-6 therapies. Additionally, only MRT-8102 inhibited release of multiple cytokines from stimulated hMDM.
• In vitro, NEK7 degradation inhibited cholesterol crystal-induced NLRP3 inflammasome activation, a key driver of atherosclerotic plaque pathogenesis, more potently than selnoflast, an NLRP3 inhibitor currently in development.
• In a mouse peritonitis model, MRT-8102 led to potent inhibition of the cytokines IL-1β, IL-1α, IL-6, and TNF in peritoneal lavage.
• MRT-8102 demonstrated near-complete suppression of IL-1β and Caspase-1 activity in ex vivo-stimulated whole blood from orally dosed cynomolgus monkeys.
• Degrading NEK7 to modulate the inflammasome represents a novel and differentiated approach with potential therapeutic application in multiple cardiovascular and cardiometabolic diseases, including pericarditis and atherosclerosis.

About MRT-8102
MRT-8102 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader (MGD) that targets NEK7 for the treatment of inflammatory diseases linked to NLRP3, IL-1β, and IL-6 dysregulation. NEK7 has been shown to be required for NLRP3 inflammasome assembly, activation and IL-1β release both in vitro and in vivo. Aberrant NLRP3 inflammasome activation and the subsequent release of active IL-1β and interleukin-18 (IL-18) has been implicated in multiple inflammatory disorders, including cardiovascular disease, gout, osteoarthritis, neurologic disorders including Parkinson’s disease and Alzheimer’s disease, and metabolic disorders. In a non-human primate model, MRT-8102 was shown to potently, selectively, and durably degrade NEK7, and resulted in near-complete reductions of IL-1β and caspase-1 following ex vivo stimulation of whole blood. MRT-8102 has demonstrated a considerable safety margin (>200-fold exposure margin over projected human efficacious dose) in GLP toxicology studies. MRT-8102 is currently being investigated in a Phase 1 study (clinicaltrials.gov identifier NCT07119125) in healthy participants and participants at elevated cardiovascular disease risk.

About Monte Rosa
Monte Rosa Therapeutics is a clinical-stage biotechnology company developing highly selective molecular glue degrader (MGD) medicines for patients living with serious diseases. MGDs are small molecule protein degraders that have the potential to treat many diseases that other modalities, including other degraders, cannot. Monte Rosa’s QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates) discovery engine combines AI-guided chemistry, diverse chemical libraries, structural biology, and proteomics to rationally design MGDs with unprecedented selectivity. Monte Rosa has developed the industry’s leading pipeline of first-in-class and only-in-class MGDs, spanning autoimmune and inflammatory diseases, oncology, and beyond, with three programs in the clinic. Monte Rosa has ongoing collaborations with leading pharmaceutical companies in the areas of immunology, oncology and neurology. For more information, visit www.monterosatx.com.

Forward-Looking Statements
This communication includes express and implied “forward-looking statements,” including forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts and in some cases, can be identified by terms such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements contained herein include, but are not limited to, statements around the potential of the Company’s NEK7-directed MGD, referred to as MRT-8102, to address inflammatory diseases driven by the NLRP3 inflammasome, including cardiovascular disease and cardiometabolic disease, including pericarditis and atherosclerosis, the Company’s belief that MRT-8102 could offer a differentiated approach to treating multiple inflammatory diseases based on the potency, selectivity, and durable pharmacodynamics seen in its preclinical studies, the Company’s belief in the potential for MRT-8102 to treat cardiovascular disease by blocking cholesterol crystal-induced cardiovascular inflammation characterized by pyroptosis and cytokine release that leads to atherosclerotic plaque pathogenesis, our expectations for the continuing advancement of our Phase 1 study and the timing thereof, including updates related to status, safety data, pharmacokinetics, NEK7 protein degradation, and key downstream pharmacodynamic markers and the timing of any clinical data read-outs, including the potential readout of initial data in healthy volunteers and elevated CVD-risk subjects expected in the first half of 2026, as well as our expectations of success for our programs, including for MRT-8102, among others. By their nature, these statements are subject to numerous risks and uncertainties, including those risks and uncertainties set forth in our most recent Annual Report on Form 10-K for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission on March 20, 2025, and any subsequent filings, that could cause actual results, performance or achievement to differ materially and adversely from those anticipated or implied in the statements. You should not rely upon forward-looking statements as predictions of future events. Although our management believes that the expectations reflected in our statements are reasonable, we cannot guarantee that the future results, performance, or events and circumstances described in the forward-looking statements will be achieved or occur. Recipients are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date such statements are made and should not be construed as statements of fact. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, any future presentations, or otherwise, except as required by applicable law. Certain information contained in these materials and any statements made orally during any presentation of these materials that relate to the materials or are based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party studies, publications, surveys and other data to be reliable as of the date of these materials, we have not independently verified, and make no representations as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, no independent source has evaluated the reasonableness or accuracy of our internal estimates or research and no reliance should be made on any information or statements made in these materials relating to or based on such internal estimates and research.

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Tenaya Therapeutics Presents Promising Interim Clinical Data from MYPEAK™-1 Phase 1b/2a Clinical Trial of TN-201 Gene Therapy for the Treatment of MYBPC3-Associated Hypertrophic Cardiomyopathy




Tenaya Therapeutics Presents Promising Interim Clinical Data from MYPEAK™-1 Phase 1b/2a Clinical Trial of TN-201 Gene Therapy for the Treatment of MYBPC3-Associated Hypertrophic Cardiomyopathy

MyPEAK-1 Data Presented During Late-Breaking Session at AHA Scientific Sessions 2025 with Simultaneous Publication in Cardiovascular Research

TN-201 Has Been Generally Well Tolerated at Both Doses

Longer-term Follow Up of Cohort 1 Patients Showed Consistent, Deeper, and Durable Improvement in Measures of Hypertrophy

Initial Cohort 2 Data Demonstrated Early Dose Responsive Increases in TN-201 Transduction and MyBP-C Protein Expression

Tenaya Management to Host Webcast Call for Analysts and Investors on Monday, November 10 at 8:00 a.m. EST

NEW ORLEANS and SOUTH SAN FRANCISCO, Calif., Nov. 08, 2025 (GLOBE NEWSWIRE) — Tenaya Therapeutics, Inc. (NASDAQ: TNYA) announced that new interim safety and efficacy data from the company’s MyPEAK™-1 Phase 1b/2a clinical trial of TN-201 were presented today during the Late-Breaking Science: Main Event session at the American Heart Association’s (AHA) Scientific Sessions 2025 by Milind Desai, M.D., MBA, director of the Hypertrophic Cardiomyopathy Center at Cleveland Clinic and vice chair of Cleveland Clinic’s Heart, Vascular & Thoracic Institute. These data, which included longer-term follow-up results for three patients dosed with TN-201 gene therapy at a dose of 3E13vg/kg (Cohort 1) and initial results for three patients who received TN-201 at a dose of 6E13 vg/kg (Cohort 2) were simultaneously published in Cardiovascular Research.

TN-201 is being developed for the potential treatment of MYBPC3-associated hypertrophic cardiomyopathy (HCM), a condition caused by insufficient levels of myosin-binding protein C (MyBP-C). Single administration of TN-201 gene therapy was generally well-tolerated at both the 3E13 vg/kg and 6E13 vg/kg dose levels and immunogenicity was well managed through monitoring and individualized tapering of immunosuppressives. TN-201 achieved robust transduction and durable expression with early dose-dependent increase in both transduction and MyBP-C protein expression. Among Cohort 1 patients for whom there was greater than one year of follow up, decreases in circulating biomarkers and reductions in measures of left ventricular hypertrophy deepened over time.

“These initial results are promising for a patient population that too often live with difficult, even dangerous, symptoms,” said Dr. Desai, an investigator for the MyPeak-1 Phase 1b/2a clinical trial. “In the past decade, we’ve made great progress in understanding and treating hypertrophic cardiomyopathy, and as our understanding of the genetic underpinnings of HCM increases, research into gene therapies such as TN-201 offer the opportunity to further advance and improve patient care.”

“Results of TN-201 treatment are in line with our expectations for this stage of trial, with a manageable safety profile and dose-dependent MyBP-C protein level increases over time. In particular, the durable changes in multiple parameters of disease – biomarkers, hypertrophy and heart failure symptoms – all moving with directional consistency toward normalization after a single dose are an encouraging early signal of TN-201’s activity,” said Whit Tingley, M.D., Ph.D., Tenaya’s Chief Medical Officer. “We look forward to building on these data with continued long-term follow-up of Cohort 1 and the maturation of early results for Cohort 2, which will inform our plans for TN-201’s late-stage development.”

Interim results from the MyPEAK-1 Phase 1b/2a Clinical Trial
Data reported today includes safety, biopsy and leading indicators of efficacy for the three patients enrolled in Cohort 1 with follow-up ranging from Week 52-78, and safety for the three patients in Cohort 2, Week 12 biopsy for Patient 6 and Week 26 assessments for Patient 4 as of the July 2025 data cut off. Patient 5 was lost to further follow-up after week 12. All patients other than Patient 5 have completed every visit and remain on study.

• All patients enrolled in MyPEAK-1 had serious burden of disease at baseline.
  • All six had objectively severe nonobstructive HCM with levels of hypertrophy significantly above average for people with HCM
  • All six were at sufficiently high risk of sudden cardiac death to warrant an implantable cardiac defibrillator (ICD) device
  • All experienced mild-to-moderate symptoms of heart failure that interfered in activities of daily living (New York Heart Association, or NYHA, Class II-III)
  • Four of the six have previously undergone surgical myectomy
• Safety data for all six patients in Cohorts 1 and 2 showed that TN-201 was generally well tolerated at both the 3E13 vg/kg and 6E13 vg/kg doses. No dose-limiting toxicities were observed and all patients have tapered off immunosuppressive medicines.
  • Reversible, asymptomatic liver enzyme elevations (Grade 1-3) were the most common treatment-related adverse events (AEs) reported
  • There were no signs of cardiotoxicities, including no declines in left ventricular ejection fraction, clinical myocarditis or ventricular arrhythmias
  • There were two treatment-related AEs classified as serious due to inpatient treatment or monitoring: a Cohort 1 patient with Grade 2 transaminase elevation that responded to steroids and a Cohort 2 patient with Grade 1 elevation of complement factors that resolved without additional intervention
  • Adjustments to monitoring and immunosuppression during Cohort 1 resulted in faster tapers and lower cumulative corticosteroid doses in Cohort 2, despite the higher TN-201 dose
• MyBP-C protein levels increased over time, with early evidence of a substantial increase commensurate with higher dose in Cohort 2. TN-201 DNA transduction and TN-201 mRNA expression following similar dose response.
  • Tenaya reported that TN-201 transduction and TN-201 mRNA expression were robust. All three patients in Cohort 1 demonstrated sustained presence of TN-201 DNA in the heart and mRNA expression that increased over time, supporting the observed increases in MyBP-C level changes.
  • In Cohort 1 patients, protein levels increased by an average of 4% from the first biopsy taken to Week 52. In Patient 3, the first patient for whom baseline biopsies were available, MyBP-C protein was shown to increase by 5% at Week 52.
  • The first evaluable patient in Cohort 2 (Patient 6) demonstrated a clear dose response, and early MyBP-C expression increased by 14% after only 12 weeks post-dose. Of note, Patient 6 had a greater than 2-fold increase in transduction and expression at Week 12 relative to the averages for these measures observed across Cohort 1.

• Multiple parameters, including biomarkers, hypertrophy, heart failure symptoms, associated with increased risks of complications or reduced survival, have improved among a majority of patients with greater than 26 weeks of follow-up.
  • Cardiac Troponin I levels declined significantly (48%-74%) to normal or near-normal levels in all Cohort 1 patients. Cardiac troponin I is a predictive risk factor of cardiac AEs such as ventricular arrhythmias, sudden cardiac death, and progression to end-stage heart failure.⁽¹⁾
  • NT-proBNP, a biomarker of cardiac muscle strain, improved or remained stable in two of three Cohort 1 patients
  • Cardiac Troponin I remained within the normal range and NT-proBNP remained stable for Patient 4 from Cohort 2 at their 26-Week assessment
  • All three patients in Cohort 1 now have evidence of significant improvement in one or more measures of hypertrophy at Week 52, including notable reductions in left ventricular posterior wall thickness (LVPWT) of between 21% and 39%. LVPWT for Patient 4 in Cohort 2 was stable at Week 26. Greater LVPWT is an independent risk factor for reduced long-term survival after septal myectomy.⁽²⁾
  • Two out of three Cohort 1 patients saw reductions in overall left ventricular mass index (LVMI) of between 12% and 22% at Week 52. LVMI for Patient 4 in Cohort 2 was stable at Week 26
  • NYHA classification, a measure of the impact of heart failure symptoms on activities of daily living, improved in all patients by at least one class by Week 26, and all Cohort 1 patients are now NYHA Class I (asymptomatic).

While the interim results from MyPEAK-1 are promising, longer-term follow-up for all patients is required to further inform Tenaya’s understanding of TN-201’s potential as a treatment for MYBPC3-associated HCM. Tenaya plans to periodically report additional results from longer-term follow-up. These interim data were presented during the “Forgotten No More: The Current Belle of the Ball? Breakthrough Evolutions in Hypertrophic Cardiomyopathy” Late-Breaking Science: Main Event session during AHA 2025 and were published simultaneously in an article titled “First-in-human study of AAV9:MYBPC3 gene replacement therapy (TN-201) in hypertrophic cardiomyopathy: Initial safety, pharmacodynamic, and imaging results from MyPEAK-1” in Cardiovascular Research.

Conference Call and Webcast
Tenaya management will host a conference call on Monday, November 10, 2025, at 8:00 a.m. ET/5:00 a.m. PT to discuss the TN-201 data presented and published today and the status of the MyPEAK-1 clinical trial.  The webcast conference call, including an accompanying slide presentation, can be accessed from the Investor section on the “Events and Presentations” page of the Tenaya website at www.tenayatherapeutics.com.

About the MyPEAK-1 Phase 1b/2a Clinical Trial
The MyPEAK-1 Phase 1b/2 clinical trial (Clinicaltrials.gov ID: NCT05836259) is a multi-center, open-label, dose-escalating (3E13 vg/kg and 6E13 vg/kg) study of symptomatic adults (up to 24) who have been diagnosed with MYBPC3-associated HCM. MyPEAK-1 is designed to assess the safety, tolerability and clinical efficacy of a one-time intravenous infusion of TN-201 gene replacement therapy. MyPEAK-1 has tested doses of 3E13 vg/kg and 6E13 vg/kg in two cohorts of three patients each. On July 30, 2025, Tenaya reported that the trial’s independent Data Safety Monitoring Board (DSMB) concluded that TN-201 had an acceptable safety profile to allow enrollment of expansion cohorts at either the 3E13 vg/kg (Cohort 1) or 6E13 vg/kg (Cohort 2) dose levels. On November 7, 2025, Tenaya announced the FDA placed MyPEAK-1 on a clinical hold. Tenaya is working with the FDA to address the agency’s concerns through an amendment to the trial protocol.

To learn more about gene therapy for HCM and participation in the MyPEAK-1 study, please visit HCMStudies.com.

About MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM)
Variants in the Myosin Binding Protein C3 (MYBPC3) gene are the most common genetic cause of hypertrophic cardiomyopathy (HCM), accounting for approximately 20% of the overall HCM population, or 120,000 patients, in the United States alone. MYBPC3-associated HCM is a severe and progressive condition affecting adults, teens, children and infants. Mutations of the MYBPC3 gene result in insufficient expression of a protein, called MyBP-C, needed to regulate heart contraction. The heart becomes hypercontractile and the left ventricle thickens, resulting in symptoms such as chest pain, shortness of breath, palpitations and fainting. Patients whose disease is caused by MYBPC3 mutations are more likely than those with non-genetic forms of HCM to experience earlier disease onset and have high rates of serious outcomes, including heart failure symptoms, arrhythmias, stroke and sudden cardiac arrest or death. There are currently no approved therapeutics that address the underlying genetic cause of HCM.

About TN-201
TN-201 is an adeno-associated virus serotype 9 (AAV9)-based gene therapy designed address the underlying cause of MYBPC3-associated hypertrophic cardiomyopathy (HCM) by delivering a working MYBPC3 gene to heart muscle cells via a single intravenous infusion and thereby increasing insufficient MyBP-C protein levels with the aim of halting or even reversing disease after a single dose. The U.S. Food and Drug Administration has granted TN-201 Fast Track, Orphan Drug and Rare Pediatric Drug Designations. TN-201 has also received orphan medicinal product designation from the European Commission.

About Tenaya Therapeutics
Tenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Tenaya’s pipeline includes clinical-stage candidates TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM) and TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC). Tenaya has employed a suite of integrated internal capabilities, including modality agnostic target validation, capsid engineering and manufacturing, to generate a portfolio of novel medicines based on genetic insights, including TN-301, a clinical-stage small molecule HDAC6 inhibitor for the potential treatment of heart failure and related cardio/muscular disease, and multiple early-stage programs in preclinical development aimed at the treatment of both rare genetic disorders and more prevalent heart conditions. For more information, visit www.tenayatherapeutics.com.

      (1)   Kubo, et al, Journal Am Coll Cardiol, 2013
      (2)   Schaff, et al, JACC Heart Failure, 2022

Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Words such as “promising,” “opportunity,” “expectations,” “encouraging,” “look forward,” “will,” “potential,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, the clinical, therapeutic and commercial potential of, and expectations regarding, TN-201 as a treatment for MYBPC3-associated HCM; the potential for additional MyPEAK-1 data to inform plans for TN-201’s late stage development; statements regarding the continued development of TN-201, clinical hold, anticipated timelines, TN-201 clinical outcomes and risk/benefit profile, which may materially change as more patient data become available and statements made by Tenaya’s Chief Medical Officer and the investigator for MyPEAK-1. The forward-looking statements contained herein are based upon Tenaya’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: the expected timing and outcome of Tenaya’s regulatory interactions related to the clinical hold on MyPEAK-1; the timing and availability of MyPEAK-1 data; the potential progress of MyPEAK-1; the potential failure of TN-201 to demonstrate safety and/or efficacy in clinical testing; the potential for any MyPEAK-1 clinical trial results to differ from preclinical, interim, preliminary or expected results; the potential for the FDA and/or other regulatory agencies to conclude at any time that TN-201 may not have an appropriate risk/benefit profile; Tenaya’s ability to enroll and maintain patients in clinical trials, including MyPEAK-1; risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early stage company; Tenaya’s continuing compliance with applicable legal and regulatory requirements; Tenaya’s ability to raise any additional funding it will need to continue to pursue its product development plans; Tenaya’s reliance on third parties; Tenaya’s manufacturing, commercialization and marketing capabilities and strategy; the loss of key scientific or management personnel; competition in the industry in which Tenaya operates; Tenaya’s ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section titled “Risk Factors” in Tenaya’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2025, and other documents that Tenaya files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Tenaya assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Tenaya Contacts
Michelle Corral
VP, Corporate Communications and Investor Relations
IR@tenayathera.com

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Precision AQ
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Ten Bridge Communications
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Judo Bio’s Megalin-STRIKERs Achieve First Demonstration of Functional Pharmacodynamic Effects from Kidney Selective Gene Silencing in Non-Human Primates




Judo Bio’s Megalin-STRIKERs Achieve First Demonstration of Functional Pharmacodynamic Effects from Kidney Selective Gene Silencing in Non-Human Primates

Data presented at Kidney Week 2025 showed single subcutaneous administration of megalin-STRIKERs resulted in increased excretion of disease-related solute levels lasting for at least 2 months  

Dr. Ravi Thadhani, internationally recognized nephrology leader, joins Judo Bio Advisory Board

CAMBRIDGE, Mass., Nov. 08, 2025 (GLOBE NEWSWIRE) — Judo Bio, a biotechnology company pioneering oligonucleotide medicines delivery to the kidney, today announced the presentation of data in non-human primates showing the first demonstration of a functional effect of its megalin-STRIKER on disease-related solute excretion in the kidney, consistent with target gene silencing by an siRNA therapeutic. The data were presented at the American Society of Nephrology (ASN) Kidney Week 2025 taking place from November 5-9 in Houston, TX. 

Megalin-STRIKERs are ligand-siRNA conjugates that bind to megalin receptors on proximal tubular epithelial cells (PTECs) in the kidney, resulting in cell-specific uptake of oligonucleotide and subsequent gene silencing of the target mRNA. The data presented at ASN demonstrate selective distribution into the PTECs and an increase in the excretion of disease-related solute from the kidney, based on measurement in urine. These data provide translational evidence for developing these siRNA therapeutics for a range of systemic and renal diseases.

“We are excited to share the progress we’ve made in advancing our STRIKE platform, culminating in an important translational milestone — the demonstration of biological change consistent with target gene silencing by an siRNA therapeutic delivered to the kidney,” said Alfica Sehgal, PhD, Chief Scientific Officer of Judo Bio. “We have taken a deliberate, stepwise approach to building a robust and modular platform that enables broad therapeutic application and advancement of our first megalin-STRIKER into the clinic in the near future.”

The data presented by Judo Bio at ASN showed preclinical translation of megalin-STRIKERs from rodents to non-human primates, and from target gene silencing to functional pharmacodynamic effect. Key findings include:

• Megalin-STRIKERs distributed specifically to PTECs in the kidney across both species.
• In rodents, single administration of megalin-STRIKERs achieved approximately 70% target gene knockdown sustained for up to 2 months.
• In non-human primates, single administration of megalin-STRIKERs significantly increased the amount of excreted disease-related solute that lasted for 2 months post dose, based on measurement in urine.
• No adverse effects were observed in both mice and non-human primates, including no change in in hematology and serum chemistry parameters or elevations in markers of kidney injury.

Judo Bio’s ASN poster presentation is available here on the company’s website.

Dr. Ravi Thadhani joins Judo Bio Advisory Board

Judo Bio also announced that Ravi Thadhani, MD, MPH, an internationally recognized leader in nephrology, has joined the company’s Advisory Board. Dr. Thadhani is Executive Vice President of Clinical Affairs and Chief Medical Officer for Cedars-Sinai Medical Center and Cedars-Sinai Health System, and has recently been elected to the National Academy of Medicine.   

“We are thrilled to welcome Dr. Thadhani, whose extensive experience in nephrology, drug development, and regulatory affairs will help guide our transition toward a clinical-stage company.” said Rajiv Patni, MD, Chief Executive Officer of Judo Bio. “He joins us as we are presenting data to the nephrology community at ASN, showing our important translational progress that supports our plans to advance megalin-STRIKERs to the clinic.”

“Judo’s progress in building a novel approach to discover siRNA therapeutics targeted to the kidney and demonstrating potent and selective gene knockdown in specific kidney regions is impressive. It is exciting to be a part of a promising therapeutic approach that has the potential to impact the health and well-being of patients, and I am delighted to join the Judo team at a time when the company is on the cusp of advancing its initial drug candidates toward the clinic.”

Dr. Thadhani has more than 30 years of experience as a general and specialized internal medicine physician, a clinical and translational investigator, and a leader in life sciences and academia. Prior to his current role at Cedars-Sinai, Dr. Thadhani oversaw Emory University’s renowned academic health sciences enterprise which included 11 hospitals and top-tier schools of medicine, nursing, and public health. He serves as a member of the Cardiovascular and Renal Drugs Advisory Panel for the U.S. Food and Drug Administration (FDA). Previously, he worked at Mass General Brigham as chief academic officer and professor of medicine at Harvard Medical School. Thadhani was Chief of the Division of Nephrology at Mass General Hospital, and for more than 20 years he managed a research laboratory with a focus on kidney disease and on developing diagnostics and therapeutics for patients with preeclampsia. He is the recipient of numerous awards and honors. Dr. Thadhani earned his Doctor of Medicine degree from the University of Pennsylvania School of Medicine, his Master of Public Health degree from the Harvard T.H. Chan School of Public Health, and his bachelor’s degree from the University of Notre Dame.

About Judo Bio
Judo Bio is pioneering oligonucleotide medicines delivered to the kidney, opening the way for new genetic medicines for systemic and renal diseases. With its STRIKE (Selectively Targeting RNA Into KidnEy) platform, the company is using a proprietary approach to create ligand-RNA conjugate drugs designed for receptor-mediated uptake by specific kidney cell types, resulting in gene silencing of disease-modifying target genes. Judo Bio’s initial pipeline programs leverage megalin-STRIKERs to selectively deliver siRNA therapeutics to the proximal tubule of the kidney to silence mRNA expression of target proteins, thereby inhibiting the uptake of circulating solutes linked to systemic diseases. Located in Cambridge, MA, Judo Bio’s team, board and advisors include experts in oligonucleotide therapies and innovative drug development. For more information, visit www.judo.bio and follow us on LinkedIn.

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Jade Biosciences Presents New Data Demonstrating a Favorable Preclinical Safety Profile of JADE101 and a Translational Analysis of APRIL Mediated Biomarker Responses at the American Society of Nephrology Kidney Week 2025




Jade Biosciences Presents New Data Demonstrating a Favorable Preclinical Safety Profile of JADE101 and a Translational Analysis of APRIL Mediated Biomarker Responses at the American Society of Nephrology Kidney Week 2025

SAN FRANCISCO and VANCOUVER, British Columbia, Nov. 08, 2025 (GLOBE NEWSWIRE) — Jade Biosciences, Inc. (“the Company” or “Jade”), (Nasdaq: JBIO), a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases, today presented two posters for JADE101, its investigational anti-A PRoliferation-Inducing Ligand (APRIL) monoclonal antibody for the treatment of immunoglobulin A nephropathy (IgAN), at the American Society of Nephrology (ASN) Kidney Week 2025.

JADE101 is designed to selectively inhibit APRIL, a key driver of pathogenic IgA production in IgAN, a progressive autoimmune disease that frequently leads to end-stage kidney disease over a patient’s lifetime. Jade has engineered JADE101 with properties intended to capture the full efficacy of APRIL pathway inhibition while enabling patient-friendly subcutaneous dosing, supported by a differentiated pharmacokinetic and pharmacodynamic profile demonstrated in non-human primates (NHPs). JADE101 is currently being evaluated in a Phase 1 healthy volunteer trial, with interim data expected in the first half of 2026 that is anticipated to define the dose and dose interval for future studies in IgAN patients.

“We believe the selective anti-APRIL class will represent the foundational therapeutic approach for treatment of IgAN, and JADE101 has been specifically engineered to deliver the full potential of this mechanism,” said Andrew King, Ph.D., Chief Scientific Officer and Head of R&D at Jade Biosciences. “These new preclinical data in NHPs demonstrate that JADE101 is highly selective, is well tolerated at toxicological doses, and is not broadly immunosuppressive. Additionally, our translational modeling builds further confidence that biomarker responses observed in healthy volunteers are expected to translate into meaningful outcomes for patients with IgAN. Interim biomarker data from our ongoing Phase 1 healthy volunteer study are anticipated to define the dose and dosing interval selection for JADE101, with the goal of supporting rapid advancement into IgAN patient trials with a potentially best-in-class therapy.”

Nonclinical Safety Profile of JADE101 (Poster #SA-PO0255)

New preclinical safety data highlight JADE101’s favorable safety profile and support its potential as a selective, disease-modifying treatment with low risk of toxicity:

• JADE101 was well tolerated in NHPs at all doses tested preclinically, including the highest dose evaluated in GLP toxicology studies, which was established as the no observed adverse effect level (NOAEL). These results provide wide safety margins that support the first-in-human doses being evaluated in the ongoing Phase 1 healthy volunteer trial.
• Across studies, JADE101 showed no off-target binding in a panel of more than 6,000 human proteins, no human tissue cross-reactivity, and no cytokine release in human whole blood assays.
• In NHPs, JADE101 treatment resulted in reversible reductions in serum immunoglobulins consistent with its mechanism of action, including IgA and IgM reductions of approximately 55–68% and 62–75%, respectively, and a more modest IgG reduction of 35–48%, all of which returned toward baseline following JADE101 clearance.
• Despite reductions in circulating immunoglobulins, JADE101-treated NHPs generated antibody responses to a test immunization (KLH) that were comparable to untreated controls, consistent with the preserved vaccination response observed in healthy volunteers following administration of a previous anti-APRIL monoclonal antibody.
• JADE101 administration in NHPs did not impact serum concentrations of BAFF or inflammatory cytokines, resulted in no histological changes in tissues, and had no effect on circulating immune cell populations, including B, T, or NK cells – supporting its potential as a well-tolerated treatment, devoid of broad immune suppression.

Translational Modeling of Biomarker Responses to APRIL Inhibition (Poster #SA-PO0272)

A second presentation described a translational assessment of the consistency of biomarker responses to APRIL inhibition across NHPs, healthy volunteers and IgAN patients, and the associations between these biomarkers and clinical responses in IgAN. Biomarker responses to JADE101 in the ongoing healthy volunteer study are anticipated to define dose and dose interval selection for future clinical trials in IgAN patients:

• Analyses demonstrated that in vitro APRIL binding affinity is predictive of in vivo IgA-lowering potency across NHP and human data sets, supporting that high APRIL binding affinity results in potent IgA reduction in vivo in NHPs and humans.
• Clinical observations from healthy volunteers further demonstrate that high APRIL binding affinity is a key determinant of the magnitude and duration of free APRIL and IgA reduction at a given anti-APRIL dose level.
• Pharmacokinetic and free APRIL suppression profiles of anti-APRIL monoclonal antibodies were consistent between healthy volunteers and patients with IgAN, supporting the use of healthy volunteer PK and biomarker results for dose selection in IgAN patients.
• Trial level analyses indicate the kinetics and magnitude of IgA reduction is highly consistent between healthy volunteers and IgAN patients (r = 0.93), and that the reduction of Gd-IgA1 measured in IgAN patients is highly consistent with the reductions in total IgA (r = 0.96). Furthermore, the early IgA reduction observed in IgAN patients is predictive of subsequent proteinuria reduction (r = 0.89).
• The largest reductions in proteinuria and the highest rates of clinical remission (proteinuria < 0.3 g/day) in IgAN patients were observed with the highest levels of APRIL suppression.

These analyses suggest that pharmacokinetic and biomarker responses observed in healthy volunteers are informative of anticipated therapeutic responses in IgAN patients. The analysis also highlights that the depth and duration of APRIL suppression can be linked to anticipated reductions in total IgA, Gd-IgA1, and proteinuria that are ultimately associated with preserving kidney function and delivering disease-modifying clinical outcomes for patients with IgAN. Based on JADE101’s differentiated NHP pharmacokinetic profile, the Company anticipates the potential for convenient, infrequent, subcutaneous dosing.

About JADE101 

JADE101 is a novel, fully human monoclonal antibody that selectively blocks APRIL with ultra-high binding affinity and is engineered for half-life extension. Preclinical studies demonstrated potent, sustained IgA suppression after a single dose in non-human primates, with a serum half-life of approximately 27 days. JADE101 was designed to avoid formation of high molecular weight immune complexes, with the goal of supporting predictable pharmacokinetics and reduced immunogenicity risk. Its differentiated pharmacokinetic and pharmacodynamic profile supports the potential for infrequent and convenient subcutaneous dosing, an important consideration for a condition often diagnosed in young adulthood and potentially requiring life-long treatment. 

A Phase 1 randomized, double-blind, placebo-controlled clinical trial evaluating single ascending subcutaneous doses of JADE101 in healthy adult volunteers is ongoing. The Company expects data from the Phase 1 trial to define dose and dosing interval selection for later-stage studies, based on biomarker responses associated with optimal clinical activity in IgAN patients. More information on the JADE101 Phase 1 trial is available on ClinicalTrials.gov.

About Jade Biosciences, Inc.  
  
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy. Jade’s pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE-003, an undisclosed antibody discovery program, both currently in preclinical development.  Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit JadeBiosciences.com and follow the Company on LinkedIn.  
  
​​Forward-Looking Statements  
  
Certain statements in this communication, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the “safe harbor” provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Jade’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, the expected timeline for interim data from the Phase 1 clinical trial of JADE101, plans for future clinical trials, the potential for the anti-APRIL class to become the foundational therapeutic approach for treatment of patients with IgAN, the potential of JADE101 and Jade’s other product candidates to become best-in-class therapies and their potential therapeutic uses, efficacy, safety profiles and dosing. The words “opportunity,” “potential,” “milestones,” “pipeline,” “can,” “goal,” “strategy,” “target,” “anticipate,” “achieve,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “plan,” “possible,” “project,” “should,” “will,” “would” and similar expressions (including the negatives of these terms or variations of them) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Jade will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Jade’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks that the Phase 1 clinical trial of JADE101 and any future clinical trials may be delayed or may not demonstrate desirable efficacy; adverse events or safety signals may occur; Jade may experience unanticipated difficulties or delays in the product development process; Jade’s product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; enrollment or regulatory challenges; risks associated with Jade’s dependence on third-parties for the development, manufacture and supply of its product candidates; and the other risks, uncertainties and factors more fully described in Jade’s most recent filings with the Securities and Exchange Commission (including the Quarterly Report on Form 10-Q for the quarter ended June 30, 2025). Should one or more of these risks or uncertainties materialize, or should any of Jade’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. You should not place undue reliance on forward-looking statements in this communication, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Jade does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements. This communication does not purport to summarize all of the conditions, risks and other attributes of an investment in Jade.   

Jade Biosciences Contact  

Priyanka Shah  
Media@JadeBiosciences.com  
IR@JadeBiosciences.com  
908-447-6134  
  

MemoMaster Unveiled: How This Memo Master Cutting-Edge Brain Support Supplement Is Redefining Focus and Memory Health for the Digital Era




MemoMaster Unveiled: How This Memo Master Cutting-Edge Brain Support Supplement Is Redefining Focus and Memory Health for the Digital Era

Boost memory, focus & mental clarity with MemoMaster – a clinically inspired brain supplement for sharper thinking, sustained energy & long-term brain health.

New York, Nov. 08, 2025 (GLOBE NEWSWIRE) — Introduction

New York City, Nov. 08, 2025, In a significant development for the global cognitive health industry, MemoMaster, a newly formulated nootropic supplement, has been officially introduced to the U.S. market this quarter, aiming to reshape the standards of memory enhancement and brain performance. Backed by neuro-nutrition research and precision formulation, MemoMaster emerges as one of 2025’s most promising entrants in the natural brain support category, offering users a clinically inspired solution to maintain focus, recall, and long-term cognitive vitality.

What sets MemoMaster apart is its fusion of ancient botanical extracts and modern neuro-nutritional science. The formulation incorporates well-researched compounds such as Bacopa Monnieri, Ginkgo Biloba, Lion’s Mane Mushroom, and Phosphatidylserine—ingredients clinically associated with cognitive endurance, memory consolidation, and neural protection. Unlike synthetic stimulants that offer only short bursts of alertness, MemoMaster supports sustained clarity and mental energy through adaptive stress modulation and antioxidant support.

MemoMaster’s launch aligns with broader industry trends identified in 2025 reports by global wellness analysts, highlighting rapid growth in cognitive enhancement products among professionals, students, and aging adults. The formula’s stimulant-free approach, backed by quality manufacturing standards and scientific rationale, positions it as a safe, long-term cognitive companion for individuals seeking natural, data-driven brain performance support.

With this timely launch, MemoMaster is not only introducing a new product—it’s setting a benchmark for how natural supplements can integrate modern neuroscience with practical daily wellness, addressing the core challenges of focus, memory, and cognitive longevity in 2025’s fast-paced digital world.

Visit the Official Memo Master Website

What Is MemoMaster?

MemoMaster is a premium brain support supplement designed to enhance cognitive performance, memory recall, and mental clarity. Developed with a focus on scientific research and natural ingredients, MemoMaster provides a holistic solution for individuals facing cognitive fatigue, mental stress, or challenges in maintaining sustained focus throughout the day. Its formulation is crafted to support both short-term mental alertness and long-term brain health.

At the core of MemoMaster’s effectiveness is its carefully selected blend of natural compounds. Lion’s Mane Mushroom, known for stimulating nerve growth factor (NGF), supports neuron repair and promotes cognitive resilience. Bacopa Monnieri aids memory formation and retention, while Ginkgo Biloba improves cerebral blood flow, delivering oxygen and nutrients efficiently to the brain. Omega-3 DHA supports the structural integrity of brain cells, protecting them against oxidative stress and age-related decline. Rhodiola Rosea works as an adaptogen, reducing mental fatigue and maintaining energy balance under stressful conditions. Each of these ingredients has been chosen for its proven ability to enhance specific aspects of cognitive function.

MemoMaster operates through a synergistic approach, where each ingredient complements the other to optimize memory, focus, and overall brain performance. By enhancing neurotransmitter activity, promoting neuroplasticity, and protecting neurons from oxidative damage, Memo Master supports sharper thinking, quicker recall, and sustained attention. This multifaceted action ensures that users experience tangible cognitive benefits while supporting long-term mental wellness.

MemoMaster represents a proactive approach to brain health. It addresses the increasing demands of modern life by providing natural, science-backed support for cognitive performance. Whether for professionals, students, or adults looking to maintain peak mental function, MemoMaster offers a reliable, research-informed solution for enhancing focus, memory, and overall mental clarity, making it an essential addition to daily cognitive wellness routines.

Experience sustained mental energy and clarity – Visit the Official MemoMaster Website

How MemoMaster Works?

MemoMaster is designed to optimize brain performance through a scientifically formulated blend of natural ingredients that target key cognitive pathways. Unlike temporary stimulants that provide short-lived energy spikes, Memo Master addresses the underlying mechanisms of memory, focus, and mental clarity, ensuring sustainable cognitive support throughout the day. Its approach focuses on three primary areas: neuron health, neurotransmitter activity, and cerebral circulation.

The supplement includes Lion’s Mane Mushroom, a clinically studied ingredient that stimulates Nerve Growth Factor (NGF). NGF is essential for the repair, growth, and maintenance of neurons, which supports long-term cognitive health and improves memory formation. Bacopa Monnieri complements this effect by enhancing neurotransmitter function, facilitating faster information processing and more efficient memory recall. These ingredients work in tandem to improve mental sharpness, allowing users to retain and retrieve information more effectively.

Ginkgo Biloba, another core component, enhances cerebral blood flow, increasing the delivery of oxygen and nutrients to brain cells. Improved circulation supports alertness, concentration, and mental energy, particularly during periods of prolonged cognitive activity. Additionally, Omega-3 DHA nourishes neurons and protects them from oxidative stress, supporting structural integrity and cognitive resilience over time.

MemoMaster also incorporates adaptogenic support through Rhodiola Rosea, which helps regulate stress hormones and reduce mental fatigue. By maintaining a balanced stress response, Memo Master ensures sustained focus and energy, even under high-pressure conditions. Phosphatidylserine is included to enhance cell-to-cell communication within the brain, improving synaptic efficiency and overall cognitive performance.

The synergistic combination of these ingredients means that MemoMaster not only addresses immediate mental performance but also promotes long-term brain health. It enhances memory, supports concentration, reduces fatigue, and protects neurons from age-related decline. Each capsule delivers precise, research-backed doses to maximize effectiveness and ensure consistent cognitive support.

Manufactured in a GMP-certified facility in the United States, MemoMaster maintains strict quality control standards. Its clean-label formulation avoids artificial additives, stimulants, and fillers, making it a reliable daily supplement. Through its multifaceted action on neuron repair, neurotransmitter optimization, and cerebral circulation, Memo Master provides comprehensive brain support designed to keep the mind sharp, focused, and resilient.

Take control of your cognitive health – Visit the Official MemoMaster Website

Memo Master Supplement Key Ingredients

MemoMaster’s effectiveness is rooted in its carefully selected natural ingredients, each chosen for their clinically supported roles in promoting cognitive health. The formulation combines nootropics, adaptogens, and brain-boosting nutrients to enhance memory, focus, and mental clarity while supporting long-term brain function. Every ingredient is included at a research-backed dose to ensure optimal performance and reliability.

Bacopa Monnieri is a cornerstone of MemoMaster, known for its ability to enhance memory formation and recall. It supports neurotransmitter activity, particularly acetylcholine, which is essential for efficient information processing. Additionally, Bacopa Monnieri has antioxidant properties that help protect neurons from oxidative stress, contributing to long-term cognitive resilience.

Lion’s Mane Mushroom stimulates the production of Nerve Growth Factor (NGF), which plays a critical role in neuron repair and growth. By promoting neuroplasticity, Lion’s Mane supports the brain’s ability to adapt, form new connections, and retain information. This ingredient is key to supporting memory retention and cognitive sharpness over time.

Ginkgo Biloba enhances cerebral blood flow, ensuring that brain cells receive adequate oxygen and nutrients. This improved circulation boosts alertness, concentration, and mental energy, making it easier to maintain focus during demanding cognitive tasks. Ginkgo also provides neuroprotective effects, helping to safeguard neurons against environmental stressors and age-related decline.

Phosphatidylserine is essential for maintaining healthy cell membranes and optimizing communication between brain cells. Its inclusion in Memo Master supports faster information processing, sharper focus, and improved memory recall.

Rhodiola Rosea, an adaptogen, helps balance stress hormones and reduces mental fatigue, promoting sustained energy and concentration. It enhances the brain’s resilience to daily stressors, ensuring stable cognitive performance throughout the day.

Omega-3 DHA, a vital fatty acid, supports the structural integrity of brain cells, protects neurons from oxidative damage, and contributes to mood stability. Its neuroprotective benefits complement the overall formula, ensuring both immediate cognitive enhancement and long-term brain health.

Together, these ingredients create a synergistic formula designed to deliver measurable cognitive benefits. MemoMaster’s clean-label, stimulant-free formulation ensures safe and reliable use, making it an effective daily solution for memory support, focus, mental clarity, and long-term brain wellness.

MemoMaster Formula Benefits

MemoMaster is designed to deliver a comprehensive suite of cognitive benefits, targeting memory, focus, mental clarity, and overall brain health. Its scientifically formulated blend of natural ingredients works synergistically to address multiple aspects of cognitive performance, offering measurable enhancements for daily mental function.

The primary benefit of Memo Master is enhanced memory recall. Ingredients like Bacopa Monnieri and Phosphatidylserine support the formation and retrieval of memories by optimizing neurotransmitter activity. This ensures that information is processed efficiently and can be recalled quickly when needed, improving overall mental performance. Lion’s Mane Mushroom contributes to neuron growth and neuroplasticity, further enhancing the brain’s capacity to retain and recall information over time.

Memo Master also delivers improved focus and attention. Ginkgo Biloba increases blood flow to the brain, providing essential oxygen and nutrients to support alertness and sustained concentration. Rhodiola Rosea balances stress hormones and combats mental fatigue, helping users maintain consistent attention during demanding cognitive tasks. These combined effects result in sharper focus and heightened mental clarity throughout the day.

Another significant benefit is neuroprotection and long-term brain support. Omega-3 DHA and antioxidant-rich compounds protect neurons from oxidative stress and age-related decline, maintaining brain structure and function. This not only supports immediate cognitive performance but also contributes to long-term mental resilience and overall brain health.

MemoMaster also helps balance mood and mental energy. By supporting neurotransmitter function and reducing the impact of stress, the supplement helps maintain mental stability, ensuring users can think clearly, make decisions effectively, and perform at their best.

Finally, MemoMaster’s clean-label, stimulant-free formula ensures safe daily use without jitters or energy crashes. With consistent use, the supplement can help optimize memory, improve focus, reduce fatigue, and enhance mental clarity, providing a complete solution for modern cognitive demands.

Unlock sharper memory and laser-like focus with MemoMaster – the brain support supplement designed for modern life.

How to Use Memo Master

For optimal results, MemoMaster is recommended for daily use, following a simple, consistent routine. Ideally taken with a meal, provides the body and brain with precise doses of key ingredients to support memory, focus, and overall cognitive function. Daily supplementation ensures that the active compounds work cumulatively, enhancing both short-term mental performance and long-term brain health.

MemoMaster integrates seamlessly into a balanced lifestyle. Adequate hydration, proper nutrition, regular physical activity, and sufficient sleep complement the supplement’s effects, creating an environment for maximal cognitive efficiency. The formula is free from stimulants, fillers, or artificial additives, making it safe for long-term use without causing energy spikes or crashes.

Consistency is essential. Regular intake over weeks ensures that the brain receives ongoing support, allowing ingredients like Bacopa Monnieri, Lion’s Mane Mushroom, and Omega-3 DHA to strengthen neural pathways, support neuron growth, and enhance memory retention. Combining MemoMaster with stress management practices, such as mindfulness or light exercise, can further amplify its benefits.

While MemoMaster is designed for general adult use, consulting a healthcare professional is recommended for individuals with pre-existing medical conditions or those taking prescription medications. By following the recommended dosage and maintaining a healthy routine, MemoMaster can serve as a reliable and effective daily cognitive support solution, promoting sharper focus, improved memory recall, and sustained mental clarity.

Who Needs the MemoMaster Supplement?

MemoMaster is ideal for anyone looking to maintain and enhance their cognitive performance. Its formulation supports memory, focus, and mental clarity, making it suitable for a wide range of individuals facing different mental challenges.

Professionals in demanding work environments benefit from MemoMaster’s focus-enhancing properties, maintaining productivity and mental sharpness throughout long workdays. Its neuroprotective ingredients help reduce mental fatigue and sustain alertness during high-pressure tasks.

Students can use MemoMaster to improve memory retention, accelerate learning, and maintain concentration during study sessions or examinations. Bacopa Monnieri and Phosphatidylserine support efficient information processing, while Ginkgo Biloba enhances focus and attention span.

Adults experiencing age-related cognitive changes gain support for memory and long-term brain health. Omega-3 DHA and Lion’s Mane Mushroom contribute to neuron protection, repair, and growth, reducing the risk of cognitive decline.

MemoMaster is also suitable for any adult seeking enhanced mental clarity and sustained energy. Rhodiola Rosea balances stress hormones and reduces fatigue, making it easier to remain mentally agile in daily life.

By addressing memory, focus, and neuroprotection simultaneously, MemoMaster serves as a proactive solution for maintaining mental performance, supporting cognitive health, and promoting overall brain wellness, making it relevant for a broad audience in today’s cognitively demanding environment.

Pricing, Packages & Official Website – Where to Buy Memo Master Safely Online

MemoMaster is available exclusively through its official website to ensure authenticity, quality, and access to promotional offers. The supplement is offered in multiple packages to meet different user needs:

• Single Bottle: Ideal for first-time users looking to experience MemoMaster’s benefits without commitment.
• Multi-Bottle Packages: Offer significant cost savings and ensure uninterrupted daily supplementation for optimal results.

Purchasing directly from the official website guarantees product authenticity and access to a 90-day money-back guarantee, allowing users to try MemoMaster risk-free. All orders are fulfilled through secure payment processing, ensuring privacy and convenience.

The official website also provides guidance on recommended usage, detailed ingredient information, and additional resources for supporting cognitive health. By buying from authorized channels, users avoid counterfeit products and receive a formula that meets strict quality standards.

MemoMaster’s pricing structure and availability are designed to support long-term cognitive wellness, offering flexibility and value for those seeking sustained brain health support.

The Science or Technical Framework Behind Brain Health Supplements

MemoMaster formulation is based on extensive research into the biological mechanisms of cognition, memory, and neuronal health. Brain health depends on effective neurotransmission, optimal blood flow, neuron protection, and neuroplasticity.

• Neuroplasticity and Nerve Growth: Ingredients like Lion’s Mane Mushroom stimulate Nerve Growth Factor (NGF), enhancing neuron repair and synaptic connectivity.
• Neurotransmitter Optimization: Bacopa Monnieri and Phosphatidylserine support acetylcholine activity, essential for memory formation, learning, and recall.
• Cerebral Circulation: Ginkgo Biloba improves blood flow to the brain, ensuring that neurons receive oxygen and nutrients necessary for energy and focus.
• Oxidative Protection: Omega-3 DHA and antioxidant compounds protect neurons from oxidative stress, reducing age-related cognitive decline.
• Stress Regulation: Rhodiola Rosea modulates stress hormones, preventing fatigue and supporting sustained mental energy.

By addressing these critical pathways simultaneously, MemoMaster provides a comprehensive, science-backed framework for cognitive enhancement and long-term brain wellness.

Visit The Official MemoMaster Website To Read Customer Reviews About MemoMaster!

Why MemoMaster Is an Emerging Trend in 2025

MemoMaster is gaining attention in 2025 due to increasing awareness of cognitive health, mental wellness, and the effects of digital fatigue on brain performance. Its combination of natural, research-backed ingredients positions it as a reliable supplement for modern cognitive demands.

The trend toward preventive mental wellness highlights the importance of neuroprotection, memory support, and focus enhancement. MemoMaster aligns with this by offering a clean-label, stimulant-free formula, appealing to health-conscious individuals seeking effective, long-term brain support.

Its scientifically inspired approach, quality manufacturing standards, and comprehensive benefits make MemoMaster a standout solution, reflecting broader shifts toward natural, clinically validated cognitive supplements in 2025.

Final Verdict: MemoMaster

Memo Master is a clinically formulated brain support supplement that delivers measurable cognitive benefits, including improved memory recall, enhanced focus, sustained mental clarity, and long-term brain health protection. Its blend of natural nootropics, adaptogens, and nutrients targets multiple cognitive pathways, providing a reliable, safe, and effective solution for adults facing cognitive fatigue, stress, or age-related memory challenges.

Manufactured in a GMP-certified facility and free from artificial stimulants, MemoMaster ensures quality, safety, and consistent performance. With regular use, it supports both immediate mental performance and long-term neuroprotection, making it a proactive solution for maintaining peak cognitive function. For anyone seeking natural, science-backed support for memory, focus, and overall brain wellness, MemoMaster offers a comprehensive, high-quality option designed for daily use.

For more information on MemoMaster, educational content, and direct purchasing, visit the official MemoMaster website.

Company: MemoMaster
555 Republic Dr, Plano, Texas, 75074
Email: support@cartpanda.com
Phone Support: +1-866-637-2482
Website: https://memomaster.cloud/

Disclaimers

The information in this article is provided for general educational purposes only. MemoMaster is marketed as a dietary supplement, not as a prescription medication or medical treatment. It is not intended to diagnose, treat, cure, or prevent any disease. Individual results vary, and readers should consult with a licensed healthcare professional before starting Memo Master or any other supplement, especially if pregnant, nursing, under 18, have a medical condition, or are taking prescription medications.

Consumers are encouraged to use these official channels for customer service requests, refund inquiries, or product-related questions. For the most accurate details on current offers and guarantees, always refer to the official MemoMaster website.

This content is not financial, medical, or legal advice. Readers are responsible for making their own decisions based on official product information and consultation with qualified professionals.

Prices, packages, guarantees, and availability for Memo Master are subject to change at any time. For the most accurate, up-to-date details, consumers should visit the official MemoMaster website directly.

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Novo Nordisk will not increase its proposal to acquire Metsera, Inc. 




Novo Nordisk will not increase its proposal to acquire Metsera, Inc. 

Bagsværd, Denmark, 8 November 2025 – Novo Nordisk today confirms that it does not intend to make an increased offer to acquire Metsera. 

On 30 October 2025, Novo Nordisk announced the submission of an unsolicited proposal to acquire Metsera, Inc. (Metsera) which was declared superior by Metsera’s board of directors.  

On 4 November 2025, Novo Nordisk confirmed that it had submitted an updated unsolicited proposal to acquire Metsera price of 62.20 USD per share in cash (equal to an approximate aggregated equity value of 7.2 billion USD or approximate enterprise value of 6.7 billion USD) and contingent value rights (CVRs) for up to 24.00 USD per share in cash (or an approximate aggregated value of up to 2.8 billion USD) based on the achievement of certain clinical and regulatory milestones which was declared superior by Metsera’s board of directors.  

On 6 November 2025, Novo Nordisk submitted a revised unsolicited proposal at a price of 65.60 USD per share in cash (equal to an approximate aggregated equity value of 7.6 billion USD or approximate enterprise value of 7.1 billion USD) and contingent value rights (CVRs) for up to 20.65 USD per share in cash (or an approximate aggregated value of up to 2.4 billion USD) based on the achievement of certain clinical and regulatory milestones.

We believe that the structure of our potential merger agreement is compliant with antitrust laws. Following a competitive process and after careful consideration, Novo Nordisk will not increase its offer to acquire Metsera consistent with its commitment to financial discipline and shareholder value.  

Novo Nordisk is advancing a pipeline of diverse treatment options for obesity and continues to invest in its promising portfolio of next-generation assets, with the ambition of meeting the needs of millions of people living with diabetes, obesity and their associated comorbidities. It will continue to assess opportunities for business development and acquisitions that meet its criteria for returns and capital allocation and that further its strategic objectives.  

Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,500 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.

Contacts for further information

Attachment

• Investor News251108-Metsera-end

Fangzhou Awarded “Golden Bull Award” for Leadership in AI-Powered Chronic Disease Management




Fangzhou Awarded “Golden Bull Award” for Leadership in AI-Powered Chronic Disease Management

XIAMEN, China, Nov. 08, 2025 (GLOBE NEWSWIRE) — Fangzhou Inc. (“Fangzhou” or the “Company”) (HKEX: 06086), a leading provider of AI-driven Internet healthcare solutions, was recognized with the “Social Responsibility Golden Bull Award” at the 2025 Xiamen Industry Development Conference and Listed Companies (Hong Kong) Golden Bull Awards Ceremony, organized by China Securities Journal.

The conference brought together corporate leaders and investors to discuss how Hong Kong-listed enterprises can leverage innovation and governance to achieve sustainable global growth. This year marked the inaugural edition of the Golden Bull Awards for Hong Kong-listed companies.

Fangzhou was recognized with the “Social Responsibility Golden Bull Award”

Fangzhou distinguished itself among the field of Hong Kong-listed companies to receive the honor, demonstrating not only strong revenue growth and solid profitability, but also leadership in technological innovation and sustained social value creation. The award underscores growing confidence in the company’s “AI + chronic disease management” strategy — a high-growth and high-impact field that is reshaping China’s digital healthcare landscape.

Dr. Xie Fangmin, Founder, Chairman and CEO of Fangzhou, remarked: “We are honored to receive the award and will continue to advance AI-driven chronic disease management and deliver lasting benefits for public health.”

The award comes as China’s National Health Commission recently released policy guidance promoting the application of “AI + Healthcare” as a key national development priority. In line with this direction, Fangzhou has built an AI + H2H (Hospital-to-Home) ecosystem that integrates its proprietary XJ LLM and XS LLM to enhance precision, efficiency, and accessibility in chronic disease management.

In April of this year, Fangzhou and the Guangdong Provincial Institute of Liver Disease jointly established the “AI + Hepatitis Prevention and Control Training Center” to enhance liver disease management through AI technology. In June, the Company joined a rural revitalization initiative led by the Guangdong Communications Administration, advancing digital healthcare infrastructure in rural areas. And more recently in October, Fangzhou launched the “AI + Psoriasis Management New Horizons” public education week, leveraging AI to expand the reach and enhance the quality of health awareness campaigns.

Fangzhou has also let efforts in responsible AI governance, becoming the first Internet healthcare enterprise to join the “Human-Centered AI Development and Governance Initiative” this past July, contributing to high-level policy dialogue on AI–Internet integration. In October, the Company’s XJ LLM received official national registration, highlighting Fangzhou’s commitment to regulatory compliance, and establishing best practices across the medical AI field.

The Company continues to strengthen its leadership position in “AI + weight management”, working with the China Food and Drug Institutions Quality and Safety Promotion Association to develop national standards for AI-enabled weight management. Fangzhou also deepened its strategic collaboration with global pharmaceutical leader Novo Nordisk to jointly develop a digital intelligence ecosystem, combining medical expertise with AI-driven insights to advance the quality and accessibility of chronic disease management across China.

Looking ahead, Fangzhou will continue to build on its leadership as a leading Internet healthcare enterprise, advancing AI-powered chronic disease management while driving forward the industry’s development.

About China Securities Journal Golden Bull Awards
Established by China Securities Journal and approved by national authorities, the Golden Bull Awards are recognized for their rigorous, transparent evaluation system and have become one of China’s most authoritative platforms for fostering positive interaction between industry and capital markets.

About Fangzhou Inc.
Fangzhou Inc. (HKEX: 06086) is China’s leading online chronic disease management platform, serving 52.8 million registered users and 229,000 physicians (as of June 30, 2025). The Company specializes in delivering tailored medical care and AI-enabled precision medicine solutions. For more information, visit https://investors.jianke.com.

Media Contact
For further inquiries or interviews, please reach out to:
Xingwei Zhao Associate Director of Public Relations Email: pr@jianke.com

Disclaimer: This press release contains forward-looking statements. Actual results may differ materially from those anticipated due to various factors. Readers are cautioned not to place undue reliance on these statements

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0e287d87-2e8c-48dd-89d8-66a52c319d55