CORRECTING and REPLACING Faeth Therapeutics’ $92 Million Total Funding Powers PIKTOR Phase 2 Following 80% Response Rate in Endometrial Cancer




CORRECTING and REPLACING Faeth Therapeutics’ $92 Million Total Funding Powers PIKTOR Phase 2 Following 80% Response Rate in Endometrial Cancer

New $25 million raise advances multi-node PI3K program; randomized phase 2 trial with Gynecologic Oncology Group Foundation now enrolling

AUSTIN, Texas–(BUSINESS WIRE)–In the first paragraph and the About Faeth Therapeutics boilerplate of release issued Oct. 20, 2025, investor name should read B Group Capital (instead of B Capital Group).

The updated release reads:

FAETH THERAPEUTICS’ $92 MILLION TOTAL FUNDING POWERS PIKTOR PHASE 2 FOLLOWING 80% RESPONSE RATE IN ENDOMETRIAL CANCER

New $25 million raise advances multi-node PI3K program; randomized phase 2 trial with Gynecologic Oncology Group Foundation now enrolling

Faeth Therapeutics, a clinical-stage biotechnology company advancing therapies that systematically target tumor metabolism, today announced the advancement of its lead PIKTOR regimen in endometrial cancer and a $25 million strategic raise, bringing total capital raised to $92 million. The financing was led by S2G Investments with participation from existing investors Khosla Ventures, Future Ventures, Digitalis Ventures, KdT Ventures and Cantos, plus new investors B Group Capital, Avicella and THO Seed Fund. Clinical data from sapanisertib in combination with paclitaxel, one component of the PIKTOR regimen, have been selected for a late-breaking oral presentation at the ESMO 2025 Congress.

Faeth’s phase 1b study of serabelisib + sapanisertib (“PIKTOR”) with paclitaxel demonstrated an 80% overall response rate in endometrial cancer patients, with a median progression-free survival of 11 months versus historical 3-4 months with chemotherapy alone. The strength of these results led the Gynecologic Oncology Group (GOG) Foundation, one of the premier U.S. clinical trial networks, to initiate a phase 2 trial (GOG-3111; NCT06463028), now enrolling patients. The study also includes a predefined substudy testing whether protocolized insulin control under trial conditions through precision nutrition enhances clinical outcomes.

Endometrial cancer is one of the highest-need solid tumors and illustrates how Faeth’s approach can change outcomes in diseases where PI3K/AKT/mTOR are implicated. This signaling axis is among the most frequently altered across solid tumors, including endometrial, breast, lung, and ovarian. Current single-node inhibitors often fail due to feedback reactivation and mutations elsewhere in the pathway that limit durability. These inhibitors can only target a small fraction of patients with pathway mutations.

Faeth’s approach is different: it delivers selective multi-node inhibition at PI3Kα, mTORC1, and mTORC2 while controlling the nutrient supply tumors depend on. Multi-node inhibition of the PI3K/AKT/mTOR pathway has already shown clinical benefit in phase 3 studies, confirming the value of pathway-level control in both mutant and wild-type tumors. Faeth’s selective approach builds on this validation while targeting specific nodes to improve the therapeutic window compared to pan-pathway inhibitors, offering less toxic, more convenient treatment options. In preclinical models, this multi-node approach achieved more complete pathway shutdown than single-agent inhibition.

“We’ve achieved the optimal balance in PI3K pathway inhibition, comprehensive enough to prevent resistance, selective enough to avoid immunosuppression,” said Anand Parikh, CEO of Faeth Therapeutics. “The 80% response rate, 11-month progression-free survival, initiation of a trial by the GOG Foundation, and recognition as a late-breaking oral presentation at ESMO show that Faeth is executing as a clinical-stage company positioned to expand across the solid tumors where PI3K alterations drive disease.”

“I believe recent phase 3 studies are showing validation of multi-node targeting,” said S2G Managing Partner Sanjeev Krishnan. “In my view, insider participation in this financing reflects conviction in Faeth’s progress, while new investors recognize metabolism as a category entering the clinic. Based on emerging evidence, Faeth’s selective multi-node approach appears well suited to capture value as metabolism gains recognition as a potential new pillar of cancer treatment.”

The $25 million will advance the phase 2 endometrial cancer program through a full data readout in Q3 2026 and expand throughput for the company’s MetabOS™ platform. The financing also supports a phase 1 study in locally advanced rectal cancer for Faeth’s non-essential amino acid restricted program and initiation of Faeth’s first non-oncology program in Hereditary Tyrosinemia Type 1 (HT1), a rare pediatric metabolic disorder, with IND-enabling studies targeting Q4 2026 clinical entry.

Beyond blocking growth signals, Faeth’s approach recognizes that tumors have significantly elevated metabolic demands and require specific nutrients to survive. The MetabOS platform integrates genomic, gene expression, and tumor microenvironment data to identify metabolic dependencies and exploit them clinically. Funding will expand MetabOS throughput, enabling Faeth to simulate and validate more regimens designed to address metabolic escape.

“If the cell is the unit of life, then metabolism is the first verb in its sentence,” said Siddhartha Mukherjee, co-founder of Faeth Therapeutics. “Faeth is intervening where cellular decisions are made fastest: at the metabolic switches tumors rely on to adapt, long before mutations accumulate. That is why metabolism is emerging alongside the genome and immunogenicity as a therapeutic discipline.”

In addition to its oncology programs, Faeth has initiated translational work to treat HT1, an ultra-rare disorder affecting 1 in 100,000 births, where toxic metabolites accumulate due to an enzyme deficiency. While current treatment prevents liver failure, patients still face unmet medical needs. The company is applying MetabOS to develop metabolic therapeutic approaches for this condition. This program is the first demonstration of MetabOS applied outside of oncology and establishes the platform’s ability to identify and address metabolic dependencies across diseases.

About Faeth Therapeutics

Faeth Therapeutics is a clinical-stage biotechnology company developing multi-node therapies that block cancer growth signals while controlling tumor fuel supply, leveraging its AI-driven MetabOS™ platform to identify and exploit metabolic dependencies. In addition to advancing multiple solid-tumor studies, Faeth is advancing a translational program in Hereditary Tyrosinemia Type 1 (HT1), the first example of how its approach can extend beyond oncology into rare diseases. Founded in 2019 by leading researchers including Lewis Cantley, PhD, Siddhartha Mukherjee, MD, DPhil, Karen Vousden, PhD, Scott Lowe, PhD, and Greg Hannon, PhD, the company has raised $92 million from S2G Investments, Khosla Ventures, Future Ventures, Digitalis Ventures, KdT Ventures, Cantos, Avicella, THO Seed Fund, and B Group Capital. For more information, visit faeththerapeutics.com.

Contacts

Media Contact

Patrick Schmidt
faeththerapeutics@consortpartners.com

Investor Contact

Stephanie.ascher@precisionaq.com

Successful Patient Outcomes Demonstrated With Edwards’ SAPIEN M3 and EVOQUE Systems, New Data Presented at TCT 2025




Successful Patient Outcomes Demonstrated With Edwards’ SAPIEN M3 and EVOQUE Systems, New Data Presented at TCT 2025

ENCIRCLE mitral trial achieves primary and secondary endpoints

EVOQUE tricuspid valve registry demonstrates more favorable outcomes than pivotal trial

SAN FRANCISCO–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced data demonstrating successful patient outcomes supporting its portfolio of mitral and tricuspid therapies. One-year data from the ENCIRCLE single-arm pivotal trial achieved all primary and secondary endpoints for safety and effectiveness, with outcomes simultaneously published in The Lancet. Thirty-day data from the EVOQUE system STS/ACC TVT Registry, the largest real-world transcatheter tricuspid valve replacement (TTVR) dataset, outperformed results from the TRISCEND II pivotal trial. These data were presented during late-breaking sessions at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.

ENCIRCLE Pivotal Trial Results

One-year outcomes in the ENCIRCLE trial’s main cohort (299 patients unsuitable for other treatment options) achieved low rates for death and low heart failure hospitalization for patients treated with the SAPIEN M3 transfemoral transcatheter mitral valve replacement (TMVR) system. Further, patients receiving the SAPIEN M3 valve therapy achieved substantial mitral regurgitation (MR) elimination (95.7% MR ≤ 0/1+) and significant improvements in symptoms and quality-of-life.

“Mitral regurgitation is highly prevalent. Many patients do not have good treatment options for mitral intervention, and therefore too many are left untreated. These patients often experience symptoms that are life threatening and significantly impact their quality-of-life,” said David Daniels, M.D., Sutter West Bay Medical Group cardiologist, principal investigator and structural heart section chief of Sutter’s Heart & Vascular Service Line. “These ENCIRCLE trial data demonstrate the near elimination of significant mitral regurgitation, drastically improved quality-of-life, and a very low 30-day mortality in patients receiving a fully percutaneous mitral valve replacement using the SAPIEN M3 system. This is a significant step forward in the treatment of these patients.”

EVOQUE TTVR System STS/ACC TVT Registry Data

With data from 1,034 patients evaluated, findings from the EVOQUE TTVR system STS/ACC TVT Registry demonstrated a positive real-world safety profile across a broad tricuspid patient population. This includes lower reported pacemaker rates (14.9%) and very low major or life-threatening bleeding rates (1.3%) at 30 days compared to the TRISCEND II pivotal trial experience. Additionally, almost all patients experienced tricuspid regurgitation (TR) elimination (98% TR ≤ 0/1+) and were discharged to home after a median stay of two days post-procedure.

“We now have established a comprehensive portfolio of mitral and tricuspid repair and replacement technologies to ensure patients can receive the right therapy to meet their unique needs,” said Daveen Chopra, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies. “The depth and breadth of evidence across our therapies reinforces the compounding value our innovations continue to deliver for patients, physicians and the healthcare system.”

The SAPIEN M3 system was approved in Europe in April 2025 and is not yet approved in the US. The EVOQUE system is approved in both the US and Europe.

About Edwards Lifesciences

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Discover more at www.edwards.com and follow us on LinkedIn, Facebook, Instagram and YouTube.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements made by Mr. Chopra and statements regarding expected product benefits, patient outcomes, including quality of life and length of stay, value delivered to patients, physicians and the healthcare system and expectations and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company’s filings with the Securities and Exchange Commission. These filings, along with important safety information about our products, may be found at Edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, ENCIRCLE, EVOQUE, SAPIEN, SAPIEN M3, TRISCEND, and TRISCEND II are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

Contacts

Media Contact: Loree Bowen, 714-403-2475

Investor Contact: Mark Wilterding, 949-250-6826

Ferring Pharmaceuticals Presents Two New Analyses of Pivotal Trial Data for Follitropin Delta (FE 999049) at ASRM 2025




Ferring Pharmaceuticals Presents Two New Analyses of Pivotal Trial Data for Follitropin Delta (FE 999049) at ASRM 2025

• Analyses from the two Phase 3 RITA trials evaluate both the suitability of age-based dosing as well as the tolerability of treatment with follitropin delta in women undergoing controlled ovarian stimulation.

• Ferring’s long-standing commitment to helping people build families is illustrated through the company’s investment in developing innovative potential treatment options that advance the science of reproductive medicine.

PARSIPPANY, N.J.–(BUSINESS WIRE)–Ferring Pharmaceuticals announced today positive, new data for follitropin delta (FE 999049), an investigational-stage human recombinant follicle stimulating hormone (rFSH) being studied for the development of multiple follicles and pregnancy in ovulatory women undergoing fresh or frozen embryo transfer as part of an assisted reproductive technology (ART) cycle. These data were presented at the Annual Meeting of the American Society for Reproductive Medicine (ASRM) (October 25-29; San Antonio, Texas).

The analyses are based on the full data set from the RITA (Recombinant FSH Investigation in the Treatment of Infertility with Assisted Reproductive Technology) clinical trials, the first randomized, double-blind, placebo-controlled registrational trials (n=1,165) of follitropin delta in women undergoing controlled ovarian stimulation for ART in the United States. The primary endpoint was cumulative ongoing pregnancy rate (≥1 intrauterine viable fetus at 8 to 9 weeks after transfer, confirmed by abdominal or transvaginal ultrasound) after fresh or cryopreserved cycles initiated within 12 months of start of ovarian stimulation. The full findings from both the RITA-1 and RITA-2 trials were recently published in Fertility & Sterility.¹

“With one in six people worldwide impacted by infertility, there is a critical need to develop new and novel treatment approaches that help physicians customize ART protocols for their patients,” said Michael D. Scheiber, M.D., M.P.H., reproductive endocrinologist and infertility specialist, Institute for Reproductive Health, Cincinnati, Ohio. “The RITA trials are unique in studying cumulative ongoing pregnancy rates and live birth rates as primary and secondary endpoints to help capture the total reproductive potential of a single gonadotropin stimulation cycle for IVF. The clinical profile, combined with the novel pharmaceutical aspects of follitropin delta, help possibly to establish an evolved treatment paradigm for patients and provides strong evidence for its use, if approved, for controlled ovarian stimulation in clinical practice in the U.S.”

Follitropin delta met its primary endpoint in both trials. The cumulative ongoing pregnancy rate with follitropin delta after 12 study months was 64.0% (p<0.001) [95% CI: 56.9% to 68.1%] in RITA-1 and 43.9% (p<0.001) [95% CI: 37.0% to 48.2%] in RITA-2; no pregnancies occurred in the placebo group. The pooled incidence of adverse drug reactions with follitropin delta was 12.0%, compared with 3.7% for placebo. The most frequently reported adverse drug reactions were pelvic discomfort (4.7%), ovarian hyperstimulation syndrome (3.0%), pelvic pain (1.5%), nausea (1.5%), headache (1.4%), and fatigue (1.2%). Most reactions were mild, with only 0.1% rates as moderate or severe with either follitropin delta or placebo.

One analysis presented at ASRM demonstrated the feasibility of age-based microgram (μg) dosing with follitropin delta. Women in the follitropin delta group (n=1,058) received a fixed starting dose of either 12 μg/d (n=525; aged <35 years, RITA-1) or 15 μg/d (n=533; aged ≥35 years, RITA-2) for the first four stimulation days. Based on responses and at the judgment of investigators, dosing could be increased or decreased in 3 μg dose adjustments, with a minimum and maximum daily dose of 6 μg and 24 μg, respectively. In the RITA-1 trial, 55.8% of patients and 50.7% of patients in RITA-2 did not require follitropin delta dose adjustments during ovarian stimulation. The RITA trials confirmed the suitability of these two starting doses based on age.²

The second analysis presented characterized the overall tolerability of follitropin delta. Study participants assessed injection site reactions immediately, 30 minutes and 24 hours after injection. The frequency of injection site reactions after administration across all timepoints was generally low (4.2% across RITA-1 and RITA-2) and comparable to placebo (4.9%). The most common injection site reactions were redness, bruising and pain – with most assessing site reactions as mild. These findings demonstrate high tolerability using a sub-cutaneous injection via a pre-filled pen.³

“Ferring is deeply committed to advancing the science of reproductive medicine to help more people, who are challenged in their family building journey, become parents,” said Olga Tarasova, M.D., MBA, U.S. Chief Medical Officer, Ferring Pharmaceuticals. “We are thrilled to share these important new data analyses that support the potential benefits of follitropin delta. With the growing demand for ART services, Ferring is focused on helping to address this treatment need in fertility care.”

Follitropin delta (FE 999049) is approved under the brand name Rekovelle^® in the European Union, Canada, Australia, Switzerland, Japan, and other global markets. It is not currently approved in the United States.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a privately-owned, specialty biopharmaceutical group committed to building families and helping people live better lives. In the United States, Ferring is a leader in reproductive medicine, and in areas of gastroenterology and orthopaedics. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. The company was founded in 1950 and is headquartered in Saint-Prex, Switzerland. Ferring employs more than 7,000 people worldwide and markets its medicines in over 100 countries. Ferring USA is based in Parsippany, New Jersey, and employs more than 900 employees.

For more information, please visit www.ferringusa.com, call 1-888-FERRING (1-888-337-7464), or connect with us on LinkedIn, and X.

About Follitropin Delta (FE 999049)

Follitropin delta (FE 999049) is an investigational-stage human recombinant follicle stimulating hormone (rFSH) being studied for the development of multiple follicles and pregnancy in ovulatory women undergoing fresh or frozen embryo transfer as part of an assisted reproductive technology (ART) cycle.

References:

1. Scheiber M, Doody KJ, Foster ED, Grover SA, et al. Ovarian stimulation with follitropin delta is safe and effective: results from the RITA randomized, double-blind, placebo-controlled trials. Fertil Steril. 10.1016/j.fertnstert.2025.07.032. Available at: https://www.fertstert.org/article/S0015-0282(25)00605-3/fulltext.
2. Hirshfeld-Cytron J, Uhler ML, Grover SA, Foster, ED, et al. American Society for Reproductive Medicine Annual Meeting Abstract. Evaluation of FE 999049 Dosage Suitability in United States (US) Women Undergoing Controlled Ovarian Stimulation, a RITA Trial Analysis (P-47). Presented on October 27, 2025. Available at: https://asrm.confex.com/asrm/2025/meetingapp.cgi/Paper/28093.
3. Schnell VL, Brenner A, Grover SA, Foster ED, et al. American Society for Reproductive Medicine Annual Meeting Abstract. Characterization of FE 999049 Tolerability in United States (US) Women Undergoing Controlled Ovarian Stimulation, a RITA Trial Analysis (P-77) Available at: https://asrm.confex.com/asrm/2025/meetingapp.cgi/Paper/28253.

Contacts

Lisa Perdomo
Director, Brand Communications
(862) 286-5769 (direct)

(862) 341-9820 (mobile)

lisa.perdomo@ferring.com

New Montreal Biotech LifeLore Pathways Launches to Accelerate Microbial Innovation




New Montreal Biotech LifeLore Pathways Launches to Accelerate Microbial Innovation

MONTREAL–(BUSINESS WIRE)–Proventus Bioscience, a recognized leader in industrial microbial fermentation, announces the launch of LifeLore Pathways, a new independent biotech company based in Montreal. Fully focused on early-stage life sciences innovation, LifeLore supports the rapid development of tailor-made microbial solutions in health, nutrition, and environmental applications.

While Proventus specializes in mature, large-scale projects, LifeLore operates upstream where promising concepts still require validation, formulation, and functional proof. Designed for speed and flexibility, the company provides the scientific infrastructure needed to secure and accelerate early-stage biological innovation.

A market shift towards biological alternatives

Microbial science is now central to innovation strategies in nutraceuticals, cosmetics, regenerative agriculture, and waste management. Thanks to advances in strain characterization and stabilization, applications like next-gen probiotics, pharmaceutical postbiotics, soil bioactivators, and functional food ingredients are rapidly moving from lab to market.

“We’re seeing a convergence between what technology enables and what the market demands,” explains Vincent DeLorenzo, founder of Proventus Bioscience. “Companies want to innovate faster, consumers demand natural and effective products, and regulators are steering the industry toward biological alternatives. LifeLore Pathways sits at this crossroads.”

A technical partner for high-stakes early-stage projects

LifeLore operates from a GMP-compliant lab facility in Montreal, designed to produce small-scale microbial batches for formulation, stability testing, and pilot trials. These early-stage lots support proof-of-concept, regulatory filings, and field validation without the need for immediate industrial scale-up.

The company offers flexible collaboration models: fee-for-service, co-development, or early-stage licensing, always with clear deliverables and scientific oversight.

“When you’re working with living systems, two things matter most: scientific rigor and trust,” adds Vincent DeLorenzo. “LifeLore is built on both with strict IP protections and a team that understands both the science and the business.”

Sector focus and global ambitions

LifeLore focuses on accelerating the transition to sustainable medicines, enzymes, and alternative proteins by combining deep bioscience, intelligent automation, and rigorous quality systems making breakthrough bioprocesses as dependable as legacy chemistry.

Its primary application areas include:

• Biologics & enzymes such as recombinant cytokines, diagnostic enzymes, vaccine antigens, and RNA polymerases.
• Precision-fermented food proteins including casein, egg-white albumen, collagen peptides, and heme analogues.
• Industrial & specialty ferments like biopolymer precursors, bioremediation enzymes, and agricultural biologicals.

Based in Montreal’s thriving biotech ecosystem, LifeLore is also preparing for expansion across Europe and Latin America, where demand for agile microbial development partners is rapidly accelerating.

Experience LifeLore : Press visits, October to November 2025

Step inside one of Canada’s most advanced microbial fermentation facilities.

During this guided visit, journalists will explore the heart of LifeLore’s labs, meet the scientists behind the innovation, and discover how microbes are redefining the future of health, nutrition, and sustainability.

To register for a visit or request an interview, please contact: julie@sunzi.be

About LifeLore Pathways

Founded in 2025, LifeLore Pathways is an independent biotech company specializing in the agile development of microbial solutions for the health, nutrition, and environmental sectors. The company helps innovators bridge the gap between discovery and commercialization through modular, science-driven collaboration.

Contacts

Media
Julie Dessart

Communication consultant

Email : julie@sunzi.be
Website: www.lifelorepathways.ca

U.S. FDA Approves Updated Indication for WINREVAIR™ (sotatercept-csrk) in Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1 Pulmonary Hypertension) Based on Phase 3 ZENITH Study




U.S. FDA Approves Updated Indication for WINREVAIR™ (sotatercept-csrk) in Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1 Pulmonary Hypertension) Based on Phase 3 ZENITH Study

Adding WINREVAIR to background PAH therapy improved exercise capacity and WHO functional class (FC), and reduced the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death

ZENITH data add to growing body of evidence supporting a positive benefit risk profile of WINREVAIR in a broad range of adult patients with PAH

RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR™ (sotatercept-csrk) for injection, 45mg, 60mg. WINREVAIR, an activin signaling inhibitor, is now FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class (FC), and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death. WINREVAIR was initially approved based on the pivotal STELLAR study in March 2024. Today’s approval expanded the indication of WINREVAIR to include components of the clinical worsening events: hospitalization for PAH, lung transplantation and death.

In ZENITH (N=172; 86 WINREVAIR, 86 placebo), adding WINREVAIR to background therapy demonstrated a statistically significant and clinically meaningful 76% reduction in the risk of major morbidity and mortality outcomes in adults with PAH WHO functional class III or IV compared to placebo (HR: 0.24; 95% CI: 0.13, 0.43; p<0.0001). The trial’s composite primary efficacy endpoint events — time to first occurrence of all-cause death, lung transplantation or PAH-worsening hospitalization of ≥24 hours — occurred in 15 WINREVAIR-treated participants (17%) versus 47 placebo-treated participants (55%). Due to overwhelming efficacy based on the primary endpoint result, the ZENITH trial was stopped early at the interim analysis and patients were offered the opportunity to receive WINREVAIR through an open-label long-term follow-up study.

“For patients with PAH, the risk of serious events such as hospitalization, transplantation or death remains unacceptably high despite being maximally treated with traditional therapies,” said Dr. Vallerie McLaughlin**, Kim A Eagle MD Endowed Professor of Cardiovascular Medicine and Director, Pulmonary Hypertension Program, University of Michigan in Ann Arbor. “Results from the pivotal ZENITH trial add to the growing body of data and support the potential for WINREVAIR as standard of care.”

Healthcare providers should monitor hemoglobin and platelets before each dose of WINREVAIR for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine if dose adjustments are required. WINREVAIR may increase hemoglobin and may lead to erythrocytosis, which if severe may increase the risk of thromboembolic events or hyperviscosity syndrome. WINREVAIR also may decrease platelet count and lead to severe thrombocytopenia, which may increase the risk of bleeding; thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Treatment should not be initiated if platelet count is <50,000/mm³. See additional Selected Safety Information below.

The most common adverse reactions (≥10% for WINREVAIR and at least 5% more than placebo) in ZENITH were infections (67.4% vs 44.2%), epistaxis (45.3% vs 9.3%), diarrhea (25.6% vs 17.4%), telangiectasia (25.6% vs 3.5%), increased hemoglobin (15.1% vs 1.2%), rash (10.5% vs 4.7%), erythema (10.5% vs 3.5%) and gingival bleeding (10.5% vs 2.3%).The median duration of exposure was longer in the WINREVAIR group (435 days) than in the placebo group (268 days). In the WINREVAIR group, 1 patient (1%) discontinued study intervention due to an adverse event, compared with 4 patients (5%) in the placebo group.

“Merck’s leadership in PAH research is anchored in a comprehensive clinical program that continues to advance science and deliver meaningful evidence for physicians and patients,” said Dr. Joerg Koglin, senior vice president, global clinical development, Merck Research Laboratories. “This approval represents another step forward in our mission to deliver on the promise of WINREVAIR, an activin signaling inhibitor with an indication recognizing its impact to adult patients with PAH on the risk of clinical worsening events, including death, lung transplantation and PAH hospitalization.”

*World Health Organization

**Dr. McLaughlin is a member of the adult sotatercept steering committee, an investigator in the ZENITH study and a paid consultant to Merck.

About ZENITH

The ZENITH study (NCT04896008) was a global, double-blind, placebo-controlled, multicenter, parallel-group clinical trial in which 172 adult participants with PAH (WHO FC III or IV) at high risk of mortality were randomized in a 1:1 ratio to either WINREVAIR (target dose 0.7 mg/kg) (n=86) plus background PAH therapy or placebo (n=86) plus background PAH therapy administered subcutaneously once every 3 weeks.

The most common PAH etiologies were idiopathic PAH (50%), PAH associated with connective tissue diseases (CTD) (28%), and heritable PAH (11%). The mean time since PAH diagnosis to screening was 8 years. The study excluded patients diagnosed with human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis or overt signs of capillary and/or venous involvement. Participants were on background PAH treatment, 72% on triple therapy, 28% on double therapy and 59% on prostacyclin infusion therapy. There were more participants in WHO FC III (74%) compared to WHO FC IV (26%). The REVEAL Lite 2 risk score was <9 for 2% of participants, 9 to 10 for 67% of participants and ≥11% for 30% of participants. The primary efficacy endpoint was time to first confirmed major morbidity or mortality event. Events were defined as all-cause death, lung transplantation or PAH worsening-related hospitalization of ≥24 hours. Secondary endpoints included overall survival and several additional measures.

About WINREVAIR™ (sotatercept-csrk) for injection, for subcutaneous use, 45 mg, 60 mg

WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity and World Health Organization (WHO) functional class (FC), and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death. WINREVAIR is the first activin signaling inhibitor therapy approved to treat PAH. WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. In preclinical models, WINREVAIR induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling and improved hemodynamics.

WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb.

Selected Safety Information

WINREVAIR may increase hemoglobin (Hgb). Severe erythrocytosis may increase the risk of thromboembolic events or hyperviscosity syndrome. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter, to determine if dose adjustments are required.

WINREVAIR may decrease platelet count. Severe thrombocytopenia may increase the risk of bleeding. Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Do not initiate treatment if platelet count is <50,000/mm³. Monitor platelets before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine whether dose adjustments are required.

In clinical studies, serious bleeding (e.g., gastrointestinal, intracranial hemorrhage) was reported in 4% vs 1% (STELLAR) and 7% vs 5% (ZENITH) of patients taking WINREVAIR vs placebo, respectively. Patients with serious bleeding were more likely to be on prostacyclin background therapy and/or antithrombotic agents, or have low platelet counts. Advise patients about signs and symptoms of blood loss. Evaluate and treat bleeding accordingly. Do not administer WINREVAIR if the patient is experiencing serious bleeding.

WINREVAIR may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with WINREVAIR and for at least 4 months after the final dose. Pregnancy testing is recommended for females of reproductive potential before starting WINREVAIR treatment.

Based on findings in animals, WINREVAIR may impair female and male fertility. Advise patients on the potential effects on fertility.

The most common adverse reactions (≥10% for WINREVAIR and at least 5% more than placebo) occurring in the STELLAR Phase 3 clinical trial were headache (24.5% vs 17.5%), epistaxis (22.1% vs 1.9%), rash (20.2% vs 8.1%), telangiectasia (16.6% vs 4.4%), diarrhea (15.3% vs 10.0%), dizziness (14.7% vs 6.3%) and erythema (13.5% vs 3.1%). The most common adverse reactions in the ZENITH trial were infections (67.4% vs 44.2%), epistaxis (45.3% vs 9.3%), diarrhea (25.6 % vs 17.4%), telangiectasia (25.6 % vs 3.5%), increased hemoglobin (15.1% vs 1.2%), rash (10.5% vs 4.7%), erythema (10.5% vs 3.5%) and gingival bleeding (10.5% vs 2.3%).

Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with WINREVAIR, and for 4 months after the final dose.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research- intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Please see Prescribing Information for WINREVAIR (sotatercept-csrk) at http://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_pi.pdf, Patient Information for WINREVAIR at http://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_ppi.pdf, and Instructions for Use for WINREVAIR (1-vial kit, 2-vial kit) at http://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_ifu_1-vial_2-vial_kits.pdf.

Contacts

Media Contacts:

Olivia Finucane

+44 7881 262476

Nikki Lupinacci

(718) 644-0730

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Ayn Wisler

(917) 691-6218

Revvity Announces Financial Results for the Third Quarter of 2025




Revvity Announces Financial Results for the Third Quarter of 2025

• Revenue of $699 million; 2% reported growth; 1% organic growth
• GAAP EPS of $0.40; Adjusted EPS from continuing operations of $1.18
• Reaffirms full year 2025 organic growth and raises adjusted EPS guidance
• Authorizes new $1 billion share repurchase program

WALTHAM, Mass.–(BUSINESS WIRE)–Revvity, Inc. (NYSE: RVTY), today reported financial results for the third quarter ended September 28, 2025.

The Company reported GAAP earnings per share of $0.40, as compared to $0.77 in the same period a year ago. Revenue for the quarter was $699 million, as compared to $684 million in the same period a year ago. GAAP operating income from continuing operations for the quarter was $82 million, as compared to $98 million for the same period a year ago. GAAP operating profit margin from continuing operations was 11.7% as a percentage of revenue, as compared to 14.3% in the same period a year ago.

Adjusted earnings per share from continuing operations for the quarter was $1.18, as compared to $1.28 in the same period a year ago. Adjusted operating income was $182 million, as compared to $193 million for the same period a year ago. Adjusted operating profit margin was 26.1% as a percentage of revenue, as compared to 28.3% in the same period a year ago.

Adjustments for the Company’s non-GAAP financial measures have been noted in the attached reconciliations.

“We performed well during the third quarter as a number of key innovations and strategic partnerships have begun to come to fruition,” said Prahlad Singh, president and chief executive officer of Revvity. “Our strong level of execution is positioning the Company for even greater success in 2026 and beyond.”

Share Repurchase Authorization

The Company’s Board of Directors has authorized a new two-year $1 billion share repurchase program which replaces the remainder of the prior repurchase program which was announced in October 2024.

Financial Overview by Reporting Segment

Life Sciences

• Third quarter 2025 revenue was $343 million, as compared to $339 million in the same period a year ago. Revenue increased 1% and organic revenue was flat as compared to the same period a year ago.

• Third quarter 2025 adjusted operating income was $101 million, as compared to $111 million in the same period a year ago. Adjusted operating profit margin was 29.5% as a percentage of revenue, as compared to 32.6% in the same period a year ago.

Diagnostics

• Third quarter 2025 revenue was $356 million, as compared to $345 million in the same period a year ago. Revenue increased 3% and organic revenue increased 2% as compared to the same period a year ago.

• Third quarter 2025 adjusted operating income was $89 million, as compared to $94 million in the same period a year ago. Adjusted operating profit margin was 25.1% as a percentage of revenue, as compared to 27.2% in the same period a year ago.

Full Year 2025 Guidance

For the full year 2025, the Company is updating its full year revenue guidance to $2.83-$2.88 billion to reflect recent changes in foreign currency exchange rates and is reaffirming its organic growth guidance of 2% to 4%. The Company is also raising its adjusted EPS guidance to a range of $4.90 to $5.00.

Guidance for the full year 2025 for adjusted EPS and organic growth is provided on a non-GAAP basis and cannot be reconciled to the closest GAAP measures without unreasonable effort due to the unpredictability of the amounts and timing of events affecting the items the Company excludes from these non-GAAP measures. The timing and amounts of such events and items could be material to the Company’s results prepared in accordance with GAAP.

Webcast Information

The Company will discuss its third quarter 2025 results and its outlook for business trends during a webcast on October 27, 2025, at 8:00 a.m. Eastern Time. A live audio webcast and presentation will be available on the Investors section of the Company’s website, ir.revvity.com.

Use of Non-GAAP Financial Measures

In addition to financial measures prepared in accordance with generally accepted accounting principles (GAAP), this earnings announcement also contains non-GAAP financial measures. The reasons that we use these measures, a reconciliation of these measures to the most directly comparable GAAP measures, and other information relating to these measures are included below following our GAAP financial statements.

Factors Affecting Future Performance

This press release contains “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to estimates and projections of future earnings per share, cash flow and revenue growth and other financial results, developments relating to our customers and end-markets, and plans concerning business development opportunities, acquisitions and divestitures. Words such as “believes”, “intends”, “anticipates”, “plans”, “expects”, “estimates”, “projects”, “forecasts”, “will” and similar expressions, and references to guidance, are intended to identify forward-looking statements. Such statements are based on management’s current assumptions and expectations and no assurances can be given that our assumptions or expectations will prove to be correct. A number of important risk factors could cause actual results to differ materially from the results described, implied or projected in any forward-looking statements. These factors include, without limitation: (1) markets into which we sell our products declining or not growing as anticipated; (2) fluctuations in the global economic and political environments, including as the result of recently implemented and recently threatened tariff increases; (3) our failure to introduce new products in a timely manner; (4) our ability to execute acquisitions and divestitures, license technologies, or to successfully integrate acquired businesses or licensed technologies into our existing businesses or to make them profitable; (5) our ability to compete effectively; (6) fluctuation in our quarterly operating results and our ability to adjust our operations to address unexpected changes; (7) significant disruption in third-party package delivery and import/export services or significant increases in prices for those services; (8) disruptions in the supply of raw materials and supplies; (9) our ability to retain key personnel; (10) significant disruption in our information technology systems, or cybercrime; (11) our ability to realize the full value of our intangible assets; (12) our failure to adequately protect our intellectual property; (13) the loss of any of our licenses or licensed rights; (14) the manufacture and sale of products exposing us to product liability claims; (15) our failure to maintain compliance with applicable government regulations; (16) our failure to comply with data privacy and information security laws and regulations; (17) regulatory changes; (18) our failure to comply with healthcare industry regulations; (19) economic, political and other risks associated with foreign operations; (20) our ability to obtain future financing; (21) restrictions in our credit agreements; (22) significant fluctuations in our stock price; (23) reduction or elimination of dividends on our common stock; and (24) other factors which we describe under the caption “Risk Factors” in our most recent quarterly report on Form 10-Q and in our other filings with the Securities and Exchange Commission. We disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

About Revvity

At Revvity, “impossible” is inspiration, and “can’t be done” is a call to action. Revvity provides health science solutions, technologies, expertise and services that deliver complete workflows from discovery to development, and diagnosis to cure. Revvity is revolutionizing what’s possible in healthcare, with specialized focus areas in translational multi-omics technologies, biomarker identification, imaging, prediction, screening, detection and diagnosis, informatics and more.

With 2024 revenue of more than $2.7 billion and approximately 11,000 employees, Revvity serves customers across pharmaceutical and biotech, diagnostic labs, academia and governments. It is part of the S&P 500 index and has customers in more than 160 countries.

Stay updated by following our Newsroom, LinkedIn, X, YouTube, Facebook and Instagram.

Explanation of Non-GAAP Financial Measures

We report our financial results in accordance with GAAP. However, management believes that, in order to more fully understand our short-term and long-term financial and operational trends, investors may wish to consider the impact of certain non-cash, non-recurring or other items, which result from facts and circumstances that vary in frequency and impact on continuing operations. Accordingly, we present non-GAAP financial measures as a supplement to the financial measures we present in accordance with GAAP. These non-GAAP financial measures provide management with additional means to understand and evaluate the operating results and trends in our ongoing business by adjusting for certain non-cash expenses and other items that management believes might otherwise make comparisons of our ongoing business with prior periods more difficult, obscure trends in ongoing operations, or reduce management’s ability to make useful forecasts. Management believes these non-GAAP financial measures provide additional means of evaluating period-over-period operating performance.

Contacts

Investor Relations:
Steve Willoughby

steve.willoughby@revvity.com

Media Relations:
Chet Murray

(781) 462-5126

chet.murray@revvity.com

Read full story here

New Poll Reveals Canadians Lack Understanding of Obesity as a Chronic Disease, Stigma Likely Bleeds Into Treatment




New Poll Reveals Canadians Lack Understanding of Obesity as a Chronic Disease, Stigma Likely Bleeds Into Treatment

– Ahead of generic alternatives to weight loss medication expected to hit the Canadian market in 2026, Phoenix’s poll also found two in five Canadians would be interested in trying them –

TORONTO–(BUSINESS WIRE)–Today, Phoenix, Canada’s leading digital health clinic for men, released new poll data with insights from over 1,500 Canadians on sentiments around weight loss and the use of GLP-1s. The poll reveals that, despite the growing prevalence of obesity in Canada, many Canadians do not understand it as a chronic disease, which may drive stigma around the condition and the use of GLP-1 drugs for weight loss. Despite this stigma, there is notable interest in using GLP-1s to manage obesity, including generic alternatives.

WEIGHT LOSS IN CANADA

A recent study found one-third of Canadians are obese, and Phoenix’s poll found weight loss is on the mind of many Canadians. The findings reveal 59 per cent of Canadians are currently trying or planning to lose weight, with notable demographic divides. Desire for weight loss is most prominent among Gen X, with 68 per cent indicating they are currently trying or planning to lose weight – a significantly higher percentage than Gen Z (44%), Millennials (58%) and the Baby Boomer generation (57%).

Among Canadians currently trying to or planning on losing weight, the primary motivations are to improve fitness and stamina (62%) and increase lifespan/longevity (50%), followed by enhancing appearance (44%), boosting self-esteem and confidence (40%), and disease prevention (34%).

Notably, the strongest motivators differed from generation to generation. Gen Z’s leading motivator was to boost self-esteem and confidence (71%); Gen X was most motivated by increasing lifespan/longevity (58%); and improving fitness and stamina was the primary motivator for Millennials (63%) and the Baby Boomer generation (70%). 23 per cent of the Baby Boomer generation was also motivated to lose weight to reduce their need for medications.

“There is a misconception that weight loss is only an issue of vanity. That is simply not true. For folks struggling with obesity, losing weight can have a significant impact on overall quality of life, from increasing mobility to improving sleep quality,” says Gavin Thompson, co-founder and co-CEO of Phoenix. “The benefits can go beyond the physical too. Weight loss can also significantly support an individual’s mental health, providing a boost to their self-esteem and confidence.”

STIGMA AROUND WEIGHT LOSS TRICKLES DOWN TO TREATMENT

While the prevalence of obesity among adults in Canada has increased since the pandemic according to Statistics Canada, many Canadians still do not understand obesity as a chronic disease. Less than one in three Canadians (32%) correctly identified that Health Canada classifies obesity as a progressive chronic disease.

The lack of understanding of obesity as a chronic disease drives the stigma around the condition and its treatment. One in three Canadians (34%) say that they would or did feel embarrassed sharing with their friends and family about using drugs like Ozempic or Wegovy for weight loss. This stigma is further perpetuated by celebrity culture, where taking GLP-1 medications for weight management is often viewed differently than using medication for other chronic illnesses. 62 per cent of Canadians agree that celebrities who share their weight loss should also disclose their use of weight loss drugs to the public. Gen Z felt especially strong about this, with 71 per cent agreeing celebrities should disclose their use of weight loss drugs.

“The common perception of obesity is that it’s solely the result of personal choices, but in reality, it’s a chronic disease influenced by many factors. Many people who struggle with obesity cannot manage it with exercise and healthy eating alone, but the stigma around obesity trickles down to its treatment too,” says Kevin Bache, co-founder and co-CEO of Phoenix. “People feel entitled to know that a celebrity has used medication to lose weight, in the same way they expect a celebrity to be transparent about using social media filters to hide their acne. But as with any chronic disease, someone’s choice to use medication as recommended by their doctor is deeply personal, and there should be no shame or expectation of transparency attached.”

NOTABLE INTEREST IN GLP-1S, ESPECIALLY GENERIC

Despite Statistics Canada reporting 68 per cent of Canadians are classified as overweight or obese, only five per cent of Canadians are currently taking GLP-1 medication for weight loss, and a further three per cent have done so in the past. However, 21 per cent of Canadians who indicated they have never taken a GLP-1 medication revealed they would consider taking one in the future.

A potential barrier to Canadians trying GLP-1 weight loss medication could be the cost, as interest in generic weight loss medication is high. 40 per cent of Canadians indicated interest in trying a generic GLP-1 medication for weight loss if they currently struggle with obesity or were to struggle in the future.

WHAT CANADIANS NEED TO KNOW ABOUT GLP-1s

• Do GLP-1 drugs mitigate the need to eat healthy and exercise? While eating less is a goal for many people who struggle with their weight, food intake is only one small piece of a healthy, sustainable weight loss plan. Lifestyle modifications, such as eating a nutritious diet or exercising regularly, are key to sustaining your results.
• Do I need a prescription to take a GLP-1 medication for weight loss? Yes, GLP-1 medication must be prescribed by a licensed physician for weight loss.
• Can anyone take a GLP-1 medication for weight loss? No. In Canada, GLP-1 drugs can only be prescribed by a licensed physician to patients who have a body mass index (BMI) of 30+ or BMI of 27+ with obesity-related health conditions.

Ontario, BC, Alberta, Saskatchewan, Manitoba, New Brunswick, Newfoundland, Nova Scotia and PEI. To learn more about Phoenix’s weight loss support, visit https://www.phoenix.ca/treatments/weight-loss.

ABOUT PHOENIX

Phoenix is Canada’s leading digital health clinic for men, specializing in three areas of treatment – erectile dysfunction, weight loss, and hair loss. The telehealth platform facilitates access to licensed Canadian physicians, treatment options, and free, discreet shipping of prescription medication from coast to coast. Visit Phoenix.ca to learn more.

SURVEY METHODOLOGY

These findings are from a survey conducted by Phoenix from September 24th to September 26th, 2025, among a representative sample of 1505 online adult Canadians who are members of the Angus Reid Forum. The survey was conducted in English and French. For comparison purposes only, a probability sample of this size would carry a margin of error of +/-2.53 percentage points, 19 times out of 20.

Contacts

MEDIA
Anne-Marie Tremble

Senior Account Manager, Talk Shop Media

annemarie@talkshopmedia.com
613-914-3551

Colorectal, Liver, and Lung Cancer Patients at Vinmec Experience Extended Survival with AIET Cell-Based Immunotherapy – Technology Transferred from Japan




Colorectal, Liver, and Lung Cancer Patients at Vinmec Experience Extended Survival with AIET Cell-Based Immunotherapy – Technology Transferred from Japan

Vinmec Health System attracts international patients to Vietnam for treatment

TOKYO–(BUSINESS WIRE)–#AIET–Significantly extended survival and improved quality of life (QoL) for cancer patients achieved through autologous cell-based AIET immunotherapy, utilizing patients’ own natural killer (NK) cells and T cells, has positioned Vinmec Hospital, Vietnam, as an emerging medical tourism destination for cancer treatment across Asian countries. This accomplishment was presented by Professor Nguyen Thanh Liem at the NCRM NICHE 2025. He acknowledged the technology transfer support from GN Corporation, Japan, enabling the implementation of standardized AIET protocols in accordance with Japanese regulations, bringing treatment access to patients at Vinmec since 2018.

AIET leverages patients’ NK and T lymphocytes alongside conventional treatments, increases treatment efficacy by 20–30% and significantly improves survival. In two clinical trials at Vinmec Hospital during 2016–2021 in advanced-stage cancers:

• Colorectal cancer patients’ average survival time increased by 14.3 months;
• Lung, liver and other cancers, average survival time increased by 18.7 months.

Among over 100 patients, including those with late-stage breast, ovarian, thyroid, and head-neck cancers, AIET improved survival rates, enhanced QoL with measurable improvements in: appetite, insomnia, drowsiness, dry mouth, nausea, depression, fatigue, overall symptom burden and physical function capacity. AIET causes virtually no side effects, as it uses patients’ own cells without any foreign biological materials or feeder layers during cultivation.

AIET cell therapy has been officially approved for implementation at Vinmec Hospital under Vietnam’s regenerative medicine regulations, aligned with Japan’s Act on the Safety of Regenerative Medicine.

AIET treatment protocol (one cycle):

• Collection of 100 ml of patient’s peripheral blood,
• Laboratory processing and cultivation over 15–21 days,
• Intravenous infusion of two doses of NK and T cells;

Patients may require 2–6 cycles, depending on cancer progression and stage, said Prof. Liem.

Prof. Liem acknowledged GN Corporation’s outstanding interdisciplinary research, yielding cell therapy solutions, being transferred to hospitals and institutes worldwide.

• BEES-HAUS and BHES-HAUS for male urethral stricture using buccal mucosal epithelium, encapsulated in Festigel scaffold;
• Novel cell therapies for treating epithelial and endothelial corneal diseases;
• EELS-TALC addressing articular cartilage damage using autologous chondrocytes, with reversed cellular aging.

GN Corporation and NCRM are now collaborating with SoulSynergy Ltd., Mauritius, an approved cell processing lab, to offer cell-based therapies practiced in Japan, to patients in Mauritius and African continent.

Contacts

Samuel JK Abraham

info@gncorporation.com

Guardant Health to Share Data Supporting Critical Role of Blood-Based Testing in Improving Cancer Screening Adherence at ACG 2025




Guardant Health to Share Data Supporting Critical Role of Blood-Based Testing in Improving Cancer Screening Adherence at ACG 2025

• Expanded cohort reiterates strong adherence rate of over 90% for Shield blood-based colorectal cancer screening test
• Survey findings show eligible individuals prefer a blood test for colorectal cancer and lung cancer compared with traditional screening methods

PALO ALTO, Calif.–(BUSINESS WIRE)–$GH–Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the company and its research collaborators will present data showing the critical role of blood-based testing in increasing cancer screening adherence at the American College of Gastroenterology (ACG) 2025 Annual Meeting in Phoenix, Arizona taking place Friday, October 24 – Wednesday, October 29, 2025.

Building off findings from Guardant Health’s 2023 ACG abstract, a study of an expanded cohort of 20,000 patients confirmed findings from earlier reports on the effectiveness of the Shield blood-based screening test in improving adherence to colorectal cancer (CRC) screening. Shield is the first and only blood test to receive FDA approval as a primary screening option for colorectal cancer in average-risk adults aged 45 and older. The findings demonstrated an over 90% adherence rate for Shield, tracking well above average screening adherence for overall CRC testing which ranges from 28-71%. ^1-4

A separate study led by researchers at Cedars Sinai found that individuals prefer a blood test for colorectal cancer and lung cancer over other methods, showing the potential for an innovative blood test like Shield to increase the overall screening rate in lung cancer screening. The survey found that more screening-eligible individuals (43.9%) prefer to do a blood test for colorectal cancer and lung cancer compared to traditional screenings.

“Today’s research reinforces what Guardant has long believed: blood-based cancer screening is the future,” said Dr. Craig Eagle, Chief Medical Officer at Guardant Health. “These studies highlight the power of a simple blood test in addressing today’s gaps in colorectal cancer screening adherence and potential to expand to an even broader population looking for a more pleasant option for their regular lung cancer screening. We’re eager to present these findings along with our research collaborators at the ACG meeting and proud to offer Shield, an FDA-approved test, as an accessible and convenient alternative to traditional screening methods.”

Guardant Health and collaborator presentations at ACG 2025

The full abstracts for Guardant Health and a list of all abstracts being presented at the ACG Annual Meeting can be found here.

About Shield

Shield is a non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Guardant Health Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2024 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

¹ Denberg TD, Melhado TV, Coombes JM, et al. Predictors of nonadherence to screening colonoscopy. J Gen Intern Med. 2005;20(11):989-995.

² Gellad ZF, Stechuchak KM, Fisher DA, et al. Longitudinal adherence to fecal occult blood testing impacts colorectal cancer screening quality. Am J Gastroenterol. 2011;106(6):1125-1134.

³ Inadomi JM, Vijan S, Janz NK, et al. Adherence to colorectal cancer screening: a randomized clinical trial of competing strategies. Arch Intern Med. 2012;172(7):575-582.

⁴ Exact Sciences. Third quarter 2019 webcast and conference call. Updated October 29, 2019. https:/ investor.exactsciences.com/investor-relations/events-and-presentations/event-details/2019/Third-Quarter-2019-Webcast-Conference-Call/default.aspx

Contacts

Investor Contact:
Zarak Khurshid

investors@guardanthealth.com

Media Contact:
Meaghan Smith

press@guardanthealth.com

Incyte Announces New Data from Phase 3b TRuE-AD4 Trial of Opzelura® (Ruxolitinib Cream) in Adults with Moderate Atopic Dermatitis




Incyte Announces New Data from Phase 3b TRuE-AD4 Trial of Opzelura® (Ruxolitinib Cream) in Adults with Moderate Atopic Dermatitis

• Eight-week results from the TRuE-AD4 trial demonstrate treatment with Opzelura^® (ruxolitinib cream) significantly improved the clinical signs of atopic dermatitis (AD), including improved itch as early as Day 2, and was well tolerated in adults with moderate AD who had an inadequate response, intolerance or contraindication to topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs)

• At Week 8, 70% of patients treated with Opzelura achieved a ≥75% improvement in the Eczema Area and Severity Index (EASI75) and 61.3% achieved Investigator’s Global Assessment Treatment Success (IGA-TS), co-primary endpoints of the study

• Based on these results, Incyte expects to file a Type-II variation application for ruxolitinib cream 1.5% for the treatment of adults with moderate AD in the European Union (EU) by end of year

WILMINGTON, Del.–(BUSINESS WIRE)–$INCY #ISAD2025–Incyte (Nasdaq:INCY) today announced new data from the Phase 3b TRuE-AD4 study evaluating the efficacy and safety of Opzelura^® (ruxolitinib cream) in adults with moderate atopic dermatitis (AD) who had an inadequate response, intolerance or contraindication to topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs). These data will be presented during the Systemic and New Therapies for Atopic Dermatitis session on Sunday, October 26 at 10:55 a.m. AEDT (Saturday, October 25 at 7:55 p.m. ET) (Abstract #1177) at the 15th Georg Rajka International Symposium on Atopic Dermatitis (ISAD), held from October 24 – 26, 2025, in Melbourne.

Data from TRuE-AD4, which build on previously announced topline results, show the study met its co-primary endpoints at Week 8, with a statistically significant proportion of patients achieving both a ≥75% improvement in Eczema Area and Severity Index (EASI75) score from baseline (70.0% with Opzelura vs. 18.5% with vehicle, P<0.0001) and Investigator’s Global Assessment Treatment Success (IGA-TS; 61.3% vs. 13.6%; P<0.0001). Patients treated with Opzelura demonstrated improvement in EASI75 (43.8% vs. 3.7%, nominal P<0.0001) and IGA-TS (29.4% vs. 2.5%, nominal P<0.0001) at Week 2. More patients treated with Opzelura achieved both EASI75 and IGA-TS at Week 8 than vehicle (59.4% vs. 13.6%; nominal P<0.0001).

“The TRuE-AD4 data further reinforce the safety and efficacy profile of Opzelura and its ability to control key signs and symptoms of moderate AD, including improvement in bothersome symptoms like itch,” said Jim Lee, M.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “These data will support the filing of a Type-II variation application for ruxolitinib cream 1.5% (Opzelura) in Europe, as we seek to meet the needs of more patients around the world who require nonsteroidal topical treatments for moderate AD.”

Additional key findings from the TRuE-AD4 study include:

• Improvement in itch as measured by a ≥4-point improvement in Itch Numeric Rating Scale (NRS4) score.
  • Nearly two-thirds (62.5%) of patients treated with Opzelura achieved Itch NRS4 by Week 8 (vs. 19.8% with vehicle, P<0.0001).
  • There was significant improvement in worst daily itch at Day 2 with 29.1% of patients treated with Opzelura achieving Itch NRS4 vs. 14.3% with vehicle (P=0.0072; by multiple imputation).
  • Current Itch NRS4 was also measured at 15 minutes (16.4% with Opzelura vs. 7.7% with vehicle).
• Improved Patient-Oriented Eczema Measure (POEM) and Dermatology Life Quality Index (DLQI) scores:
  • More patients treated with Opzelura vs. vehicle achieved a POEM score 0–2 (clear or almost clear) at Week 8 (39.7% vs. 8.6%).
  • Patients treated with Opzelura showed a mean DLQI score improvement at Week 8 (from 19.3 to 4.3 with Opzelura vs. 19.1 to 10.7 with vehicle).
• Opzelura was well tolerated with no serious infections, major adverse cardiovascular events (MACE), malignancies or thromboses reported during the 8-week vehicle-controlled period. The most common treatment-related adverse event observed in the Opzelura arm was application site acne (4.4% vs 0% in vehicle arm).

“TRuE-AD4 offers compelling support for the utility of Opzelura for patients with moderate AD who have limited treatment options due to inadequate responses or intolerances to TCS and TCI-based topical therapies, who may otherwise be recommended for systemic therapy,” said Dr. Andreas Wollenberg, Professor of Dermatology and Allergy, Augsburg University Hospital, Germany. “AD is a challenging, chronic condition and I believe that these data reinforce Opzelura as an important therapeutic option.”

Atopic dermatitis (AD) – the most common type of eczema –is a chronic, recurring, inflammatory and highly pruritic skin condition that affects up to 25% of children and up to 12% of adults worldwide, with an estimated prevalence among adults of 5.5% across 27 European countries.^{1,2,3,4,5,6,7} Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and crust.

More information regarding the Georg RAJKA International Symposium on Atopic Dermatitis (ISAD) can be found at https://isad.org/rajka-symposium.

About TRuE-AD4

TRuE-AD4 (NCT06238817) is a randomized, double-blind, vehicle-controlled Phase 3b study designed to evaluate the efficacy and safety of Opzelura^® (ruxolitinib cream) in adults with moderate atopic dermatitis (AD). The study enrolled 241 patients (≥18 years old) who meet the specific inclusion criteria, including an Investigator’s Global Assessment (IGA) score of 3 and an Eczema Area and Severity Index (EASI) score greater than 7 at both screening and Day 1 and who have AD on 10% to 20% of their Body Surface Area (BSA; excluding scalp). Patients also had to have a documented history of inadequate response, intolerance or contraindication to topical corticosteroid (TCS)s and topical calcineurin inhibitor (TCI)s within the 12 months prior to the screening visit.

Patients were randomized 2:1 to receive Opzelura administered twice daily (BID) or vehicle (non-medicated cream) BID.

The co-primary endpoints of TRuE-AD4 are the proportion of patients achieving IGA Treatment Success (IGA-TS), defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline, and EASI-75, defined as ≥75% improvement in EASI score, at Week 8. Key secondary endpoints include the proportion of patients with a ≥4-point improvement in Itch Numeric Rating Scale (NRS4) score at various time points. Other exploratory endpoints include the proportion of patients who achieved IGA-TS, NRS4, EASI-75, a decrease from baseline in the affected body surface area (%BSA), change from baseline in the skin pain NRS score, EASI90 and more, measured at various time points. The study also tracked the frequency, duration and severity of adverse events associated with the use of ruxolitinib cream.

For more information on the study, visit https://www.clinicaltrials.gov/study/NCT06238817.

About Opzelura^® (ruxolitinib) Cream

Opzelura (ruxolitinib) cream, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 2 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.

In Europe, Opzelura^® (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.

Opzelura and the Opzelura logo are registered trademarks of Incyte.

IMPORTANT SAFETY INFORMATION

OPZELURA is for use on the skin only. Do not use OPZELURA in your eyes, mouth, or vagina.

OPZELURA may cause serious side effects, including:

Serious Infections: OPZELURA contains ruxolitinib. Ruxolitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. Some people have had serious infections of their lungs while taking OPZELURA. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with OPZELURA.

OPZELURA should not be used in people with an active, serious infection, including localized infections. You should not start using OPZELURA if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster) while using OPZELURA.

Increased risk of death due to any reason (all causes): Increased risk of death has happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called JAK inhibitors by mouth.

Cancer and immune system problems: OPZELURA may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers have happened in people taking a medicine in the class of medicines called JAK inhibitors by mouth. People taking JAK inhibitors by mouth have a higher risk of certain cancers including lymphoma and lung cancer, especially if they are a current or past smoker. Some people have had skin cancers while using OPZELURA. Your healthcare provider will regularly check your skin during your treatment with OPZELURA. Limit the amount of time you spend in the sunlight. Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen.

Increased risk of major cardiovascular events: Increased risk of major cardiovascular events such as heart attack, stroke, or death have happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and taking a medicine in the class of medicines called JAK inhibitors by mouth, especially in current or past smokers.

Blood clots: Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen in some people taking OPZELURA. This may be life-threatening. Blood clots in the vein of the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a medicine in the class of medicines called JAK inhibitors by mouth.

Low blood cell counts: OPZELURA may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). Your healthcare provider may do a blood test to check your blood cell counts during your treatment with OPZELURA and may stop your treatment if signs or symptoms of low blood cell counts happen.

Cholesterol increases: Cholesterol increase has happened in people when ruxolitinib is taken by mouth. Tell your healthcare provider if you have high cholesterol or triglycerides.

Before starting OPZELURA, tell your healthcare provider if you:

• have an infection, are being treated for one, or have had an infection that does not go away or keeps coming back
• have diabetes, chronic lung disease, HIV, or a weak immune system
• have TB or have been in close contact with someone with TB
• have had shingles (herpes zoster)
• have or have had hepatitis B or C
• live, have lived in, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections. These infections may happen or become more severe if you use OPZELURA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
• think you have an infection or have symptoms of an infection such as: fever, sweating, or chills, muscle aches, cough or shortness of breath, blood in your phlegm, weight loss, warm, red, or painful skin or sores on your body, diarrhea or stomach pain, burning when you urinate or urinating more often than usual, feeling very tired.
• have ever had any type of cancer, or are a current or past smoker
• have had a heart attack, other heart problems, or a stroke
• have had blood clots in the veins of your legs or lungs in the past
• have high cholesterol or triglycerides
• have or have had low white or red blood cell counts
• are pregnant or plan to become pregnant. It is not known if OPZELURA will harm your unborn baby. There is a pregnancy exposure registry for individuals who use OPZELURA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you become exposed to OPZELURA during pregnancy, you and your healthcare provider should report exposure to Incyte Corporation at 1-855-463-3463 or www.opzelura.pregnancy.incyte.com.
• are breastfeeding or plan to breastfeed. It is not known if OPZELURA passes into your breast milk. Do not breastfeed during treatment with OPZELURA and for about 4 weeks after the last dose.

After starting OPZELURA:

• Call your healthcare provider right away if you have any symptoms of an infection. OPZELURA can make you more likely to get infections or make worse any infections that you have.
• Get emergency help right away if you have any symptoms of a heart attack or stroke while using OPZELURA, including:
  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded
  • weakness in one part or on one side of your body
  • slurred speech

• Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with OPZELURA, including: swelling, pain, or tenderness in one or both legs, sudden, unexplained chest or upper back pain, or shortness of breath or difficulty breathing.
• Tell your healthcare provider right away if you develop or have worsening of any symptoms of low blood cell counts, such as: unusual bleeding, bruising, tiredness, shortness of breath, or fever.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of OPZELURA in people 12 years of age and older treated for atopic dermatitis include: common cold (nasopharyngitis), bronchitis, ear infection, increase in a type of white blood cell (eosinophil) count, hives, diarrhea, inflamed hair pores (folliculitis), swelling of the tonsils (tonsillitis), and runny nose (rhinorrhea). For people 2-11 years: upper respiratory tract infection, COVID-19, application site reaction, fever, white blood cell count decreased.

These are not all of the possible side effects of OPZELURA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Incyte Corporation at 1-855-463-3463.

Please see the Full Prescribing Information, including Boxed Warning, and Medication Guide for OPZELURA at Opzelura.com.

INDICATION AND USAGE

OPZELURA is a prescription medicine used on the skin (topical) for the short-term and non-continuous chronic treatment of mild to moderate eczema (atopic dermatitis) in non-immunocompromised adults and children 2 years of age and older whose disease is not well controlled with topical prescription therapies or when those therapies are not recommended.

The use of OPZELURA along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended.

It is not known if OPZELURA is safe and effective in children less than 2 years of age with atopic dermatitis.

About Incyte

A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.

For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.

Incyte Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from the TRuE-AD4 study, Incyte’s plans to file an application with regulators in Europe, and whether and when Opzelura might provide a successful treatment option to patients beyond its already-approved indications in specific regions, contain predictions, estimates, and other forward-looking statements.

These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA, EMA, and other regulatory authorities; the efficacy or safety of Incyte and its partners’ products; the acceptance of Incyte and its partners’ products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-K for the quarter ended June 30, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements.

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