Soleno Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides Update on U.S. Launch of VYKAT™ XR




Soleno Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides Update on U.S. Launch of VYKAT™ XR

REDWOOD CITY, Calif., Feb. 25, 2026 (GLOBE NEWSWIRE) — Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today reported financial results for the fourth quarter and full-year ended December 31, 2025 and provided an update on the U.S. launch of VYKAT™ XR (diazoxide choline) extended-release tablets.

Fourth Quarter and Full-Year 2025 and Recent Corporate Highlights

• Revenue, net, from the sale of VYKAT XR for the three and twelve months ended December 31, 2025, was $91.7 million and $190.4 million, respectively.
• From approval on March 26, 2025 through December 31, 2025, Soleno reports:
  • 1,250 patient start forms received, including 207 in the fourth quarter
  • 630 unique prescribers, including 136 new prescribers in the fourth quarter
  • 859 active patients on drug as of December 31, 2025
  • Over 185 million lives covered
• Achieved profitability with positive net income of $20.9 million for the year.
• Generated $48.7 million of cash flow from operating activities in the fourth quarter.
• Invested $100 million in accelerated share repurchase program announced in November 2025 and ended the year with $506.1 million of cash, cash equivalents and marketable securities.

“Our first year as a commercial organization has been an outstanding success,” stated Anish Bhatnagar, M.D., Chairman and Chief Executive Officer of Soleno Therapeutics. “In just nine months, we received patient start forms representing over 12% of the U.S. VYKAT XR addressable market, reflecting both the strength of our world-class commercial team as well as the substantial disease burden that is addressed by VYKAT XR. We are very pleased with the positive trajectory of our other leading indicators, including patient start forms, patients on active therapy, unique prescribers, and lives covered.”

“Looking ahead, with the U.S. VYKAT XR launch well underway, we plan to pursue regulatory approval in other territories, starting with the EU. We will also begin to evaluate diazoxide choline extended-release (DCCR) in additional high-need rare diseases as we expand our development pipeline. We have made excellent progress in 2025 and are excited for the year ahead.”

Fourth Quarter and Full-Year Ended December 31, 2025 Financial Results

Product revenue, net, was $91.7 million and $190.4 million for the three and twelve months ended December 31, 2025, respectively. VYKAT XR had not been approved or commercially launched in the three and twelve months ended December 31, 2024, and accordingly, generated no revenue during those periods.

Research and development expense was $9.6 million, which includes $2.8 million of non-cash stock-based compensation, for the three months ended December 31, 2025, compared to $21.5 million, which includes $10.1 million of non-cash stock-based compensation, in the same period of 2024. For the year ended December 31, 2025, research and development expense was $40.6 million, which includes $11.7 million of non-cash stock-based compensation, a decrease of $38.0 million compared to $78.6 million, which includes $33.7 million non-cash stock-based compensation, in the same period of 2024.

For the year, the $15.9 million decrease in expense not related to stock-based compensation was due to a reduction in pre-commercial launch costs in support of the Company’s 2024 NDA submission, supply chain, and clinical activities. These expenses decreased $7.5 million, $6.0 million, and $3.8 million, respectively. These decreases were partially offset by the Company incurring an additional $1.4 million of expense towards its MAA submission in Europe, which was submitted in the second quarter of 2025. The cadence of the Company’s research and development expenditures will fluctuate depending upon the state of its research activities, clinical programs, and the timing of manufacturing and other projects necessary to support the submission of its regulatory filings.

Selling, general and administrative expense was $40.9 million, which includes $8.7 million of non-cash stock-based compensation, for the three months ended December 31, 2025, compared to $37.3 million, which includes $19.7 million of non-cash stock-based compensation, in the same period of 2024. For the year ended December 31, 2025, selling, general and administrative expense was $132.1 million, which includes $34.1 million of non-cash stock-based compensation, an increase of $26.2 million compared to $105.9 million, which includes $66.2 million of non-cash stock-based compensation, in the same period of 2024.

For the year, personnel costs, including hiring expense and other associated headcount costs, increased $31.3 million as the Company hired additional employees in support of its commercial launch and increased business activities. New program costs associated with commercial launch activities, including disease state education, analytics, other marketing programs, medical affairs and patient advocacy activities, increased $23.4 million. Costs for international expansion increased $3.5 million. These increases were offset by the $32.1 million reduction in stock-based compensation. Selling, general and administrative expenses are anticipated to increase as the Company continues commercialization of VYKAT XR.

The Company is obligated to make cash payments of up to a maximum of $21.2 million to the former Essentialis stockholders upon the achievement of certain commercial milestones associated with the sales of DCCR in accordance with the terms of the Company’s 2017 merger agreement with Essentialis. The fair value of the liability for the contingent consideration payable by the Company upon the achievement of commercial sales milestones of $100 million and $200 million in aggregate revenue, respectively, was estimated to be $20.3 million as of December 31, 2025, a $5.5 million increase from the estimate as of December 31, 2024. The first commercial milestone was achieved in the fourth quarter 2025 and $7.0 million will be paid in the first quarter 2026.

Total other income, net, was $3.8 million for the three months ended December 31, 2025, compared to total other income, net, of $3.1 million in the same period of 2024. For the year, total other income, net, was $11.5 million for 2025, compared to $11.8 million for 2024.

For the year ended December 31, 2025, net income was approximately $20.9 million, or $0.40 per basic and $0.39 per diluted share, compared to a net loss of $(175.9) million, or $(4.38) per basic and diluted share, for the same period of 2024.

Conference Call and Webcast Information

Soleno management will host an investor conference call and webcast to discuss its fourth quarter and full-year 2025 financial and operating results and provide an update on the U.S. launch of VYKAT XR today, February 25, 2026, at 4:30pm ET. Details can be found below:

About PWS
Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in the gene expression on chromosome 15. The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The defining symptom of PWS is hyperphagia, a chronic and life-threatening condition characterized by an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behavior problems, and a lack of normal satiety, which can severely diminish the quality of life for individuals with PWS and their families. Hyperphagia can lead to significant mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior) and longer term, co-morbidities such as diabetes, obesity, and cardiovascular disease.

INDICATION
VYKAT XR (diazoxide choline) extended-release tablets is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).

IMPORTANT SAFETY INFORMATION

Contraindications
Use of VYKAT XR is contraindicated in patients who have a known hypersensitivity to diazoxide, other components of VYKAT XR, or to thiazides.

Warnings and Precautions

Hyperglycemia
Hyperglycemia, including diabetic ketoacidosis, has been reported. Before initiating VYKAT XR, test fasting plasma glucose (FPG) and HbA1c; optimize blood glucose in patients who have hyperglycemia. During treatment, regularly monitor fasting glucose (FPG or fasting blood glucose) and HbA1c. Monitor fasting glucose more frequently during the first few weeks of treatment in patients with risk factors for hyperglycemia.

Risk of Fluid Overload
Edema, including severe reactions associated with fluid overload, has been reported. Monitor for signs or symptoms of edema or fluid overload. VYKAT XR has not been studied in patients with compromised cardiac reserve and should be used with caution in these patients.

Adverse Reactions
The most common adverse reactions (incidence ≥10% and at least 2% greater than placebo) included hypertrichosis, edema, hyperglycemia, and rash.

Please see the full Prescribing Information, including Medication Guide.

About Soleno Therapeutics, Inc.
Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The Company’s first commercial product, VYKAT XR (diazoxide choline) extended-release tablets, formerly known as DCCR, is a once-daily oral treatment for hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome. For more information, please visit www.soleno.life.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those described in the company’s prior press releases and in the periodic reports it files with the SEC including its Annual Report on Form 10-K which it intends to release later today. The events and circumstances reflected in the company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Corporate Contact:
Brian Ritchie
LifeSci Advisors, LLC
212-915-2578

Soleno Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides Update on U.S. Launch of VYKAT™ XR




Soleno Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides Update on U.S. Launch of VYKAT™ XR

REDWOOD CITY, Calif., Feb. 25, 2026 (GLOBE NEWSWIRE) — Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today reported financial results for the fourth quarter and full-year ended December 31, 2025 and provided an update on the U.S. launch of VYKAT™ XR (diazoxide choline) extended-release tablets.

Fourth Quarter and Full-Year 2025 and Recent Corporate Highlights

• Revenue, net, from the sale of VYKAT XR for the three and twelve months ended December 31, 2025, was $91.7 million and $190.4 million, respectively.
• From approval on March 26, 2025 through December 31, 2025, Soleno reports:
  • 1,250 patient start forms received, including 207 in the fourth quarter
  • 630 unique prescribers, including 136 new prescribers in the fourth quarter
  • 859 active patients on drug as of December 31, 2025
  • Over 185 million lives covered
• Achieved profitability with positive net income of $20.9 million for the year.
• Generated $48.7 million of cash flow from operating activities in the fourth quarter.
• Invested $100 million in accelerated share repurchase program announced in November 2025 and ended the year with $506.1 million of cash, cash equivalents and marketable securities.

“Our first year as a commercial organization has been an outstanding success,” stated Anish Bhatnagar, M.D., Chairman and Chief Executive Officer of Soleno Therapeutics. “In just nine months, we received patient start forms representing over 12% of the U.S. VYKAT XR addressable market, reflecting both the strength of our world-class commercial team as well as the substantial disease burden that is addressed by VYKAT XR. We are very pleased with the positive trajectory of our other leading indicators, including patient start forms, patients on active therapy, unique prescribers, and lives covered.”

“Looking ahead, with the U.S. VYKAT XR launch well underway, we plan to pursue regulatory approval in other territories, starting with the EU. We will also begin to evaluate diazoxide choline extended-release (DCCR) in additional high-need rare diseases as we expand our development pipeline. We have made excellent progress in 2025 and are excited for the year ahead.”

Fourth Quarter and Full-Year Ended December 31, 2025 Financial Results

Product revenue, net, was $91.7 million and $190.4 million for the three and twelve months ended December 31, 2025, respectively. VYKAT XR had not been approved or commercially launched in the three and twelve months ended December 31, 2024, and accordingly, generated no revenue during those periods.

Research and development expense was $9.6 million, which includes $2.8 million of non-cash stock-based compensation, for the three months ended December 31, 2025, compared to $21.5 million, which includes $10.1 million of non-cash stock-based compensation, in the same period of 2024. For the year ended December 31, 2025, research and development expense was $40.6 million, which includes $11.7 million of non-cash stock-based compensation, a decrease of $38.0 million compared to $78.6 million, which includes $33.7 million non-cash stock-based compensation, in the same period of 2024.

For the year, the $15.9 million decrease in expense not related to stock-based compensation was due to a reduction in pre-commercial launch costs in support of the Company’s 2024 NDA submission, supply chain, and clinical activities. These expenses decreased $7.5 million, $6.0 million, and $3.8 million, respectively. These decreases were partially offset by the Company incurring an additional $1.4 million of expense towards its MAA submission in Europe, which was submitted in the second quarter of 2025. The cadence of the Company’s research and development expenditures will fluctuate depending upon the state of its research activities, clinical programs, and the timing of manufacturing and other projects necessary to support the submission of its regulatory filings.

Selling, general and administrative expense was $40.9 million, which includes $8.7 million of non-cash stock-based compensation, for the three months ended December 31, 2025, compared to $37.3 million, which includes $19.7 million of non-cash stock-based compensation, in the same period of 2024. For the year ended December 31, 2025, selling, general and administrative expense was $132.1 million, which includes $34.1 million of non-cash stock-based compensation, an increase of $26.2 million compared to $105.9 million, which includes $66.2 million of non-cash stock-based compensation, in the same period of 2024.

For the year, personnel costs, including hiring expense and other associated headcount costs, increased $31.3 million as the Company hired additional employees in support of its commercial launch and increased business activities. New program costs associated with commercial launch activities, including disease state education, analytics, other marketing programs, medical affairs and patient advocacy activities, increased $23.4 million. Costs for international expansion increased $3.5 million. These increases were offset by the $32.1 million reduction in stock-based compensation. Selling, general and administrative expenses are anticipated to increase as the Company continues commercialization of VYKAT XR.

The Company is obligated to make cash payments of up to a maximum of $21.2 million to the former Essentialis stockholders upon the achievement of certain commercial milestones associated with the sales of DCCR in accordance with the terms of the Company’s 2017 merger agreement with Essentialis. The fair value of the liability for the contingent consideration payable by the Company upon the achievement of commercial sales milestones of $100 million and $200 million in aggregate revenue, respectively, was estimated to be $20.3 million as of December 31, 2025, a $5.5 million increase from the estimate as of December 31, 2024. The first commercial milestone was achieved in the fourth quarter 2025 and $7.0 million will be paid in the first quarter 2026.

Total other income, net, was $3.8 million for the three months ended December 31, 2025, compared to total other income, net, of $3.1 million in the same period of 2024. For the year, total other income, net, was $11.5 million for 2025, compared to $11.8 million for 2024.

For the year ended December 31, 2025, net income was approximately $20.9 million, or $0.40 per basic and $0.39 per diluted share, compared to a net loss of $(175.9) million, or $(4.38) per basic and diluted share, for the same period of 2024.

Conference Call and Webcast Information

Soleno management will host an investor conference call and webcast to discuss its fourth quarter and full-year 2025 financial and operating results and provide an update on the U.S. launch of VYKAT XR today, February 25, 2026, at 4:30pm ET. Details can be found below:

About PWS
Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in the gene expression on chromosome 15. The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The defining symptom of PWS is hyperphagia, a chronic and life-threatening condition characterized by an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behavior problems, and a lack of normal satiety, which can severely diminish the quality of life for individuals with PWS and their families. Hyperphagia can lead to significant mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior) and longer term, co-morbidities such as diabetes, obesity, and cardiovascular disease.

INDICATION
VYKAT XR (diazoxide choline) extended-release tablets is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).

IMPORTANT SAFETY INFORMATION

Contraindications
Use of VYKAT XR is contraindicated in patients who have a known hypersensitivity to diazoxide, other components of VYKAT XR, or to thiazides.

Warnings and Precautions

Hyperglycemia
Hyperglycemia, including diabetic ketoacidosis, has been reported. Before initiating VYKAT XR, test fasting plasma glucose (FPG) and HbA1c; optimize blood glucose in patients who have hyperglycemia. During treatment, regularly monitor fasting glucose (FPG or fasting blood glucose) and HbA1c. Monitor fasting glucose more frequently during the first few weeks of treatment in patients with risk factors for hyperglycemia.

Risk of Fluid Overload
Edema, including severe reactions associated with fluid overload, has been reported. Monitor for signs or symptoms of edema or fluid overload. VYKAT XR has not been studied in patients with compromised cardiac reserve and should be used with caution in these patients.

Adverse Reactions
The most common adverse reactions (incidence ≥10% and at least 2% greater than placebo) included hypertrichosis, edema, hyperglycemia, and rash.

Please see the full Prescribing Information, including Medication Guide.

About Soleno Therapeutics, Inc.
Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The Company’s first commercial product, VYKAT XR (diazoxide choline) extended-release tablets, formerly known as DCCR, is a once-daily oral treatment for hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome. For more information, please visit www.soleno.life.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those described in the company’s prior press releases and in the periodic reports it files with the SEC including its Annual Report on Form 10-K which it intends to release later today. The events and circumstances reflected in the company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Corporate Contact:
Brian Ritchie
LifeSci Advisors, LLC
212-915-2578

Cellectar Biosciences to Report Full Year Financial Results and Host a Conference Call on Wednesday, March 4, 2026




Cellectar Biosciences to Report Full Year Financial Results and Host a Conference Call on Wednesday, March 4, 2026

FLORHAM PARK, N.J., Feb. 25, 2026 (GLOBE NEWSWIRE) — Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced that the Company will report financial results for the full year ended December 31, 2025, and provide a corporate update on March 4, 2026, at 8:30 a.m. Eastern Time.

A replay of the corporate presentation will be available on the Events section of the Company’s Investor Relations website.

About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical radiopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments that deliver improved efficacy and better safety.

The company’s product pipeline includes its lead assets: iopofosine I 131, a PDC designed to provide targeted delivery of iodine-131 (radioisotope) for the treatment of hematologic and solid tumor cancers such as Waldenstrom’s macroglobulinemia (WM) and pediatric high grade gliomas; CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeting solid tumors, such as triple negative breast, lung and colorectal cancers; CLR 121225 (CLR 225), an actinium-225 based program targeting solid tumors with significant unmet need, such as pancreatic cancer; and proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.

Iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory WM and multiple myeloma (MM), non-Hodgkin’s lymphomas and central nervous system (CNS) lymphoma, and the CLOVER-2 Phase 1b study, targeting pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has granted iopofosine I 131 Breakthrough Therapy, six Orphan Drug, five Rare Pediatric Drug and two Fast Track Designations for various cancer indications. The European Medicines Agency (EMA) has also granted iopofosine I 131 PRIME and orphan drug designations for the treatment of WM.

For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: X, LinkedIn, and Facebook.

Investor Contact:
Anne Marie Fields
Precision AQ
212-362-1200
annemarie.fields@precisionaq.com

Rivus Pharmaceuticals Appoints Jorge Bartolome as Chief Executive Officer




Rivus Pharmaceuticals Appoints Jorge Bartolome as Chief Executive Officer

Pharmaceutical veteran with extensive late-stage development and commercial experience to lead Rivus as it advances its pipeline of oral medicines that leverage energy expenditure for the treatment of MASH, obesity, and associated cardiometabolic diseases

CHARLOTTESVILLE, Va. and SOUTH SAN FRANCISCO, Calif., Feb. 25, 2026 (GLOBE NEWSWIRE) — Rivus Pharmaceuticals Inc., a clinical-stage biopharmaceutical company dedicated to treating MASH, obesity, and associated cardiometabolic diseases, today announced the appointment of Jorge Bartolome as Chief Executive Officer and member of the Board. He succeeds Allen Cunningham, a co-founder who will move to the role of Chief Operating Officer.

Mr. Bartolome has over 25 years of leadership experience in the pharmaceutical and biotechnology industry. With a proven track record of building high-performing organizations, he brings extensive leadership experience in late-stage clinical development, commercial launch, and sales and marketing. Before joining Rivus, he served as Chief Executive Officer and Director of AreteiaTx and earlier served as President of Janssen Canada (Johnson & Johnson) and held increasingly senior positions over 20 years at GSK.

“Rivus is embarking on an important stage of its journey as the company advances two potentially transformative oral medicines targeting MASH, obesity, and associated cardiometabolic diseases,” said Ian F. Smith, Co-Chair of the Board of Rivus Pharmaceuticals. “Jorge’s extensive pharmaceutical background in late-stage drug development and commercialization makes him the ideal leader for Rivus to navigate the unprecedented opportunity to treat MASH, obesity, and its co-morbidities. It is an exciting time at Rivus, a company on the forefront of the next era for obesity treatments, focused on energy expenditure and preservation of muscle for sustained metabolic health.”

“I am honored to lead this talented team as we drive Rivus forward as a company with multiple oral therapies to address the growing unmet patient needs in MASH, obesity, and associated cardiometabolic diseases,” said Jorge Bartolome, Chief Executive Officer and Director, Rivus Pharmaceuticals. “Rivus has made remarkable progress developing a best-in-class oral mitochondrial uncoupler HU6 through three Phase 2 trials that achieved their primary endpoints and demonstrated a favorable safety and tolerability profile. 2026 will be a pivotal year for Rivus as we advance HU6 in the AMPLIFY Phase 2 trial in MASH and prepare for our first clinical trial for RV-8451, our differentiated oral, muscle-preserving GLP-1, in obesity.”

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c999693b-65d5-4e13-9622-8175bc2f813a

Jorge Bartolome has over 25 years of leadership experience in the pharmaceutical and biotechnology industry. With a proven track record building high-performing organizations, he brings extensive leadership experience in late-stage clinical development, commercial launch, and sales and marketing. Previously, he served as Chief Executive Officer and Director of AreteiaTx, leading the company through positive Phase 3 trial data for a first-in-class oral therapy for asthma and COPD. Earlier, he served as President of Janssen Canada (Johnson & Johnson) after serving as Vice President, Cardiovascular business in the U.S. Mr. Bartolome began his career at GSK, serving in positions of increasing responsibility for over 20 years across North America, Asia, and Latin America, ultimately serving as Senior Vice President, Business Unit Leader in the U.S. for multiple therapeutic areas generating $8 billion in annual sales. He earned a B.A. in Economics from Duke University.

About Rivus Pharmaceuticals
Rivus Pharmaceuticals, Inc. is a clinical-stage biotechnology company advancing new oral investigational medicines for MASH (metabolic dysfunction-associated steatohepatitis), obesity, and associated cardiometabolic diseases. Rivus is developing oral small molecule therapeutics that are designed to increase energy expenditure for sustained, fat-selective, muscle-preserving weight loss. These medicines leverage validated mechanisms, including mitochondrial uncoupling and GLP-1 agonism, to address the limitations of current treatments for these chronic diseases that need new chronic treatment options. Rivus’ lead candidate HU6 is a potential best-in-class oral mitochondrial uncoupler that has demonstrated positive results in three Phase 2 clinical trials. In addition, Rivus has a research and discovery platform and is developing a pipeline of preclinical therapies, including RV-8451, a differentiated oral muscle-preserving GLP-1, for obesity. Follow Rivus on LinkedIn and X and visit www.rivuspharma.com.

CONTACT: Company Contact: 
Amy Figueroa, CFA
Rivus Pharmaceuticals
afigueroa@rivuspharma.com

Media Contact:
Matt Wright
Real Chemistry
mwright@realchemistry.com

Prime Medicine to Participate in Upcoming Investor Conferences




Prime Medicine to Participate in Upcoming Investor Conferences

CAMBRIDGE, Mass., Feb. 25, 2026 (GLOBE NEWSWIRE) — Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today announced that company management will participate in three upcoming conferences:

• TD Cowen 46^th Annual Health Care Conference: Fireside chat on Wednesday, March 4, 2026, at 1:10 p.m. ET in Boston, MA.
• 2026 Jefferies Biotech on the Beach Summit: Company management will host 1×1 meetings on Tuesday, March 10, 2026, in Miami Beach, FL.
• The Citizens Life Sciences Conference: Fireside chat on Wednesday, March 11, 2026, at 2:15 p.m. ET in Miami Beach, FL.

Live audio webcasts of the fireside chats will be available under “Events & Presentations” in the News & Events section of the Company’s website at www.primemedicine.com. Replays of each webcast will be available on the Prime Medicine website for 90 days following the event.

About Prime Medicine

Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is deploying its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated one-time curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. Taken together, Prime Editing’s versatile gene editing capabilities could unlock opportunities across thousands of potential indications.

Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: liver, lung, and immunology and oncology. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. Over time, the Company intends to maximize Prime Editing’s broad and versatile therapeutic potential, as well as the modularity of the Prime Editing platform, to rapidly and efficiently expand beyond the diseases in its current pipeline, potentially including additional genetic diseases, immunological diseases, cancers, infectious diseases, and targeting genetic risk factors in common diseases, which collectively impact millions of people. For more information, please visit www.primemedicine.com.

© 2026 Prime Medicine, Inc. All rights reserved. PRIME MEDICINE, the Prime Medicine logos, and PASSIGE are trademarks of Prime Medicine, Inc. All other trademarks referred to herein are the property of their respective owners.

Investor and Media Contacts

Gregory Dearborn
Prime Medicine
857-209-0696
gdearborn@primemedicine.com 

Hannah Deresiewicz
Precision AQ
212-362-1200
hannah.deresiewicz@precisionaq.com

BrainsWay to Report Fourth Quarter and Full Year 2025 Financial Results on March 11, 2026




BrainsWay to Report Fourth Quarter and Full Year 2025 Financial Results on March 11, 2026

BURLINGTON, Mass. and JERUSALEM, Feb. 25, 2026 (GLOBE NEWSWIRE) — BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation technologies, today announced that it will report its fourth quarter and full year 2025 financial results, as well as operational highlights, before the open of the U.S. financial markets on Wednesday, March 11, 2026. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations.

Conference Call Dial-In & Webcast Information

The conference call will be broadcast live and will be available for replay for 30 days on the Company’s website, https://investors.brainsway.com/events-and-presentations/event-calendar. Please access the Company’s website at least 10 minutes ahead of the conference call to register.

About BrainsWay
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with operations in the United States and Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.

Contacts:
BrainsWay:
Ido Marom
Chief Financial Officer
Ido.Marom@BrainsWay.com

Investors:
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com

Grace Therapeutics to Participate in the TD Cowen 46th Annual Health Care Conference




Grace Therapeutics to Participate in the TD Cowen 46th Annual Health Care Conference

PRINCETON, N.J., Feb. 25, 2026 (GLOBE NEWSWIRE) — Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced that Chief Executive Officer Prashant Kohli will participate and present in TD Cowen’s 46^th Annual Health Care Conference, to be held March 2-4, 2026 in Boston, MA.

Mr. Kohli’s presentation is schedule for March 4, 2026 at 10:30 AM Eastern Time. To register for the webcast, click here. An archived replay will be available for 90 days following the event.

In addition, Mr. Kohli will participate in one-on-one and group investor meetings.

About aneurysmal Subarachnoid Hemorrhage (aSAH)

aSAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain. A primary cause of such bleeding is the rupture of an aneurysm in the brain. The result is a relatively uncommon type of stroke (aSAH) that accounts for about 5% of all strokes and an estimated 42,500 U.S. hospital treated patients.

About GTx-104

GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for IV infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTx-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTx-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTx-104 has the potential to better manage hypotension in aSAH patients. GTx-104 has been administered in over 200 patients and healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine.

About Grace Therapeutics

Grace Therapeutics, Inc. (Grace Therapeutics or the Company) is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Grace Therapeutics’ novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Grace Therapeutic’s lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States if certain conditions are met at NDA approval, and additional intellectual property protection with over 40 granted and pending patents. Grace Therapeutics’ lead clinical asset, GTx-104, is an IV infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull.

For more information, please visit: www.gracetx.com. 

For more information, please contact:

Grace Therapeutics Contact:

Prashant Kohli
Chief Executive Officer
Tel: 609-322-1602
Email: info@gracetx.com
www.gracetx.com

Investor Relations:

LifeSci Advisors
Mike Moyer
Managing Director
Phone: 617-308-4306
Email: mmoyer@lifesciadvisors.com

Novo Nordisk and Vivtex partner to develop next-generation oral medicines for obesity and diabetes




Novo Nordisk and Vivtex partner to develop next-generation oral medicines for obesity and diabetes

• Partnership will leverage Vivtex’s proprietary technologies built to identify optimal oral formulations for peptide and protein therapeutics with improved bioavailability
• Novo Nordisk will lead global development and commercialization, and Vivtex is eligible to receive up to 2.1 billion US dollars, as well as royalties on net sales of future products
• Partnership expands Vivtex’s platform to metabolic diseases and supports Novo Nordisk’s mission to deliver scalable and innovative medicines to people with obesity and diabetes

Bagsværd, Denmark and Boston, MA, US, 25 February 2026 – Novo Nordisk and Vivtex Corporation today announced a partnership to develop next-generation oral biologic medicines for obesity, diabetes and associated comorbidities.

Under the agreement, Vivtex will license select oral drug-delivery technologies to Novo Nordisk, while Vivtex is eligible to receive upfront consideration, research funding and milestone payments totalling up to 2.1 billion US dollars, and tiered royalties on future product sales.

“Novo Nordisk has been at the forefront of innovation in protein and peptide engineering for several decades, and not least within oral formulation of peptides. We launched the first-ever oral biologic more than five years ago and have recently launched the world’s first oral biologic for obesity,” said Brian Vandahl, senior vice president, Therapeutics Discovery, at Novo Nordisk. “We continue to push the boundaries of science through both internal and external innovation to fulfil our mission of treating millions more people living with obesity and diabetes and their associated comorbidities.”

The collaboration aims to enable the oral delivery of biologic drug candidates that are traditionally limited to injectable administration due to poor absorption in the gastrointestinal tract. The partnership combines Novo Nordisk’s deep expertise in peptide and protein therapeutics with Vivtex’s proprietary gastrointestinal screening and formulation platform to identify next-generation oral therapeutics.

“Making biologics oral has been one of the most difficult challenges in drug delivery,” said Thomas von Erlach, Ph.D., CEO and co-founder of Vivtex. “Vivtex was founded to systematically solve this problem by integrating high-throughput experimentation with computational and AI-enabled analytics. Partnering with Novo Nordisk allows us to apply our platform across important metabolic disease areas, with the goal of enabling oral therapies that would otherwise require injection.”

Vivtex’s platform combines multiple proprietary gastrointestinal screening assays, drug-delivery technologies, and computational simulation and AI capabilities to optimize the oral delivery of biologic medicines. The platform is designed to achieve high oral bioavailability and consistent in-human performance.

Following research and formulation selection, Novo Nordisk will assume responsibility for global development, regulatory activities, manufacturing, and commercialization of any resulting products.

About Vivtex Corporation
Vivtex Corporation is a biotechnology company transforming the oral delivery of therapeutics. Founded by MIT scientists Drs. Thomas von Erlach, Giovanni Traverso, and Robert S. Langer, Vivtex has developed a robotics-driven platform that integrates its proprietary GI-ORIS™ high-throughput screening system — a “GI tract on a chip” — whole-gastrointestinal tissue robotic interface published in Nature Biomedical Engineering, with AI-enabled computational modeling to design and optimize orally delivered therapeutics, including biologics, for predictable human performance. The platform enables rapid screening of thousands of formulations per day and has demonstrated near-perfect correlation with human intestinal absorption, substantially outperforming conventional in vitro models. Vivtex partners with leading biotechnology and pharmaceutical companies to advance clinical programs and expand patient access to convenient, effective oral therapies.  Vivtex operates in Cambridge, Massachusetts, USA, and Schlieren, Switzerland. For more information, visit www.vivtex.com.

About Novo Nordisk
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 68,800 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, X, LinkedIn and YouTube.

Contacts for further information

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• PR260225-Vivtex.