Tag: GlobeNewswire

TAIPEI, Taiwan, and BOTHELL, Wash., Oct. 06, 2026 (GLOBE NEWSWIRE) — YD Bio Limited (“YD Bio” or the “Company”) (Nasdaq: YDES), a biotechnology company advancing DNA methylation-based cancer detection technology and ophthalmologic innovations, today announced that the Company and EG BioMed Co., Ltd., a Taiwan registered company (“EG BioMed”), officially launched the AI Cancer Risk Assessment (the “Assessment”), an online assessment that organizes an individual’s self-reported health information into a personalized report in English and Chinese, covering ten cancer types with promotional pricing of US$10.

The Assessment is based on a 52-question health survey covering personal and family history, symptoms, lifestyle, environmental exposures and diet. The survey takes approximately ten minutes, with a personalized report generated shortly after completion. The report provides low, moderate or high risk stratification overall and for each of ten cancer types: breast, colorectal, lung, head and neck, pancreatic, liver, endometrial, prostate, biliary tract and gastric cancer. It identifies the factors that contributed most to each result, explains why they may be relevant, and includes screening information and personalized follow-up guidance. The Assessment requires no blood draw, imaging or a clinic visit.

Assessment Methodology and Report

Responses are processed by a 48-feature pan-cancer model and ten cancer-specific models, together with a separate rule layer built from published clinical literature. This rule layer draws on more than 140 primary research studies and over 300 traceable risk estimates, with each rule tied to a source study and reported measure. The report includes the rules triggered by the user’s responses, their bases and references to the underlying medical literature.

Results are presented against the population baseline of the country the respondent selects, using age-standardized incidence rates. The accompanying screening information also reflects guidance issued by a particular country, as applicable (currently, the United States, Canada and Taiwan). Where a country has no national recommendation for a given cancer, the report says so rather than substituting another country’s advice.

Integration with the Companies’ Oncology Services

The Assessment sits upstream of the companies’ laboratory and clinical services. EG BioMed US Inc. (“EG BioMed US”) operates a CLIA-certified and CAP-accredited laboratory in Bothell, Washington, offering DNA methylation–based oncology tests as laboratory-developed tests. Its operational footprint spans 47 U.S. states, Washington, D.C., Guam, the U.S. Virgin Islands and American Samoa. In March 2026, YD Bio and EG BioMed launched a nationwide telehealth platform to support decentralized access to such services.

For individuals whose Assessment indicates a denser cluster of risk factors associated with certain cancer types, the report may reference the availability of related blood tests for discussion with a physician. Whether any test is appropriate remains a decision for a licensed physician.

“Understanding personal health risk factors can be a useful starting point for more informed discussions with healthcare professionals,” said Dr. Ethan Shen, Founder, Chairman and Chief Executive Officer of YD Bio. “This Assessment brings self-reported health information and published research together in a structured, personalized report. As part of our broader oncology platform, we believe it can help individuals better understand their risk factors and discuss appropriate next steps with their physicians.”

The AI Cancer Risk Assessment is available now in English and Chinese at mdi.eg-bio.com/product/ai-cancer-risk-assessment. During the promotional period, the Assessment is offered at US$10, reduced from its regular price of US$50.

Important Disclosure about the Assessment

The AI Cancer Risk Assessment is a cancer risk-stratification and health guidance tool. It uses statistical and artificial intelligence methods applied to health information self-reported by the user. Its output does not represent the probability of developing cancer. It does not diagnose cancer and is not intended for cancer diagnosis, screening, early detection, disease prediction or treatment decision-making; it cannot replace professional medical evaluation, diagnostic testing or consultation with a qualified healthcare provider.

About EG BioMed

EG BioMed is a biotechnology and clinical services company focused on advancing early cancer detection and diagnostic solutions. YD Bio entered into a Memorandum of Understanding to merge with EG BioMed in January 2026 and is advancing the transaction, which is anticipated to close in 2026, subject to customary closing conditions, regulatory approvals, and the finalization of definitive agreements.

EG BioMed US is the U.S. clinical-laboratory subsidiary of EG BioMed and operates a CLIA-certified, CAP-accredited clinical laboratory in Bothell, Washington, focused on DNA methylation–based early cancer detection and AI-driven biomarker analytics. EG BioMed and EG BioMed US are affiliates of YD Bio.

About YD Bio Limited

YD Bio is a U.S.-anchored public biotechnology company building an integrated healthcare platform spanning regulated molecular diagnostics, clinical services, precision medicine, and life science commercialization. The Company operates DNA methylation–based oncology testing programs in the United States under a laboratory-developed test strategy and supports pharmaceutical and biotechnology partners through compliant life science distribution and clinical trial supply chain services. In addition, the Company maintains regulated ocular health commercialization operations and a consumer health distribution platform in Asia. For more information, visit ir.ydesgroup.com and follow the Company on Facebook, X, Threads, Instagram and LinkedIn.

Forward-looking statements

This press release contains 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, which are intended to be covered by the safe harbor provisions created by the U.S. Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s plans, objectives and expectations for its business, strategy, operations, and certain on-going transactions, and the potential benefit of the Assessment and any synergies with its other oncology services. Forward-looking statements are not guarantees of future performance and can be identified by words such as “aim,” “intend,” “seek,” “believe,” “designed to,” “expects,” “anticipates,” “plans,” “may,” “could,” “will” and other similar expressions. Actual results may differ materially from those expressed or implied due to a variety of factors, including consumer demand and market acceptance; competition; regulatory and labeling requirements in Taiwan and other jurisdictions; currency exchange rates; geopolitical tensions and macroeconomic conditions; and other risks and uncertainties described in YD Bio’s filings with the U.S. Securities and Exchange Commission. The Company cautions investors not to place undue reliance on such forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update any forward-looking statement, except as required by law, and encourages investors to review the risk factors in its Annual Report on Form 20-F and other SEC filings.

For investor and media inquiries, please contact:
YD Bio Limited
Investor Relations
Email: investor@ydesgroup.com

WFS Investor Relations Inc.
Email: services@wfsir.com
Phone: +1 628 283 9214

Former Gilead and Amgen executive joins Entera with over 35 years of experience advancing and commercializing impactful and blockbuster therapies

TEL AVIV, Israel, Oct. 06, 2026 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides, today announced the appointment of biopharmaceutical executive Laura Hamill to its Board of Directors, effective December 1, 2026. Ms. Hamill brings more than 35 years of global commercial, market access and business leadership experience across multiple therapeutic areas. She succeeds Yonatan Malca, who is stepping down from the Board.

“I am delighted to welcome Laura to our Board as Entera enters an important new chapter of late-stage clinical execution, commercial preparedness for EB613 and advancement of our broader pipeline,” said Miranda Toledano, Chief Executive Officer of Entera. “Laura is an exceptional leader with vast experience stewarding multi-billion dollar global therapeutic franchises. Her perspective will be invaluable as we think strategically about the potential of EB613 and our oral peptide platform.” “I would also like to express my sincere gratitude to Yonatan for his 16 years of dedicated service to Entera,” Ms. Toledano continued. “His leadership and commitment have helped guide the Company from its inception through a period of meaningful growth and transformation.”

“Entera has built a unique oral peptide pipeline with the potential to transform how important therapies are delivered to patients,” said Ms. Hamill. “I am particularly inspired by the potential of EB613 in osteoporosis and the opportunity to help millions of women preserve their bone health and maintain active, vibrant lives. I am excited to join the Board at this important stage and support Entera as it works to advance EB613 and realize the broader potential of Entera’s oral peptide platform.”

Ms. Hamill is a seasoned biopharmaceutical executive with more than 35 years of global commercial leadership experience spanning product launches, global franchise development, market access and payer strategy. Most recently, she served as Executive Vice President, Worldwide Commercial Operations at Gilead Sciences, Inc., where she led an organization of approximately 2,500 employees responsible for $22 billion in annual revenue and oversaw the transformation of the company’s global commercial operations. Prior to Gilead, Ms. Hamill spent nearly two decades at Amgen Inc. in leadership roles of increasing scope. As Senior Vice President of U.S. Commercial Business Operations, she led commercial activities and supporting functions across Amgen’s therapeutic areas, representing approximately 80% of Amgen’s revenue. She previously served as Senior Vice President of Amgen’s Intercontinental Region, overseeing 26 countries worldwide. Earlier in her Amgen career, she held leadership roles including Vice President of International Marketing and Business Operations in Switzerland and Vice President of U.S. Corporate Accounts and Reimbursement. Ms. Hamill currently serves on the Boards of Directors of Jazz Pharmaceuticals plc (Nasdaq: JAZZ), BB Biotech AG and Fate Therapeutics, Inc. (Nasdaq: FATE). She previously served on the boards of Acceleron Pharma Inc., Pardes Biosciences and Y-mAbs Therapeutics, Inc. Ms. Hamill holds a Bachelor of Business Administration in Marketing from the University of Arizona.

About Entera
Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages a disruptive and proprietary technology platform (N-Tab®) and its pipeline of first-in-class oral peptide programs. The Company’s most advanced product candidate, EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet for osteoporosis. A placebo-controlled, dose-ranging Phase 2 study of EB613 tablets (n = 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is also developing the first oral Long Acting PTH(1-34) tablet as a replacement therapy for patients with hypoparathyroidism (EB612), the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide tablet for the treatment of obesity and metabolic syndromes; and the first oral GLP-2 tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health, Inc. For more information on Entera, visit www.enterabio.com or follow us on LinkedIn, Twitter, and Facebook.

Cautionary Statement Regarding Forward Looking Statements
Various statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy, clinical development activities, collaboration arrangements and expected financial and operational results are forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

Company Contact:
IR@enterabio.com

NEW YORK, Oct. 06, 2026 (GLOBE NEWSWIRE) — LB Pharmaceuticals Inc (“LB Pharmaceuticals” or the “Company”) (Nasdaq: LBRX), a neuromedicines company dedicated to developing and commercializing high-impact therapies that address the multiple dimensions of underserved brain disorders, today announced that it will host an in-person and virtual R&D Day on Tuesday, October 27, 2026, with presentations beginning at 2:00 PM ET and a reception to follow. The event will feature Roger S. McIntyre, MD, FRCPC (University of Toronto), alongside LB management team members Heather Turner (CEO), Susan G. Kozauer (CMO), Kaya Pai Panandiker (CCO), Gad Soffer (COBO), and Joe Miller (CFO), as the Company looks ahead to its upcoming topline Phase 3 data readout in schizophrenia. To register, click here.

LB-102 is a novel, investigational, once-daily oral selective antagonist of D2, D3 and 5HT7 receptors with a unique bimodal mechanism. It is being developed by LB Pharma for the treatment of schizophrenia, bipolar depression, the adjunctive treatment of major depressive disorder, as well as other neuropsychiatric disorders, and has the potential to be the first therapy with this unique mechanism approved for neuropsychiatric disorders in the United States.

Topics will include:

• New scientific insights on LB-102’s unique mechanism of action that underlies the emerging clinical profile and potential opportunity across a wide variety of brain disorders
• Discussion of the Phase 3 trial program in schizophrenia, its upcoming topline data readout expected in the first half of 2027, and ongoing pre-commercial planning activities

A live question and answer session will follow the formal presentations.

About Roger S. McIntyre, MD, FRCPC
Dr. Roger McIntyre is currently a Professor of Psychiatry and Pharmacology at the University of Toronto. For a decade, he was recognized by Clarivate Analytics one of “The World’s Most Influential Scientific Minds”. This distinction is given by publishing the largest number of articles that rank among those most frequently cited by researchers globally in 21 broad fields of science and social science during the previous decade. Dr. McIntyre has authored/co-authored more than 1200 articles/manuscripts and has edited and/or co-edited several textbooks on mood disorders.

His research focuses primarily on characterizing the phenomenology and neurobiology of mood disorders and advancing novel therapeutics. He has been especially interested in identifying innovative, rapid acting psychotropic treatments for mood disorders, and his research has also extended into public health and implementation research at the population-based level.

Dr. McIntyre completed his medical degree at Dalhousie University. He received his Psychiatry residency training and Fellowship in Psychiatric Pharmacology at the University of Toronto.

About LB-102
LB-102 is a novel, once-daily, orally administered investigational small molecule being developed for multiple neuropsychiatric disorders.  It is a new chemical entity that has been structurally engineered with a modification to amisulpride, a widely used antipsychotic outside the United States, and has the potential to be the first benzamide antipsychotic in the United States for the treatment of neuropsychiatric disorders. LB-102 was developed with the aim of retaining amisulpride’s benefits while addressing its limitations. LB-102 is a potent and selective antagonist of D2, D3, and 5-HT7 receptors with few off-target effects and which may have broad therapeutic potential across psychosis and mood disorders. In early 2025, LB Pharmaceuticals announced positive data from a four-week placebo-controlled, double-blinded, Phase 2 trial in patients with acute schizophrenia. In this trial, LB-102 demonstrated statistically significant benefit versus placebo at all doses studied, including rapid onset of effect at week 1 and sustained benefit through the endpoint of the trial, a potentially class-leading safety profile with low rates of EPS (including akathisia), minimal sedation and few GI side effects, alongside effects on negative symptoms and cognitive performance. These data underscore LB-102’s potential to address multiple dimensions of neuropsychiatric illness. The pivotal Phase 3 NOVA-2 trial of LB-102 for acute schizophrenia and the Phase 2 ILLUMINATE-1 trial of LB-102 for bipolar 1 depression are ongoing, and a Phase 2 trial of LB-102 in adjunctive treatment of MDD is planned. The Company is also pursuing additional expansion opportunities for LB-102 including predominantly negative symptoms of schizophrenia, Alzheimer’s disease psychosis and agitation, as well as other neuropsychiatric diseases. 

About LB Pharmaceuticals

LB Pharmaceuticals is a neuromedicines company dedicated to developing and commercializing high-impact therapies that address the multiple dimensions of underserved brain disorders. The Company is building a pipeline that leverages the broad therapeutic potential of its lead product candidate, LB-102, which the Company believes has the opportunity to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. LB-102, if approved, has the potential to become a mainstay of psychiatric practice by offering a balanced clinical activity and tolerability profile that provides a potentially attractive alternative to branded and generic therapeutics for the treatment of a broad range of neuropsychiatric diseases.

Cautionary Note Regarding Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” or similar expressions are intended to identify forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the therapeutic benefits of LB-102; and the expected topline results from the Phase 3 NOVA-2 trial. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: the Company’s limited operating history and historical losses; the Company’s ability to raise additional funding to complete the development and any commercialization of LB-102; the Company’s dependence on the success of its lead product candidate, LB-102; the Company’s ability to obtain regulatory approval of and successfully commercialize its product candidate; the early stages of clinical development of the Company’s lead product candidate, LB-102; any undesirable side effects or other properties of the Company’s product candidate; that the Company may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; the Company’s ability to obtain, maintain and protect its intellectual property; and the Company’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies.

These and other risks are described more fully in the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 and its other documents to be subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Media and Investor Contact:
Ellen Rose
erose@lbpharma.us

Additional poster presentations highlight Vafseo® (vadadustat) clinical and economic data

WALTHAM, Mass., Oct. 06, 2026 (GLOBE NEWSWIRE) — Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced upcoming presentations at the American Society of Nephrology Kidney Week 2026 (ASN Kidney Week), which will take place in Denver, CO from October 21-25, 2026. U.S. Renal Care will present the results of the VOICE trial evaluating the safety of three-times-weekly vadadustat compared with an erythropoiesis-stimulating agent (ESA) in patients receiving in-center hemodialysis as a late-breaking presentation. Additionally, Akebia will have multiple poster presentations featuring its rare kidney disease pipeline, including a poster highlighting preclinical research of praliciguat in focal segmental glomerulosclerosis (FSGS), the Phase 2 trial evaluating praliciguat in FSGS, and the Phase 2 basket trial of ebribafusp alfa in complement-mediated kidney diseases. Akebia will also present posters evaluating clinical and economic outcomes associated with Vafseo® (vadadustat).

ASN Kidney Week attendees can visit Akebia at Booth #682 in the Exhibit Hall.

Late-breaking presentation by U.S. Renal Care details:

Vadadustat Three Times Weekly for the Treatment of Anemia in Patients Receiving Hemodialysis
Presenter: Geoffrey A. Block, M.D., FASN, Associate Chief Medical Officer and Senior Vice President, Clinical Research & Medical Affairs for U.S. Renal Care
Date and Time: October 23, 2026; 12:00 to 12:15 PM MT

Akebia-supported posters to be presented in the Exhibit Hall

Posters related to rare kidney disease pipeline:

Renal-Protective Effects of Praliciguat in Preclinical Models of Focal Segmental Glomerulosclerosis
Poster #: TH-PO0380
Date and Time: October 22, 2026; 10:00 AM to 12:00 PM MT

A Phase 2 Trial of Praliciguat Therapy in Patients with FSGS
Poster #: INFO18-SA
Date and Time: October 24, 2026; 10:00 AM to 12:00 PM MT

Tissue-Targeted Complement Inhibition in Rare Kidney Disease: A Phase 2 Open-Label Basket Trial of Ebribafusp Alfa
Poster #: INFO12-SA
Date and Time: October 24, 2026; 10:00 AM to 12:00 PM MT

Posters related to Vafseo® (vadadustat):

Cost Analysis of Hospitalizations for Vadadustat vs. Darbepoetin Alfa Based on the Phase 3 INNO₂VATE Trials
Poster #: FR-PO0609
Date and Time: October 23, 2026; 10:00 AM to 12:00 PM MT

Comparison of Major Adverse Cardiovascular Events with Once-Daily vs. Three-Times-Weekly Vadadustat Dosing in Patients with Dialysis-Dependent CKD
Poster #: SA-PO1096
Date and Time: October 24, 2026; 10:00 AM to 12:00 PM

Comparison Between Vadadustat Exposure (Cmax) and Major Adverse Cardiovascular Events in Patients with Dialysis-Dependent CKD
Poster #: SA-PO1097
Date and Time: October 24, 2026; 10:00 AM to 12:00 PM MT

About Akebia Therapeutics
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Waltham, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.

About Vafseo® (vadadustat) tablets
Vafseo® (vadadustat) tablets is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin, increasing hemoglobin and red blood cell production to manage anemia. Vafseo is approved for use in 37 countries.

INDICATION
VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.

Limitations of Use

• VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being.
• VAFSEO is not indicated for use:
  • As a substitute for red blood cell transfusions in patients who require immediate correction of anemia.
  • In patients with anemia due to CKD not on dialysis.

IMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat) tablets

WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS.

VAFSEO increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE).

Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels.

No trial has identified a hemoglobin target level, dose of VAFSEO, or dosing strategy that does not increase these risks.

Use the lowest dose of VAFSEO sufficient to reduce the need for red blood cell transfusions.

CONTRAINDICATIONS

• Known hypersensitivity to VAFSEO or any of its components
• Uncontrolled hypertension

WARNINGS AND PRECAUTIONS

• Increased Risk of Death, Myocardial Infarction (MI), Stroke, Venous Thromboembolism, and Thrombosis of Vascular Access
  A rise in hemoglobin (Hb) levels greater than 1 g/dL over 2 weeks can increase these risks. Avoid in patients with a history of MI, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting VAFSEO. Targeting a Hb level of greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events. Use the lowest effective dose to reduce the need for red blood cell (RBC) transfusions. Adhere to dosing and Hb monitoring recommendations to avoid excessive erythropoiesis.

• Hepatotoxicity
  Hepatocellular injury attributed to VAFSEO was reported in less than 1% of patients, including one severe case with jaundice. Elevated serum ALT, AST, and bilirubin levels were observed in 1.8%, 1.8%, and 0.3% of CKD patients treated with VAFSEO, respectively. Measure ALT, AST, and bilirubin before treatment and monthly for the first 6 months, then as clinically indicated. Discontinue VAFSEO if ALT or AST is persistently elevated or accompanied by elevated bilirubin. Not recommended in patients with cirrhosis or active, acute liver disease.

• Hypertension
  Worsening of hypertension was reported in 14% of VAFSEO and 17% of darbepoetin alfa patients. Serious worsening of hypertension was reported in 2.7% of VAFSEO and 3% of darbepoetin alfa patients. Cases of hypertensive crisis, including hypertensive encephalopathy and seizures, have also been reported in patients receiving VAFSEO. Monitor blood pressure. Adjust anti-hypertensive therapy as needed.

• Seizures
  Seizures occurred in 1.6% of VAFSEO and 1.6% of darbepoetin alfa patients. Monitor for new-onset seizures, premonitory symptoms, or change in seizure frequency.

• Gastrointestinal (GI) Erosion
  Gastric or esophageal erosions occurred in 6.4% of VAFSEO and 5.3% of darbepoetin alfa patients. Serious GI erosions, including GI bleeding and the need for RBC transfusions, were reported in 3.4% of VAFSEO and 3.3% of darbepoetin alfa patients. Consider this risk in patients at increased risk of GI erosion. Advise patients about signs of erosions and GI bleeding and urge them to seek prompt medical care if present.

• Serious Adverse Reactions in Patients with Anemia Due to CKD and Not on Dialysis
  The safety of VAFSEO has not been established for the treatment of anemia due to CKD in adults not on dialysis and its use is not recommended in this setting. In large clinical trials in adults with anemia of CKD who were not on dialysis, an increased risk of mortality, stroke, MI, serious acute kidney injury, serious hepatic injury, and serious GI erosions was observed in patients treated with VAFSEO compared to darbepoetin alfa.

• Malignancy
  VAFSEO has not been studied and is not recommended in patients with active malignancies. Malignancies were observed in 2.2% of VAFSEO and 3.0% of darbepoetin alfa patients. No evidence of increased carcinogenicity was observed in animal studies.

ADVERSE REACTIONS

• The most common adverse reactions (occurring at ≥ 10%) were hypertension and diarrhea.

DRUG INTERACTIONS

• Iron supplements and iron-containing phosphate binders: Administer VAFSEO at least 1 hour before products containing iron.
• Non-iron-containing phosphate binders: Administer VAFSEO at least 1 hour before or 2 hours after non-iron-containing phosphate binders.
• BCRP substrates: Monitor for signs of substrate adverse reactions and consider dose reduction.
• Statins: Monitor for statin-related adverse reactions. Limit the daily dose of simvastatin to 20 mg and rosuvastatin to 5 mg.

USE IN SPECIFIC POPULATIONS

• Pregnancy: May cause fetal harm. A pregnancy exposure registry is available to monitor outcomes in women exposed to VAFSEO during pregnancy. Report pregnancies to 1-844-445-3799.
• Lactation: Breastfeeding not recommended until two days after the final dose.
• Hepatic Impairment: Not recommended in patients with cirrhosis or active, acute liver disease.

Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING and Medication Guide.

Akebia Therapeutics® and Vafseo® are registered trademarks of Akebia Therapeutics, Inc.

Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com

• Secondary analysis of the Phase 3 MAESTRO-NASH trial demonstrated Rezdiffra improved histology and MRI-PDFF across common genetic variants associated with MASH progression

CONSHOHOCKEN, Pa., Oct. 06, 2026 (GLOBE NEWSWIRE) — Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today announced the publication of a pre-specified secondary analysis from the Phase 3 MAESTRO-NASH trial in the Journal of Hepatology evaluating whether common genetic risk variants associated with MASH altered patient response to Rezdiffra^® (resmetirom).

The analysis demonstrated that treatment with Rezdiffra resulted in fibrosis improvement, MASH resolution and liver fat and biomarker reductions across patients with several well-established genetic variants associated with MASH progression, including PNPLA3, HSD17B13, TM6SF2, MTARC1 and MBOAT7. The findings suggest that Rezdiffra may have a therapeutic effect regardless of genetic risk factors that contribute to more severe disease.

“Understanding how common MASH risk alleles may influence a patient’s response to treatment will be increasingly important as the treatment landscape and number of diagnosed patients continue to evolve. For example, there is emerging evidence suggesting that response to various therapies could differ in individuals with MASH carrying the PNPLA3 allele, and it will be important to perform similar analyses for other approved and investigational MASH therapies moving forward,” said Naga Chalasani, M.D., David W. Crabb Professor of Gastroenterology and Hepatology at Indiana University School of Medicine and lead author of the study. “It is encouraging to see that Rezdiffra demonstrated consistent effects on liver histology and biomarkers across the genetic risk subgroups evaluated, supporting broad applicability across patients with this serious liver disease.”

“MASH is a complex, heterogeneous disease driven by both metabolic and genetic factors,” said David Soergel, M.D., Chief Medical Officer of Madrigal. “These data reinforce that Rezdiffra provides broad benefit across patients with MASH, including those with the most common genetic risk variants that may put them at higher risk of disease progression, cirrhosis and liver cancer, strengthening its position as a foundation of MASH treatment. These results also support our pipeline strategy of developing precision approaches targeting well-defined genetic drivers of disease that may complement Rezdiffra in specific patient populations.”

About the Analysis
The publication, “Effects of select MASH risk genotypes on resmetirom efficacy on liver histology and biomarkers in patients with MASH and liver fibrosis: a secondary analysis of the MAESTRO-NASH trial,” reports results from a pre-specified secondary analysis of 738 patients from the Phase 3 MAESTRO-NASH trial who consented to genetic testing and completed baseline and Week 52 liver biopsies. The analysis was not prospectively powered to detect small genotype-by-treatment interactions, and only select common variants were assessed. Across all major efficacy endpoints, including MASH resolution, fibrosis improvement, MRI-PDFF reduction and multiple biomarkers, there was no meaningful difference in treatment response based on MASH genetic risk variants or a composite genetic risk score.

Among the findings:

• Resmetirom responses were consistent across PNPLA3, HSD17B13, TM6SF2, MTARC1 and MBOAT7 risk groups for MASH resolution, fibrosis improvement and MRI-PDFF reduction.
• The treatment effect remained consistent after accounting for sex and Hispanic ethnicity.
• Results suggested Rezdiffra’s mechanism of action as a thyroid hormone receptor-beta (THR-β) agonist is not affected by common genetic pathways associated with MASH progression and severity.
• Patients with high-risk genotypes of PNPLA3 or HSD17B13 demonstrated reduced frequency of metabolic risk factors, including diabetes and hypertension, suggesting patients with greater genetic risk could still have high stages of fibrosis, even if they had fewer traditional metabolic risk factors.
• Because this was a secondary analysis with limited numbers in some genotype groups, smaller genotype-specific effects or rarer variants cannot be excluded.
• In the overall MAESTRO-NASH trial (n=966), Rezdiffra was generally well tolerated, with the frequency of serious adverse events similar across treatment groups. See additional risk information below.

Madrigal’s R&D strategy includes developing therapies that target validated disease mechanisms and may complement Rezdiffra’s broad therapeutic effects, especially in patient populations with specific needs. In May 2026, the company announced the addition of MGL-0795 (formerly ARO-PNPLA3), a clinical-stage, small interfering RNA (siRNA) asset targeting PNPLA3 to its pipeline as a potential precision-medicine approach. Mutations in the PNPLA3 gene are strongly associated with MASH progression and a high risk of developing hepatocellular carcinoma (HCC). Madrigal will consult with the FDA on design of a Phase 2 combination trial with Rezdiffra.

In this analysis, MASH resolution in the PNPLA3 subgroup was achieved in 38.4%, 30.8% and 30.5% of Rezdiffra-treated patients, versus 12.9%, 5.1% and 11.7% in patients in the placebo group across low, intermediate and high-risk genotypes, respectively, while fibrosis improvement was 34.2%, 29.5% and 31.4% versus 14.1%, 13.7% and 15.0%, respectively.

About MASH
Metabolic dysfunction-associated steatohepatitis (MASH) is a serious liver disease that can progress to cirrhosis, liver failure, liver cancer, the need for liver transplantation and premature mortality. MASH is the leading cause of liver transplantation in women and the second leading cause of all liver transplantation in the U.S., and the fastest-growing indication for liver transplantation in Europe.

Once patients progress to MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), the risk of adverse liver outcomes increases dramatically: these patients have a 10 to 17 times higher risk of liver-related mortality as compared to patients without fibrosis.

Patients with MASH who progress to cirrhosis face a 42 times higher risk of liver-related mortality, underscoring the need to treat MASH before complications of cirrhosis develop. MASH is also an independent driver of cardiovascular disease, the leading cause of mortality for patients.

As disease awareness improves and disease prevalence increases, the number of patients diagnosed with F2 to F4c MASH is growing.

About Rezdiffra
What is Rezdiffra?
Rezdiffra is a prescribed medicine used along with diet and exercise to treat adults with metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver.

This indication is approved based on improvement of MASH and liver scarring (fibrosis). There are ongoing studies to confirm the clinical benefit of Rezdiffra.

Before you take Rezdiffra, tell your healthcare provider about all of your medical conditions, including if you:

• have any liver problems other than MASH.
• have gallbladder problems or have been told you have gallbladder problems, including gallstones.
• are pregnant or plan to become pregnant. It is not known if Rezdiffra will harm your unborn baby.
  • A pregnancy safety study for women who take Rezdiffra during pregnancy collects information about the health of you and your baby. You or your healthcare provider can report your pregnancy by visiting https://pregnancyregistry.madrigalpharma.com/ or calling 1-800-905-0324.
• are breastfeeding or plan to breastfeed. It is not known if Rezdiffra passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Rezdiffra.

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

• Rezdiffra and other medicines may affect each other, causing side effects. Rezdiffra may affect the way other medicines work, and other medicines may affect how Rezdiffra works.
• Especially tell your healthcare provider if you take medicines that contain gemfibrozil to help lower your triglycerides, because Rezdiffra is not recommended in patients taking these medicines.
• Tell your healthcare provider if you are taking medicines such as clopidogrel to thin your blood or statin medicines to help lower your cholesterol.
• Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of Rezdiffra?
Rezdiffra may cause serious side effects, including:

• liver injury (hepatotoxicity). Stop taking Rezdiffra and call your healthcare provider right away if you develop the following signs or symptoms of hepatotoxicity: tiredness, nausea, vomiting, fever, rash, your skin or the white part of your eyes turns yellow (jaundice) or stomach pain/tenderness.
• gallbladder problems. Gallbladder problems such as gallstones, or inflammation of the gallbladder, or inflammation of the pancreas from gallstones can occur with MASH and may occur if you take Rezdiffra. Call your healthcare provider right away if you develop any signs or symptoms of these conditions including nausea, vomiting, fever, or pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen to your back and the pain may happen with or without vomiting.
• The most common side effects of Rezdiffra include: diarrhea, nausea, itching, stomach pain, vomiting, dizziness and constipation.

These are not all the possible side effects of Rezdiffra. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Madrigal at 1-800-905-0324.

Please see the full Prescribing Information, including Patient Information, for Rezdiffra.

About Madrigal
Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra was the first medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). For more information, visit www.madrigalpharma.com and follow us on LinkedIn.

Forward-Looking Statements
This press release includes “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including statements related to the therapeutic effect of Rezdiffra across genetic variants associated with MASH, Madrigal’s ability to develop its pipeline and the potential benefit of Madrigal’s pipeline candidates for the treatment of MASH. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: the assumptions underlying the forward-looking statements; our ability to successfully commercialize Rezdiffra in the U.S. and Europe; risks related to obtaining and maintaining regulatory approvals, including, but not limited to, potential regulatory delays or rejections; our history of operating losses and the possibility that we may never achieve or maintain profitability; risks associated with meeting the objectives of our clinical trials, including, but not limited to our ability to achieve enrollment objectives concerning patient numbers (including an adequate safety database), outcomes objectives and/or timing objectives for our trials; any delays or failures in enrollment, and the occurrence of adverse safety events; risks related to the effects of Rezdiffra’s (resmetirom’s) mechanism of action or of any other product candidate; market demand for and acceptance of Rezdiffra; our ability to service indebtedness and otherwise comply with debt covenants; outcomes or trends from competitors; future topline data timing or results; our ability to prevent and/or mitigate cyber-attacks; our ability to protect our intellectual property rights; the uncertainties inherent in clinical testing; uncertainties concerning analyses or assessments outside of a controlled clinical trial; and changes in laws and regulations applicable to our business and our ability to comply with such laws and regulations. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Madrigal undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Madrigal’s submissions filed with the U.S. Securities and Exchange Commission (SEC) for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. Madrigal specifically discusses these risks and uncertainties in greater detail in the sections appearing in Part I, Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2025, and as updated from time to time by Madrigal’s other filings with the SEC.

Madrigal may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Madrigal’s website in addition to following its press releases, filings with the SEC, public conference calls, and webcasts.

Madrigal Pharmaceuticals, Rezdiffra^® and associated logos are trademarks of Madrigal Pharmaceuticals, Inc.

Investor Contact
Tina Ventura, IR@madrigalpharma.com

Media Contact
Krysta Pellegrino, media@madrigalpharma.com

New resource hub builds on Collegium’s growing ADHD portfolio and commitment to supporting people and families beyond the clinical setting

STOUGHTON, Mass., Oct. 06, 2026 (GLOBE NEWSWIRE) — Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading biopharmaceutical company focused on improving the lives of people living with serious and often misunderstood conditions, launched Start Talking ADHD, an online resource hub offering practical guides to people living with attention-deficit/hyperactivity disorder (ADHD), and the families who support them. The guides are designed to help patients and caregivers prepare for conversations with healthcare providers, school administrators, and the people in their support networks.

ADHD is a neurodevelopmental disorder characterized by patterns of inattention, hyperactivity and impulsivity, or a combination of both, at a level that interferes with functioning or development.¹ An estimated 7 million children and 15.5 million adults in the U.S. have ADHD.^2,3 For many people living with ADHD, the moments that matter most are also the hardest to describe like the scramble before the school bus, the homework hour, the tasks that pile up after the workday ends. Helping people identify and communicate what happens during these everyday moments can support more informed conversations about their needs.

“The clearest picture of ADHD comes from understanding how it shows up throughout the day,” said Ingrid McPhilliamy, General Manager, ADHD, Collegium Pharmaceutical, Inc. “The support that makes the biggest difference often comes from the people who see the day-to-day and building that circle takes intention. This input can be an important part of painting a more specific picture that a family can share with their care team, ultimately leading to a more productive conversation.”

ADHD Resources for Healthcare, School and Everyday Support Conversations

Start Talking ADHD includes three downloadable guides, each designed support different conversations:

• ADHD Doctor Discussion Guide. A fill-in worksheet that walks through a typical day, across mornings, daytime, afternoons, evenings and sleep, so a parent, caregiver or adult with ADHD can arrive at a healthcare appointment with concrete examples of daily experiences.
• 504 Plan/Individualized Education Program (IEP) Educational Guide. A side-by-side explanation of the 504 Plans and Individualized Education Programs (IEPs), two main pathways for school support, plus a seven-step overview of the evaluation process, a preparation checklist, a glossary of key terms, and links to resources including Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD) and the U.S. Department of Education.
• Building Your Community of Support Guide. A worksheet for mapping a personal ADHD support network across home, school and the healthcare team, plus a directory of national advocacy, caregiver, school-support and mental-wellness organizations.

These guides are educational and do not diagnose ADHD or recommend any specific treatment.

Expanding Collegium’s Commitment to ADHD

Over the last year, Collegium has expanded its presence and investment in ADHD, including adding a second medicine to its portfolio in May 2026 and extending the company’s long-term commitment.

“Leadership in ADHD starts with listening to the people who live with it and acting on what we hear,” said Vikram Karnani, President and Chief Executive Officer, Collegium Pharmaceutical, Inc. “Medicine is an important part of our work, but support extends beyond a prescription. With Start Talking ADHD, we’re providing straightforward information to help people living with ADHD and those who support them have more informed conversations with doctors, schools and each other.”

Collegium’s commitment extends into the community. In February 2026, Collegium became an Official Partner of Boston Legacy Football Club, the National Women’s Soccer League’s 15th club, sponsoring the Collegium Sensory Room at the club’s home matches. This room, designed with input from CHADD, offers a quieter space for fans who need a break from the noise, crowds and visual stimulation of a matchday. Together, Boston Legacy FC and Collegium are helping to create access to youth and family experiences across the Boston area, including local adaptive soccer clinics and player engagements.

About Collegium Pharmaceutical, Inc.

Collegium Pharmaceutical is a dynamic, biopharmaceutical company delivering medicines with formulation and delivery innovation for people living with complex central nervous system and pain conditions. Collegium has spent more than a decade proving that responsible stewardship and bold, science-backed approaches can redefine what treatment looks like in categories too often shaped by complexity and misconceptions.

With a portfolio of differentiated ADHD medications and an established leadership position in responsible pain management, Collegium leads with the scientific rigor and commercial expertise to deliver treatment options around how people live their lives. For more information, please visit collegiumpharma.com or find us on LinkedIn.

Investor Contact:
Ian Karp
Head of Investor Relations
ir@collegiumpharma.com

Media Contact:
Jessica Cotrone
Senior Vice President, Corporate Communications & Corporate Affairs
communications@collegiumpharma.com

REFERENCES

1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR). Washington, DC: American Psychiatric Association Publishing; 2022.
2. Centers for Disease Control and Prevention. Data on ADHD in Children. https://www.cdc.gov/adhd/data/index.html. Estimate based on 2024 National Survey of Children’s Health data. Accessed August 2026.
3. Staley BS, Robinson LR, Claussen AH, et al. Attention-Deficit/Hyperactivity Disorder Diagnosis, Treatment, and Telehealth Use in Adults — National Center for Health Statistics Rapid Surveys System, United States, October–November 2023. MMWR Morb Mortal Wkly Rep. 2024;73(40):890–895.

RENO, Nev., Oct. 06, 2026 (GLOBE NEWSWIRE) — Ormat Technologies, Inc. (NYSE: ORA) (the “Company” or “Ormat”), a leading geothermal and renewable energy company, today announced that it plans to publish its third quarter financial results in a press release that will be issued on Wednesday, November 4, 2026, after the market closes. In conjunction with this report, the Company has scheduled a conference call to discuss the results at 10:00 a.m. ET on Thursday, November 5, 2026.

Participants within the United States and Canada, please dial 1-833-461-5787, approximately 15 minutes prior to the scheduled start of the call. If you are calling from outside the United States or Canada, please dial +1-585-542-9983. The access code for the call is 244015737. Please request the “Ormat Technologies, Inc. call” when prompted by the conference call operator. The conference call will also be accompanied by a live webcast, accessed on the Investor Relations section of the Company’s website.

A replay will be available one hour after the end of the conference call. To access the replay within the United States and Canada, please dial 1-833-309-1852. From outside of the United States and Canada, please dial +1-929-828-5978. Please use the replay access code 244015737. The webcast will also be archived on the Investor Relations section of the Company’s website.

ABOUT ORMAT TECHNOLOGIES

With over six decades of experience, Ormat Technologies, Inc. is a leading geothermal company, and the only vertically integrated company engaged in geothermal and recovered energy generation (“REG”), with robust plans to accelerate long-term growth in the energy storage market and to establish a leading position in the U.S. energy storage market. The Company owns, operates, designs, manufactures and sells geothermal and REG power plants primarily based on the Ormat Energy Converter – a power generation unit that converts low-, medium- and high-temperature heat into electricity. The Company has engineered, manufactured and constructed power plants, which it currently owns or has installed for utilities and developers worldwide, totaling approximately 3,600MW of gross capacity. Ormat leveraged its core capabilities in the geothermal and REG industries and its global presence to expand the Company’s activity into energy storage services, solar Photovoltaic (PV) and energy storage plus Solar PV. Ormat’s current total generating portfolio is 1,850MW with a 1,355MW geothermal and solar generation portfolio that is spread globally in the U.S., Kenya, Guatemala, Indonesia, Honduras, and Guadeloupe, and a 495MW energy storage portfolio that is located in the U.S.

Ormat is the only single-solution company with tangible and proven end-to-end capabilities to commercialize, scale, and operate Enhanced Geothermal Systems. As electricity demand accelerates, driven by AI data centers, electric vehicles, industrial reshoring, and the electrification of heating and cooling, Ormat’s geothermal and EGS capabilities position the Company to help meet this growing demand and lead technological advancement in the market. The Company’s industry-leading business model and strong reputation are built on long-standing expertise, operational excellence, high-performance teams, and delivering reliable long-term energy generation.

Ormat Technologies Contact: Smadar Lavi VP, Head of IR and ESG Planning & Reporting 775-356-9029 (ext. 65726) slavi@ormat.com

Investor Relations Agency Contact: Joseph Caminiti or Josh Carroll Alpha IR Group 312-445-2870 ORA@alpha-ir.com

Company exercises options for two additional, attractively priced mid-size newbuildings delivering 4Q29

ATHENS, Greece, Oct. 06, 2026 (GLOBE NEWSWIRE) — Global Ship Lease, Inc. (NYSE:GSL) (the “Company” or “Global Ship Lease”), a containership owner and lessor, today announced that, subject to certain conditions precedent being met, the Company has exercised options to build two additional mid-size, ultra-high-reefer, wide-beam, latest-generation containerships (the “Additional Newbuilds”) for an aggregate contract price of approximately $163 million. These highly flexible ships have been designed and specified to ensure a superior fit for existing and anticipated future market needs. The Additional Newbuilds are scheduled to be delivered in the fourth quarter of 2029, and the Company is in discussions with prospective charterers regarding their employment upon delivery. With these Additional Newbuilds, the Company’s newbuilding orderbook is 17 ships.

George Youroukos, Executive Chairman of Global Ship Lease, commented: “We are strong believers in the value proposition of high specification, highly flexible, mid-sized containerships and expect them to play a crucial role for our industry for many years to come. By exercising these additional newbuild options, we are very pleased to be growing our exposure to this increasingly valuable vessel class on attractive terms agreed earlier this year and at prices no longer available in the market for comparably specified ships with 2029 deliveries.”

About Global Ship Lease 

Global Ship Lease is a leading independent owner of containerships with a diversified fleet of mid-sized and smaller containerships. Incorporated in the Marshall Islands, Global Ship Lease commenced operations in December 2007 with a business of owning and chartering out containerships under fixed-rate charters to top tier container liner companies. It was listed on the New York Stock Exchange in August 2008.

Our operating fleet of 71 containerships as of June 30, 2026, had an average age weighted by TEU capacity of 18.4 years. 41 ships are wide-beam Post-Panamax. As of June 30, 2026, our fleet also included 15 newbuilding containerships under construction with scheduled deliveries between the fourth quarter of 2028 and the first quarter of 2030 (the “Initial Newbuilds”).

As of June 30, 2026, the average remaining term of the Company’s charters, to the mid-point of redelivery, including options under the Company’s control and other than if a redelivery notice has been received, including the Initial Newbuilds, was 3.3 years on a TEU-weighted basis. Contracted revenue on the same basis was $3.2 billion. Contracted revenue was $4.1 billion, including options under charterers’ control and with latest redelivery date, representing a weighted average remaining term of 4.4 years.

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements provide the Company’s current expectations or forecasts of future events. Forward-looking statements include statements about the Company’s expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as “anticipate,” “believe,” “continue,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “will” or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. These forward-looking statements are based on assumptions that may be incorrect, and the Company cannot assure you that the events or expectations included in these forward-looking statements will come to pass. Actual results could differ materially from those expressed or implied by the forward-looking statements as a result of various factors, including the factors described in “Risk Factors” in the Company’s Annual Report on Form 20-F and the factors and risks the Company describes in subsequent reports filed from time to time with the U.S. Securities and Exchange Commission. Accordingly, you should not unduly rely on these forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events.

Investor and Media Contact: 
IGB Group 
Bryan Degnan 
646-673-9701 
or 
Leon Berman 
212-477-8438 

FORT WAYNE, Ind., Oct. 06, 2026 (GLOBE NEWSWIRE) — Fort Wayne Medical Oncology and Hematology (FWMOH), a partner practice of American Oncology Network (AON), has launched a new radiation oncology division, Fort Wayne Radiation Oncology. The Fort Wayne Radiation Oncology clinic, located at 10307 Dupont Circle Drive West, Suite B, Fort Wayne, IN 46825, is now open Monday through Friday from 8 a.m. to 4:30 p.m. Prospective patients can call 260-818-7001 with questions or to schedule an appointment.

Fort Wayne Radiation Oncology is led by Board-certified radiation oncologists Mark Ranck, MD; Nathan Comsia, MD; and Zhigang Yuan, MD, PhD; of Radiation Oncology Associates.

“We are excited to be part of Fort Wayne Radiation Oncology in collaboration with Fort Wayne Medical Oncology and Hematology,” said Dr. Ranck. “Together, we share a commitment to ensuring community oncology patients have access to comprehensive cancer care and advanced imaging and treatment technologies. Our patients can expect the same level of compassionate care they receive at Fort Wayne Medical Oncology and Hematology.”

The state-of-the-art clinic offers comprehensive radiation oncology services, access to clinical trials and cutting-edge treatments, including the latest advances in linear accelerator technology.

“We are thrilled to open this new division of Fort Wayne Medical Oncology and Hematology,” said Dr. Praveen Kollipara, Board-certified medical oncologist and hematologist at Fort Wayne Medical Oncology and Hematology. “Offering radiation oncology services expands our patients’ access to exceptional cancer care and further enhances the high-quality care we provide to our community.”

For more information about Fort Wayne Radiation Oncology, visit fortwayneradiationoncology.com. For more information about Fort Wayne Medical Oncology and Hematology, visit fwmoh.com. To learn more about American Oncology Network, visit AONcology.com.

About Fort Wayne Medical Oncology and Hematology

Fort Wayne Medical Oncology and Hematology (FWMOH) provides state-of-the-art cancer and blood disorder treatments through a team of dedicated healthcare providers serving northeastern Indiana. Since 1977, FWMOH has cared for thousands of patients, treating more than 40 types of cancer – from bladder to bone, pancreatic to prostate – as well as blood disorders such as hemophilia, sickle cell anemia, and idiopathic thrombocytopenic purpura (ITP).

FWMOH’s experience physicians, nurse practitioners, nurses, and clinical support staff work collaboratively to deliver the high-quality oncologic and hematologic care informed by cutting-edge research and decades of experience. The team emphasizes compassionate, patient-centered care that respects the needs of the whole person.

The following Board-certified physicians are accepting appointments at FWMOH: Farrukh M. Adhami, MD; Sunil Babu, MD; Matthew L. Carr, MD; Shalini Chitneni, MD; Michael Epstein, MD; Gary G. Gize, MD; Ryan Gonzales, MD; Praveen Kollipara, MD; Yasolatha Nalamolu, MD; Sreenivasa R. Nattam, MD; Dolly Rosa Quispe, MD; Steven N. Rhinehart, MD; Ahad Sadiq, MD; Naga Vutukuri, MD; Richard Zhang, MD; and David M. Zimmerman, MD. FWMOH’s gynecologic oncologists include Dr. Iwona Podzielinski and Dr. Scott Goodrich.

Learn more at fwmoh.com.

About American Oncology Network

American Oncology Network (AON) is an alliance of physicians and seasoned healthcare leaders partnering to ensure the long-term success and viability of community oncology and other specialties. Founded in 2018, AON’s rapidly expanding network represents more than 350 providers practicing across 21 states. AON pioneers innovative healthcare solutions through its physician-led model, fostering value-based care that improves patient outcomes while reducing costs and expanding access to quality care. AON equips its network physicians with the tools they need to thrive independently while providing comprehensive support, integrated revenue-diversifying ancillary services, and practice management expertise, enabling physicians to focus on what matters most – providing the highest standard of care for every patient. AON is committed to promoting health equity by addressing disparities in cancer care and ensuring that all patients have access to the care they need to achieve optimal health outcomes. With a focus on innovation and collaboration, AON is shaping the future of community oncology. For more information, please visit AONcology.com or follow us on LinkedIn, Facebook, X (formerly Twitter) and YouTube.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/6d0ed74a-81de-4508-b402-3d37efcc143a

CONTACT: Media Contact:
Karen Riley Sawyer
American Oncology Network
Karen.Sawyer@AONcology.com

Project establishes a blueprint for future deployments across additional communities managed by the Forza Esmeralda Group

NEW YORK, Oct. 06, 2026 (GLOBE NEWSWIRE) — Veea Inc., a leader in edge computing, intelligent connectivity, cybersecurity, and AI-powered edge applications, today announced the successful signing of a one-year agreement with La Estadia Community of 220 exclusive residential properties to deploy Veea’s SecureConnect™ platform and Veea Vision™ AI video analytics solution across the community’s network infrastructure.

The project will deliver a secure, managed digital infrastructure that combines enterprise-grade connectivity, cybersecurity, and AI-powered video inferencing at the edge to enhance operational efficiency, resident safety, and community management.

Under the agreement, Veea will deploy its SecureConnect platform to provide secure networking, centralized management, and advanced cybersecurity capabilities throughout the community. In addition, Veea Vision will enable intelligent video analytics through edge-based AI processing, allowing cameras to generate real-time insights while minimizing bandwidth consumption and reducing reliance on cloud-based processing.

“This deployment demonstrates how communities can modernize their infrastructure while improving security, operational visibility, and residents’ quality of life and daily experience in a residential community,” said Helder Antunes, Chief Revenue Officer of Veea. “By combining secure connectivity with AI-powered video analytics and automated personalized notifications for each residential unit, we are enabling a real-time aware community and more secure environments while reducing complexity and ongoing operational costs.”

The deployment represents the first phase of a broader strategic opportunity between Veea and Forza Esmeralda Group. The parties are currently evaluating expansion opportunities across seven additional communities managed by the group, as well as multi-year managed services agreements that would provide ongoing deployment, monitoring, maintenance, cybersecurity, and lifecycle management services.

“We didn’t want more cameras. We wanted smarter ones,” said Hector Silva, President of La Estadia Community. “With Veea, our security team gets real-time awareness instead of hours of footage to review, and our residents get a connected community they can count on. We wanted one partner who could deliver all of it on a single platform and grow with us, and Veea was that partner.”

The project highlights the growing demand for intelligent edge infrastructure within residential communities, mixed-use developments, smart buildings, and distributed properties seeking to improve security, connectivity, and operational efficiency without the complexity associated with traditional multi-vendor solutions.

Veea’s integrated platform enables organizations to converge networking, cybersecurity, IoT, edge computing, and AI applications into a single architecture managed through a centralized cloud platform.

If the initial deployment achieves its targeted objectives, the parties expect to explore expansion opportunities that could significantly increase the scope of the relationship over the coming years.

About Veea

Veea Inc. (NASDAQ: VEEA) is a global leader in edge solutions and infrastructure. Founded in 2014 and headquartered in New York City, Veea enables enterprises, service providers and public sector organizations to deploy AI-powered applications at the edge. The VeeaONE platform integrates connectivity, computing, cybersecurity and storage into a unified hyperconverged network solution, from edge to cloud. Veea holds more than 123 patents across related technology domains and has been recognized by Gartner for its innovations in edge computing. www.veea.com

Media contact

Thomas Latiolais · Veea Inc. · thomas.latiolais@veea.com

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements typically include projections of future revenues, earnings, strategies, and operational growth. These statements are based on current beliefs, assumptions and expectations and involve known and unknown risks and uncertainties that could cause actual results to differ materially from current projections due to factors including, but not limited to, market conditions, economic shifts, and operational challenges. Operational factors that could cause results to differ include Veea’s ability to maintain adequate financial resources, execute its growth strategy, achieve market acceptance, and compete effectively. Forward-looking statements may be identified by words such as “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “project,” “will” and similar expressions. Forward-looking statements speak only as of the date made. Veea disclaims any obligation to update them publicly.