SAN CARLOS, Calif., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced that Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member, will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026 from 5:15 PM to 5:55 PM Pacific Time. Additionally, Biomea’s management team will host one-on-one meetings throughout the conference, which will take place from January 12-1 ...

Core Opinion - The interview with Dr. Ralph DeFronzo emphasizes the potential of icovamenib as a promising therapy for diabetes, particularly in restoring beta cell function and addressing unmet medical needs in insulin-deficient diabetes patients [1][4]. Company Overview - Biomea Fusion, Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for diabetes and obesity, with icovamenib being a key investigational product [11]. - The company aims to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions [11]. Product Insights - Icovamenib is described as an investigational, orally bioavailable, potent, and selective covalent inhibitor of menin, which plays a crucial role in regulating beta cell quantity and function [6]. - The proposed mechanism of action for icovamenib involves selective and partial inhibition of menin, potentially enabling the proliferation and preservation of healthy insulin-producing beta cells [6][7]. Clinical Research - Dr. DeFronzo discussed the mechanistic rationale for menin inhibition and shared clinical insights from the COVALENT-111 study, highlighting the potential of icovamenib in combination with GLP-1 based therapies to improve glycemic control and insulin secretion [2][3]. - Long-term follow-up data from clinical studies suggest that icovamenib could serve as a disease-modifying therapy for diabetes [3]. Market Context - There are currently over 60 therapies available for type 2 diabetes, but none have demonstrated the ability to restore beta cell mass and function, indicating a significant unmet need in the market [4]. - The prevalence of diabetes is rising, with estimates suggesting that about 38 million people in the U.S. have diabetes, and 98 million adults have prediabetes, highlighting the urgent need for effective treatments [9].

SAN CARLOS, Calif., Dec. 05, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced that it presented COVALENT-111 study results at the 23rd WCIRDC which took place December 3-6, 2025 in Los Angeles, California. The data showed durable glycemic and c-peptide improvements with icovamenib, a menin inhibitor targeting beta-cell restoration in insulin deficient type 2 diabetes. “I am very pleased ...

Core Insights - Several biotech and therapeutics companies experienced significant gains in after-hours trading on December 2, 2025, driven by corporate updates, investor anticipation, and scientific disclosures [1] Company Updates - Clene Inc. (CLNN) shares surged 8.53% to $10.05 after a regular session close of $9.26, following the announcement of an upcoming update on its CNM-Au8 program for ALS, which is expected to boost investor optimism [2] - Werewolf Therapeutics, Inc. (HOWL) advanced 6.12% to $0.91, recovering from a decline, as investors reacted to the company's presentation at the Society for Immunotherapy of Cancer's Annual Meeting and its narrower Q3 net loss of $16.4 million compared to the previous year [3] - Biomea Fusion, Inc. (BMEA) gained 7.31% to $1.03 after announcing its selection for an oral presentation at the 23rd World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease, showcasing advancements in metabolic disease research [4] - Denali Therapeutics Inc. (DNLI) rose 3.14% to $18.40 despite no new news, indicating steady investor interest in the neurodegenerative disease sector [5] - TScan Therapeutics, Inc. (TCRX) added 3.97% to $0.99, recovering from a drop, with Q3 revenue growth reported at $2.5 million, up from $1.0 million a year earlier, despite widening net losses to $35.7 million [6] - Nyxoah SA (NYXH) climbed 4.03% to $4.90, following an increase in insider voting rights to 10.14%, reflecting growing insider ownership [7] - Dyne Therapeutics, Inc. (DYN) rose 4.80% to $20.95, despite widening net losses to $108.0 million in Q3, compared to $97.1 million a year earlier, as it advances its muscle disease therapy pipeline [8] - Outlook Therapeutics, Inc. (OTLK) gained 3.83% to $1.90, with no new updates but reflecting investor positioning ahead of regulatory milestones for its ophthalmic drug candidate [9]

Core Insights - Biomea Fusion, Inc. has been selected for an oral presentation of its long-term icovamenib follow-up data at the 23rd World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC) in December 2025, highlighting the significance of its research in diabetes treatment [1][2] Company Overview - Biomea Fusion is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies, including icovamenib and BMF-650, targeting diabetes and obesity, which are significant global health challenges affecting nearly half of Americans and one-fifth of the world's population [5] Product Details - Icovamenib is an investigational, orally bioavailable, potent, and selective covalent inhibitor of menin, aimed at restoring insulin-producing beta cells in patients with insulin-deficient type 2 diabetes, potentially representing a novel treatment option [4] Presentation Details - The oral presentation of the COVALENT-111 study, which discusses the durable glycemic and C-Peptide improvements with icovamenib, is scheduled for December 5, 2025, from 6:15 pm to 7:45 pm PST [3]

Core Insights - Biomea Fusion, Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for diabetes and obesity [2] - The company will participate in two upcoming investor conferences, providing opportunities for engagement with investors [1][4] Company Overview - Biomea Fusion is advancing therapies such as icovamenib, a selective menin inhibitor for diabetes, and BMF-650, a next-generation oral GLP-1 receptor agonist for obesity [2] - The company's mission is to deliver transformative treatments for patients with diabetes, obesity, and related conditions, addressing a significant global health challenge [2] Upcoming Events - Biomea will participate in the Piper Sandler 37th Annual Healthcare Conference on December 2, 2025, with a fireside chat at 8:00 AM (EST) and one-on-one meetings [4] - The company will also take part in the 8th Annual Evercore Healthcare Conference on December 3, 2025, with a fireside chat at 7:30 AM (EST) [4]

Summary of Biomea Fusion Conference Call Company Overview - **Company**: Biomea Fusion (NasdaqGS:BMEA) - **Industry**: Biotechnology, focusing on metabolic diseases, specifically diabetes and obesity [14][15] Core Points and Arguments Metabolic Disease Focus - Biomea is positioned in the metabolic space, targeting diabetes and obesity, which are identified as significant health challenges [14][15] - The company aims to address the root causes of diabetes by focusing on insulin deficiency rather than just symptom management [19][20] Product Development - **Icovamenib**: A menin inhibitor designed to regenerate beta cells in the pancreas, targeting insulin-deficient patients [21][22] - The drug aims to provide a more effective treatment for diabetes by addressing the underlying issue of insufficient insulin production [20][21] - **Next-Generation GLP-1 Receptor Agonist**: Biomea is developing an oral GLP-1 receptor agonist based on the orforglipron scaffold, which aims to improve patient compliance and efficacy [23][41] Clinical Trials and Data - The company is preparing for Phase 2 trials, focusing on insulin-deficient patients and those failing GLP-1 therapy [40][41] - Initial data from trials show promising results, with a significant reduction in HbA1c levels and weight loss in patients [27][50] - The company plans to release data in Q1 of the following year, with expectations of enrolling patients quickly [31][41] Safety and Efficacy - Biomea emphasizes a favorable safety profile for icovamenib, with minimal side effects compared to placebo [26][27] - The company has a safety database covering over 400 patients, which is considered sufficient for regulatory discussions with the FDA [44][45] Future Directions - Biomea is exploring additional applications for icovamenib in obesity and Type 1 diabetes, indicating a broader potential for the drug beyond its initial indications [51][57] - The company is focused on refining dosing instructions to minimize variability in trial results [30][36] Important but Overlooked Content - The discussion highlights the innovative approach of icovamenib in directly targeting menin, contrasting with other menin inhibitors that focus on preventing protein interactions, which may lead to side effects [25][26] - The potential for icovamenib to enhance the effects of existing GLP-1 therapies, leading to greater weight loss and improved metabolic outcomes, is a significant point of interest [50][51] - Biomea's strategic focus on a defined patient population (insulin-deficient and GLP-1 failing patients) is crucial for its clinical development and regulatory strategy [39][40]

Core Insights - Biomea Fusion, Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for diabetes and obesity [3] - The company will participate in the Jefferies London Healthcare Conference on November 17, 2025, including a fireside chat and one-on-one meetings [1] - Biomea's key products include icovamenib, a selective menin inhibitor for diabetes, and BMF-650, a next-generation oral GLP-1 receptor agonist for obesity [3] Company Overview - Biomea Fusion aims to address cardiometabolic disorders, which affect nearly half of Americans and one-fifth of the global population [3] - The company's mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions [3]

Core Insights - Biomea Fusion, Inc. presented two late-breaking posters at ObesityWeek® 2025, showcasing preclinical data for its investigational drugs BMF-650 and icovamenib [1][2] Group 1: BMF-650 - BMF-650 is an oral small-molecule GLP-1 receptor agonist currently in Phase I study, with 28-day weight loss data expected in the first half of 2026 [5] - In preclinical studies, BMF-650 demonstrated potent weight loss effects, achieving a 12-15% body weight reduction in obese cynomolgus monkeys after 28 days of daily oral dosing [8] - The drug showed strong oral bioavailability of 33% in rats and 54% in monkeys, exceeding that of orforglipron under matched conditions [8] Group 2: Icovamenib - Icovamenib, a covalent menin inhibitor, was tested in combination with low-dose semaglutide in ZDF rats, showing superior weight loss and glycemic control compared to semaglutide alone [7] - The combination treatment resulted in a 60% lower fasting blood glucose compared to semaglutide alone and a greater improvement in insulin sensitivity, with a 75% lower HOMA-IR [9] - Clinical evaluation of icovamenib is set to begin in T2D patients currently on GLP-1 based treatment, with the first patient expected to be dosed in the first quarter of 2026 [10] Group 3: Company Overview - Biomea Fusion focuses on developing oral small molecule therapies for diabetes and obesity, targeting metabolic disorders affecting a significant portion of the global population [13] - The company's mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions [13]

Core Insights - Biomea Fusion, Inc. has made significant advancements in its diabetes and obesity programs, particularly with icovamenib showing durable results in a 52-week Phase II study and BMF-650 entering Phase I clinical trials [1][5][8] - The company raised approximately $68 million through public offerings, extending its cash runway into the first quarter of 2027 [1][6] Icovamenib Developments - Icovamenib, an oral small molecule menin inhibitor, demonstrated a sustained 1.5% mean reduction in HbA1c at Week 52 in patients with severe insulin-deficient diabetes [5] - The drug was well tolerated, with no serious adverse events reported during the 52-week observation period [5] - Preclinical data presented at the EASD Annual Meeting showed enhanced glycemic control and body weight reduction when icovamenib was combined with semaglutide in a T2D animal model [5] BMF-650 Progress - BMF-650, a next-generation oral small molecule GLP-1 receptor agonist, has dosed its first patient in a Phase I study, which will evaluate its weight loss potential in obese volunteers [1][4][8] - Preclinical findings indicated that BMF-650 led to significant reductions in food intake and body weight in obese nonhuman primates [5] Financial Performance - For Q3 2025, Biomea reported a net loss of $16.4 million, a decrease from a net loss of $32.8 million in Q3 2024 [11][12] - Research and development expenses were $14.4 million for Q3 2025, down from $27.2 million in the same period of 2024, reflecting a year-over-year decrease of over 50% in operating expenses [11][12] - As of September 30, 2025, the company had cash, cash equivalents, and restricted cash totaling $47 million [11][19] Key Milestones - The initiation of Phase IIb trial (COVALENT-211) in severe insulin-deficient T2D patients is expected in Q4 2025, with the first patient expected to be dosed in Q1 2026 [10] - The ongoing Food Effect Study (COVALENT-121) aims to optimize dosing criteria for icovamenib and is expected to be completed by December 2025 [10]