Welcome to our dedicated page for Biomea Fusion news (Ticker: BMEA), a resource for investors and traders seeking the latest updates and insights on Biomea Fusion stock.
Biomea Fusion, Inc. reports clinical and corporate developments for a clinical-stage biopharmaceutical company focused on oral small-molecule therapies for diabetes, obesity and related metabolic diseases. Its updates center on icovamenib, an investigational oral covalent menin inhibitor being evaluated in type 1 and type 2 diabetes, and BMF-650, an investigational oral GLP-1 receptor agonist candidate for obesity.
Recurring announcements include COVALENT trial results and study initiations, measures of beta-cell function, C-peptide, glycemic control and safety, scientific presentations at diabetes and metabolic-disease meetings, investor-conference activity, and periodic financial results with pipeline updates.
Biomea Fusion (Nasdaq:BMEA) reported new icovamenib data at the ADA 86th Scientific Sessions and expanded its Phase I BMF-650 study.
Clinical and translational results show improved HbA1c and C-peptide in T1D/T2D, activation of metabolic pathways linked to fat loss and muscle preservation, and support for combination with GLP-1 RAs. An added BMF-650 cohort will test rapid titration (200→400 mg QD) and weight-loss potential, with 28-day data expected in Q3 2026.
Biomea Fusion (Nasdaq:BMEA) will collaborate with the University of Leicester to evaluate investigational menin inhibitor icovamenib plus semaglutide in obesity within the OPAL platform trial. The randomized, double-blind arm will study body weight, composition, muscle health, physical function, and metabolic outcomes in overweight or obese adults without type 2 diabetes.
Biomea Fusion (Nasdaq:BMEA) reported first quarter 2026 results and pipeline progress in diabetes and obesity.
Chronic toxicology studies for icovamenib were completed, Phase II T2D trials (COVALENT-211/212) are enrolling, and 52-week Phase II T1D data showed preserved C-peptide with favorable safety. Phase I BMF-650 obesity trial is ongoing. Cash was $45.1M with runway into Q1 2027; Q1 net loss was $12.4M, with R&D and G&A expenses significantly lower year-over-year.
Biomea Fusion (Nasdaq: BMEA) announced three late-breaking poster presentations of icovamenib at the American Diabetes Association 86th Scientific Sessions, June 5–8, 2026 in New Orleans. Presentations cover type 1 and type 2 diabetes and mechanisms supporting beta cell function and metabolic health.
All posters will be embargoed until June 5, 2026 at 6:30 PM CT and then posted on Diabetes journal and Biomea’s Investors & Media site. Session dates and presenters are scheduled for June 7, 2026.
Biomea Fusion (NASDAQ: BMEA) reported positive 52-week Phase 2 COVALENT-112 results for icovamenib in type 1 diabetes. In patients diagnosed 0–3 years, 200 mg produced a 52% mean C-peptide AUC increase at Week 12 (p < 0.001; n=5), with durability through Week 52 (~7% decline from baseline). Dose response favored 200 mg versus 100 mg. C-peptide was generally preserved in 3–15 year patients (n=9). Icovamenib was generally well tolerated. Enrollment was interrupted by an FDA clinical hold that was later resolved; planned Part 2 placebo-controlled study was not completed.
Full dataset to be presented at ADA; company call April 28, 2026.
Biomea Fusion (Nasdaq: BMEA) dosed the first patient in two Phase II studies, COVALENT-211 and COVALENT-212, evaluating icovamenib in distinct type 2 diabetes populations failing standard-of-care therapies.
Each ~60-participant study (2:1 randomization) tests 100 mg once daily for 12 weeks with Week 26 primary endpoints; topline 26-week data from both studies are anticipated in 4Q 2026.
Biomea Fusion (Nasdaq: BMEA) reported full-year 2025 results and clinical progress on March 24, 2026. Key items: cash $56.2M and projected runway into Q1 2027; net loss $61.8M (2025) vs $138.4M (2024); R&D spend down to $62.0M.
Clinical advances include durable 52-week HbA1c reductions of 1.2% after a 12-week icovamenib course, initiation of two Phase II studies with topline data expected Q4 2026, and Phase I BMF-650 weight data expected Q2 2026.
Biomea Fusion (Nasdaq: BMEA) will participate in three investor conferences in Feb–Mar 2026. Presentations and investor meetings are scheduled at Oppenheimer (virtual) on Feb 26, 2026 at 10:00 AM EDT, Citizens (Miami) on Mar 10, 2026 at 2:50 PM EDT, and BMO Metabolic Health Summit (panel) on Mar 24, 2026 at 11:00 AM EDT.
An audio webcast and replay will be available via the company’s News & Events page under Investors & Media.
Biomea Fusion (Nasdaq: BMEA) outlined 2026 priorities focused on advancing icovamenib and BMF-650. Icovamenib, a potential first-in-class covalent menin inhibitor, showed durable glycemic benefit at 52 weeks after a 12-week regimen and completed a 60-participant food-effect study with optimal exposure when dosed within 30 minutes after a meal. Chronic toxicology studies in two species were completed and >400 subjects have been dosed. BMF-650, an oral next-generation GLP-1 receptor agonist, will report 28-day weight-loss data from Phase I in Q2 2026. Company expects Phase II enrollments in Q1 2026 and HbA1c readouts in Q4 2026.
Biomea Fusion (Nasdaq: BMEA) announced that Mick Hitchcock, Ph.D., Interim CEO and board member, will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026 from 5:15 PM to 5:55 PM PT. Management will also host one-on-one meetings during the conference running January 12–15, 2026.
A live audio webcast of the presentation will be available on the company's Investors & Media website, with a replay posted after the live event.