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 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.
Biomea Fusion (Nasdaq: BMEA) announced a KOL interview and WCIRDC 2025 presentation on Dec 9, 2025 featuring Dr. Ralph DeFronzo discussing menin inhibitors and the company’s candidate icovamenib.
Dr. DeFronzo reviewed mechanistic rationale, clinical insights from COVALENT-111, long‑term follow‑up data, and emerging combination data with GLP‑1 therapies. The interview is on the astr<60 platform and the WCIRDC Session 12 presentation is available on‑demand.
Biomea Fusion (NASDAQ: BMEA) presented COVALENT-111 results at WCIRDC (Dec 3-6, 2025) showing durable glycemic and C‑peptide improvements with icovamenib, a selective menin inhibitor for insulin‑deficient type 2 diabetes. Data reported durable and continuous treatment effect at week 52 (9 months post last dose), exposure‑response for HbA1c, improved long‑term insulin secretion, benefit in prior GLP‑1 “failures,” and generally good tolerability with no related serious adverse events or AE‑related discontinuations. The abstract will appear in Metabolism: Experimental and Clinical and the presentation will be posted on Biomea Fusion’s investor relations site.