BMEA

Mean weight reduction ranged from 1.5% to 3.2% at Day 29 across Cohorts 1-4, compared with 0.1% for pooled placebo.No severe or serious TEAEs, no TEAE-related dose modifications, and no TEAE-related discontinuations among all BMF-650-treated MAD participants.A rapid one-step titration to the target dose of 400 mg QD in Cohort 5 was equally well tolerated with all TEAEs being mild, with nausea and vomiting each reported in only 12.5% of participants, supporting further evaluation of "no titration" dosing for patients.Company to host conference call on October 13 at 4:30 p.m. ET (1:30 p.m. PT). SAN CARLOS, Calif., Oct. 13, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or the "Compa

SAN CARLOS, Calif., Oct. 12, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or the "Company") (NASDAQ:BMEA), a clinical-stage biopharmaceutical company, today announced that it will report results from its Phase I GLP-131 clinical study evaluating BMF-650, an investigational next-generation oral small-molecule GLP-1 receptor agonist, on Tuesday, October 13, 2026. The Company will host a conference call and webcast at 4:30 p.m. ET (1:30 p.m. PT) to discuss the results. Conference Call and Webcast Details Biomea’s management will host a conference call and webcast on Tuesday, October 13, 2026, at 4:30 p.m. ET (1:30 p.m. PT). The live webcast will be accessible through the Investors

SAN CARLOS, Calif., Sept. 23, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or the "Company") (NASDAQ:BMEA), a clinical-stage diabetes and obesity company, today announced that it has terminated its proposed public offering of securities, previously announced on September 22, 2026. The termination results from an assessment by the Company's management that current market conditions are not conducive for an offering on terms that would be in the best interests of the Company's stockholders. No securities were sold in connection with the proposed offering. The offering was made by Biomea pursuant to a shelf registration statement on Form S-3 (File No. 333-289262) that was filed wit

424B5 - Biomea Fusion, Inc. (0001840439) (Filer)

SAN CARLOS, Calif., Sept. 22, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a clinical-stage diabetes and obesity company, announced today that it has commenced an underwritten public offering of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock. In addition, Biomea intends to grant the underwriter a 30-day option to purchase up to an additional fifteen percent (15%) of the total number of shares of common stock and pre-funded warrants in the proposed offering. All of the shares of common stock and pre-funded warrants to be sold in the proposed offering are to be sold by Biomea.

8-K - Biomea Fusion, Inc. (0001840439) (Filer)

SAN CARLOS, Calif., Sept. 03, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "Company" or "Company management") (NASDAQ:BMEA), a clinical-stage diabetes and obesity company, today announced that members of its management team will participate in the following upcoming investor conferences: Citi's 2026 Biopharma Back to School Conference: Biomea will participate in one-on-one investor meetings on September 10, 2026, in New York, NY.H.C. Wainwright 28th Annual Global Investment Conference: Biomea will present at 11:00 a.m. ET on September 15, 2026, in New York, NY. Management will also participate in one-on-one investor meetings during the conference. An audio webcast of the pre

Topline 26-week primary endpoint data from COVALENT-211 in insulin deficient type 2 diabetes ("T2D") patients who are not achieving glycemic targets despite antihyperglycemic medications anticipated in the first quarter of 2027COVALENT-212 Phase II enrollment T2D patients who are not achieving glycemic targets despite GLP-1 based therapy is still ongoing, with topline 26-week primary endpoint data anticipated in the second quarter of 2027These ongoing Phase II diabetes trials target two distinct T2D populations that demonstrated durable glycemic improvements following 12 weeks of icovamenib treatment in COVALENT-111 SAN CARLOS, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc.

10-Q - Biomea Fusion, Inc. (0001840439) (Filer)

8-K - Biomea Fusion, Inc. (0001840439) (Filer)

Enrollment ongoing for the Phase II COVALENT-211 clinical trial in patients with insulin deficiency in Type 2 diabetes ("T2D"); data expected in the first quarter of 2027Enrollment also ongoing for the Phase II COVALENT-212 clinical trial in patients with T2D not achieving glycemic targets while on glucagon-like peptide-1 receptor agonists ("GLP-1 RA")-based therapy; data expected in the second quarter of 2027Phase I GLP-131 (BMF-650) obesity clinical trial on track with initial 28-day weight reduction data expected in the third quarter of 2026Research collaboration initiated with the University of Leicester to evaluate icovamenib in combination with semaglutide in a Phase II clinical trial

4 - Biomea Fusion, Inc. (0001840439) (Issuer)

4 - Biomea Fusion, Inc. (0001840439) (Issuer)

4 - Biomea Fusion, Inc. (0001840439) (Issuer)

4 - Biomea Fusion, Inc. (0001840439) (Issuer)

8-K - Biomea Fusion, Inc. (0001840439) (Filer)

•Translational data presented at ADA demonstrate icovamenib's potential to promote muscle preservation and fat reduction, supporting its broader therapeutic utility in obesity and diabetes, including as a complementary therapy alongside GLP-1 receptor agonists to enhance metabolic health outcomes • Clinical data presented at ADA from COVALENT-112 show improvements in HbA1c and C-peptide in type 1 diabetes patients treated with icovamenib, with no evidence of immune activation, and inflammatory markers stable or reduced • Additionally, the Company expanded its Phase I BMF-650 study to evaluate a rapid one-step titration and enhanced weight loss potential with its oral GLP-1 receptor agonist

Collaboration will Assess the Potential Impact of the Combination of Icovamenib and Semaglutide on Physical Function, Body Weight, Body Composition, Muscle Health and Metabolic OutcomesLate-Breaking Preclinical Findings at the American Diabetes Association Annual Meeting June 5-8 Highlighting Potential Mechanisms through which Icovamenib may Support Metabolic Health SAN CARLOS, Calif., June 03, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea," "Biomea Fusion" or "the Company") (NASDAQ:BMEA), a clinical-stage diabetes and obesity company, today announced a collaboration with the University of Leicester as part of the ongoing platform research study titled Investigating and Optimizing

SAN CARLOS, Calif., May 12, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion") (NASDAQ:BMEA), a clinical-stage diabetes and obesity company, today announced that management will participate in the following investor conferences: H.C. Wainwright 4th Annual BioConnect Investor Conference: Biomea will participate in a fireside chat from 3:00–3:30 PM ET and in one-on-one meetings on May 19, 2026, in New York, NY.2026 Jefferies Global Healthcare Conference: Biomea will participate in a fireside chat from 8:10–8:40 AM ET and in one-on-one meetings on June 4, 2026, in New York, NY. An audio webcast of the fireside chats will be available here or by visiting the News & Ev

10-Q - Biomea Fusion, Inc. (0001840439) (Filer)

8-K - Biomea Fusion, Inc. (0001840439) (Filer)

Successfully completed chronic toxicology studies for icovamenib, providing the nonclinical support for advancing to chronic clinical dosing, beyond the 12-week clinical dosing that has been used to dateTopline data reported from the Phase II COVALENT-112 clinical trial of icovamenib in type 1 diabetes ("T1D"), supporting proposed mechanism of actionFirst patients dosed in the Phase II COVALENT-211 and COVALENT-212 clinical trials of icovamenib in type 2 diabetes ("T2D"); both trials are on track with topline 26-week data expected in the fourth quarter of 2026The Phase I GLP-131 (BMF-650) obesity clinical trial is on track; initial 28-day weight reduction data expected in the second quarter

SAN CARLOS, Calif., May 05, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (NASDAQ:BMEA), a clinical-stage diabetes and obesity company, today announced that three icovamenib abstracts have been selected for late-breaking poster presentations at the American Diabetes Association (ADA) 86th Scientific Sessions, taking place June 5–8, 2026 in New Orleans. The presentations include data from icovamenib, the Company's investigational oral menin inhibitor, across both type 1 and type 2 diabetes, highlighting its potential to improve beta cell function and support metabolic health. Presentation Details Title: Glycemic Improvements with Icovamenib in

8-K - Biomea Fusion, Inc. (0001840439) (Filer)

A 52% increase from baseline in mean C-peptide AUC at Week 12 in patients diagnosed within 0–3 years (n=5) receiving icovamenib 200 mg, with a clear dose response observed vs 100 mg (n=6)Persistence observed through Week 52, with mean C-peptide AUC largely preserved in 200 mg group (~7% decline from baseline) following only 12 weeks of dosingPreservation of C-peptide also observed in patients diagnosed between 3-15 years (n=9)Icovamenib was generally well tolerated across all dosing arms and demonstrated a favorable safety and tolerability profile through Week 52 Comprehensive dataset to be presented at the American Diabetes Association's (ADA) Scientific Sessions (abstract is preliminary un