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BMEA News

Biomea Fusion Reports FY 2025 Earnings Results

Mar 24 2026seekingalpha

Biomea Fusion Reports Positive Results from Diabetes Study

Mar 14 2026Yahoo Finance

Biomea Fusion to Present at 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026

Dec 17 2025Globenewswire

Biomea Fusion Unveils Clinical Results of Icovamenib, Advancing Diabetes Treatment

Dec 10 2025Globenewswire

Biomea Fusion Unveils Clinical Results of Icovamenib, Advancing Diabetes Treatment

Dec 10 2025Newsfilter

Biomea Fusion Highlights Long-lasting Advantages of Menin Inhibitor for Type 2 Diabetes

Dec 05 2025NASDAQ.COM

Biomea Fusion Presents COVALENT-111 Study Results, New Breakthrough in Diabetes Treatment

Dec 05 2025Globenewswire

Biotech Stocks Rise After Hours: Clene Jumps Ahead of ALS Update; Werewolf, Biomea, and Dyne Also Gain

Dec 03 2025NASDAQ.COM

BMEA Events

03/31 07:20
Biomea Fusion Initiates Phase II Trials for Icavamenib
Biomea Fusion announced that the first patient has been dosed in its newly initiated Phase II programs, COVALENT-211 and COVALENT-212, evaluating icovamenib in patients with type 2 diabetes, marking a key step in advancing icovamenib into Phase II development in targeted patient populations failing standard-of-care therapies as established in the clinical trial COVALENT-111.
03/15 10:50
Biomea Fusion Presents Positive Diabetes Study Results in Barcelona
Biomea Fusion announced that Juan Pablo Frias, MD, delivered an oral presentation at the 19th International Conference on Advanced Technologies & Treatments for Diabetes in Barcelona on March 14, 2026 highlighting positive 52-week follow-up results from the Company's Phase II COVALENT-111 study evaluating the efficacy, safety, and tolerability of icovamenib in patients with type 2 diabetes. The study showed positive results, while exploratory, through Week 52 across multiple subgroups, with certain groups demonstrating statistically significant and clinically meaningful reductions in HbA1c, the gold standard for assessing glycemic control in T2D, observed nine months after dosing. In the 26-week analysis, 8 weeks of dosing was found to be less effective than 12. Accordingly, the 52-week readout primarily focused on patients in Arms B and C who received 12 weeks of treatment. Among the severe insulin-deficient patients, icovamenib achieved anHbA1c reduction that improved over time reaching 1.2% at Week 52. The strongest performing arm for this prespecified population was Arm B, with a mean HbA1c reduction of 1.5%. Severe insulin-deficient diabetes is characterized by impaired insulin secretion, the lowest beta cell function among T2D subtypes, and rapid disease progression. This group was prospectively defined prior to unblinding and represents a population with substantial unmet need.

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