03:21 PM EDT, 09/26/2024 (MT Newswires) -- Biomea Fusion ( BMEA ) shares were gaining over 5% Thursday after the US Food and Drug Administration lifted a clinical hold on the company's two phase 1/2 trials evaluating BMF-219, a covalent menin inhibitor for type 1 and type 2 diabetes treatment.
The trials, Covalent-111 and Covalent-112, are focused on evaluating the efficacy and safety of BMF-219 in treating diabetes types 1 and 2, respectively, the company said.
The FDA's review of the trial data confirmed that the earlier safety concerns, particularly from phase 2a escalation study, did not persist in the larger phase 2b expansion study, it added.
Price: 9.11, Change: +0.34, Percent Change: +3.88