BMEA Stock Up 9% as FDA Lifts Clinical Hold on 2 Diabetes Studies

Core Viewpoint - Biomea Fusion's shares rose by 9.1% following the FDA's decision to lift the clinical hold on its studies for BMF-219, a candidate for treating type 1 and type 2 diabetes, indicating positive regulatory progress for the company [1]. Regulatory Updates - In June 2024, the FDA had placed a full clinical hold on Biomea's phase I/II studies (COVALENT-111 and COVALENT-112) for BMF-219 due to concerns over potential drug-induced liver toxicity [2]. - The FDA's review revealed issues related to elevated liver enzymes during the Dose Escalation phase of COVALENT-111, which were possibly influenced by high doses of BMF-219 and other factors [3]. Clinical Study Insights - Biomea reported that BMF-219 has been generally well tolerated in clinical studies, with most adverse events being mild to moderate, and no serious adverse reactions identified in either COVALENT-111 or COVALENT-112 [4]. - The FDA's safety review indicated that concerning safety signals from the phase IIa portion of COVALENT-111 did not carry over to the ongoing phase IIb expansion, with no confirmed serious liver injury reported [5]. Future Expectations - The company anticipates reporting top-line 26-week data from the phase IIb portion of COVALENT-111, involving approximately 200 patients, and top-line data from the phase IIa portion of COVALENT-112, involving around 20 patients, both expected in the fourth quarter of 2024 [7]. - Biomea plans to announce a new development candidate, a selective oral small molecule GLP-1 receptor agonist, by the end of this year [7]. Pipeline Overview - In addition to diabetes, Biomea is developing BMF-219 for oncology indications, with ongoing studies (COVALENT-101 and COVALENT-102) evaluating the candidate in patients with liquid tumors and KRAS solid tumors [8]. - Biomea also has another investigational candidate, BMF-500, in development for relapsed or refractory acute leukemia, currently in an early-stage study (COVALENT-103) [9].