Biomea Fusion, Inc. BMEA saw its stock drop by 60.3% pre-market on Friday after the United States Food and Drug Administration (FDA) imposed a full clinical hold on its Phase I/II trials for BMF-219, a diabetes treatment.
What Happened: The FDA’s decision was driven by concerns over potential drug-induced hepatotoxicity observed during the Dose Escalation Phase of the trials, according to their press release. Elevated liver enzyme levels were noted, although most adverse events were mild to moderate, with no severe reactions reported.
At the time of writing, Biomea Fusion’s stock was trading at $4.470, down from $11.27 at Thursday’s close, Benzinga Pro data revealed.
The trials, COVALENT-111 and COVALENT-112, are investigating BMF-219 in type 2 and type 1 diabetes, respectively. Despite the hold, Biomea Fusion will continue to gather safety and efficacy data.
Thomas Butler, CEO and Chairman of Biomea Fusion stressed the company’s dedication to patient safety and its ongoing collaboration with the FDA to resume the studies. He highlighted BMF-219’s potential in restoring glucose-controlled insulin production and improving glycemic control.
Why It Matters: The FDA’s clinical hold on Biomea Fusion’s trials has significant implications for the company’s future. The halted trials, COVALENT-111 and COVALENT-112, are crucial for the development of BMF-219, a promising diabetes treatment. The trials had shown some positive results, including a placebo-adjusted mean reduction in HbA1c of 0.8% at Week 26 for participants in the 100 mg BMF-219 QD (without food) cohort.
Photo by Romix Image via Shutterstock
This story was generated using Benzinga Neuro and edited by Pooja Rajkumari
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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