FDA Hold on Diabetes Drug Sends Biomea Stock Plummeting Over 60%

Biomea Fusion announced Thursday that the FDA has placed a full clinical hold on all trials investigating its diabetes candidate, BMF-219, leading to a dramatic drop in the company’s stock price by more than 60% on Friday morning.

BMF-219, a menin inhibitor, is currently being studied in two Phase I/II trials targeting type 1 and type 2 diabetes. The clinical hold was prompted by the FDA citing deficiencies due to potential "drug-induced hepatotoxicity" observed during the dose escalation phase of the type 2 diabetes trial, known as COVALENT-111.

During the dose escalation phase, factors such as higher doses of BMF-219, food intake routines, medical history, and other medications “may have contributed to observed liver enzyme elevations,” according to Biomea. Despite these concerns, the majority of adverse events reported have been “mild to moderate,” and no serious adverse reactions have been identified in either the COVALENT-111 or COVALENT-112 trials.

Thomas Butler, CEO of Biomea, emphasized in a statement that BMF-219 has been “generally well tolerated” thus far. He reiterated the company's commitment to advancing the drug, citing the “totality” of the safety and efficacy data as supportive evidence. Butler also expressed respect for the FDA’s decision, underscoring the importance of patient safety as the company’s top priority. He assured that Biomea is fully collaborating with the FDA to quickly establish a plan to ensure patient safety and resume the studies once authorized.

In March 2024, Biomea revealed data from the Phase II COVALENT-111 trial which demonstrated that BMF-219 improved glycemic control while off therapy and supported enhanced pancreatic function post-treatment. Patients who were not responding to the current standard of care showed mean percent changes in HbA1C of -0.2% at 100mg with food, -0.8% at 100mg, and -1.4% at 200mg with food while on BMF-219.

Beyond its diabetes research, Biomea is also conducting early-stage trials for BMF-219 in oncology, including leukemia and lymphoma, as well as colon and lung cancer.