Biomea’s Early-Stage Diabetes Drug Placed on Full Clinical Hold, Stock Plummets

1. FDA Imposes Clinical Hold: The FDA has placed a full clinical hold on Biomea Fusion's Phase 1/2 trials for its early-stage diabetes drug, BMF-219, due to concerns over liver toxicity.
2. Stock Crash: Biomea's stock price plummeted by over 60% following the FDA's announcement, dropping to $4.50 from a previous high of $40.
3. BMF-219 Mechanism: BMF-219 is designed to stop the menin protein from blocking beta cell replication and expansion, potentially treating Type 1 and 2 diabetes.
4. Liver Toxicity Concerns: The FDA identified possible drug-induced liver damage in Type 2 diabetes patients treated in the dose-escalation portion of Biomea's phase 1/2 study.
5. Company Response: Biomea is collaborating with the FDA to resolve the issue and plans to continue collecting safety and efficacy data during the hold.
6. Financial Concerns: Biomea had $145.3 million in cash at the end of March but warned investors that it may need to raise more funds to continue operations.