FDA临床搁置数小时后，Biomea股价暴跌62%

Shares of Biomea (NASDAQ:BMEA) plunged 62% in post-market trading Thursday on news that the FDA has placed a full clinical hold on Phase 1/2 clinical trials for the company’s drug candidate BMF-219 in the treatment of type 1 and type 2 diabetes.

The hold affects Biomea’s Phase 1/2 study COVALENT-111 for type 2 diabetes and Phase 2 study COVALENT-112 for type 1 diabetes, according to the company.

Biomea said the hold was imposed due to the level of possible drug-induced liver toxicity observed in the completed dose escalation phase of the COVALENT-111 study. The company added that no serious adverse events have been reported in the COVALENT-111 and COVALENT-112 studies.