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Re: DewDiligence post# 247698

Thursday, 06/06/2024 4:53:02 PM

Thursday, June 06, 2024 4:53:02 PM

Post# of 253265
BMEA -63%/AH on FDA clinical hold:

https://finance.yahoo.com/news/biomea-fusion-announces-bmf-219-200500839.html

…the Company has received notice from the U.S. Food and Drug Administration (FDA) that a full clinical hold has been placed on Biomea’s ongoing Phase I/II clinical trials of the Company’s investigational covalent menin inhibitor BMF-219 in type 2 and type 1 diabetes (COVALENT-111 and COVALENT-112), respectively.

The FDA cited deficiencies based on the level of possible drug-induced hepatotoxicity observed in the completed Dose Escalation Phase of COVALENT-111.


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