Ensem Therapeutics Announces U.S. FDA IND Clearance to Initiate Clinical Development of ETX-636.

Ensem Therapeutics Inc. (ENSEM), today announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for ETX-636, a potential best-in-class novel allosteric pan-mutant-selective PI3Kα inhibitor and degrader, with its first-in-human study anticipated in the second quarter of 2025.