Veru announces FDA meeting providing regulatory clarity for Enobosarm

Veru (VERU) announced a successful meeting with FDA providing regulatory clarity for enobosarm, a selective androgen receptor modulator, as a muscle preservation drug product candidate in combination with GLP-1 RA for greater weight loss for the treatment of obesity. The regulatory landscape continues to evolve for muscle preservation drugs in the treatment of obesity. Based on FDA feedback on Veru’s clinical development program for enobosarm, FDA now guides that incremental weight loss with enobosarm added to GLP-1 RA treatment over the GLP-1 RA treatment alone is an acceptable primary endpoint to support approval. FDA confirmed that enobosarm 3mg is an acceptable dosage for future Veru clinical development. Further, FDA has encouraged Veru to expand the enobosarm development program to include a younger population with obesity as younger patients could also benefit from a muscle preservation drug like enobosarm.