Veru Announces Successful FDA Meeting Providing Regulatory Clarity for Enobosarm for Muscle Preservation in Combination with GLP-1 RA for Greater Weight Loss in the Treatment of Obesity [Y...
Veru Inc. (VERU)
Last veru inc. earnings: 2/12 06:30 am
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Source: Yahoo! Finance
stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today 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. Highlights from FDA meeting 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 o
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News
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- Veru to Present Two Abstracts at ObesityWeek 2025GlobeNewswire
- Veru Announces Pricing of $25 Million Public OfferingGlobeNewswire
VERU
Earnings
- 8/12/25 - Miss
VERU
Sec Filings
- 10/30/25 - Form 8-K
- 10/30/25 - Form 424B5
- 10/29/25 - Form 424B5
- VERU's page on the SEC website