By Chris Wack

Veru Inc. shares were down 6% to $5.16 Monday after the company said the U.S. Food and Drug Administration granted fast track designation to the Phase 3 registration program for the investigation of enobosarm.

The stock, which was in positive territory premarket, hit a 52-week low of $5.11 earlier in the session.

The company said enobosarm is a selective androgen receptor targeting agonist, for the treatment of androgen receptor positive, estrogen receptor positive, human epidermal growth factor receptor 2 negative metastatic breast cancer patients who have shown previous disease progression on a nonsteroidal AI, fulvestrant and CDK 4/6 inhibitor therapy.

FDA fast track designation aims to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to fill unmet medical needs.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

01-10-22 1303ET