By Chris Wack

Veru Inc. said the U.S. Food and Drug Administration has granted Fast Track designation to the Phase 3 registration program for the investigation of enobosarm.

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.

"We are very pleased that enobosarm has received Fast Track designation from the FDA, a distinction that underscores the urgent need for new, novel, targeted therapies for this important patient population suffering from this aggressive disease," said Mitchell Steiner, chief executive of Veru Inc. "We look forward to ongoing, productive regulatory interactions with the FDA, which are further enabled with this designation."

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. Veru shares were up 6% to $5.80 in premarket trading.

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

(END) Dow Jones Newswires

01-10-22 0902ET