By Michael Dabaie

Veru Inc. shares rose 14% to $7.14 premarket after the company said the U.S. Food and Drug Administration approved Entadfi for urinary tract symptoms caused by an enlarged prostate, called benign prostatic hyperplasia.

The oncology biopharmaceutical company focused on management of breast and prostate cancer said the Entadfi capsule for oral use has also been shown to be more effective to treat urinary tract symptoms caused by BPH with less potential for adverse sexual side effects compared to finasteride monotherapy.

Entadfi will be marketed and distributed by Veru's own direct to patient telemedicine and telepharmacy services platform. Veru has also partnered with GoodRx, a U.S. based digital resource for healthcare, to reach their almost 20 million monthly visitors, which include both consumers and healthcare providers, and offer a unique cash price to ensure the treatment is more affordable and accessible, the company said.

"We are in the process of augmenting our marketing and sales efforts by adding commercialization partners in the U.S. and ex-U.S. We expect to begin commercialization in early calendar year 2022. The treatment of BPH is an annual multi-billion dollar market with over 45 million U.S. prescriptions filled each year and is projected to continue to grow with an aging male population," Chief Executive Mitchell Steiner said.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

12-13-21 0906ET