FDA Approves Veru’s ENTADFI Oral Capsule

Veru, Inc. (VERU), an oncology biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved its ENTADFI (finasteride and tadalafil) capsule for oral use. The capsule is designed to treat urinary tract symptoms caused by an enlarged prostate called benign prostatic hyperplasia (BPH).

ENTADFI has also shown effectiveness in treating BPH-related urinary tract symptoms, with less potential for adverse sexual side effects versus finasteride monotherapy.

Veru will market and distribute the ENTADFI capsule through its own direct-to-patient telemedicine and telepharmacy services platform. To make the treatment more affordable and accessible, the company has partnered with U.S.-based digital healthcare resource GoodRx to gain access to their almost 20 million monthly visitors, including consumers and healthcare providers, at discounted cash prices. (See Veru stock charts on TipRanks)

Official Comments

Veru CEO Mitchell Steiner said, “FDA approval of ENTADFI, a new treatment for BPH, is a significant execution milestone for Veru and an important step in expanding revenues from our commercial Sexual Health Division. We use these revenues to invest and advance our late clinical stage oncology drug pipeline portfolio as well as our global Phase 3 COVID clinical study.”

“We are in the process of augmenting our marketing and sales efforts by adding commercialization partners in the US and ex-US. 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 US prescriptions filled each year and is projected to continue to grow with an aging male population,” Steiner added.

Wall Street’s Take

Following the update, Cantor Fitzgerald analyst Brandon Folkes reiterated a Buy rating and a price target of $24 (292.8% upside potential) on the stock.

Folkes believes that the stock is undervalued at current levels.

The rest of the Street is cautiously optimistic about the stock, with a Moderate Buy consensus rating based on 2 Buys. The average Veru price target stands at $22.50 and implies upside potential of 268.25% to current levels. VERU Shares have lost 37% over the past year.

Risk Analysis

According to the new TipRanks Risk Factors tool, Veru stock is at risk mainly from three factors: Finance and Corporate, Tech and Innovation, and Legal and Regulatory, which contribute 27%, 20%, and 19%, respectively to the total 59 risks identified for the stock.