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Biotech Stocks Facing FDA Decision In December 2021

Veru
Veru

The FDA decision on Veru Inc.’s (VERU) Tadfin, proposed for the treatment of patients with benign prostatic hyperplasia, is expected in December.

Benign prostatic hyperplasia (BPH) refers to noncancerous enlargement of the prostate. This condition is common in men over 50 years of age.

Veru’s Tadfin combines 5 mg of Eli Lily’s Cialis and 5 mg of Merck’s Proscar into 1 capsule formulation.

Cialis is currently approved for treatment of BPH and erectile dysfunction and Proscar is currently approved for treatment of BPH.

The co-administration of Cialis and Proscar is currently approved by the FDA for the initial treatment of symptoms of BPH for up to 26 weeks.

If approved, Veru currently plans to launch Tadfin through third-party telemedicine sales channels or out-license the product to specialty pharmaceutical companies, thus eliminating the need for and cost of a direct sales force.

According to the company, the market potential for Tadfin in the U.S. and worldwide is expected to be over $200 million through telemedicine channels.

VERU closed Friday’s trading at $7.77, down 1.52%.