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Biotech Stocks Facing FDA Decision In September 2021

Verrica Pharmaceuticals
Verrica Pharmaceuticals

The FDA decision on Verrica Pharmaceuticals Inc.’s (VRCA) YCANTH is expected on September 23.

YCANTH is proposed for the treatment of molluscum contagiosum, a highly contagious viral skin disease that affects approximately six million people - primarily children - in the United States.

Formerly known as VP-102, YCANTH is a proprietary drug-device combination of Cantharidin administered through the company's single-use precision applicator.

This is YCANTH's second go-around with the FDA. Last July, the U.S. regulatory agency denied approval for YCANTH and sought certain aspects of the CMC (Chemistry, Manufacturing, and Controls) process for the drug/device combination, as well as Human Factors validation.

Currently, there is no approved treatment for molluscum contagiosum. If approved, YCANTH could potentially be the first product approved by the FDA to treat molluscum contagiosum.

H.C. Wainwright analyst Oren Livnat expects YCANTH to achieve peak sales of about $400 million in the indication of molluscum contagiosum.

VRCA closed Friday’s trading at $11.07, up 0.27%.