FDA Extends Review Period for Verrica Pharmaceuticals’ VP-102 Drug Application


Verrica Pharmaceuticals Inc. (VRCA) revealed that the U.S. Food and Drug Administration (FDA) extended the review period by three months for its New Drug Application (NDA) of VP-102 for the treatment of molluscum contagiosum (molluscum), a highly contagious viral skin disease.

The Prescription Drug User Fee Act (PDUFA) goal date has also been postponed by three months to September 23, 2021. (See Verrica Pharmaceuticals stock analysis on TipRanks)

The extension has provided the agency some additional time to review the information submitted by Verrica, including its training program and distribution model, in response to comments from the agency regarding the company’s human factors study, the company said.

On May 26, the company was informed by the FDA that the information submitted has been designated a major amendment, and therefore, the FDA will take an additional three months to review the submitted information.

Verrica’s CEO Ted White commented, “We remain confident in VP-102 as a potential treatment option for patients with molluscum. Importantly, the FDA has recently completed one of the two pre-approval inspections required for approval. We look forward to our continued productive discussions with the FDA as it completes its review of our VP-102 NDA.”

On May 13, RBC Capital analyst Daniel Busby initiated coverage on the stock with a Buy rating and a price target of $19 (80.1% upside potential).

Busby believes that Verrica’s main product, YCANTH can supplant compounded cantharidin in “several important dermatology markets”. The analyst predicts total sales of $500 million for YCANTH across three indications and considers the current stock price a favorable entry point.

Overall, the stock has a Strong Buy consensus rating based on 4 unanimous Buys. The average analyst price target of $21 implies 99% upside potential from current levels. Shares of VRCA have jumped 15.2% over the past six months.

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