Shares of Verrica Pharmaceuticals Inc. lost more than half of their value in premarket trading Wednesday after the U.S. Food and Drug Administration once again turned away the company’s new drug application for VP-102 for the skin disease molluscum contagiosum due to issues at a contract manufacturer.
The West Chester, Pa., medical dermatology company said it received a second complete response letter from the FDA, indicating the agency won’t approve the application in its current form.
Verrica said the only deficiency the FDA listed in the letter was related to issues identified at a reinspection of Sterling Pharmaceuticals Services LLC, the contract manufacturing organization that makes Verrica’s bulk solution drug product.
Verrica said none of the issues identified by FDA during the reinspection were specific to the manufacturing of VP-102, and that while the FDA had completed its review of the application, FDA policy prevents the agency from approving the drug due to the issues at Sterling.
The FDA last September issued a complete response letter for VP-102, the company’s lead drug candidate, citing, in part, a deficiency related to the agency’s inspection of Sterling.
Verrica said it plans to file a request for a meeting with the FDA by the end of the week, adding that it is working to help Sterling address the issues the agency identified and also engaging an additional contract manufacturing organization to serve as an alternative supplier of VP-102’s bulk solution.
Verrica shares, which closed Tuesday at $5.56, were recently down 56% to $2.43 in premarket trading.