Verrica Pharmaceuticals, Inc. (VRCA) Received a Complete Response Letter from the FDA relating to its New Drug Application for VP-102
A shareholder filed a class action on behalf of all persons and entities that purchased Verrica Pharmaceuticals Inc. (NASDAQ: VRCA) securities between May 28, 2021 and May 24, 2022, for violations of the Securities Exchange Act of 1934. Verrica is a dermatology therapeutics company that develops medications for viral skin diseases requiring medical intervention.
Verrica has spent several years working to bring to market VP-102, the Company’s investigational, proprietary, drug-device combination for the treatment of molluscum contagiosum. However, several challenges have prevented this from happening. Verrica received its first Complete Response Letter (CRL) regarding the New Drug Application (NDA) in September 2021 due to deficiencies at a facility of Verrica’s contract manufacturer. Verrica resubmitted the NDA for VP-102 in November 2021, claiming “[t]he resubmission addresses the successful resolution of inspection deficiencies” at the manufacturing facility.
On May 24, 2022, Verrica received yet another CRL from the FDA related to its NDA for VP-102, citing “deficiencies identified during a general inspection of Sterling Pharmaceuticals Services, LLC (Sterling) the contract manufacturing organization (CMO) that manufacture’s Verrica’s bulk solution drug product.” On this news, the Company’s stock price fell 63.85%, to close at $2.01 per share on May 25, 2022.
According to the complaint, defendants failed to disclose that there were manufacturing deficiencies at the facility where Verrica’s contract manufacturer produced bulk solution for VP-102 and that these deficiencies were not remediated when Verrica resubmitted its NDA for VP-102, which presented a significant risk to Verrica obtaining regulatory approval for VP-102.
Next Steps: If you acquired your shares of Verrica Pharmaceuticals Inc. (VRCA) securities between May 28, 2021 and May 24, 2022, you have until August 5, 2022, to ask the court to appoint you lead plaintiff for the class. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. You do not have to participate in the case to be eligible for a recovery.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.
