Verrica Pharmaceuticals Inc.
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Verrica is a dermatology therapeutics company developing medication for skin diseases that require medical treatment. Verrica’s lead product candidate, VP-102, is a drug device combination of Verrica’s topical solution, cantharidin, administered through a single-use precision applicator. The Company is developing VP-102 for the treatment of molluscum contagiosum.
In December 2020, Verrica submitted its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) seeking regulatory approval of VP-102 for the treatment of molluscum.
On September 20, 2021, after the market closed, Verrica announced receipt of a Complete Response Letter (“CRL”) due to deficiencies at a facility of Verrica’s contract manufacturer in connection with the Company’s NDA. On this news, the Company’s stock price declined by $1.00 per share, or approximately 8.31%, from $12.03 per share to close at $11.03 per share on September 21, 2021.
In November 2021, Verrica resubmitted the NDA for VP -102, claiming “[t]he resubmission addresses the successful resolution of inspection deficiencies” at the manufacturing facility.
On May 24, 2022, after the market closed, Verrica announced receipt of another Complete Response Letter regarding the VP-102 NDA citing “deficiencies identified during a general reinspection of Sterling Pharmaceuticals Services, LLC (Sterling), the contract manufacturing organization (CMO) that manufactures Verrica’s bulk solution drug product.” On this news, the Company’s stock price declined by $3.55 per share, or approximately 63.85%, from $5.56 per share to close at $2.01 per share on May 25, 2022.
The lawsuit alleges that, throughout the Class Period, Defendants made false and/or misleading statements and/or failed to disclose that: (1) there were manufacturing deficiencies at the facility where Verrica’s contract manufacturer produced bulk solution for VP-102; (2) these deficiencies were not remediated when Verrica resubmitted its NDA for VP-12 for molluscum; (3) the foregoing presented significant risks to Verrica obtaining regulatory approval of VP-102 for molluscum; and (4) as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.