Verrica Pharmaceuticals Inc.
|Company Name||Verrica Pharmaceuticals Inc.|
|Class Period||May 28, 2021 to May 24, 2022|
|Lead Plaintiff Motion Deadline||August 05, 2022|
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 fell $1.00, or 8.3%, to close at $11.03 per share on September 21, 2021, on unusually heavy trading volume.
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.
Then, 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 shares fell $3.55, or 63.8%, to close at $2.01 per share on May 25, 2022, on unusually heavy trading volume.
The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that there were manufacturing deficiencies at the facility where Verrica’s contract manufacturer produced bulk solution for VP-102; (2) that these deficiencies were not remediated when Verrica resubmitted its NDA for VP-102 for molluscum; (3) that the foregoing presented significant risks to Verrica obtaining regulatory approval of VP-102 for molluscum; and (4) that, 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.
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