On June 29, 2020, Verrica disclosed receipt of a letter from the U.S. Food and Drug Administration (“FDA”) regarding the Company’s New Drug Application (“NDA”) for VP-102 for the treatment of molluscum contagiosum. The letter identified certain deficiencies that preclude discussion of labeling and post-marketing requirements. Moreover, according to the Company, the FDA’s information requests have included “a specific request related to a potential safety issue with the applicator that could arise if the instructions for use were not properly followed.”
On this news, the Company’s share price fell $3.06, or nearly 22%, to close at $11.01 per share on June 30, 2020, 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 the Company’s proprietary applicator used for VP-102 posed certain safety risks if the instructions were not properly followed; (2) that, as a result, Verrica would incorporate certain user features to mitigate the safety risk; (3) that the addition of the user feature would require additional testing for stability supportive data; (4) that, as a result of the foregoing, regulatory approval for VP-102 was reasonably likely to be delayed; and (5) 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.
Verrica Pharmaceuticals Inc.
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