Item 8.01 Other Events.
On September 13, 2019, Verrica Pharmaceuticals Inc. (the “Company”) submitted to the U.S. Food and Drug Administration (the “FDA”) a New Drug Application (the “NDA”) under section 505(b) of the Federal Food, Drug, and Cosmetic Act for its product candidateVP-102 for the treatment of molluscum. Under the Prescription Drug User Fee Act (“PDUFA”), the FDA set a PDUFA goal date of July 13, 2020. On June 24, 2020, the Company received a notification from the FDA (the “Notification”) stating that, as part of its ongoing review of the Company’s NDA, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. The FDA stated that the Notification does not reflect a final decision on the information under review.
The Notification does not specify the deficiencies identified by the FDA.
On June 29, 2020, the Company issued a press release announcing its receipt of the Notification. A copy of Company’s press release is filed herewith as Exhibit 99.1 and is incorporated into this Item 8.01 by reference.
Any statements contained in this report that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on the Company’s current beliefs and expectations. These forward-looking statements include expectations regarding the potential receipt and timing of the FDA’s approval of the NDA, the Company’s expectations with regard to its interactions and communications with the FDA, plans, and expectations related to the PDUFA date. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug development process and the regulatory approval process, the Company’s reliance on third parties over which it may not always have full control, uncertainties related to theCOVID-19 pandemic and other risks and uncertainties that are described in the Company’s Annual Report on Form10-K for the year ended December 31, 2019, the Company’s Quarterly Report on Form10-Q for the quarter ended March 31, 2020, and other filings the Company makes with the U.S. Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this report and are based on information available to the Company as of the date of this report, and the Company has no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits:
