Verrica Pharmaceuticals Inc. (VRCA) Accused of Misleading Shareholders
On September 16, 2019, Verrica announced it had submitted its New Drug Application (“NDA”) for VP-102 with the U.S. Food & Drug Administration (“FDA”) after “positive results from two double-blind Phase 3 trials (CAMP-1 and CAMP-2) that evaluated the safety and efficacy of VP-102.” Then in March 2020, the Company touted in its annual report on Form 10-K that Verrica “anticipate that VP-102 will be regulated as a drug, and that the FDA will permit a single regulatory submission seeking approval of VP-102 with the applicator in each indication for which we seek approval.” Despite Verrica’s confidence, on June 29, 2020, Verrica disclosed that on June 24, 2020, the Company received a letter from the FDA stating “that there deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.” Verrica then noted that the FDA requested information “related to a potential safety issue with the applicator that could arise if the instructions for use were not properly followed.” On this news, Verrica’s share price fell nearly 22% to close at $11.01 per share. The stock has since continued to decline.