Business
Verrica Pharmaceuticals Reports Second Quarter 2020 Financial Results
- Company intends to request a Type A meeting with FDA during the third quarter of 2020 to discuss next steps for resubmission of an NDA for VP-102 following
About this update from Verrica Pharmaceuticals Inc.
[{"type":"text","content":"- Company intends to request a Type A meeting with FDA during the third quarter of 2020 to discuss next steps for resubmission of an NDA for VP-102 following Complete Response Letter -\n - Key leadership additions strengthen depth of expertise in Clinical, Chemistry, Manufacturing, and Controls (CMC) and Regulatory Affairs - - Lawrence Eichenfield, M.D., and Diem Nguyen, Ph.D., M.B.A., joined the Board of Directors - - Entered into an Option Agreement with Torii Pharmaceutical for the development and commercialization of VP-102 in Japan - WEST CHESTER, Pa., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for viral skin diseases requiring medical interventions, today announced financial results for the second quarter ended June 30, 2020. “We have made recent key personnel changes that will be important as we work to resubmit the New Drug Application for VP-102, following receipt of a Complete Response Letter from the U.S. Food and Drug Administration. We’re encouraged that the FDA did not raise any clinical safety or efficacy questions, and having recently strengthened leadership in clinical, CMC, and regulatory affairs, we intend to request a Type A meeting with FDA during the third quarter to discuss next steps for resubmission of our NDA. We continue to believe VP-102 can potentially be approved as a safe, effective treatment for molluscum,” said Ted White, Verrica’s President and Chief Executive Officer. Business Highlights and Recent Developments Verrica received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for VP-102, in which the FDA requested additional information regarding certain aspects of the CMC (Chemistry, Manufacturing, and Controls) process, as well as Human Factors validation. The Agency noted no clinical safety or efficacy deficiencies were identified. Verrica intends to request a Type A meeting with the FDA during the third quarter of 2020, and is committed to working to resubmit the NDA as quickly as possible. The Company announced changes to its Board of Directors, as well as its CMC, and Regulatory Affairs leadership. Dr. Lawrence Eichenfield, a leading pediatric dermatologist, has been appointed to the Board. Dr. Eichenfield repla...