Business
Verrica Pharmaceuticals Reports First Quarter 2023 Financial Results
New Drug Application for YCANTH™ (VP-102) PDUFA Goal Date of July 23, 2023 - Potential to Become Only FDA-approved Therapy for Treatment of Molluscum
About this update from Verrica Pharmaceuticals Inc.
[{"type":"text","content":"New Drug Application for YCANTH™ (VP-102) PDUFA Goal Date of July 23, 2023 - Potential to Become Only FDA-approved Therapy for Treatment of Molluscum Contagiosum Raised Gross Proceeds of $32.5 Million in February 2023 in an Underwritten Offering VP-315 Advanced into Part 2 of Phase 2 Trial in Basal Cell Carcinoma WEST CHESTER, Pa., May 09, 2023 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or “the Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced financial results for the first quarter ended March 31, 2023. “The first quarter of 2023 saw continued execution across our pipeline and strengthening of our financial position,” said Ted White, Verrica’s President and Chief Executive Officer. “With the upcoming PDUFA goal date of July 23, we may be poised to reach a major inflection point with the potential approval of YCANTH™ for the treatment of molluscum contagiosum. Molluscum is a dermatological condition that afflicts millions of children each year in the U.S., and with no FDA approved therapies, we believe YCANTH™ has the potential to address this significant unmet medical need. We also made progress with our novel oncolytic peptide, VP-315, which advanced into the second part of our ongoing Phase 2 study in basal cell carcinoma in April 2023 following a positive safety assessment and promising signs of activity from Part 1 of the study. “We also had the opportunity to strengthen our balance sheet during the quarter, raising an additional $32.5 million in gross proceeds in an underwritten offering to further extend our cash runway. This additional capital will help support our pre-commercial activities for YCANTH™ and fund our ongoing VP-315 Phase 2 study. Looking ahead, we are excited about the progress we expect to make throughout the remainder of the year.” Business Highlights and Recent Developments VP-102 On February 27, 2023, the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) of July 23, 2023, for Verrica’s New Drug Application (NDA) for YCANTH™ (VP-102), which is being developed for the treatment of molluscum contagiosum (molluscum).On January 4, 2023, Verrica announced the successful completion of the technology transfer of bulk solution manufacturing of YCANTH to Pi...