21.09.2021 00:19:21
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Verrica Pharma Tanks 25% After Receiving Complete Response Letter From FDA
(RTTNews) - Shares of Verrica Pharmaceuticals Inc. (VRCA) tanked nearly 25% in extended session on Monday after the company received a complete response letter from the U.S. Food and Drug Administration identifying deficiencies at a contract manufacturer's facilty for VP-102.
Verrica Pharmaceuticals is a dermatology therapeutics company developing medications for skin diseases requiring medical intervention.
FDA has issued a CRL regarding its New Drug Application for VP-102 for the treatment of molluscum contagiosum. The FDA said it has identified deficiencies at a facility of a contract manufacturing organization, which are not specifically related to the manufacturing of VP-102 but instead raise general quality issues at the facility.
Molluscum is a highly contagious viral skin disease that affects approximately six million people — primarily children — in the United States. Molluscum is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection.
VP-102 is Verrica's lead product candidate and is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin delivered via a single-use applicator that allows for precise topical dosing and targeted administration.
VRCA closed Monday's trading at $12.03, down $0.14 or 1.15%, on the Nasdaq. The stock further slipped $2.90 or 24.11% in the after-hours trading.
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