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Verrica Pharma Shares Slide After Response Letter From FDA

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  • The FDA has issued a Complete Response Letter (CRL) regarding Verrica Pharmaceuticals Inc's (NASDAQ: VRCA) marketing application seeking approval for VP-102 for molluscum contagiosum, a highly contagious viral skin disease.

  • The FDA had previously extended the Prescription Drug User Fee Act (PDUFA) goal date for the application by three months.

  • Related: Verrica's VP-102 Application Review for Molluscum Contagiosum Delayed till September.

  • The Agency needed additional time to review the information submitted in response to comments regarding the Company's human factors study.

  • According to the CRL, the FDA has identified deficiencies at a contract manufacturing organization (CMO) facility.

  • The issue is not specifically related to the manufacturing of VP-102 but instead raises general quality issues at the facility.

  • The FDA did not identify any clinical, safety, or product-specific Chemistry, Manufacturing, and Controls (CMC) deficiencies related to VP-102.

  • Verrica expects a resolution of the facility's identified deficiencies from the FDA within the next 30 business days.

  • Related content: Benzinga's Full FDA Calendar.

  • Price Action: VRCA stock is down 26.2% at $8.88 during the premarket session on the last check Tuesday.

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