• 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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