The FDA has accepted Verrica Pharmaceuticals Inc's (NASDAQ:VRCA) resubmitted marketing application seeking approval for VP-102 to treat molluscum contagiosum (molluscum), a common, highly contagious skin disease.
- The assigned Prescription Drug User Fee Act (PDUFA) goal date is May 24, 2022.
- In September, the FDA issued a complete response letter for VP-102 after identifying deficiencies at a contract manufacturing organization facility.
- VP-102 is Verrica's lead product candidate, a proprietary drug-device combination product that contains a controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration.
- If approved, VP-102 would be the first product approved by the FDA to treat molluscum contagiosum.
- VP-102 would be marketed in the U.S. under the conditionally accepted brand name, 'Ycanth.'
- Price Action: VRCA shares closed 12.9% higher at $10.64 during after-hours trading on Wednesday.
