Grandbrothers/iStock Editorial via Getty Images
Verrica Pharmaceuticals (NASDAQ:VRCA) resubmitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of VP-102 to treat a viral skin infection called molluscum contagiosum (MC).
The FDA had declined to approve the company’s NDA in March 2022 citing deficiencies identified at a general reinspection of Sterling Pharmaceuticals Services, a contract manufacturing organization (CMO) that makes Verrica’s bulk solution drug product.
“We are pleased with the hard work and commitment from the entire Verrica team that has allowed us to resubmit the NDA for VP-102 for molluscum,” said Ted White, President and CEO of Verrica in a press release on Tuesday.
White added, “We believe the successful tech transfer of our bulk solution manufacturing addresses the only deficiency in our previous filing that resulted in our Complete Response Letter last year.”
MC is caused by a poxvirus that leads to small raised growths on the skin that may appear anywhere on the body. The condition can resolve within six to 12 months on its own but may take up to four years as well, according to the CDC.
VRCA +0.22% to $4.62 premarket Jan. 24