By Chris Wack
Shares of Verrica Pharmaceuticals Inc. fell 17% to $ 9.99 after the company said the United States Food and Drug Administration issued a comprehensive response letter regarding its new drug application for VP- 102 for the treatment of molluscum contagiosum.
The company previously revealed that the FDA extended the Prescription Drug User Fee Act deadline for the NDA by three months, to give the FDA more time to review the information in response to comments regarding the study of the factors. humans of society.
According to CRL, the FDA has identified deficiencies in a facility of a contract manufacturing organization that are not specifically related to the manufacturing of VP-102, but rather raise general quality issues at the facility.
Verrica said that at no time before the LCR had the FDA been notified of any deficiencies to the CMO related specifically to the manufacture of VP-102 or that its general investigation of the facility would impact the NDA of the. company. In addition, the FDA has not identified any clinical, safety or chemical, manufacturing, and product-specific control deficiencies related to VP-102.
The company said that the CMO has implemented corrective actions to address the concerns of the FDA, and the CMO has informed Verrica that it expects a satisfactory resolution of the identified deficiencies of the facility by the FDA in the Next 30 working days.
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