By Chris Wack
Verrica Pharmaceuticals Inc. shares were down 17% to $9.99 after the company said the U.S. Food and Drug Administration has issued a Complete Response Letter regarding its New Drug Application for VP-102 for the treatment of molluscum contagiosum.
The company had previously disclosed that the FDA extended the Prescription Drug User Fee Act goal date for the NDA by three months to this Thursday, to allow the FDA additional time to review information in response to comments regarding the company's human factors study.
According to the CRL, the FDA has identified deficiencies at a facility of a contract manufacturing organization, which are not specifically related to the manufacturing of VP-102 but instead raise general quality issues at the facility.
Verrica said that at no time prior to the CRL was it notified by the FDA of any deficiencies at the CMO related specifically to the manufacturing of VP-102 or that its general investigation of the facility would have any impact on the company's NDA. Also, the FDA didn't identify any clinical, safety or product specific chemistry, manufacturing and controls deficiencies related to VP-102.
The company said the CMO has implemented corrective actions to address the FDA's concerns, and the CMO has advised Verrica that it is expecting a satisfactory resolution of the facility's identified deficiencies from the FDA within the next 30 business days.
Write to Chris Wack at firstname.lastname@example.org
(END) Dow Jones Newswires