Verrica Shares Plummet Premarket as FDA Again Rejects VP-102
May 25 2022 - 6:50AM
Dow Jones News
By Colin Kellaher
Shares of Verrica Pharmaceuticals Inc. lost more than half of
their value in premarket trading Wednesday after the U.S. Food and
Drug Administration once again turned away the company's new drug
application for VP-102 for the skin disease molluscum contagiosum
due to issues at a contract manufacturer.
The West Chester, Pa., medical dermatology company said it
received a second complete response letter from the FDA, indicating
the agency won't approve the application in its current form.
Verrica said the only deficiency the FDA listed in the letter
was related to issues identified at a reinspection of Sterling
Pharmaceuticals Services LLC, the contract manufacturing
organization that makes Verrica's bulk solution drug product.
Verrica said none of the issues identified by FDA during the
reinspection were specific to the manufacturing of VP-102, and that
while the FDA had completed its review of the application, FDA
policy prevents the agency from approving the drug due to the
issues at Sterling.
The FDA last September issued a complete response letter for
VP-102, the company's lead drug candidate, citing, in part, a
deficiency related to the agency's inspection of Sterling.
Verrica said it plans to file a request for a meeting with the
FDA by the end of the week, adding that it is working to help
Sterling address the issues the agency identified and also engaging
an additional contract manufacturing organization to serve as an
alternative supplier of VP-102's bulk solution.
Verrica shares, which closed Tuesday at $5.56, were recently
down 56% to $2.43 in premarket trading.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 25, 2022 06:35 ET (10:35 GMT)
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