By Colin Kellaher

 

Fennec Pharmaceuticals Inc. on Monday said it expects the U.S. Food and Drug Administration will once again reject the company's application for Pedmark due to issues at the plant where the drug is made.

The Durham, N.C., specialty pharmaceutical company said it expects to receive an FDA complete response letter, indicating that the agency won't approve the application in its current form, now that the Nov. 27 target action date for the application has passed.

Fennec is seeking approval of Pedmark for intravenous administration for the prevention of hearing loss associated with cisplatin chemotherapy in children.

The FDA last year turned away Fennec's application after finding deficiencies during a pre-approval inspection of the facility of the company's drug-product manufacturer. Fennec resubmitted its application earlier this year, and the FDA accepted it June with the Nov. 27 target action date.

Fennec on Monday said the FDA has again found deficiencies at its drug-product manufacturer> Once it receives official rejection, Fennec will request a meeting with the agency to discuss the steps needed to resubmit the Pedmark application, the company said.

Shares of Fennec, which closed Friday at $9.64, fell 33% to $6.44 in premarket trading Monday.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

November 29, 2021 06:40 ET (11:40 GMT)

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