By Colin Kellaher

 

Shares of Fennec Pharmaceuticals Inc. lost nearly half their value Monday after the specialty pharmaceutical company's latest regulatory setback for its lead product candidate Pedmark.

The Durham, N.C., company said it expects the U.S. Food and Drug Administration will again turn away its application for Pedmark due to issues at the plant where the drug is made after a similar rejection last year.

Fennec, which is seeking approval of Pedmark for the prevention of hearing loss associated with cisplatin chemotherapy in children, said it expects the FDA will issue a complete response letter, indicating that the agency won't approve the application in its current form.

The FDA had set a target action date of Nov. 27 for Fennec's resubmission of its Pedmark application following last year's rejection.

Fennec shares were recently down 48.2% to $4.99 after hitting a 52-week low of $4.83 early in the session.

 

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

 

(END) Dow Jones Newswires

November 29, 2021 10:34 ET (15:34 GMT)

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