Yahoo Finance Fennec Pharmaceuticals Expects FDA Rejection for New Drug
By Sam Boughedda
Investing.com — Fennec Pharmaceuticals Inc (NASDAQ:FENC) shares hit a 14-month low on Monday after it said it expects to receive a complete response letter from the U.S. Food and Drug Administration for its new drug application for PEDMARK.
A complete response letter from the FDA signals a second rejection following last year's new drug application.
Specialty pharmaceutical company Fennec said following the completion of a pre-approval inspection of the manufacturing facility of its drug product manufacturer, deficiencies were identified — the same reason for last year's rejection.
PEDMARK has the potential to be used as a prevention from hearing loss connected with cisplatin chemotherapy in children.
Once Fennec receives the official CRL, it plans to request a meeting to discuss the deficiencies and next steps required for the resubmission of the NDA.
As of midday, Fennec Pharmaceuticals shares are down 48.3% at $4.98.
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