Fennec Pharmaceuticals Completes Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for PEDMARK™ and Also Submits Marketing Authorization Application (MA...
Fennec Pharmaceuticals Inc. (FENC)
Last fennec pharmaceuticals inc. earnings: 11/12 06:00 am
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Source: GlobeNewswire
RESEARCH TRIANGLE PARK, N.C., Feb. 11, 2020 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (Nasdaq:FENC; TSX: FRX), a specialty pharmaceutical company, today announced it has completed its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PEDMARK™ (a unique formulation of sodium thiosulfate) for intravenous use and submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sodium thiosulfate (tradename to be determined). The PEDMARK™ indication requested is for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to Fennec’s PEDMARK regulatory submissions follow: a pre-NDA meeting with the FDA in December 2018 after which Fennec initiated a rolling NDA; and pre-submission meetings with the EMA and an approved pediatric investigation plan (PIP). Both applications are based upon clinical results from two pivotal Phase 3 clinical trials: SIOPEL 6 conducted by t
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FENC
Earnings
- 3/21/24 - Miss
FENC
Sec Filings
- 4/18/24 - Form 4
- 4/18/24 - Form 144
- 4/17/24 - Form 144
- FENC's page on the SEC website