~ Resubmission of NDA for PEDMARKTM Targeted for the First Quarter of 2022 ~ ~ Company has Approximately $21.1 Million in Cash and $5 Million of Funded Debt ~ Research Triangle Park, NC, February 28, 2022 – Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate (STS)) for […]
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FENNEC PHARMACEUTICALS ANNOUNCES MANAGEMENT CHANGE
Research Triangle Park, NC, Jan. 31, 2022 – Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate) for the prevention of platinum-induced ototoxicity in pediatric patients, today announced that Shubh Goel, the Company’s chief commercial officer, has tendered her resignation and will depart Fennec in […]
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Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for PEDMARK™ to Prevent Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumors
RESEARCH TRIANGLE PARK, N.C., November 30, 2021 – Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter (CRL) on November 29, 2021 from the U.S. Food and Drug Administration (FDA), after the PDUFA target action date of November 27, 2021, regarding its New Drug Application (NDA) for PEDMARKTM (a unique formulation […]
Fennec Pharmaceuticals Expects to Receive Complete Response Letter from the FDA for its New Drug Application for PEDMARK™ to Prevent Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumors
~ FDA Pre-Approval Inspection Identified Deficiencies with the Facility of the Drug Product Manufacturer, Which Require Resolution Prior to PEDMARK Approval ~ RESEARCH TRIANGLE PARK, N.C., November 29, 2021 – Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that it expects to receive a Complete Response Letter (CRL) after the PDUFA target action date of […]
FENNEC PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2021 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
FDA Prescription Drug User Fee Act (PDUFA) Target Action Date Set for November 27, 2021 If Approved by the FDA, PEDMARKTM Stands to Be the First Therapy for the Prevention of Cisplatin-Induced Hearing Loss in Children Company Has Approximately $24 Million in Cash and Cash Equivalents Research Triangle Park, NC, November 10, 2021 – Fennec […]
FENNEC PHARMACEUTICALS TO PARTICIPATE IN UPCOMING INVESTOR CONFERENCES
Research Triangle Park, NC, September 9, 2021 – Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate) for the prevention of platinum-induced ototoxicity in pediatric patients, today announced that management will participate in three upcoming virtual investor conferences, including H.C. Wainwright 23rd Annual Global Investment […]
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FENNEC PHARMACEUTICALS ANNOUNCES SECOND QUARTER 2021 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
~ FDA Prescription Drug User Fee Act (PDUFA) Target Action Date Set for November 27, 2021 ~ ~ If Approved by the FDA, PEDMARKTM Stands to Be the First Therapy for the Prevention of Cisplatin-Induced Hearing Loss in Children ~ ~ Company Has Approximately $27 Million in Cash and Cash Equivalents ~ Research Triangle Park, […]
FENNEC ANNOUNCES RESULTS OF ANNUAL MEETING
Research Triangle Park, NC — (GlobeNewswire) – June 29, 2021 – Fennec Pharmaceuticals Inc. (the “Company”) (NASDAQ:FENC) (TSX:FRX) today announced that the nominees listed in the management proxy circular dated May 14, 2021 for the Annual General Meeting of Shareholders were elected as directors of the Company at the Annual General Meeting of Shareholders held […]
FENNEC PHARMACEUTICALS ANNOUNCES AMENDMENT TO INCREASE EXISTING SENIOR DEBT FACILITY
Research Triangle Park, NC, June 24, 2021 – Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate) for the prevention of platinum-induced ototoxicity in pediatric patients with localized, non-metastatic solid tumors, today announced an amendment to its existing senior debt facility with […]
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FENNEC PHARMACEUTICALS ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION RESUBMISSION FOR PEDMARKTM
~ Prescription Drug User Fee Act (PDUFA) Target Action Date Set for November 27, 2021 ~ ~ NDA Resubmission for PEDMARK for the Prevention of Cisplatin-Induced Ototoxicity for Pediatric Patients with Localized, Non-Metastatic Solid Tumors ~ ~ If Approved by the FDA, PEDMARK Stands to Be the First Therapy for the Prevention of Cisplatin-Induced Hearing […]