Fennec Pharmaceuticals Inc Stock Price, News & Analysis

Fennec Pharmaceuticals announced that its resubmitted New Drug Application (NDA) for PEDMARK, aimed at preventing platinum-induced ototoxicity in pediatric patients, has been accepted by the FDA. The PDUFA action date is set for September 23, 2022. This development is significant as PEDMARK has received Breakthrough Therapy and Fast Track Designation, indicating its potential to transform treatment for children at risk of hearing loss from chemotherapy. The company continues its efforts to facilitate the FDA's review process.

Fennec Pharmaceuticals (NASDAQ: FENC) will participate in the 2022 Maxim Group Virtual Growth Conference from March 28-30, 2022. CFO Robert Andrade will engage in a fireside chat on March 28 at 4:00 p.m. ET. The conference will cover key discussions on Fennec's developments, including PEDMARK™, aimed at preventing platinum-induced ototoxicity in children undergoing chemotherapy. PEDMARK has garnered Breakthrough Therapy and Fast Track Designations from the FDA and is currently under evaluation by the European Medicines Agency for marketing authorization.

Fennec Pharmaceuticals has resubmitted its New Drug Application (NDA) for PEDMARK™, aimed at preventing platinum-induced ototoxicity in pediatric cancer patients. The FDA's feedback during the process was appreciated, and the company is committed to making PEDMARK™ available for those affected. With over 10,000 children potentially receiving platinum-based chemotherapy annually in the U.S. and Europe, the need for an effective preventive agent is vital. The application is also under review by the European Medicines Agency, highlighting the global importance of PEDMARK™.

Fennec Pharmaceuticals (NASDAQ:FENC) announced a planned resubmission of the New Drug Application (NDA) for PEDMARK™ in Q1 2022. The company reported a net loss of $17.3 million for 2021 ($0.67 per share), a slight improvement from $18.1 million in 2020. Cash and cash equivalents stood at $21.1 million as of December 31, 2021, down from $30.3 million the previous year. Research and Development expenditures were $5 million, with General and Administrative expenses totaling $12.2 million, both showing minor fluctuations compared to 2020.

Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX:FRX) announced the resignation of Chief Commercial Officer Shubh Goel, effective late February 2022. The company's CEO, Rosty Raykov, expressed gratitude for Goel's contributions while emphasizing the commitment to commercialize PEDMARK™, a sodium thiosulfate formulation designed to prevent platinum-induced ototoxicity in children receiving chemotherapy. PEDMARK™ has received FDA Breakthrough Therapy and Fast Track Designations, and its Marketing Authorization Application is under review by the European Medicines Agency.

Fennec Pharmaceuticals announced on Nov. 30, 2021, that it received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for PEDMARK™, intended to prevent ototoxicity in pediatric patients undergoing cisplatin chemotherapy. The CRL cited manufacturing deficiencies that must be resolved before approval. Fennec plans to request a Type A meeting with the FDA to discuss the issues and the NDA resubmission process. Currently, the company has approximately $24 million in cash and equivalents as of September 30, 2021.

Fennec Pharmaceuticals announced it anticipates receiving a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for PEDMARK after the PDUFA target date of November 27, 2021. The CRL is due to identified deficiencies during a pre-approval inspection of the drug product manufacturer’s facility. The company plans to address these issues and seek a Type A meeting with the FDA to discuss the necessary steps for resubmission. PEDMARK aims to prevent ototoxicity in pediatric patients undergoing platinum-based chemotherapy.

Fennec Pharmaceuticals (NASDAQ:FENC) reported third-quarter financial results for 2021, highlighting a net loss of $4.2 million, or $0.16 per share, an improvement from a $6.2 million loss in Q3 2020. The company had approximately $24.3 million in cash as of September 30, 2021. Their NDA application for PEDMARK™, aimed at preventing cisplatin-induced hearing loss in children, is under FDA review with a target action date set for November 27, 2021. R&D expenses decreased to $1.2 million, while G&A expenses fell by $1.6 million due to timing related to NDA approval.

Fennec Pharmaceuticals announced participation in three virtual investor conferences in September 2021. These include the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, Oppenheimer Fall Healthcare Life Sciences & MedTech Summit from September 20-23, and the Cantor Virtual Global Healthcare Conference from September 27-30. The company focuses on its product PEDMARK™, designed to prevent platinum-induced ototoxicity in pediatric cancer patients, which is pivotal as over 10,000 children annually risk hearing loss from treatments.