Welcome to our dedicated page for Fennec Pharmaceuticals news (Ticker: FENC), a resource for investors and traders seeking the latest updates and insights on Fennec Pharmaceuticals stock.
Fennec Pharmaceuticals Inc. reports developments as a commercial-stage specialty pharmaceutical company focused on PEDMARK® (sodium thiosulfate injection), a therapy used to reduce the risk of cisplatin-induced ototoxicity in pediatric patients with localized, non-metastatic solid tumors. The company also markets the product in Europe and the United Kingdom under the PEDMARQSI® name and has disclosed a licensing arrangement for commercialization in additional non-U.S. markets.
Recurring news themes include PEDMARK product sales and financial results, commercialization updates, scientific abstracts, investigator-sponsored and real-world studies in cancer patients receiving cisplatin-based chemotherapy, product exclusivity and patent matters, and equity compensation actions under Nasdaq rules.
Fennec Pharmaceuticals Inc. (NASDAQ:FENC) announced its participation in several upcoming investor conferences, including the H.C. Wainwright Global Investment Conference on May 24, the Craig-Hallum Institutional Investor Conference on June 1, and the JMP Securities Life Sciences Conference on June 15. The focus of the company is on PEDMARK™, a formulation aimed at preventing platinum-induced ototoxicity in pediatric patients, with significant implications for children undergoing chemotherapy. The Marketing Authorization Application for PEDMARK is under review by the European Medicines Agency.
Fennec Pharmaceuticals Inc. reported its Q1 2022 financial results, highlighting a net loss of $3.7 million, a decrease from $4.7 million in Q1 2021. Cash and cash equivalents stand at approximately $18.3 million, down from $21.1 million at year-end 2021, primarily due to ongoing costs related to the resubmission of the NDA for PEDMARK™. R&D expenses fell to $1.4 million from $2.4 million year-over-year, reflecting a shift towards pre-commercialization efforts. The FDA's PDUFA target action date for PEDMARK™ is set for September 23, 2022, potentially marking a significant milestone if approved.
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.