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 (FENC) delivers innovative therapies targeting cisplatin-induced hearing loss in pediatric cancer patients. This news hub provides investors and healthcare professionals with essential updates on clinical advancements, regulatory milestones, and strategic partnerships.
Access timely reports on PEDMARK® development progress, including FDA communications and international commercialization efforts through European licensing agreements. Our curated news collection ensures you stay informed about pivotal Phase III trial outcomes and market expansion initiatives without promotional bias.
Key updates include earnings announcements, research publications, manufacturing developments, and conference participation details. All content undergoes rigorous verification to maintain compliance with financial disclosure standards and medical reporting best practices.
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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.
Fennec Pharmaceuticals reported its Q2 2021 financial results, highlighting a net loss of $4 million ($0.15 per share), improved from a $4.8 million loss in Q2 2020. The company has $27.3 million in cash and equivalents, down from $30.3 million at the end of 2020, due to R&D and administrative expenses. Fennec is focused on its PEDMARK™ therapy for preventing cisplatin-induced hearing loss in children, with a crucial FDA PDUFA action date set for November 27, 2021. R&D expenses decreased to $800,000 from $1.1 million, reflecting a shift towards essential launch preparations.
On June 29, 2021, Fennec Pharmaceuticals announced the election of its management's proposed board nominees at the Annual General Meeting in Irvine, California. The results show strong shareholder support, with Dr. Khalid Islam receiving 99.05% approval and other nominees like Adrian Haigh and Chris A. Rallis also garnering over 97% support. Furthermore, 99.88% of shareholders approved the appointment of Haskell & White LLP as auditors, and 97.48% voted in favor of executive compensation. This indicates significant confidence from shareholders in the company's direction.
Fennec Pharmaceuticals (NASDAQ:FENC; TSX:FRX) has announced an amendment to its debt facility with Bridge Bank, increasing the total amount from $18 million to $20 million. This facility includes three term loans, with $5 million available upon closing and $7.5 million contingent on FDA approval of PEDMARKTM. The funds will support the company’s working capital and commercialization activities for PEDMARK, which aims to prevent platinum-induced ototoxicity in pediatric patients. The FDA has set a PDUFA date for the NDA of PEDMARK on November 27, 2021.
