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 (NASDAQ:FENC) is moving forward with plans to finalize and resubmit its New Drug Application for PEDMARK to the FDA by Q2 2021. The company reported Q1 2021 financial results, showing cash reserves of approximately $27 million and no outstanding debt. R&D expenses increased to $2.4 million, reflecting heightened development activities, while general and administrative costs remained stable at $2.5 million. The net loss for the quarter was $4.7 million, or $0.18 per share, slightly up from a loss of $3.8 million in Q1 2020.
Fennec Pharmaceuticals (NASDAQ:FENC) is advancing its New Drug Application (NDA) resubmission for PEDMARK™, a treatment for preventing platinum-induced ototoxicity in children, targeting Q2 2021. The company has $30 million in cash and no debt, with a net loss of $18.1 million ($0.76 per share) for 2020. R&D expenses fell to $5.1 million, while G&A costs rose to $13 million due to commercialization efforts. Despite a net increase in cash from a $32 million equity financing, Fennec sees ongoing losses but confirms financial stability for planned activities in 2021.
Fennec Pharmaceuticals reports Q3 2020 financial results, highlighting key developments on PEDMARK™, aimed at preventing platinum-induced ototoxicity in children. Following a constructive FDA meeting, the company plans to resubmit its New Drug Application without the need for additional studies. Financially, Fennec holds $33.2 million in cash and no debt. However, it posted a net loss of $6.2 million, an increase from $1.8 million the previous year, primarily due to rising R&D and G&A expenses related to commercialization efforts.
Fennec Pharmaceuticals announced that the U.S. Patent and Trademark Office will issue U.S. Patent 10,792,363 covering anhydrous sodium thiosulfate formulations for its drug PEDMARK. This patent enhances the drug's intellectual property protection as Fennec aims to prevent platinum-induced ototoxicity in pediatric patients. PEDMARK, previously designated as an Orphan Drug, is pivotal for children undergoing platinum-based chemotherapy. The European Medicines Agency is currently evaluating its Marketing Authorization Application.
Fennec Pharmaceuticals announced that CEO Rosty Raykov will present at several upcoming investor conferences, including the Wedbush PacGrow Healthcare Conference on August 12, H.C. Wainwright Global Investment Conference from September 14-16, and the Cantor Fitzgerald Virtual Global Healthcare Conference on September 15. Live webcasts and replays will be accessible on the company’s investor relations website. The focus of Fennec is on PEDMARK, aimed at preventing ototoxicity in pediatric patients undergoing platinum chemotherapy, with a Marketing Authorization Application under review by the European Medicines Agency.
Fennec Pharmaceuticals announced receiving a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for PEDMARK™. The CRL, received on August 10, 2020, cites deficiencies identified in the manufacturing facility that need resolution before approval. No clinical safety or efficacy issues were noted, and no additional clinical data is required. The company, with approximately $38.7 million in cash as of June 30, 2020, plans to hold a Type A meeting with the FDA to discuss the necessary steps for resubmission.