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 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.