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 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.