Fennec Pharmaceuticals Inc. - FENC STOCK NEWS

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 PEDMARK^TM. 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.

Fennec Pharmaceuticals announced that the FDA has accepted its NDA resubmission for PEDMARK™ to prevent cisplatin-induced ototoxicity in pediatric patients with localized, non-metastatic solid tumors. The PDUFA action date is set for November 27, 2021. If approved, PEDMARK™ would be the first therapy for this indication. The drug has received Fast Track and Breakthrough Therapy Designations. The previous CRL cited manufacturing deficiencies but raised no safety or efficacy concerns, indicating no need for additional clinical data.

Fennec Pharmaceuticals Inc. has resubmitted its New Drug Application (NDA) to the FDA for PEDMARK™, a therapy aimed at preventing cisplatin-induced hearing loss in children aged 1 month to < 18 years. The resubmission follows FDA's Type A meeting feedback and focuses on resolving manufacturing facility issues, with no additional clinical data required. If approved, PEDMARK would be the first therapy to address this serious side effect of chemotherapy. The drug has received Breakthrough Therapy and Fast Track Designation from the FDA.

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.