Tag: FDA approval

Fennec's Pedmark is reportedly the only FDA-approved therapy to reduce cisplatin-induced hearing loss in pediatric patients. Fennec Pharmaceuticals reported its strongest quarter yet for Pedmark (sodium thiosulfate injection), with second-quarter 2026 net product sales climbing to $17.1 million, up 78% year over year compared to $9.7 million in the same period a year earlier. The Research Triangle Park, NC-based specialty pharmaceutical company also posted a non-GAAP adjusted EBITDA of $2.8 million for the quarter, versus an adjusted EBITDA loss of $1.2 million in Q2 2025 — marking what the company calls a record quarter for that metric. The results represent the company's seventh consecutive quarter of growth and come as Fennec continues to expand its sales organization and broaden Pedmark's reach across both established and new accounts, including in the adolescent and young adult (AYA) population. "Our second quarter reflects another period of strong execution across the business, highlighted by our seventh consecutive quarter of growth," says Jeff Hackman, chief executive officer of Fennec Pharmaceuticals, in a release. "As evidenced in our record EBITDA generation in the second quarter, we have a highly effective business model that is primed to optimize our anticipated growth while advancing our mission to improve outcomes for patients." https://hearingreview.com/inside-hearing/regulation/fda-approves-fennec-pedmark-ototoxicity-drug Pedmark Demand and Commercial Expansion The Q2 period marked the first full quarter following the expansion of Fennec's commercial organization, which the company credits with driving unprecedented enrollment. Demand grew across both new and existing accounts, with Fennec's commercial, patient services, and medical affairs teams working in tandem to support prescribers and patients throughout the treatment journey. The company noted that record Pedmark demand has carried into the third quarter of 2026, offering further validation of its commercial growth strategy. For the first six months of 2026, Pedmark net product sales totaled $32.3 million, compared to $18.4 million in the same period of 2025 — more than a 75% increase year over year. Real-World Evidence at ASCO 2026 Four independently led investigator-sponsored studies evaluating Pedmark were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The data expanded understanding of the drug's clinical utility across multiple patient populations and tumor types, particularly in AYA and adult populations where, according to the company, significant unmet need remains. The studies built on Pedmark's established safety and efficacy profile, reinforcing that the therapy can be integrated into standard patient care without compromising cisplatin's established antitumor activity. Pedmark currently holds FDA approval for pediatric patients 1 month of age and older with localized, non-metastatic solid tumors and carries a National Comprehensive Cancer Network (NCCN) 2A recommendation for use in AYA patients. https://hearingreview.com/hearing-loss/chemo-drug-may-cause-hearing-loss-in-cancer-survivors Context: Cisplatin-Induced Ototoxicity Cisplatin-induced ototoxicity remains a significant clinical concern across oncology. Studies indicate that between 60% and 90% of patients treated with cisplatin may develop hearing loss, depending on the dose and duration of therapy. Many affected patients require lifelong hearing aids or cochlear implants — interventions that, while helpful for some, do not reverse the underlying damage and carry long-term costs. Treatment-induced hearing loss can affect speech and language development, academic performance, social-emotional functioning, and career potential. Pedmark received FDA approval in September 2022 and European Commission approval in June 2023, with UK approval following in October 2023 under the brand name PEDMARQSI. In March 2024, Fennec entered an exclusive licensing agreement with Norgine Pharmaceuticals Ltd. to commercialize PEDMARQSI across Europe, the UK, Australia, and New Zealand. Approximately 500,000 patients in the US are diagnosed annually with cancers that may be treated with platinum-based chemotherapy, according to the company. Fennec is scheduled to present at the H.C. Wainwright 27th Annual Global Investment Conference, set for September 14–17, 2026, in New York City.

Tag: FDA approval

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Cochlear Nucleus 8 Sound Processor Receives FDA Approval

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