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Fennec Announces Clinical Trial Results for Pedmark in Japan
Fennec announced the oral presentation of detailed results from the investigator-initiated Phase 2 STS-J01 clinical trial evaluating Pedmark for the reduction of cisplatin-induced ototoxicity in pediatric and adolescent and young adult, or AYA, patients with non-metastatic solid tumors in Japan. The data will be presented today during the 58th Annual International Society of Pediatric Oncology annual meeting in San Antonio. Pedmark is the first and only FDA approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients one month of age and older with localized, non-metastatic, solid tumors, and is also recognized by the National Comprehensive Cancer Network with a 2A endorsement for use in AYA patients. The study enrolled 33 patients across 11 institutions in Japan, including 27 patients in the primary cohort and six in exploratory cohorts. Among the 25 patients comprising the primary efficacy population, ASHA-defined hearing loss occurred in 24%, significantly lower than the prespecified historical benchmark of 56.4%. Nineteen of 25 patients remained free of ASHA-defined hearing loss. By Brock criteria, 84.0% of patients had Grade 0 hearing loss, and no patient experienced Grade 3 or Grade 4 hearing loss. Objective tumor responses were observed in 23 of 24 evaluable patients, providing reassuring clinical context for delayed Pedmark administration six hours following cisplatin. Prospective pharmacokinetic analyses further characterized the interaction between Pedmark and cisplatin-derived platinum and provide mechanistic support for the six-hour administration strategy for pediatric and adolescent and young adult patients.
Fennec Pharmaceuticals Q2 Revenue Reaches $17.87M
Reports Q2 revenue $17.87M, consensus $16.12M. "Our second quarter reflects another period of strong execution across the business, highlighted by our seventh consecutive quarter of growth. We continue to build momentum by investing in the evidence that will shape the future of PEDMARK, with important data presented at ASCO and a growing pipeline of investigator-sponsored studies that we believe will further expand our understanding of its potential," said Jeff Hackman, chief executive officer of Fennec Pharmaceuticals. "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."
Fennec Pharmaceuticals Q1 Revenue $15.1M Beats Expectations
Reports Q1 revenue $15.1M, consensus $13.84M. "We are encouraged by our continued quarter-over-quarter growth and strong start to the year. 2026 is a defining period for Fennec, with growing clinical interest in independently evaluating PEDMARK across new patient populations and tumor types that reinforces our confidence in its broader potential," said Jeff Hackman, CEO of Fennec Pharmaceuticals. "At the same time, the strategic enhancements we've made to our field force are already sharpening our execution and expanding our reach - in tandem, the positive experiences we're seeing through our Fennec HEARS program are translating into meaningful access and strong conversion rates, resulting in more patients being treated. Coupled with our solid financial foundation, we believe we are well-positioned to continue to build momentum and deliver sustained growth throughout 2026."
Fennec Pharmaceuticals Reports Q4 Revenue of $13.78M
Reports Q4 revenue $13.78M, consensus $14.73M. "Our 2025 results validate that our strategy is clear and the foundation we built over the past year is now propelling Fennec into its next chapter of growth. We delivered record net product sales, achieved significant growth within our Fennec Hears program, and advanced independent clinical evidence generation for Pedmark - all while driving quarter-over-quarter growth in every quarter in 2025. These results demonstrate increasing Pedmark adoption across key accounts and patient segments, effective field execution, and sustained progress across the organization," said Jeff Hackman, chief executive officer of Fennec Pharmaceuticals. "Concurrently, we strengthened our financial position through prudent operating decisions and strategic financial initiatives, including the closing of public and private offerings and the completion of full debt redemption."
Fennec Pharmaceuticals Settles Litigation with Cipla
Fennec Pharmaceuticals announces that it has entered into an agreement with Cipla Limited and Cipla USA, Inc. to settle the litigation between them regarding Cipla's application to FDA for approval to market a generic version of Fennec's PEDMARK product. Under the terms of the agreement, the lawsuit will be dismissed with each party bearing their own costs, and Cipla will not enter the market with its generic sodium thiosulfate product until September 1, 2033, or earlier under certain circumstances.
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