RESEARCH TRIANGLE PARK, NC – Fennec Pharmaceuticals has announced a robust second quarter for 2026, driven by continued surging demand for PEDMARK® (sodium thiosulfate), its groundbreaking treatment designed to mitigate the risk of hearing loss associated with cisplatin chemotherapy. The company’s impressive financial performance is bolstered by an accumulating body of new clinical evidence, which consistently reinforces PEDMARK’s ability to safeguard auditory function without compromising the vital antitumor efficacy of cisplatin. This confluence of strong sales and scientific validation positions PEDMARK as a critical component in the evolving landscape of supportive care for cancer patients, particularly in pediatric oncology.
PEDMARK net product sales soared to $17.1 million during the second quarter of 2026, marking a substantial 78% increase from $9.7 million reported in the corresponding period last year. Fennec attributes this significant growth to a dual-pronged strategy: an expansion of its commercial organization that has successfully broadened its reach, and a marked increase in demand across both its established and newly acquired accounts. The momentum has shown no signs of abating, with the company reporting record demand continuing well into the third quarter. This sustained upward trajectory underscores not only the commercial effectiveness of Fennec’s strategy but also the growing recognition among oncologists and healthcare providers of PEDMARK’s crucial role in improving patient outcomes and quality of life.
The company’s financial success arrives at a pivotal time when the scientific community continues to meticulously examine the multifaceted role of sodium thiosulfate in preventing cisplatin-induced ototoxicity. This ongoing research extends beyond the currently approved indications, exploring its potential utility across a broader spectrum of patient demographics, including adolescent and young adult (AYA) patients, and various cancer types. The expansion of investigator-sponsored studies and presentations at prestigious medical conferences like the American Society of Clinical Oncology (ASCO) are instrumental in deepening the understanding of PEDMARK’s therapeutic potential and its optimal integration into diverse treatment protocols.
Jeff Hackman, CEO of Fennec Pharmaceuticals, articulated the company’s achievements and strategic vision, stating, "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® (sodium thiosulfate), 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." This statement underscores Fennec’s commitment to both commercial success and continuous scientific inquiry, recognizing that long-term growth is intrinsically linked to robust clinical validation and expanded utility.
The Enduring Challenge of Cisplatin-Induced Ototoxicity
Cisplatin stands as a cornerstone chemotherapy agent, lauded for its potent efficacy against a wide array of cancers, including osteosarcoma, germ cell tumors, medulloblastoma, neuroblastoma, and hepatoblastoma. Its platinum-based mechanism, which involves forming DNA adducts that interfere with cell division, makes it indispensable in curative regimens, especially for pediatric patients. However, the drug’s effectiveness comes with a significant and often devastating side effect: ototoxicity, or damage to the inner ear, leading to permanent hearing loss.
This chemotherapy-induced hearing loss (CIHL) can affect up to 60-80% of children treated with cisplatin, depending on dosage, duration, and individual patient factors. The mechanism involves the generation of reactive oxygen species and damage to the cochlear hair cells, which are critical for hearing. For pediatric patients, the implications of permanent hearing loss are particularly profound, extending far beyond the immediate medical context. It can severely impact language development, educational attainment, social integration, and overall quality of life, often necessitating hearing aids or cochlear implants and ongoing rehabilitative support. The long-term consequences underscore the urgent need for effective otoprotective strategies that do not compromise the primary goal of cancer eradication.
A paramount concern surrounding any otoprotective treatment is the potential for interference with cisplatin’s primary antitumor activity. Oncologists have historically been wary of co-administering agents that might "rescue" cancer cells from cisplatin’s cytotoxic effects, thereby undermining the chemotherapy’s efficacy. This delicate balance – protecting vital organs without compromising cancer treatment – has been a significant hurdle in the development of supportive therapies. PEDMARK’s development and clinical validation have specifically addressed this critical concern, offering a solution that prioritizes both hearing preservation and oncologic outcomes.
Clinical Validation: Preserving Efficacy While Protecting Hearing
Fennec Pharmaceuticals prominently highlighted research presented during the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, which provided crucial additional evidence directly addressing the concern of potential interference with cisplatin’s antitumor activity. ASCO, one of the largest and most influential oncology conferences globally, serves as a vital platform for disseminating cutting-edge research and shaping clinical practice. The data presented there carried significant weight, reinforcing the clinical utility and safety profile of PEDMARK.
According to the company, real-world evidence presented at ASCO unequivocally reinforced that PEDMARK can be seamlessly integrated into patient care protocols when administered approximately six hours after cisplatin, critically, without compromising cisplatin’s established antitumor activity. This finding is not merely an observational note but a pivotal piece of evidence that provides clinicians with confidence in using PEDMARK. The strategic timing of administration is key to this success. PEDMARK is specifically designed to be administered after cisplatin has had sufficient time to exert its cytotoxic effects on cancer cells. This delayed administration approach allows cisplatin to bind to DNA and initiate its antineoplastic action before sodium thiosulfate is introduced to mitigate its toxic effects on the sensitive cells of the inner ear.
These recent findings build upon and strengthen previous robust clinical evidence supporting the delayed administration of sodium thiosulfate. A comprehensive pooled analysis of data from two pivotal Phase 3 clinical trials – COG ACCL0431 and SIOPEL 6 – found no statistically significant differences in critical oncologic endpoints between patients receiving sodium thiosulfate and control groups. Specifically, there were no significant disparities observed in overall survival (OS), event-free survival (EFS), or objective chemotherapy response rates. This aggregated data provides a strong foundation, assuring the oncology community that the protective benefits of PEDMARK do not come at the expense of cancer control, a concern that had historically impeded the widespread adoption of otoprotective agents. The consistency across multiple studies and analyses is vital for establishing clinical guidelines and fostering physician confidence.
PEDMARK’s Journey: From Unmet Need to FDA Approval
The path to PEDMARK’s current success is rooted in years of dedicated research and clinical development aimed at addressing a significant unmet medical need. Sodium thiosulfate has been investigated for its chelating and antioxidant properties for decades, with early studies hinting at its potential in mitigating heavy metal toxicities. However, its specific application as an otoprotective agent against cisplatin-induced hearing loss required rigorous scientific investigation and clinical trials.
PEDMARK’s development culminated in its landmark FDA approval in September 2022. This approval was a watershed moment, as it designated PEDMARK as the first and, to date, only FDA-approved therapy specifically indicated to reduce the risk of cisplatin-induced ototoxicity in pediatric patients one month of age and older with localized, non-metastatic solid tumors. This approval was primarily based on the compelling results from the two randomized Phase 3 clinical studies: COG ACCL0431 and SIOPEL 6.
- COG ACCL0431: This multicenter, randomized, controlled trial enrolled pediatric patients receiving cisplatin for various solid tumors. It demonstrated a statistically significant reduction in the incidence and severity of hearing loss in patients treated with sodium thiosulfate compared to those receiving cisplatin alone.
- SIOPEL 6: This study specifically focused on pediatric patients with hepatoblastoma receiving cisplatin-based chemotherapy. It similarly showed a significant protective effect against ototoxicity without compromising the excellent survival rates typically achieved in this patient population.
These trials collectively provided the robust efficacy and safety data required for regulatory approval, establishing PEDMARK as a transformative therapy. Outside the United States, the therapy is marketed under the brand name PEDMARQSI®, extending its reach to international markets and further solidifying Fennec’s global footprint in supportive cancer care.
Expanding Research Horizons and Patient Populations
While PEDMARK is currently FDA approved for a specific pediatric patient population, the scope of research into sodium thiosulfate’s otoprotective benefits is rapidly expanding. The National Comprehensive Cancer Network (NCCN), a leading alliance of cancer centers, already provides sodium thiosulfate with a Category 2A recommendation for adolescent and young adult (AYA) patients. This recommendation signifies that there is uniform NCCN consensus that the intervention is appropriate, based on lower-level evidence. This recognition by a prestigious body like the NCCN often precedes broader clinical adoption and potential label expansion.
The 2026 ASCO program notably featured four independently led studies examining PEDMARK across multiple patient populations and tumor types. Fennec highlighted that this research is instrumental in expanding the understanding of its potential use beyond the current label, specifically among adolescent and young adult (AYA) and adult patients. These studies are crucial for gathering real-world data and conducting prospective investigations in populations where cisplatin is still a frontline therapy, but where the long-term impact of ototoxicity may also be significant for quality of life and vocational outcomes.
Furthermore, additional investigator-sponsored studies are actively examining sodium thiosulfate in patients with several other cancers where cisplatin remains an important and often curative part of treatment, and where treatment-related hearing loss is a significant concern. These include, but are not limited to, germ cell tumors, head and neck cancers, and bladder cancers in adult populations. The breadth of these ongoing investigations suggests a strong belief within the oncology community that the otoprotective benefits of sodium thiosulfate could extend to a wider patient demographic, potentially transforming supportive care standards across a broader spectrum of cancer treatments. The insights gleaned from these studies are vital for informing future clinical guidelines, promoting wider accessibility, and potentially leading to expanded regulatory approvals.
Growing Adoption and Broader Impact on Cancer Care
Fennec Pharmaceuticals’ report of continued increase in demand for PEDMARK during the second quarter, with growth observed across both established and new accounts, is a strong indicator of its accelerating market penetration and acceptance. The company’s substantial year-over-year growth during the first half of 2026 further underscores the broader adoption of the treatment within the clinical community. This growing uptake reflects a paradigm shift in supportive cancer care, where the long-term quality of life for cancer survivors is gaining increasing prominence alongside primary oncologic outcomes.
The combination of growing clinical use and continued research reflects increasing attention to a longstanding and critical challenge in cancer care: the imperative to reduce the risk of permanent treatment-related hearing loss while unequivocally preserving the effectiveness of life-saving cisplatin chemotherapy. For decades, clinicians and patients faced a difficult choice, often sacrificing auditory health for the sake of cancer cure. With PEDMARK, Fennec Pharmaceuticals has introduced a solution that effectively addresses both concerns, offering a pathway to better long-term outcomes for countless patients.
The success of PEDMARK also signals a broader trend in oncology, where supportive care is increasingly viewed not as an ancillary service but as an integral component of comprehensive cancer treatment. This holistic approach recognizes that treating cancer effectively involves not only eradicating the disease but also minimizing treatment-related morbidities that can profoundly impact a patient’s life long after therapy concludes. As Fennec Pharmaceuticals continues to invest in research and expand its commercial footprint, PEDMARK is poised to solidify its position as a standard of care for otoprotection in cisplatin-treated patients, potentially leading to a future where fewer cancer survivors must contend with the debilitating effects of permanent hearing loss. This ongoing evolution in supportive care underscores a commitment to not just extending lives, but also enriching them.
