Fennec Pharmaceuticals has announced a period of exceptional financial performance driven by robust and escalating demand for PEDMARK® (sodium thiosulfate), its groundbreaking therapeutic designed to mitigate the risk of hearing loss associated with cisplatin chemotherapy. This surge in market adoption is significantly underpinned by a growing body of new clinical evidence that consistently reinforces the drug’s ability to protect auditory function without impinging upon cisplatin’s vital antitumor activity, a critical concern in oncology. The company’s second-quarter 2026 financial results highlight this trajectory, marking its seventh consecutive quarter of growth and signaling a deepening impact on pediatric oncology care and beyond.
The strong commercial momentum for PEDMARK was evident in the second quarter of 2026, with net product sales reaching an impressive $17.1 million. This figure represents a substantial 78% increase compared to the $9.7 million recorded during the same period in the previous year. Fennec Pharmaceuticals attributed this significant growth to a dual-pronged strategy: increased uptake from both established healthcare accounts and the successful penetration of new clinical sites. This expansion in market reach was facilitated by a strategic enhancement of its commercial organization, allowing for broader engagement with oncologists, pharmacists, and hospital systems. The company further noted that this record demand has shown no signs of abating, continuing strongly into the third quarter, suggesting a sustained positive trend in adoption.
At the heart of this commercial success is the ongoing validation of sodium thiosulfate’s role in preventing cisplatin-induced ototoxicity. Researchers globally continue to investigate the compound, exploring not only its established use but also its potential utility across a broader spectrum of ages and various cancer types. This expanded research pipeline, including a growing number of investigator-sponsored studies, is crucial for unlocking the full therapeutic potential of PEDMARK and further solidifying its position as a standard of care in supportive oncology.
Jeff Hackman, CEO of Fennec Pharmaceuticals, articulated the company’s satisfaction with its performance and strategic direction: "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." Hackman’s statement underscores a clear vision: to leverage robust clinical data and strategic commercial expansion to ensure PEDMARK reaches every patient who can benefit from its hearing-preserving capabilities. The emphasis on "investing in the evidence" signals a commitment to long-term clinical development and market expansion, positioning PEDMARK not just as a current treatment but as a foundational element of future supportive cancer care protocols.
Addressing the Critical Balance: Protecting Hearing While Preserving Cancer Treatment Efficacy
Cisplatin stands as a cornerstone chemotherapy agent, lauded for its potent efficacy against a wide array of cancers, including various solid tumors in pediatric, adolescent, and adult populations such as osteosarcoma, hepatoblastoma, germ cell tumors, and certain head and neck cancers. However, its significant antineoplastic activity comes with a well-documented and often debilitating side effect: ototoxicity. This damage to the delicate sensory hair cells within the inner ear can lead to permanent, irreversible hearing loss, profoundly impacting a patient’s quality of life. In pediatric patients, this risk is particularly acute, as hearing impairment can severely impede language development, educational attainment, and social integration. Historically, a significant challenge surrounding otoprotective treatments has been the critical concern of whether protecting the ear could inadvertently interfere with cisplatin’s cytotoxic mechanisms, thereby compromising its ability to effectively combat cancer. This dilemma has long presented a therapeutic tightrope walk for oncologists.
Fennec Pharmaceuticals actively addressed this crucial consideration by highlighting compelling research presented during the prestigious 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. This renowned global gathering of oncology professionals serves as a vital platform for disseminating cutting-edge research and shaping future clinical practices. The data unveiled at ASCO provided additional, robust evidence directly addressing the concern of potential interference with cisplatin’s anti-tumor activity.
According to the company’s summary of the ASCO presentations, real-world evidence reinforced a pivotal finding: PEDMARK can be seamlessly integrated into patient care protocols when administered approximately six hours following cisplatin infusion, critically without compromising cisplatin’s established and life-saving antitumor efficacy. This specific timing, known as delayed administration, is a cornerstone of PEDMARK’s therapeutic approach. The findings from ASCO further buttress previous clinical evidence supporting this delayed administration strategy for sodium thiosulfate. A comprehensive pooled analysis of data from pivotal clinical trials – specifically COG ACCL0431 and SIOPEL 6 – found no statistically significant differences in key oncological outcomes, including overall survival, event-free survival, or objective chemotherapy response rates, between patient cohorts receiving sodium thiosulfate and their respective control groups. This powerful aggregation of data provides high-level assurance that the otoprotective benefits do not come at the cost of therapeutic compromise.
The precise timing of PEDMARK’s administration is indeed an indispensable component of its mechanism of action. Unlike a simultaneous co-administration, PEDMARK is given after cisplatin, typically within a 6-10 hour window. The rationale behind this strategy is to allow cisplatin sufficient time to exert its full antitumor effects on cancer cells before sodium thiosulfate is introduced into the patient’s system. Sodium thiosulfate then acts as a potent antioxidant and chelating agent, working to neutralize the reactive oxygen species and platinum compounds that are primarily responsible for cisplatin’s toxic effects on the inner ear, thereby selectively reducing ototoxicity while preserving the chemotherapy’s systemic cytotoxic impact on malignant cells. This nuanced approach has been a game-changer in managing one of the most feared side effects of a critically important cancer drug.
Expanding the Horizon: Research Targets Additional Patient Populations
PEDMARK’s initial FDA approval in September 2022 marked a significant milestone, making it the first and only FDA-approved therapy specifically indicated to reduce the risk of cisplatin-associated ototoxicity. Its current approval extends to pediatric patients aged one month and older who are undergoing cisplatin treatment for localized, non-metastatic solid tumors. This initial indication addressed a critical unmet need in a vulnerable population. Building on this foundation, the National Comprehensive Cancer Network (NCCN), a leading alliance of cancer centers, has also issued a Category 2A recommendation for sodium thiosulfate’s use in 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, paving the way for broader clinical consideration in this age group.
The 2026 ASCO program further underscored the expanding investigative scope of PEDMARK. Four independently led studies presented at the meeting specifically examined sodium thiosulfate across multiple patient populations and diverse tumor types. Fennec Pharmaceuticals highlighted that this research is instrumental in broadening the understanding of PEDMARK’s potential utility among adolescent and young adult (AYA) and, significantly, adult patients. These studies are critical for gathering the necessary efficacy and safety data that could support future label expansion and wider clinical application.
Beyond the ASCO presentations, a robust pipeline of additional investigator-sponsored studies is actively examining sodium thiosulfate’s role in patients diagnosed with several types of cancer where cisplatin remains an indispensable part of the treatment regimen, and where treatment-related hearing loss is a significant and ongoing concern. These include, but are not limited to, germ cell tumors (testicular, ovarian), bladder cancer, lung cancer, head and neck cancers, and various pediatric solid tumors not covered by the initial approval. The collaborative nature of these investigator-sponsored trials reflects a growing scientific interest and clinical imperative to address ototoxicity more comprehensively across the oncology landscape. This expansion into AYA and adult populations holds the potential to dramatically increase the addressable market for PEDMARK, further solidifying its role in supportive cancer care.
A Timeline of Innovation and Impact: PEDMARK’s Journey
The development and adoption of PEDMARK represent a significant chapter in supportive cancer care.
- Early 1970s: Cisplatin is approved for clinical use, quickly becoming a foundational chemotherapy agent but with early recognition of its severe side effects, including ototoxicity.
- Late 1990s – Early 2000s: Initial research into otoprotective agents, including sodium thiosulfate, begins to gather momentum, particularly in the context of pediatric oncology where the long-term impact of hearing loss is most profound.
- 2007 – 2012: The pivotal COG ACCL0431 study, a randomized Phase 3 clinical trial, is initiated to evaluate sodium thiosulfate in pediatric patients receiving cisplatin.
- 2010 – 2016: The SIOPEL 6 study, another critical randomized Phase 3 trial, commences, focusing on sodium thiosulfate in pediatric patients with hepatoblastoma treated with cisplatin.
- September 2022: PEDMARK® (sodium thiosulfate injection) receives FDA approval, making it the first and only 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 a direct result of the compelling data from COG ACCL0431 and SIOPEL 6.
- 2023 – Present: Fennec Pharmaceuticals initiates commercial launch and market penetration efforts, focusing on educating the oncology community about PEDMARK’s benefits and the importance of timely administration.
- 2024 – 2026: Sustained commercial growth and increasing adoption, fueled by expanding clinical evidence and the strategic expansion of Fennec’s commercial organization. The NCCN issues its Category 2A recommendation for AYA patients.
- ASCO 2026: Presentation of new real-world evidence and data from investigator-sponsored studies further validates PEDMARK’s efficacy and explores its potential in broader patient populations, reinforcing its position as a critical supportive care agent.
Growing Adoption Reflects a Shifting Paradigm in Cancer Care
Fennec Pharmaceuticals’ report of continued increases in demand for PEDMARK during the second quarter, characterized by growth across both established and newly acquired accounts, underscores a broader and increasingly widespread adoption of the treatment. This momentum is further highlighted by substantial year-over-year growth observed throughout the entire first half of 2026, signaling that PEDMARK is steadily becoming an integral part of standard care protocols where cisplatin is used. The growing commercial footprint and the consistent demand reflect a paradigm shift in how oncologists and healthcare providers approach the management of cisplatin-induced toxicities.
This dual trend of growing clinical utilization alongside a vigorous program of ongoing research vividly illustrates the increasing attention being paid to a longstanding and significant challenge in cancer care: the imperative to reduce the risk of permanent, treatment-related hearing loss while unequivocally preserving the life-saving effectiveness of cisplatin chemotherapy. For decades, clinicians and patients alike have grappled with the difficult trade-off between aggressive, curative cancer treatment and the potential for severe, lifelong side effects. PEDMARK offers a powerful solution to this dilemma, allowing for aggressive treatment while proactively safeguarding a crucial aspect of a patient’s long-term quality of life.
The implications of PEDMARK’s success extend beyond financial metrics for Fennec Pharmaceuticals. For patients, particularly children, it offers the hope of a future free from the profound developmental and social challenges associated with severe hearing impairment. For healthcare systems, it represents a step forward in comprehensive cancer care, acknowledging that successful treatment encompasses not only disease eradication but also the preservation of patient well-being and function. The ongoing expansion of research into AYA and adult populations suggests that the benefits of this otoprotective strategy could eventually reach a far wider demographic, potentially mitigating hearing loss for countless more individuals undergoing cisplatin chemotherapy. This collective commitment to innovation in supportive care signifies a maturing field of oncology that increasingly prioritizes holistic patient outcomes.
About PEDMARK® (sodium thiosulfate injection)
PEDMARK® (sodium thiosulfate injection) is an intravenous therapy that holds the distinction of being the first and only FDA-approved medication specifically indicated to reduce the risk of ototoxicity associated with cisplatin treatment. This crucial approval targets pediatric patients aged one month and older who are battling localized, non-metastatic solid tumors, a population particularly vulnerable to the devastating effects of cisplatin-induced hearing loss.
The therapy is administered intravenously following cisplatin treatment, typically within 6-10 hours, a timing strategy carefully designed to allow cisplatin to exert its full antitumor effects before the otoprotective action of sodium thiosulfate commences. The approval of PEDMARK was predicated on compelling evidence derived from two pivotal, randomized Phase 3 clinical studies: COG ACCL0431 and SIOPEL 6. These trials demonstrated the statistically significant ability of sodium thiosulfate to reduce the incidence and severity of hearing loss without compromising oncological outcomes.
When it received FDA approval in September 2022, PEDMARK became a landmark therapy, addressing a critical unmet medical need that had persisted for decades in pediatric oncology. Its introduction has provided oncologists with a powerful tool to enhance the quality of life for young cancer survivors. Outside the United States, the therapy is recognized and marketed under the brand name PEDMARQSI®. The ongoing clinical research and increasing adoption worldwide underscore its global significance in advancing supportive care standards for patients receiving cisplatin-based chemotherapy.
Source: Fennec Pharmaceuticals
