This section highlights FDA-related milestones and regulatory updates for drugs developed by Fennec Pharmaceuticals (FRX).
Over the past two years, Fennec Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Pedmark and PEDMARQSI. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Pedmark (Sodium Thiosulfate-STS) FDA Regulatory Events
Pedmark (Sodium Thiosulfate-STS) is a drug developed by Fennec Pharmaceuticals for the following indication: Life-long hearing loss for children receiving cisplatin chemotherapy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Pedmark (Sodium Thiosulfate-STS)
- Announced Date:
- February 20, 2026
- Indication:
- Life-long hearing loss for children receiving cisplatin chemotherapy
Announcement
Fennec Pharmaceuticals Inc. announced new real world data supporting potential use of PEDMARK® (sodium thiosulfate injection) in adults with head and neck cancers were presented as a digital poster at the 2026 Multidisciplinary Head and Neck Cancers Symposium (MHNCS) in Palm Desert, CA from February 19 – 21, 2026.
AI Summary
Fennec Pharmaceuticals presented real-world data as a digital poster at the 2026 Multidisciplinary Head and Neck Cancers Symposium (MHNCS) in Palm Desert, CA (Feb 19–21, 2026) supporting the potential use of PEDMARK® (sodium thiosulfate injection) in adults with head and neck cancers. The study showed that giving PEDMARK about six hours after cisplatin was safe and could be easily integrated into routine care. The primary endpoint measured feasibility by timing adherence (≥6 hours) and operational factors like home versus clinic dosing and infusion chair time. Secondary measures included infusion-related events, need for more antiemetics, and completion of audiology assessments.
Early signals suggested PEDMARK may preserve hearing: most high‑risk patients experienced no measurable hearing loss during or after treatment despite existing baseline impairment. PEDMARK was well tolerated, with only isolated, short lived infusion reactions and no grade 3 or 4 toxicities. The data support feasibility and scalability and highlight the potential to address cisplatin‑related hearing loss without undermining cisplatin’s antitumor effects.
Read Announcement- Drug:
- Pedmark (Sodium Thiosulfate-STS)
- Announced Date:
- December 2, 2025
- Indication:
- Life-long hearing loss for children receiving cisplatin chemotherapy
Announcement
Fennec Pharmaceuticals Inc. announced positive topline results from the investigator-initiated Phase 2/3 STS-J01 clinical trial evaluating PEDMARK® (sodium thiosulfate injection) for the reduction of cisplatin-induced ototoxicity in pediatric and adolescent and young adult (AYA) patients with non-metastatic solid tumors in Japan.
AI Summary
Fennec Pharmaceuticals announced positive topline results from the investigator‑initiated Phase 2/3 STS‑J01 trial in Japan testing PEDMARK® (sodium thiosulfate) to prevent cisplatin‑induced hearing loss in children and AYA patients with non‑metastatic solid tumors. The study enrolled 27 patients in the primary 3–18 year cohort (plus six infants in exploratory cohorts). PEDMARK was given six hours after cisplatin.
The trial met its primary endpoint. Hearing loss occurred in 24% of evaluable patients by ASHA criteria and 16% by Brock grade, compared with historically reported cisplatin‑only rates of about 56–63%. In the 7–18 year subgroup rates were 19% (ASHA) and 14.3% (Brock). Pharmacokinetic data showed no reduction in cisplatin exposure, and the overall tumor response rate was about 95%, indicating no interference with anticancer activity.
PEDMARK was well tolerated; more than 200 treatment‑emergent events were reported but none attributed to the drug. Fennec plans to pursue registration in Japan and is exploring partnering or licensing opportunities. Full results will be presented and submitted for publication.
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PEDMARQSI FDA Regulatory Events
PEDMARQSI is a drug developed by Fennec Pharmaceuticals for the following indication: For the prevention of ototoxicity.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PEDMARQSI
- Announced Date:
- December 20, 2024
- Indication:
- For the prevention of ototoxicity
Announcement
Fennec Pharmaceuticals Inc announced that Norgine Pharmaceuticals Ltd., a leading European specialist pharmaceutical company, has received positive final draft guidance from National Institute for Health and Care Excellence (NICE) recommending PEDMARQSI for the prevention of cisplatin-induced hearing loss in patients (aged 1 month to 17 years) with localized, non-metastatic, solid tumors.
AI Summary
Fennec Pharmaceuticals Inc announced that its partner, Norgine Pharmaceuticals Ltd, has received positive final draft guidance from the National Institute for Health and Care Excellence (NICE). The guidance recommends using PEDMARQSI® (anhydrous sodium thiosulfate) to prevent cisplatin-induced hearing loss in children and young people aged 1 month to 17 years with localized, non-metastatic solid tumors. This step is significant because cisplatin, a common chemotherapy treatment, can cause irreversible hearing loss, severely impacting the quality of life of pediatric cancer patients. The NICE recommendation marks a major milestone, as PEDMARQSI® is the first and only approved therapy in the EU and U.K. for this use, promising to address a long-standing, unmet need in oncology care.
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