FDA Events for Fennec Pharmaceuticals (FRX)
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
PEDMARQSI. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
PEDMARQSI - FDA Regulatory Timeline and 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that Norgine Pharmaceuticals Ltd., a leading European specialist pharmaceutical company, has received positive final draft guidance from National Institute for Health and Care Excellence (NICE) recommending PEDMARQSI for the prevention of cisplatin-induced hearing loss in patients (aged 1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Fennec Pharmaceuticals Inc announced that its partner, Norgine Pharmaceuticals Ltd, has received positive final draft guidance from the National Institute for Health and Care Excellence (NICE).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.
Read Announcement
Fennec Pharmaceuticals FDA Events - Frequently Asked Questions
As of now, Fennec Pharmaceuticals (FRX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Fennec Pharmaceuticals (FRX) has reported FDA regulatory activity for PEDMARQSI.
The most recent FDA-related event for Fennec Pharmaceuticals occurred on December 20, 2024, involving PEDMARQSI. The update was categorized as "Guidance," with the company reporting: "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."
Currently, Fennec Pharmaceuticals has one therapy (PEDMARQSI) targeting the following condition: For the prevention of ototoxicity.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (TSE:FRX) was last updated on 7/13/2025 by MarketBeat.com Staff
Free FRX Stock Alerts