Monitor for future data readouts from this real-world study, which could support label expansion or increased off-label adoption. Watch for additional institutional studies that may validate broader clinical utility beyond pediatrics.
Price Chart
Executive Summary
Fennec Pharmaceuticals announced that Tampa General Hospital (TGH) Cancer Institute is initiating a real-world study evaluating the clinical utility of PEDMARK® (sodium thiosulfate) in reducing cisplatin-induced ototoxicity in adolescent and young adult (AYA) and adult cancer patients. The study aims to generate real-world evidence to support broader clinical adoption and inform future research on hearing protection during chemotherapy.
Key Facts
- Tampa General Hospital Cancer Institute is launching a real-world study on PEDMARK® for ototoxicity prevention in AYA and adult cisplatin-treated cancer patients.
- PEDMARK® is currently FDA-approved only for pediatric patients (1 month and older) with localized, non-metastatic solid tumors.
- National Comprehensive Cancer Network (NCCN) gives a 2A recommendation for PEDMARK® use in AYA patients.
- The study is observational and aims to collect real-world clinical and audiology data to inform future research and quality initiatives.
- No financial terms, funding commitments, or commercial expansion plans were disclosed.
Financial Impact
No immediate financial impact; potential long-term benefit if real-world data supports expanded use in AYA/adult populations.
Risk Factors
- Study results may not demonstrate significant ototoxicity reduction in AYA/adult populations.
- Regulatory approval for adult use would require additional clinical trials, not just real-world data.
- Adoption remains limited without reimbursement or guideline upgrades beyond NCCN 2A.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3249229 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 19, 2026 8d ago | SC 13G/A | $10.27 | awaiting T+60 | — | $10.54 (+2.63%) |
Aug 31, 2026 8w ago | Insider Cluster | $12.03 | awaiting T+60 | — | $10.54 (−12.39%) |
Aug 31, 2026 8w ago | Insider Cluster | $12.03 | awaiting T+60 | — | $10.54 (−12.39%) |
Aug 11, 2026 11w ago | Press Release | $12.78 | awaiting T+60 | — | $10.54 (−17.53%) |
Jun 15, 2026 19w ago | Press Release | $9.19 $11.65 | ▲ +26.77% | ▲ +25.77% | $10.54 (+14.69%) |
May 22, 2026 22w ago | 8-K | $9.89 $11.87 | ▲ +20.02% | ▲ +17.30% | $10.54 (+6.57%) |
May 18, 2026 23w ago | 8-K | $9.76 $12.06 | ▲ +23.57% | ▲ +17.28% | $10.54 (+7.99%) |
May 14, 2026 23w ago | Press Release | $9.24 $10.94 | ▲ +18.40% | ▲ +14.81% | $10.54 (+14.07%) |
May 7, 2026 24w ago | Press Release | $6.90 $9.59 | ▲ +38.99% | ▲ +35.15% | $10.54 (+52.75%) |
Apr 28, 2026 25w ago | 8-K | $6.26 $9.99 | ▲ +59.58% | ▲ +55.47% | $10.54 (+68.37%) |
US Market Status
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