Clinical TrialJun 22, 2026, 07:06 AM
Traws Pharma to Resubmit Tivoxavir Marboxil Data to MHRA for Flu Study
AI Summary
Traws Pharma announced its intention to resubmit an updated data package to the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) for the planned testing of tivoxavir marboxil (TXM). This resubmission, which includes updated toxicology and preclinical safety information, is for a Phase 2a human influenza Challenge study and is expected in the third quarter of 2026. The company anticipates a formal response from MHRA within 30 days of the resubmission, with CEO Iain D. Dukes expressing confidence that the updated package will support the study and provide important proof of concept data for TXM as an oral prophylaxis medicine.
Key Highlights
- Traws Pharma to resubmit updated data package to UK MHRA.
- Data package is for planned testing of tivoxavir marboxil (TXM).
- Resubmission is for a Phase 2a human influenza Challenge study.
- Updated data package expected to be resubmitted in Q3 2026.
- MHRA feedback enabled preparation of additional preclinical safety information.
- Formal MHRA response expected within 30 days of resubmission.
- TXM showed broad in vitro efficacy across multiple influenza strains.
- Company will profile additional molecules for influenza treatment program.
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