RegulatoryJun 22, 2026, 07:02 AM
Traws Pharma to Resubmit TXM Toxicology Data to MHRA in Q3 2026
AI Summary
Traws Pharma, Inc. announced it is preparing an updated toxicology data package for tivoxavir marboxil (TXM) to address requirements from the UK's MHRA. This package is for a planned Phase 2a human influenza Challenge study and is expected to be resubmitted in Q3 2026. The company anticipates a formal response from the MHRA within 30 days of resubmission, expressing confidence that the updated data will support the proposed study.
Key Highlights
- Traws Pharma is developing an updated toxicology data package for tivoxavir marboxil (TXM).
- The package is in response to MHRA requirements for a planned Phase 2a human influenza Challenge study.
- Resubmission of the data package to MHRA is expected during the third quarter of 2026.
- Traws Pharma anticipates a formal response from MHRA within 30 days of the resubmission.
- TXM has shown broad in vitro efficacy against multiple seasonal influenza strains.
- The company plans to initiate profiling of additional molecules for its influenza treatment program.
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