Traws Pharma Updates Toxicology Data Package for MHRA Requirements
Traws Pharma announced that an updated toxicology data package is in the process of being developed in response to information requirements from the United Kingdom's Medicines and Healthcare Products Regulatory Agency for the planned testing of tivoxavir marboxil in a Phase 2a human influenza Challenge study. The updated data package is expected to be resubmitted to MHRA during the third quarter of 2026. Following Traws' announcement on June 12, the MHRA provided more detailed feedback that has enabled the company to prepare additional preclinical safety information for inclusion in the TXM data package. Following the resubmission, the company expects a formal response from MHRA within 30 days.
