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Aug 14, 2026Regulatory decision

Traws Pharma preps revised toxicology data for MHRA resubmission by Q3 2026

The company plans to resubmit an updated toxicology package for tivoxavir marboxil after MHRA feedback, aiming to support a Phase 2a influenza Challenge study.

Traws Pharma reported financial results for the quarter ended June 30, 2026, and outlined progress on its lead antiviral program, tivoxavir marboxil (TXM), on August 14, 2026.

After receiving feedback from the MHRA on its planned Phase 2a human influenza Challenge study, Traws is preparing an updated toxicology data package.1 The company expects to resubmit this package at the end of the third quarter of 2026.1 If the MHRA accepts the resubmission, the Challenge study is planned to be conducted in healthy volunteers at hVIVO in the UK.1

Separately, the FDA placed the U.S. IND for TXM on clinical hold due to concerns with the toxicology data package, and Traws is preparing a response with the goal of resolving the hold and advancing the program in the U.S. by the end of 2026.1

On financing, in April 2026 the company completed a placement delivering $10.0 million upfront, with potential for up to $50.0 million more through three tranches of warrants tied to clinical and regulatory milestones.1 On July 8, 2026, shareholders approved the Series B and Series C tranches, though access to that capital still depends on milestone achievement, sequential exercise of earlier tranches, and investor participation.1

Financially, cash and cash equivalents were $5.0 million as of June 30, 2026, up from $3.8 million at year-end 2025.1 The company said existing cash plus anticipated ATM proceeds should fund operations into the first quarter of 2027, but additional financing may be needed beyond that point.1 Net loss for the quarter was $3.0 million, or $0.16 per share, compared with a $0.9 million loss a year earlier.1

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.