aibioTraws Pharma prepares updated MHRA data package for third quarter
Tickers TRAW
Traws says MHRA feedback has led it to add preclinical safety information to the tivoxavir marboxil data package, which it expects to resubmit in the third quarter of 2026.
Key facts
- Company
- Traws Pharma, Inc. (NASDAQ: TRAW)
- News type
- Company Updates
- Primary source
- Traws Pharma, Inc. SEC filing (Form 8-K)
Traws Pharma, Inc. (NASDAQ: TRAW) said on June 22, 2026 that it is preparing an updated toxicology data package for its tivoxavir marboxil (TXM) influenza program. The work responds to information requirements from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for a planned Phase 2a human influenza challenge study. The company expects to resubmit the updated package during the third quarter of 2026. The press release was issued from Newtown, Pennsylvania.
A setback for the challenge study
The release is framed as updated guidance, but its substance is a delay. The MHRA has asked for more preclinical safety information before the Phase 2a challenge study can go ahead, so the study is not approved. The release does not say what the safety questions are, or that the MHRA has agreed the new package will be enough.
Traws said that its June 12 announcement was followed by more detailed feedback from the MHRA. That feedback allowed the company to prepare additional preclinical safety information for the TXM data package. After the resubmission, Traws expects a formal response from the MHRA within 30 days.
Chief Executive Officer Iain Dukes said: "Based upon recent feedback and further guidance from the MHRA, we believe our updated data package will support the proposed seasonal influenza Challenge study to be conducted in healthy volunteers and provide important proof of concept data for TXM's use as an oral prophylaxis medicine."
Program context
Chief Science Officer C. David Pauza, PhD, said: "TXM demonstrated broad in vitro efficacy across multiple strains of seasonal influenza and a pharmacokinetic profile consistent with its use as a chemoprophylactic agent." The company also said it will start profiling additional molecules for its influenza treatment program.
Chief Medical Officer Robert R. Redfield, MD, said influenza prevention is especially important for elderly and immunocompromised people. The release describes a broader platform aimed at other viruses but shows no data for them.
Company background
Traws, formerly Onconova Therapeutics, Inc., merged with Trawsfynydd Therapeutics, Inc. on April 1, 2024. Before the merger, its focus was cancer. The company now targets respiratory viral diseases through four clinical programs: TXM, ratutrelvir, narazaciclib and rigosertib. TXM is an investigational oral, small molecule cap-dependent endonuclease inhibitor designed to be given as a single dose for bird flu and seasonal influenza.
A Phase 1 study in Australia enrolled four cohorts of eight participants. Topline data showed good overall tolerability, and a single dose kept detectable plasma drug levels for 23 days. Traws said those Phase 1 results support further investigation of TXM as a one-time influenza treatment and as a once-monthly oral drug for influenza prevention. In 2025, the company reported preclinical data in mice, ferrets and nonhuman primates infected with an H5N1 virus. The company reported that TXM reduced disease progression and increased survival in those animals. Animal results do not show benefit in people, and the only human data are from small Phase 1 studies.
Financial position
The XBRL financial data for the company show 2025 revenue of $2.8 million and net income of $9.2 million, with cash used in operations of $18.2 million. For 2024, revenue was $226,000, the net loss was $166.5 million and cash used in operations was $29.8 million.
The next steps are the resubmission in the third quarter and the MHRA's formal response within 30 days after that. Both dates are expectations, and a response could ask for more. The release lists John Fraunces of LifeSci Advisors, LLC as the investor contact.
The delay has a cost. The company used $18.2 million of cash in operations in 2025, and the release gives no cash figure or runway. The 2025 net income of $9.2 million does not make it self-funding, since cash from operations was negative.