Traws Pharma filed an IND with the FDA for its single‑dose influenza therapy tivoxavir marboxil (TXM), moving the candidate closer to potential inclusion in the U.S. strategic national stockpile managed by BARDA. The filing marks the final regulatory step before the company can begin human trials.
The company also released interim data from a 50‑patient Phase II study of its ritonavir‑free COVID‑19 protease inhibitor ratutrelvir. Patients treated with ratutrelvir experienced faster symptom resolution and no viral rebound events, outperforming the nirmatrelvir/ritonavir (Paxlovid) comparator. The data support the drug’s potential to treat patients who cannot receive Paxlovid.
Management highlighted the clinical significance of the findings. Chief Medical Officer Robert R. Redfield said the absence of viral rebound and the rapid symptom improvement “encourage continued evaluation of ratutrelvir in both acute COVID‑19 and in studies designed to better understand its impact on long‑term outcomes.” Chief Scientific Officer C. David Pauza noted that the IND filing “represents an important step toward formal consideration of TXM for influenza therapy and inclusion in the national stockpile.”
The dual announcements have already attracted investor attention, with Traws Pharma shares rising 6.3 % in pre‑market trading on NasdaqCM. The market reaction reflects confidence that the company’s pipeline is advancing in two high‑impact therapeutic areas and that the regulatory and clinical milestones could open new revenue streams.
Financially, the company reported a net loss of $4.0 million for Q3 2025 and held $6.4 million in cash as of September 30 2025. While the company remains in a loss‑making phase, the cash position provides a runway to support the next stages of development for TXM and ratutrelvir.
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