(RTTNews) - Shares of Traws Pharma Inc (TRAW) are down over 28%, on news of its US IND for Tivoxavir marboxil being placed on clinical hold by the FDA due to concerns with the mutagenicity data package.
The company had filed the IND application for Tivoxavir marboxil to enable a complete review by the Biomedical Advanced Research and Development Authority (BARDA) for potential inclusion in the strategic stockpile for the treatment of avian influenza.
The FDA is expected to communicate its concerns formally, together with suggested mitigation steps, by March 16, 2026. However, the clinical hold does not directly impact ongoing and planned studies outside of the United States, the company noted.
The company also provided an update on progress in advancing an additional indication for Tivoxavir marboxil, as a once-monthly, single oral tablet for prevention of seasonal influenza.
Preclinical tablet data of Tivoxavir marboxil showed increased exposure compared to prototype formulations, with modelling suggesting 28-day protection.
Preparations are underway for a human influenza prophylaxis challenge study with Tivoxavir marboxil in the UK.
The company also announced completion of its Phase 2 analysis of Ratutrelvir, an investigational oral, ritonavir-free Mpro/3CL protease inhibitor, in COVID-19 patients eligible and ineligible for PAXLOVID.
The 90-patient, open-label study confirmed a differentiated profile versus PAXLOVID, with fewer adverse events, no viral rebounds, and equivalent time to sustained symptom resolution. In PAXLOVID-ineligible patients, Ratutrelvir demonstrated faster symptom resolution and a favorable tolerability profile, highlighting its potential to address a significant population lacking effective treatment options.
"Collectively, the advancement of our antiviral portfolio provides significant value inflection points and could deliver treatment and prevention options for clinically important viral diseases," said lain Dukes, CEO of Traws Pharma.
TRAW has traded between $0.97 and $6.71 over the past year. The stock closed Wednesday's trading at $1.97, up 0.51%. In pre-market trading on Thursday, TRAW is down over 23% at $1.50.
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