Traws Pharma, Inc. ( TRAW ) shares are rocketing on Monday after the company disclosed advancements in the development of its one-dose investigational treatment for H5N1 bird flu, tivoxavir marboxil.

The Phase 1 trial was a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics (PK) of single-dose tivoxavir marboxil in healthy, influenza-negative adults.

Topline data revealed that a single dose maintained plasma drug levels above the EC90 for over 23 days, with results from a higher dose still pending.

Preclinical studies demonstrated that tivoxavir marboxil effectively inhibited drug-resistant influenza and highly pathogenic bird flu viruses both in vitro and in vivo. The company didn’t report any treatment-related adverse events.

Notably, the Type A H5N1 virus, first detected in U.S. dairy cattle in March 2024, has since spread to at least 866 herds across 16 states.

According to the U.S. Centers for Disease Control and Prevention, over 60 people in eight states have been infected, with the first severe U.S. case confirmed in December 2024.

C. David Pauza, PhD, Chief Science Officer said, “In laboratory testing, tivoxavir marboxil inhibited multiple isolates of highly pathogenic avian influenza H5N1. We evaluated the effects of drug treatment in mice exposed to human H5N1, where the virus was isolated from a dairy worker exposed to infected cattle,”

“Oral treatment with tivoxavir marboxil after the virus infection resulted in complete survival and lung virus levels below the limit of quantitation1. This result is highly encouraging for future clinical development of tivoxavir marboxil for treating human H5N1 influenza.”

Price Action: TRAW shares are up 147.5% at $12.41 at the last check Monday.

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