Traws Pharma gets FDA guidance on bird flu drug tivoxavir; details stockpiling plans; cash $15.9M

Traws Pharma, Inc.

Received FDA guidance on path forward for tivoxavir marboxil (TXM) for bird flu and seasonal flu; pursuing Animal Rule for accelerated approval.
Preclinical data: single oral dose of TXM protected against lethal H5N1 (dairy-worker strain) in mice, ferrets, and non-human primates.
Phase 1 data: single 480 mg dose maintained plasma levels above EC90 for ~3 weeks; no treatment-related adverse events.
US strategic stockpile estimated at 300-600 million doses; company discussing TXM inclusion with BARDA.
Cash and equivalents of $15.9M as of March 31, 2025; expected runway into Q1 2026.

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