regulatory
confidence medium
sentiment positive
materiality 0.60
Traws Pharma submits Phase 2 protocols for bird flu and COVID drugs; requests FDA meeting
Traws Pharma, Inc.
- Submitted HREC Phase 2 protocol for tivoxavir marboxil (TXM) to treat H5N1 bird flu and seasonal influenza.
- Submitted Type D FDA meeting request to discuss accelerated approval for TXM under the Animal Rule.
- Submitted HREC Phase 2 protocol for ratutrelvir in acute COVID, including PAXLOVID-ineligible patients, with rebound and Long COVID assessments.
- Cash and equivalents of $15.9M as of March 31, 2025, expected to fund operations into Q1 2026.
- Continuing discussions with BARDA regarding strategic stockpile inclusion for TXM.
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