regulatory
confidence high
sentiment positive
materiality 0.65
Cocrystal Pharma gets FDA Pre-IND feedback on oral CC-42344 for influenza A
Cocrystal Pharma, Inc.
- Received FDA Pre-IND written response to January 2024 submission for oral CC-42344.
- Guidance clarifies regulatory requirements for planned Phase 2b trial design.
- Phase 2a challenge study in UK ongoing; topline results expected H2 2024.
- Preparations underway for inhaled CC-42344 Phase 1 study in Australia.
- Inhaled formulation showed superior lung exposure and favorable safety in preclinical data.