regulatory
confidence high
sentiment positive
materiality 0.60
Cocrystal Pharma receives FDA Fast Track designation for norovirus antiviral CDI-988
Cocrystal Pharma, Inc.
- FDA granted Fast Track designation for oral, direct-acting protease inhibitor CDI-988 for norovirus.
- CDI-988 is first oral antiviral candidate for both treatment and prophylaxis of norovirus infection.
- Phase 1b double-blind challenge study (NCT07198139) ongoing at Emory University in up to 40 adults.
- Norovirus causes ~685M global infections/year with ~$60B worldwide economic impact.
- Fast Track enables rolling NDA review and potential Priority Review; no financial terms disclosed.