regulatory
confidence high
sentiment positive
materiality 0.78
Cadrenal completes FDA End-of-Phase 2 meeting; gets guidance for Phase 3 pivotal trial of CAD-1005 in HIT
Cadrenal Therapeutics, Inc.
- Phase 2 data showed >25% absolute reduction in thrombotic events when CAD-1005 added to standard anticoagulant therapy.
- Planned Phase 3 trial: randomized, blinded, placebo-controlled; ~120 patients at up to 50 sites worldwide.
- Primary endpoint: incidence of new or worsening thrombotic events (centrally adjudicated) in SRA-confirmed HIT patients.
- Projected NDA submission in 2029; first randomized, blinded, placebo-controlled registration trial in HIT.