Clinical TrialMay 7, 2026, 08:44 AM
Cadrenal Therapeutics Gets FDA Guidance for CAD-1005 Phase 3 Trial
AI Summary
Cadrenal Therapeutics announced that it received official FDA End-of-Phase 2 meeting minutes, providing clear guidance for the pivotal Phase 3 registration trial of CAD-1005 for heparin-induced thrombocytopenia (HIT). The company plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study involving approximately 120 patients globally, targeting an NDA submission in 2029. Financially, Cadrenal reported a reduced net loss of $2.5 million for Q1 2026, compared to $3.8 million in the prior year, with lower R&D and G&A expenses. The company held $2.3 million in cash and cash equivalents as of March 31, 2026, and secured an additional $2.5 million in financing in April 2026.
Key Highlights
- Received official FDA End-of-Phase 2 meeting minutes for CAD-1005 in HIT.
- Plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study for CAD-1005.
- Phase 3 study to enroll approximately 120 patients across clinical centers worldwide.
- Aims for projected NDA submission for CAD-1005 in 2029.
- Reported Q1 2026 net loss of $2.5 million, an improvement from $3.8 million in Q1 2025.
- Research and development expenses for Q1 2026 were $0.8 million, down from $1.7 million in Q1 2025.
- Cash and cash equivalents totaled $2.3 million as of March 31, 2026.
- Completed a $2.5 million financing on April 1, 2026, post-quarter end.
Price Impact
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