Catalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for Coramitug (PRX004) in Transthyretin amyloidosis. The expected timing is based on the latest available company guidance and may change.
Collab w/ Novo Nordisk. 11/12/24- Completed enrollment. 5/8/25- Trial completion in H1 and topline data in H2 2025. Initiate Ph3 program in 2025. 12/01/25:- Novo Nordisk initiated the Phase 3 CLEOPATTRA trial of coramitug for ATTR amyloidosis with cardiomyopathy and will present Phase 2 results at the American Heart Association Scientific Sessions on November 10, 2025. Prothena expects to earn clinical milestones as Phase 3 enrollment criteria and other development milestones are achieved by the end of 2026. 02/19/26:- Phase 3 CLEOPATTRA trial ongoing with 2029 primary completion; enrollment-milestone payment possible in H1 2026. 04/27/26:- FDA granted Fast Track for coramitug in ATTR-CM. Phase 3 CLEOPATTRA primary completion expected 2029. 05/07/26:- Phase 3 enrollment milestone achieved; $50M paid. CLEOPATTRA Ph3 primary completion 2029; 89Zr-coramitug imaging study completes 2027. 08/06/26:- CLEOPATTRA Ph3 ongoing; primary completion 2029; imaging study completion 2027.
Verification
Confirm timing and program details against the company announcement or filing.