Prothena Announces Novo Nordisk Obtains Fast Track Designation from the U.S. FDA for Coramitug (PRX004) in ATTR Amyloidosis with Cardiomyopathy
Novo Nordisk received FDA Fast Track Designation for Coramitug (PRX004) to treat ATTR amyloidosis with cardiomyopathy, an asset fully licensed from Prothena. The designation facilitates expedited review for the ongoing Phase 3 CLEOPATRA trial, which is enrolling approximately 1,280 patients with primary data expected in 2029.
Key figures
- Deal Value Usd
- 1200000000
- Participants phase 3
- ~1280
- Milestones earned to date
- $150 million
- Phase 3 primary completion
- 2029
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