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Prothena says FDA grants Fast Track designation to Novo Nordisk’s coramitug PRX004 for ATTR-CM

PUBT·04/27/2026 20:06:30
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Prothena says FDA grants Fast Track designation to Novo Nordisk’s coramitug PRX004 for ATTR-CM
  • Prothena disclosed U.S. FDA Fast Track designation for Novo Nordisk’s coramitug (PRX004) for ATTR amyloidosis with cardiomyopathy.
  • No clinical results were presented; coramitug remains in Phase 3 development.
  • Drug is designed to clear existing transthyretin amyloid deposits, addressing a gap where current therapies mainly slow progression.
  • Novo Nordisk is running Phase 3 CLEOPATTRA trial in about 1,280 participants, with primary completion expected in 2029.
  • Prothena remains eligible for up to $1.2 billion in milestone and sales payments under 2021 deal, with $150 million earned to date.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Prothena Corporation plc published the original content used to generate this news brief via Business Wire (Ref. ID: 20260427325583) on April 27, 2026, and is solely responsible for the information contained therein.