Prothena Announces Novo Nordisk Obtains Fast Track Designation from the U.S. FDA for Coramitug (PRX004) in ATTR Amyloidosis with Cardiomyopathy [Yahoo! Finance]
Novo Nordisk A/S (NVO)
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Source: Yahoo! Finance
Coramitug is being evaluated by Novo Nordisk in the ongoing Phase 3 CLEOPATTRA clinical trial in ~1280 participants with ATTR-CM; primary completion expected in 2029 The Fast Track Designation underscores the unmet need within ATTR-CM and could expedite the review of coramitug DUBLIN, April 27, 2026 BUSINESS WIRE )--Prothena Corporation plc (NASDAQ:PRTA) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to coramitug, a potential best-in-class amyloid depleter antibody currently in Phase 3 development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM). Fast Track Designation is intended to facilitate the development and expedite the review of investigational drugs that treat serious conditions and fill an unmet medical need. "We are encouraged by Novo Nordisk's receipt of Fast Track Designation for coramitug, which underscores their continued commitment to advancing coramitug for patients living with ATTR-CM," sa
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