Prothena Announces Novo Nordisk Obtains Fast Track Designation from the U.S. FDA for Coramitug (PRX004) in ATTR Amyloidosis with Cardiomyopathy
Prothena Corporation plc - Ordinary Shares (PRTA)
Last prothena corporation plc - ordinary shares earnings: 2/12 04:05 pm
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Source: Business Wire
Coramitug is a potential best-in-class amyloid depleter antibody for the treatment of ATTR amyloidosis with cardiomyopathy1-3Coramitug is being evaluated by Novo Nordisk in the ongoing Phase 3 CLEOPATTRA clinical trial in ~1280 participants with ATTR-CM; primary completion expected in 2029The Fast Track Designation underscores the unmet need within ATTR-CM and could expedite the review of coramitug DUBLIN--(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, w
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News
- Prothena (PRTA) was downgraded by <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a> from "sell (d-)" to "sell (e+)".MarketBeat
- Prothena Announces Leadership Team UpdatesBusiness Wire
- Prothena Partners Present Data Supporting Next Generation Treatments for Parkinson’s and Alzheimer’s Disease at AD/PD™ 2026Business Wire
- Prothena Announces Achievement of $50 Million Clinical Milestone Payment from Novo Nordisk Related to Ongoing Phase 3 Clinical Trial for Coramitug (Formerly PRX004) in ATTR Amyloidosis with Cardiomyopathy [Yahoo! Finance]Yahoo! Finance
- Prothena Announces Achievement of $50 Million Clinical Milestone Payment from Novo Nordisk Related to Ongoing Phase 3 Clinical Trial for Coramitug (Formerly PRX004) in ATTR Amyloidosis with CardiomyopathyBusiness Wire
PRTA
Earnings
- 2/19/26 - Beat
PRTA
Sec Filings
- 4/10/26 - Form 3
- 4/10/26 - Form 4
- 3/27/26 - Form ARS
- PRTA's page on the SEC website