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Stock impact report

DMX-200 ACTION3 PHASE 3 TRIAL COMPLETES RECRUITMENT [Yahoo! Finance]

Amicus Therapeutics, Inc. (FOLD) 
Last amicus therapeutics, inc. earnings: 11/11 07:00 am Check Earnings Report
US:NASDAQ Investor Relations: ir.amicusrx.com/investor-relations
Company Research Source: Yahoo! Finance
The ACTION3 Phase 3 trial explores the efficacy and safety of DMX-200 in FSGS patients when dosed in combination with standard-of-care blood pressure medication over 2 years Of the 286 adult patients dosed in the trial, 69 have already completed the full 2-year treatment period and of those, 65 entered voluntarily into the Open Label Extension ( OLE ) study, representing 94% OLE uptake The study has now successfully passed seven scheduled Independent Data Monitoring Committee (IDMC) reviews with no changes to the protocol required or safety concerns identified [2] Following the successful outcome of the PARASOL collaboration data analysis ( PARASOL Findings ), Dimerix and its U.S. partner, Amicus Therapeutics, intend to seek feedback from the FDA on the proposed clinical trial endpoints, prior to a blinded analysis of ACTION3 data [3] Recruitment of pediatric patients remains ongoing as an independent cohort in the trial, and if successful, may allow Dimerix to expand its app Show less Read more
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