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January 13, 2014
07:39 EDTFOLDAmicus Therapeutics announces 3-in-3 strategy for the next generation ERTs
Amicus Therapeutics provided its FY14 strategic outlook and financial guidance. Key Highlights include: Amicus announces "3-in-3" strategy for three next-generation Enzyme Replacement Therapies, or ERTs, expected to enter the clinic in next three years with lead programs in Fabry, Pompe and Mucopolysaccharidosis I; preclinical proof-of-concept data for next-generation ERTs for Fabry and Pompe to be featured at Lysosomal Disease Network WORLD Symposium and American College of Medical Genetics meetings in 1H14; data from global registration studies of migalastat HCl monotherapy for Fabry disease expected to include complete 12- and 24-month data from Study 011 in 2Q14 and 18-month clinical data from Study 012 in 2H14. Company also stated "As we enter 2014, Amicus is strongly positioned to continue our focus on advancing a pipeline of next-generation enzyme replacement therapies for patients with lysosomal storage diseases. "
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May 26, 2015
07:06 EDTFOLDAmicus granted Accelerated Assessment by EMA
Amicus Therapeutics announced that the Committee for Medicinal Products for Human Use, or CHMP. of the European Medicines Agency, or EMA, has granted Accelerated Assessment to the oral small molecule pharmacological chaperone migalastat HCl monotherapy for Fabry patients who have amenable genetic mutations. Migalastat is the first investigational Fabry drug to be granted Accelerated Assessment.
May 15, 2015
08:57 EDTFOLDAmicus management to meet with Leerink
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