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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. "
News For FOLD From The Last 14 Days
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March 3, 2015
17:18 EDTFOLDAmicus files to sell 1M shares of common stock for holders
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17:17 EDTFOLDAmicus files $250M mixed securities shelf
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16:07 EDTFOLDAmicus says on track for mid-year marketing application in Europe
The company said, "We remain on track for a mid-year marketing application in Europe for migalastat monotherapy for Fabry disease and we look forward to an upcoming meeting with the FDA to discuss a path forward for an NDA submission for migalastat monotherapy in the United States. We continue to believe firmly that the totality of the data with this important new precision medicine-based therapy should be available to Fabry patients in the U.S. as soon as possible. Finally, advancing our next-generation enzyme replacement therapy for people living with Pompe disease is a key priority and that important program remains on track. Indeed, a busy and important set of activities are ahead for the Amicus team this year. We hope that success in these endeavors will enhance the lives of many people living with Fabry and Pompe diseases."
16:06 EDTFOLDAmicus Therapeutics reports Q4 EPS (24c), consenus (18c)
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14:36 EDTFOLDAmicus Therapeutics March volatility elevated into O4 and outlook
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February 24, 2015
08:33 EDTFOLDArgos Therapeutics hires Joan Winterbottom as Chief Human Resources Officer
Argos Therapeutics (ARGS) announced that Joan Winterbottom will join the company as chief human resources officer. Winterbottom most recently served as senior vice president of human resources at Amicus Therapeutics (FOLD).
February 23, 2015
07:22 EDTFOLDSunTrust to hold a conference
2015 Biotechnology and Pharmaceutical 1:1 Orphan Drug Day is being held in New York on February 23.

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