amicus therapeutics inc (FOLD) Key Developments
Amicus Therapeutics, Inc. Presents at SunTrust Robinson Humphrey Biotechnology and Pharmaceutical One-on-One Orphan Drug Day, Feb-23-2015
Feb 18 15
Amicus Therapeutics, Inc. Presents at SunTrust Robinson Humphrey Biotechnology and Pharmaceutical One-on-One Orphan Drug Day, Feb-23-2015 . Venue: JW Marriott Essex House, 160 Central Park South, b/w 6th & 7th Avenue, New York, New York, United States.
Amicus Therapeutics Announces Additional Positive Phase 3 Fabry Data on Patient Reported Outcomes at WORLDSymposium(TM) 2015
Feb 10 15
Amicus Therapeutics announced positive data on pre-specified patient reported outcomes from both of its Phase 3 studies of the oral small molecule pharmacological chaperone migalastat HCl for Fabry disease at WORLDSymposium 2015 in Orlando, Florida. The company previously reported positive Phase 3 data in both treatment (Study 011 , or FACETS) and enzyme replacement therapy (ERT) switch patients (Study 012 , or ATTRACT). Results from these studies have shown that treatment with migalastat has resulted in reductions in disease substrate, stability of kidney function and improvement in a key cardiac parameter (left ventricular mass index, or LVMi) in patients with amenable mutations. Pre-specified secondary and tertiary endpoints on patient-reported outcome measures from both Phase 3 studies are being reported for the first time at WORLDSymposium 2015. Study 011 was a Phase 3 study designed to measure the reduction of disease substrate (globotriaosylceramide, or
GL-3) following treatment with migalastat in Fabry patients with amenable mutations. The study also measured clinical outcomes, including renal function and LVMi, as secondary endpoints. The 24-month study began with a 6-month double-blind, placebo-controlled treatment period, after which all patients were treated with migalastat for a 6-month open-label follow-up period and a subsequent 12-month open-label extension phase.
Amicus Therapeutics, Inc. Presents at Leerink's Global Healthcare Conference, Feb-11-2015 03:05 PM
Jan 30 15
Amicus Therapeutics, Inc. Presents at Leerink's Global Healthcare Conference, Feb-11-2015 03:05 PM. Venue: Waldorf Astoria New York, New York, New York, United States. Speakers: William D. Baird, Chief Financial Officer and Secretary.
Amicus Therapeutics, Inc. Appoints Bradley L. Campbell as President and Chief Operating Officer
Jan 15 15
On January 12, 2015, the board of directors of Amicus Therapeutics, Inc. announced the appointment of Bradley L. Campbell as president and chief operating officer, effective immediately. Prior to this appointment, Campbell served as chief operating officer since December 2013 and chief business officer since February 2012.
Amicus Therapeutics, Inc. Announces Positive Phase 3 Data on Cardiac Endpoints From Fabry Monotherapy Study 011 and Long Term Extension Study
Jan 8 15
Amicus Therapeutics announced additional positive data on an important cardiac endpoint from its first Phase 3 study and the Phase 3 extension of the oral small molecule chaperone migalastat HCl for Fabry disease. Data from the Fabry Registry indicate that the cause of death in patients is from cardiovascular disease1. In Study 011 and Study 041, previously untreated patients with amenable mutations showed a statistically significant decrease in left ventricular mass index (LVMi) following treatment with migalastat for up to 36 months (average of 22 months).