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amicus therapeutics inc (FOLD) Key Developments

Amicus Therapeutics, Inc.(NasdaqGM:FOLD) added to NASDAQ Biotechnology Index

Amicus Therapeutics, Inc. will be added to the NASDAQ Biotechnology Index.

Amicus Therapeutics, Inc. Presents at Oppenheimer 25th Annual Healthcare Conference, Dec-11-2014 01:35 PM

Amicus Therapeutics, Inc. Presents at Oppenheimer 25th Annual Healthcare Conference, Dec-11-2014 01:35 PM. Venue: The Crowne Plaza Hotel, New York, New York, United States. Speakers: Chip Baird, Chief Financial Officer.

Amicus Therapeutics Announces Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2014; Provides Net Cash Spend Guidance for the Full Year 2014; Provides Program Updates

Amicus Therapeutics announced unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2014. For the third quarter, the company reported total revenue of $293,000 against $39,000 a year ago. Loss from operations was $16,816,000 against $15,135,000 a year ago. Net loss was $17,149,000 or $0.22 per basic and diluted share against $14,589,000 or $0.29 per basic and diluted share a year ago. For the nine months, the company reported total revenue of $1,224,000 against $39,000 a year ago. Loss from operations was $46,703,000 against $48,391,000 a year ago. Net loss was $47,706,000 or $0.68 per basic and diluted share against $47,396,000 or $0.96 per basic and diluted share a year ago. The company provided net cash spend guidance for the full year 2014. For the year, the company continues to expect full-year 2014 net cash spend of between $54 million and $59 million. The company announced that it is developing its wholly owned pharmacological chaperone migalastat HCl (migalastat) monotherapy for the treatment of people with Fabry disease. As a monotherapy, migalastat is designed to bind and stabilize alpha-Gal A enzyme in patients with amenable mutations. Migalastat monotherapy is being investigated in two phase 3 registration studies (Study 011 and Study 012) and an open-label extension study (Study 041) in Fabry patients with amenable mutations. Positive phase 3 results from study 011 reported at american society of human genetics (ASHG) annual meeting: In October 2014, positive results from Study 011 and Study 041 were presented in a poster at ASHG by Daniel G. Bichet, M.D., M.Sc., Professor, Department of Physiology, University of Montreal. Data presented showed that patients receiving migalastat for an average of 32 months showed continued stability of kidney function and compared favorably to published natural history in Fabry disease. Decline in kidney function is a key cause of morbidity and mortality in patients with Fabry disease. Data from Study 012 will be presented at a scientific congress for the first time at the American Society of Nephrology (ASN) Kidney Week 2014 in Philadelphia on November 15, 2014. The data will be in a poster entitled Migalastat and Enzyme Replacement Therapy Have Comparable Effects on Renal Function in Fabry Disease: Phase 3 study results. This presentation will also include important new data on cardiac and other key secondary endpoints from Study 012. Based on the positive results from Study 012, Amicus expects to submit a marketing application for migalastat monotherapy in Europe, and is scheduled to meet with the European Medicines Agency in the fourth quarter of this year. Amicus also plans to meet with the U.S. Food and Drug Administration in the first quarter of 2015 to discuss the data from both Phase 3 Fabry monotherapy studies to determine the fast U.S. registration pathway for migalastat.

Amicus Therapeutics, Inc., Q3 2014 Earnings Call, Nov 06, 2014

Amicus Therapeutics, Inc., Q3 2014 Earnings Call, Nov 06, 2014

Amicus Therapeutics Announces Additional Positive Phase 3 Data From Fabry Monotherapy Study 011

Amicus Therapeutics announced additional positive data from a Phase 3 study (Study 011) of the oral small molecule chaperone migalastat HCl ("migalastat") in Fabry disease patients with amenable mutations. Assessment of kidney function by various measures of glomerular filtration rate (GFR) for patients receiving migalastat in Study 011 for at least 18 months and continuing migalastat treatment in Study 041 showed continued stability of kidney function for an average of 32 months. Decline in kidney function is a key cause of morbidity and mortality in patients with Fabry disease. Measured (iohexol) GFR (mGFR) showed stability over 18-24 months in Study 011 but was not collected in Study 041; mGFR was previously reported with topline Study 011 results. Stratifying patients for gender and baseline proteinuria demonstrated that patients treated with migalastat experienced less decline in kidney function than untreated patients from a previously published natural history study. Data from a subgroup analysis comparing the change in GL-3 substrate levels between amenable patients and non-amenable patients based on the GLP HEK cell assay provided additional validation of the sensitivity of the GLP HEK assay for identifying patients who will respond to migalastat monotherapy. Overall, patients with amenable mutations had declining levels of GL-3 when treated for six months with migalastat. In contrast, patients with non-amenable mutations had no change or increasing levels of GL-3 after six months of migalastat treatment.

 

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