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Amigal in Medical Technology

Amicus Therapeutics Announces Successful Completion of End of Phase 2 Meeting With FDA for Amigal in Fabry Disease

Agency Supports Amigal Move to Phase 3; Eligible for Accelerated Approval; Final Global Regulatory Plan Expected by Year End CRANBURY, N.J., Aug. 4 /PRNewswire-FirstCall/ -- Amicus Therapeutics (Nasdaq: FOLD ), a biopharmaceutical company developing small molecule, orally-administere...

Amicus Therapeutics Presents Data From Preclinical and Phase 1 Studies of Amigal for Fabry Disease

Studies in Mice Show Reduction of Enzyme Substrate CRANBURY, N.J., March 19, 2007 /PRNewswire/ -- Amicus Therapeutics, a biopharmaceutical company developing small-molecule, orally administered pharmacological chaperones for the treatment of human genetic diseases, announced today that the Company...

Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) for the Treatment of Fabry Disease

...mpany is eligible to seek Accelerated Approval for amigal according to Subpart H regulations. The Company ha...micus stated, "The start of our Phase 3 trial with amigal is a major milestone for Amicus and highlights our...essful Phase 3 study. We continue to believe that amigal may be an important treatment option for patients ...

Amicus Therapeutics Suspends Enrollment for Phase 2 Clinical Trial of AT2220 for Pompe Disease

...ting lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs. Amicus has completed Phase 2 clinical trials of amigal for the treatment of Fabry disease and is conducting Phase 2 clinical trials of Plicera for the treatment of Gaucher disease and AT2220 for the treatm...

Amicus Therapeutics Announces Positive Progress of Three Lead Clinical Programs and General Outlook for 2009

... Multiple Clinical Milestones throughout the Year; amigal to Initiate Phase 3 Global Development in Second Q...ire HGT), plans to initiate Phase 3 development of amigal for the treatment of Fabry disease in the second q...and CEO. CLINICAL PROGRAM ADVANCEMENTS amigal (migalastat hydrochloride) for the treatment of Fa...

Amicus Therapeutics Announces Second Quarter 2008 Financial Results

...meeting with the FDA related to our development of amigal for the treatment of Fabry Disease," said John F. ...ccessfully completed an End of Phase 2 meeting for amigal with the U.S. Food and Drug Administration (FDA). ...e Company plans to initiate Phase 3 development of amigal in the first half of 2009. In parallel with the ...

Amicus Therapeutics to Present at the 26th Annual JPMorgan Healthcare Conference

...ks and uncertainties inherent in the business of Amicus, including, without limitation: the effect of the completion of the Phase 2 clinical trial for amigal for the treatment of Fabry disease, the plans for the Phase 3 clinical trial for Amigal, the Phase II clinical trials for Plicera(TM) for the treatmen...
Amigal in Biological Technology

Amicus Therapeutics Announces Second Quarter 2009 Financial Results

...cant achievement for Amicus with our lead program, amigal for Fabry disease, entering Phase 3 development." ...sease." Clinical Program Updates amigal (TM) (migalastat hydrochloride) for the treatme...mpany is eligible to seek Accelerated Approval for amigal according to Subpart H regulations. Amicus has beg...

Amicus Therapeutics Presents Positive Results From Phase 2 Extension Study of Amigal(TM) for Fabry Disease at ACMG 2009 Annual Meeting

.... Preliminary Results: Treatment with amigal was generally well-tolerated, with no drug-related...rrhea. Subjects identified as responders to amigal at the completion of the Phase 2 studies continued...he FDA supports a Phase 3 clinical trial comparing amigal to placebo based on a surrogate primary endpoint o...

Publication of Shire plc's Annual Report 2008

...t received the rights to three compounds, PLICERA, amigal and AT2220, in markets outside the US. PLIC...ights to PLICERA in markets outside the US. amigal (HGT-3310 for the treatment Fabry disease) amigal is an orally-administered, small molecule pharmaco...

Amicus Therapeutics Announces Change to Board of Directors

...ting lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs. Amicus has completed Phase 2 clinical trials of amigal for the treatment of Fabry disease and is conducting Phase 2 clinical trials of Plicera for the treatment of Gaucher disease and AT2220 for the treatm...

Amicus Therapeutics Announces Fourth Quarter and Full Year 2008 Financial Results

...e Company plans to initiate Phase 3 development of amigal for the treatment of Fabry disease in the second q...he FDA supports a Phase 3 clinical trial comparing amigal to placebo based on a surrogate primary endpoint o...al designed to evaluate the safety and efficacy of amigal versus enzyme replacement therapy (ERT) in Fabry p...

Amicus Therapeutics Announces Fourth Quarter and Year End 2008 Financial Results Release Date

...ting lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs. Amicus has completed Phase 2 clinical trials of amigal for the treatment of Fabry disease and is conducting Phase 2 clinical trials of Plicera for the treatment of Gaucher disease and AT2220 for the treatm...

Amicus Therapeutics Adds Sol J. Barer, Ph.D. to Board of Directors

...ing lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs. Amicus has completed Phase 2 clinical trials of amigal for the treatment of Fabry disease and is conducting Phase 2 clinical trials of Plicera for the treatment of Gaucher disease and AT2220 for the treatm...

Amicus Therapeutics to Present at Lazard Capital Markets Healthcare Conference

...ting lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs. Amicus has completed Phase 2 clinical trials of amigal for the treatment of Fabry disease and is conducting Phase 2 clinical trials of Plicera for the treatment of Gaucher disease and AT2220 for the treatm...

Amicus Therapeutics Announces Third Quarter 2008 Financial Results

...yments." Program Advancements Fabry Disease: amigal (migalastat hydrochloride) is an investigational, ...Company expects to initiate Phase 3 development of amigal in the first half of 2009. In addition, 23 of th...s. Amicus has completed Phase 2 clinical trials of amigal for the treatment of Fabry disease and is conducti...

Amicus Therapeutics Announces Third Quarter 2008 Results Release Date

...ting lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs. Amicus has completed Phase 2 clinical trials of amigal for the treatment of Fabry disease and is conducting Phase 2 clinical trials of Plicera for the treatment of Gaucher disease and AT2220 for the treatm...
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