Company Overview and News

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Amicus (FOLD) Gets FDA Nod for Fabry Disease Drug Galafold

2018-08-13 zacks
Amicus Therapeutics (FOLD - Free Report) announced that the FDA has granted accelerated approval to Galafold (migalastat) 123 mg capsules for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data.
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FDA Action Alert: Amicus, Vertex and TherapeuticsMD

2018-08-13 biospace - 1
This week had three important target action dates, known as Prescription Drug User Fee Act (PDUFA) dates, for the U.S. Food and Drug Administration (FDA). The agency got ahead of its schedule and approved all of these drugs. Let’s take a look.
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Amicus sets US$315,000 price for new Fabry disease treatment - Channel NewsAsia

2018-08-13 channelnewsasia
REUTERS: Amicus Therapeutics priced its new Fabry disease treatment at an average US$315,000 per year in the United States, the company said on Monday.
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Amicus sets $315,000 price for new Fabry disease treatment

2018-08-13 reuters - 1
(Reuters) - Amicus Therapeutics priced its new Fabry disease treatment at an average $315,000 per year in the United States, the company said on Monday.
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FOLD / Amicus Therapeutics, Inc. 8-K (Current Report)

2018-08-13 sec.gov
Document UNITED STATES
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Your Daily Pharma Scoop: Amicus Cleared, Gemphire Tumbles, ASLAN Proceeds

2018-08-13 seekingalpha - 2
Discussion: Amicus Therapeutics' (FOLD) Galafold (migalastat) for the treatment of adult patients with Fabry disease is now FDA-approved. Migalastat as a monotherapy is already approved in EU and other geographies and has moved to commercialization stage. Almost negligible gross income in 2016 (<$1M) has zoomed to $63.61M over the last financial, indicating a 290.59% revenue growth.
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Amicus Receives First FDA Approval For Fabry Disease Treatment In 15 Years

2018-08-13 seekingalpha
Galafold is expected to treat up to 35% to 50% of the Fabry Disease population, those who have the amenable GLA variant.
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Stocks To Watch: Any Privacy For Tesla?

2018-08-11 seekingalpha - 4
Welcome to Seeking Alpha's Stocks to Watch - a preview of key events scheduled for the next week. Follow this account and turn the e-mail alert on to receive this article in your inbox every Saturday morning.
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UPDATE 2-Amicus Therapeutics receives U.S. approval for Fabry disease drug

2018-08-11 reuters
(Reuters) - U.S. health regulators on Friday approved Amicus Therapeutics’ Galafold, the first oral therapy to treat Fabry disease, a rare, sometimes fatal condition in which accumulation of fat damages several organs.
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FOLD / Amicus Therapeutics, Inc. 8-K (Current Report)

2018-08-10 sec.gov
Document UNITED STATES
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Amicus Therapeutics receives US approval for Fabry disease drug - Channel NewsAsia

2018-08-10 channelnewsasia - 1
REUTERS: U.S. health regulators on Friday approved Amicus Therapeutics' Galafold, the first oral therapy to treat Fabry disease, a rare, sometimes fatal condition in which accumulation of fat damages several organs.
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Amicus Therapeutics, Inc. (FOLD) CEO John Crowley on Q2 2018 Results - Earnings Call Transcript

2018-08-07 seekingalpha - 1
Amicus Therapeutics, Inc. (NASDAQ:FOLD) Q2 2018 Results Earnings Conference Call August 7, 2018 8:30 AM ET
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Amicus Therapeutics (FOLD) Reports Q2 Loss, Tops Revenue Estimates

2018-08-07 zacks
Amicus Therapeutics (FOLD - Free Report) just came out with a quarterly loss of $0.33 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.34 per share a year ago. These figures are adjusted for non-recurring items.
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CUSIP: 03152W109