AMICUS THERAPEUTICS,INC. (NASDAQ:FOLD) Files An 8-K Other EventsItem 8.01. Other Events.
On July11, 2017, Amicus Therapeutics,Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (the “U.S. FDA”) confirmed that the Company may submit new drug application for migalastat for Fabry Disease in the U.S. A copy of this press release is attached hereto as Exhibit99.1.
The Company also provided an update on the European launch of Galafold that as of June 30, 2017, there were 151 patients on reimbursed Galafold.
Item 9.01. Financial Statements and Exhibits.
(d)Exhibits: The ExhibitIndex annexed hereto is incorporated herein by reference.
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Exhibit No.
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Description
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99.1
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Press Release dated July11, 2017 titled “U.S. FDA Confirms Amicus Therapeutics MaySubmit New Drug Application for Migalastat for Fabry Disease.”
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AMICUS THERAPEUTICS INC ExhibitEX-99.1 2 a17-17143_1ex99d1.htm EX-99.1 Exhibit 99.1 U.S. FDA Confirms Amicus Therapeutics May Submit New Drug Application for Migalastat for Fabry Disease Data Deemed Sufficient to Support NDA Submission NDA Submission Targeted for 4Q17 Conference Call Today at 8:30am ET CRANBURY,…To view the full exhibit click here
About AMICUS THERAPEUTICS,INC. (NASDAQ:FOLD)
Amicus Therapeutics, Inc. is a biopharmaceutical company. The Company is focused on the discovery and development of therapies to treat a range of rare and orphan diseases. Its lead product candidate, migalastat HCl (Galafold), is an orally administered small molecule pharmacological chaperone for the treatment of Fabry disease, which is a type of lysosomal storage disorder (LSD). It has completed two Phase III global registration studies (Study 011 and Study 012) of migalastat monotherapy. It is also engaged in Phase III clinical development of a topical cream, SD-101, for the treatment of the genetic connective tissue disorder Epidermolysis Bullosa. It has also initiated a clinical study in patients with Pompe disease, a LSD to investigate its treatment paradigm that consists of ATB200, which is an engineered recombinant human acid alpha-glucosidase enzyme with an optimized carbohydrate structure to enhance uptake, co-administered with AT2221, to improve activity and stability.