AMICUS THERAPEUTICS,INC. (NASDAQ:FOLD) Files An 8-K Other EventsItem 8.01. Other Events.
On December14, 2017, Amicus Therapeutics,Inc. (the “Company”) issued a press release announcing that the Company submitted a new drug application to the United States Food and Drug Administration to request approval of the oral precision medicine migalastat HCl (“migalastat”) for the treatment of patients 16 years and older with Fabry disease who have amenable mutations. A copy of this press release is attached hereto as Exhibit99.1.
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 December14, 2017
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AMICUS THERAPEUTICS INC ExhibitEX-99.1 2 a17-28444_1ex99d1.htm EX-99.1 Exhibit 99.1 Amicus Therapeutics Submits New Drug Application to U.S. FDA for Migalastat for Treatment of Fabry Disease 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.