AMICUS THERAPEUTICS, INC. (NASDAQ:FOLD) Files An 8-K Other Events
Item 8.01. Other Events
On February 25, 2019, Amicus Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration has granted the Company Breakthrough Therapy Designation for AT-GAA, a treatment for late onset Pompe disease. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits
Exhibits:
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Exhibit No. |
Description |
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Press release dated February 25, 2019
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AMICUS THERAPEUTICS, INC. Exhibit
EX-99.1 2 exhibit991.htm EXHIBIT 99.1 Exhibit U.S. FDA Grants Breakthrough Therapy Designation (“BTD”) to Amicus’ AT-GAA in Late Onset Pompe Disease First BTD Granted for a Second Generation Lysosomal Storage Disorder TherapyFirst BTD for an Investigational Treatment in Pompe Disease CRANBURY,…
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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.