AMICUS THERAPEUTICS,INC. (NASDAQ:FOLD) Files An 8-K Regulation FD DisclosureItem 7.01. Regulation FD Disclosure.
On November 28, 2016, Amicus Therapeutics, Inc. (the “Company”) hosted a conference call and webcast to discuss the U.S. Regulatory Pathway for Migalastat for Fabry Disease.
Item 8.01. Other Events.
On November 28, 2016, the Company issued a press release announcing the U.S. Regulatory Pathway for Migalastat for Fabry Disease. A copy of this press release is attached hereto as Exhibit 99.1.
In accordance with General Instruction B.2. of Form 8-K, the information in this Current Report on Form 8-K and the Exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits: The Exhibit Index annexed hereto is incorporated herein by reference.
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. AMICUS THERAPEUTICS, INC. (NASDAQ:FOLD) Recent Trading Information
AMICUS THERAPEUTICS, INC. (NASDAQ:FOLD) closed its last trading session down -0.58 at 8.32 with 1,789,730 shares trading hands.