Positive Data from Study of Oral Therapy for Fabry Disease (Must Read!!)

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Amicus Therapeutics, Inc. (FOLD)

FOLD reported additional positive data on important secondary endpoints from its second Phase 3 study (Study 012) of the oral small molecule chaperone migalastat HCl for Fabry disease.

FOLD 's migalastat to standard of care enzyme replacement therapies (ERTs) (Fabrazyme(R) and Replagal(R)) in patients with Fabry disease who have amenable mutations.

FOLD intends to seek approval of migalastat in both the European Union and in the U.S. According to the company, it is on track to hold its pre-submission meeting with European regulators this quarter, and expects to interact with the FDA in early 2015.

FOLD is a biopharmaceutical company at the forefront of therapies for rare and orphan diseases. FOLD is developing novel, first-in-class treatments for a broad range of human genetic diseases, with a focus on delivering new benefits to individuals with lysosomal storage diseases.

More about Amicus Therapeutics, Inc. (FOLD) at www.pennyomega.com/disclaimer

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