New Cardiac Data from Migalastat Monotherapy Phase 3 Study 011 for Fabry Disease
Pompe ERT Product Candidate Selection and Clinical Development Plan
FY15 Financial Outlook
CRANBURY, N.J., Dec. 22, 2014 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD) today announced that John F. Crowley, Chairman and Chief Executive Officer, will present a corporate overview at the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Tuesday, January 13, 2015 at 10:30 a.m. PT (1:30 p.m. ET).
Mr. Crowley will provide the Company's strategic outlook, financial guidance, and anticipated milestones for 2015. Highlights will include the following:
- New cardiac data from migalastat monotherapy Phase 3 Study 011 and long-term extension Study 041 for Fabry disease;
- Details on the final candidate selection of the next-generation Pompe ERT product to advance into clinical studies in 2015; and
- Full-year 2015 cash spend guidance and cash runway guidance.
"2014 was an extraordinary year for Amicus," stated John F. Crowley, Chairman and CEO of Amicus Therapeutics. "Over the past 12 months we've released positive data from two Phase 3 studies for migalastat monotherapy, made significant progress in advancing our next-generation ERT for Pompe disease, and strengthened our balance sheet. Looking forward, 2015 will mark our first planned regulatory submission for market approval of migalastat in Europe, with hopefully the U.S. to follow – significant milestones for Amicus and the Fabry community. We look forward to providing additional guidance on other important upcoming milestones in January."
A live webcast of the presentation can be accessed through the Investors section of the Amicus Therapeutics corporate web site at http://ir.amicustherapeutics.com/events.cfm, and will be archived for 90 days.
About Amicus Therapeutics
Amicus Therapeutics (Nasdaq:FOLD) is a biopharmaceutical company at the forefront of therapies for rare and orphan diseases. The Company 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. Amicus' lead programs in development include the small molecule pharmacological chaperone migalastat as a monotherapy for Fabry disease, as well as next-generation enzyme replacement therapy (ERT) products for Fabry disease, Pompe disease, and MPS-1.
CONTACT: Sara Pellegrino Director, Investor Relations firstname.lastname@example.org (609) 662-5044
Source:Amicus Therapeutics, Inc.