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Results From Second Phase 3 Fabry Monotherapy Study (Study 012) on Track for 3Q14
Updated Preclinical Data for Next-Generation Pompe ERT Shows Superior Substrate Reduction Compared to Current Standard-of-Care ERTCompletion of $40M At-the-Market (ATM) Equity Financing Extends Cash Runway Into 2016Conference Call and Webcast Today at 5:00pm ET
CRANBURY, N.J., Aug. 7, 2014 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced financial results for the second quarter ended June 30, 2014. The Company also provided program updates, reiterated full-year 2014 operating expense guidance, and extended cash runway guidance.
John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics, Inc., stated, "We reached a major inflection point for Amicus in the second quarter. Following positive 12- and 24-month data from our first Phase 3 Fabry monotherapy study, or Study 011, we completed the primary treatment period and finalized the statistical analysis plan for our second Phase 3 Fabry monotherapy, or Study 012. In the third quarter we look forward to releasing top-line data from Study 012, in which patients volunteered to switch from ERT to our oral chaperone migalastat as their only therapy for Fabry disease. We also continue to advance development of next-generation ERTs. Additional proof-of-concept data from preclinical studies of our next-generation Pompe ERT continue to show superior substrate reduction compared to standard-of-care ERT, and we remain on track to identify the optimal therapeutic to bring into the clinic next year. Finally, we significantly strengthened our balance sheet with the completion of an ATM financing that has added multiple new top-tier investors to our shareholder base. With the proceeds from this financing, we are well-positioned to execute our operating plan and our commitment to deliver value to our shareholders and, importantly, to these patient communities."