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Company Advancing Core Lysosomal Storage Disorder Programs to Key Milestones in 2009; Expects Continued Strong Financial Position
CRANBURY, N.J., Feb. 5 /PRNewswire-FirstCall/ -- Amicus Therapeutics (Nasdaq: FOLD) today announced financial results for the fourth quarter and full year 2008.
On a reported basis calculated in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Amicus announced a net loss attributable to common stockholders of $0.63 per share ($0.55 per share on a non-GAAP basis) for the three months ended December 31, 2008. For the year ended December 31, 2008, on a GAAP basis, the net loss attributable to common stockholders was $1.75 per share ($1.46 per share on a non-GAAP basis). As of December 31, 2008, cash, cash equivalents, and marketable securities totaled $121 million.
"In 2008, we made great strides in advancing our lead clinical development programs for Fabry, Gaucher and Pompe diseases while maintaining a strong financial position. We plan to continue this momentum and believe 2009 will be a transformational year for Amicus, as we are committed to achieving several key milestones and to transitioning into a late-stage biopharmaceutical company," said John F. Crowley, Amicus' president and CEO.
Clinical Program Advancements
Amigal(TM) (migalastat hydrochloride) for the treatment of Fabry disease
In the fourth quarter of 2008, Amicus continued to work closely with the U.S. and E.U. regulatory authorities to advance its lead program, Amigal, into Phase 3 development. As previously announced, the Company plans to initiate Phase 3 development of Amigal for the treatment of Fabry disease in the second quarter of 2009.
In January 2009, the Company announced that the FDA supports a Phase 3 clin
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