FOLD – Amicus approaches inflection point

With Phase 3 data expected from Amicus Therapeutics (NASDAQ : FOLD), we wanted to take the time to do a thorough analysis of the trial and what to expect. Jason Chew has covered Amicus since early 2012, so their story should be familiar for our readers. Now, we would like to review some insightful points revealed during their recent third quarter conference call and frame the current  trial in more detail.

(Updated: 12/7) During after-hours yesterday, Amicus filed an S-3 establishing a new $145 million registration statement. This shelf replaces their previous shelf from 2009. Amicus currently has over $100 million in cash and no debt, so we do not foresee a raise before their Phase III trial topline results. With positive data in hand, Amicus should be able to tap the equity markets during the first or second quarter.

Upcoming Catalysts

Amigal Phase 3 Study 011 top-line data readout in Q4 for Fabry disease
AT2220 final cohort Phase 2 Study 010 co‐administration data in Q4 for Pompe’s disease
Completion of additional AT3375 IND‐enabling studies in Q4 for Parkinson’s disease
Presentation of Phase 3 Study 011 results at the Lysosomal Disease Network WORLD Symposium Orlando, Florida – February 12-15, 2013.
Amigal Phase 3 Study 011 – 12‐month data H1’13
Amigal+ERT Phase 3 Study 012 – 18-month GFR data in 2H’14

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