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Amicus Therapeutics, Inc.(NASDAQ:FOLD) Jumps to 17-Month High

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By on BioPharma

Amicus Therapeutics, Inc.(NASDAQ:FOLD) extends gains to hit a 17-month high after the biopharmaceutical company said the 18-month primary treatment period in the second phase 3 study of its Migalstat monotherapy for Fabry patients is now complete and top-line data are expected in Q3. 

Shares are up 14.85% at $3.48, and earlier touched $4 – the highest since January 2013.

If the study is successful, Amicus said it will trigger the process for European regulatory approval of migalastat as a monotherapy for Fabry patients with amenable mutations. 

“We also plan to meet with the Food and Drug Administration in the fourth quarter of this year to discuss the data from both of our Phase 3 Fabry monotherapy studies, to determine the fastest U.S. registration pathway for migalastat,” CEO John Crowley said in a statement. “Hopefully, migalastat will become an important new medicine for the treatment of Fabry disease, where so much unmet need remains.” 

The study enrolled 60 patients who had been treated with enzyme replacement therapies for Fabry disease for a minimum of 12 months prior to study entry. The patients were randomized to switch to Migalstat or remain on ERT. 

 

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