Amicus suffered a major setback for its therapy in November, 2016 when the U.S. Food and Drug Administration said it won't consider approving migalastat until the company provides more data in a process that could take up to four years to complete.
But now the FDA reversed its prior position and is open to reviewing migalastat with existing dataset, Cowen's Ritu Baral commented in a research report. The FDA's position change is likely driven by the agency's commission Scott Gottlieb "new more practical/flexible" approach to the regulatory process, which bodes well for rare disease drug reviews.
The FDA's new approach of reviewing the totality of the clinical data which has been generated by Amicus to date implies there is a "good chance" the company's planned new drug approval in the fourth quarter of 2017 will be a success.
Meanwhile, Amicus believes there are around 3,000 diagnosed Fabry patients in the U.S. and can grow by up to 10 percent annually due to better awareness and diagnosis rates, the analyst added. Finally, total peak sales of $357 million is based on a conservative estimate.
At time of publication, shares of Amicus were up 27.29 percent on the day at $13.06.Related Links: Mid-Day Market Update: Halcon Resources Jumps After Announcing Sale of Williston Basin Assets; Shiloh Industries Shares Slide 12 Biggest Mid-Day Gainers For Tuesday
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