Leerink Partners Cuts Price Target on Amicus Therapeutics (FOLD) Following FDA Feedback
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Leerink Partners maintained an Outperform rating on Amicus Therapeutics (NASDAQ: FOLD), and cut the price target to $15.00 (from $17.00), following the company's announcement that the FDA feedback will lead to a new Galafold Ph.3 study slated to begin in 2017. Management will avoid disruptions to commercial launch in the EU and anticipates top-line data by 2019.
Analyst Joseph Schwartz commented, "The much anticipated and long unfolding US regulatory update (4Q16) advanced yet another step after many twists and turns over the past few years. FOLD announced tonight that FDA feedback will lead the company to perform a new Galafold (migalastat) Ph.3 study (slated to begin in 2017; data anticipated in 2019) focusing on gastrointestinal (GI) symptoms and particularly on diarrhea. Recall, the earlier Ph.3 study ('011) demonstrated stat. sig. improvements on diarrhea (p=0.03 over 6 mos.), which may bode well for success of this new endeavor depending on trial design specifics still to come. Although trial details are still scant (protocol still being finalized), mgmt. believes that a small (n~35), 12-mos., cross-over study design should suffice in combination with previous trial data to gain a full approval for migalastat in the US. We are revising down our PT to $15 (from $17) on adjustments to our model but maintain our OP rating."
Shares of Amicus Therapeutics closed at $8.32 yesterday.
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