Leerink Partners Cuts Price Target on Amicus Therapeutics (FOLD) Following FDA Feedback

November 29, 2016 7:59 AM EST
Get Alerts FOLD Hot Sheet
Price: $5.37 -0.37%

Rating Summary:
    8 Buy, 2 Hold, 1 Sell

Rating Trend: Up Up

Today's Overall Ratings:
    Up: 23 | Down: 34 | New: 34
Trade FOLD Now!
Join SI Premium – FREE

Find out which companies are about to raise their dividend well before the news hits the Street with StreetInsider.com's Dividend Insider Elite. Sign-up for a FREE trial here.

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."

For an analyst ratings summary and ratings history on Amicus Therapeutics click here. For more ratings news on Amicus Therapeutics click here.

Shares of Amicus Therapeutics closed at $8.32 yesterday.

Serious News for Serious Traders! Try StreetInsider.com Premium Free!

You May Also Be Interested In

Related Categories

Analyst Comments, Analyst EPS Change, Analyst PT Change

Add Your Comment