Wk chg

12/21 cls

Amicus Therapeutics Inc. (NASDAQ:FOLD)


Gregory Wade


Underperform (from neutral)



Wade also lowered his target to $1.50 from $6 after Amicus and partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said Amigal migalastat missed the primary endpoint in the Phase III FACETS (Study 011) trial to treat Fabry's disease (see B20). He believes the "odds favor migalastat not proceeding successfully through the regulatory process" and has removed the product from his valuation. Amigal is a small molecule that enhances alpha galactosidase A activity.

Ariad Pharmaceuticals Inc. (NASDAQ:ARIA)

Dawson James

Michael King


Market outperform



Stifel Nicolaus

Joel Sendek

Price target


King maintained his $32 target after FDA granted accelerated approval to leukemia drug Iclusig ponatinib with a black box warning about the risk of arterial thrombosis and liver toxicity. Iclusig is approved to treat chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) that is resistant or intolerant to prior treatment with tyrosine kinase inhibitors (TKIs). King said the approval, more than three months ahead of the March 27, 2013, PDUFA date, shows FDA believes the drug is a "breakthrough." Although King said the black box was a "surprise," he believes it was a prudent move by FDA to encourage physicians to use caution when prescribing the drug. Iclusig was approved based on the single-arm pivotal Phase II PACE trial (see "Iclusig Black Out," A14). The pan-BCR-ABL tyrosine kinase inhibitor is under accelerated assessment in Europe for the indications.