Company

Bank

Analyst

Coverage

Opinion

Wk chg

10/118 cls

AMAG Pharmaceuticals Inc. (NASDAQ:AMAG)

Baird

Christopher Raymond

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Outperform (from neutral)

8%

$21.53

Raymond also raised his target to $26 from $25 after FDA extended the PDUFA date by three months for an sNDA for anemia drug Feraheme ferumoxytol. He said applications with three-month PDUFA extensions have a "decent" record of gaining FDA approval. The new date is Jan. 21, 2014. The sNDA seeks to expand Feraheme's indication to all adult patients with iron deficiency anemia who have failed or could not tolerate oral iron treatment. Feraheme is approved to treat iron deficiency anemia in adult patients with chronic kidney disease (CKD).

Amarin Corp. plc(NASDAQ:AMRN)

Canaccord

Ritu Baral

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Hold (from buy)

-60%

$2.03

H.C. Wainwright

Andrew Fein

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Neutral (from buy)

Baral also lowered her target to $3 from $10 after FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 9-2 against expanding the label of the company's Vascepa icosapent ethyl to adults with high triglycerides with mixed dyslipidemia. Baral estimates a 15% chance of approval by the Dec. 20 PDUFA date. The committee voted against approval prior to the completion of Amarin's REDUCE-IT cardiovascular outcomes trial, which are not expected until at least 2016 (see B12). Amarin markets Vascepa in the U.S. as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia