AMAG Pharmaceuticals Inc. (AMAG) soared 20 percent in early trading Monday after the Lexington, Massachusetts-base drug developer said it had reached an agreement with the U.S. Food and Drug Administration [FDA] over new labeling for its hematology drug Feraheme.
AMAG said the FDA required additional warnings on Feraheme’s label and prolonged the observation period from 30 to 60 minutes, but did not require a “black box” warning, the sternest a drug can carry and still remain on the U.S. market.
““We are pleased to have reached resolution with the [FDA] and have this uncertainty behind us,” said in a statement Brian J.G. Pereira, president and CEO of AMAG.
Shares of AMAG are higher on the session by 14.59%, currently trading at $16.10. The stock, which has been moving largely lower over the past five months, earned some bullish attention this morning, as MLV Capital upgraded the ticker to “Buy” from “Hold,” setting a target price of $25 per share.
Today’s volume on the name is huge: AMAG shares have already traded more than 1.4 million shares, well above the daily average volume of 637,000 shares.
The intraday trading range for shares of AMAG Pharma, Inc has been between $15.74 and $17.17 per share.