AMAG Pharmaceuticals falls after FDA denies supplemental NDA for Feraheme


AMAG Pharmaceuticals (AMAG -7.9%) shares are off sharply after the FDA issues a complete response letter denying the company's supplemental NDA for Feraheme, which had sought to expand the drug's indication beyond chronic kidney disease.

The FDA stated that AMAG had not provided sufficient information on safe and effective use for the additional indications and suggested the company generate additional clinical data.

AMAG intends to "work with the FDA to determine the best regulatory path for Feraheme" in the broader IDA patient population.

Following the news, Ladenburg Thalmann downgraded AMAG shares to Neutral from Buy and removed its $26 PT.

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