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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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