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.

From other sites
Comments (0)
Be the first to comment
DJIA (DIA) S&P 500 (SPY)
ETF Screener: Search and filter by asset class, strategy, theme, performance, yield, and much more
ETF Performance: View ETF performance across key asset classes and investing themes
ETF Investing Guide: Learn how to build and manage a well-diversified, low cost ETF portfolio
ETF Selector: An explanation of how to select and use ETFs