Shares of Amag Pharmaceuticals (AMAG) plunged after regulators declined to approve wider marketing for its Feraheme drug. AMAG stock sank more than 16% in Wednesday premarket trading.
Feraheme has been approved to treat iron deficiency in adult chronic kidney disease patients, but the U.S. Food and Drug Administration has refused to clear the drug for use among patients suffering from adult iron deficiency anemia (IDA). The agency also told AMAG to provide more data regarding the drug’s health risks. Feraheme has also been approved for sale in Europe, Reuters notes.
Three deaths occurred during one late-stage clinical trials of Feraheme. While none of the deaths were linked to the drug, the FDA told AMAG to provide more data on a larger patient groups.
AMAG stock has rise more than 35% over the past twelve months. AMAG stock closed at $21.86 on Tuesday.