Why AMAG Pharmaceuticals Is Tanking Today

Shares of AMAG Pharmaceuticals (NASDAQ: AMAG), a commercial-stage pharmaceutical company, fell as much as 30% in early-morning trading on Wednesday. Shares are down about 28% as of 11:00 a.m. EDT. The double-digit decline is traceable to an FDA committee vote that recommended that AMAG's best-selling drug, Makena, be removed from the market.

The FDA's Bone, Reproductive and Urologic Drugs Advisory Committee met yesterday to take another look at AMAG's PROLONG clinical trial. This study was used to gain FDA approval for Makena, a drug used to prevent preterm birth in pregnant women.

During the meeting, 9 of the 16 advisory committee members voted to recommend that the FDA pursue withdrawal of its approval of Makena.

Continue reading


Source Fool.com