We are investigating AMAG Pharmaceuticals, Inc. (AMAG) (“AMAG” or the “Company”) for potential violations of the federal securities laws.
On October 29, 2019, AMAG announced that the Food and Drug Administration’s (“FDA”) Bone, Reproductive and Urologic Drugs Advisory Committee had voted 16-0 that the Company’s confirmatory study, Trial 003, failed to demonstrate the effectiveness of AMAG’s Makena product in reducing the risk of preterm births in women with histories of singleton spontaneous preterm birth. The FDA committee also voted 13-3 that the clinical data (Trials 002 and 003) in the Company’s application failed to demonstrate substantial evidence of effectiveness. On this news, AMAG’s stock price fell $2.98 per share, or 22.36%, to close at $10.35 per share on October 30, 2019. Then, on January 9, 2020, AMAG disclosed plans to divest its Intrarosa and Vyleesi products in order to lower operating expenses. Concurrently, AMAG announced that William Heiden would step down as AMAG’s President and Chief Executive Officer following the appointment of a successor by the Company’s Board of Directors. On this news, AMAG’s stock price fell sharply on January 9, 2020.