AMAG sinks after Makena misses confirmatory trial

AMAG lost $2.43 (18%) to $11.29 on Friday after reporting that intramuscular Makena hydroxyprogesterone caproate -- the drug that created a political firestorm over its pricing eight years ago -- missed the co-primary endpoints in the confirmatory Phase III PROLONG trial to reduce the risk of preterm birth.

On the trial's co-primary endpoints, Makena did not reduce the incidence of preterm delivery at less than 35 weeks (11% vs. 11.5%, p=0.72) or the percentage of patients who met criteria for the prespecified neonatal morbidity and mortality composite index (5.4% vs 5.2%, p=0.84) vs. placebo. AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) was conducting PROLONG as an approval commitment under FDA’s accelerated approval pathway...