AMAG Pharmaceuticals (AMAG -10.4%) is down on average volume in apparent profit-taking after its recent rally. Shares were up almost 80% since touching $6.81 on August 7.
A key upcoming event is an FDA advisory committee meeting to discuss its Phase 3 PROLONG clinical trial evaluating Makena (hydroxyprogesterone caproate injection) for the prevention of preterm birth prior to week 35 in women who have experienced a previous spontaneous preterm delivery (single fetus). The meeting should take place next quarter.
The co-primary endpoints are the rates of preterm birth and neonatal mortality/morbidity compared to placebo.
The FDA approved the progestin in February 2011 to reduce the risk of preterm birth. Its effectiveness was based on the improvement in the proportion of women who delivered before week 37 (normal gestation period is 40 weeks). No controlled studies demonstrating a direct clinical benefit (e.g., improvement in neonatal mortality/morbidity) were conducted.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.