Leerink analyst Joseph Schwartz notes that shares of AMAG Pharmaceuticals (AMAG) are trading lower due to concerns over Makena after the Abbreviated New Drug Approval was granted to McGuff Pharmaceuticals for the generic version of Bristol-Myers' long-since withdrawn hydroxyprogesterone caproate Delalutin. Schwartz points out that the approved indication is not in pregnancy. He sees a high likelihood that the drug is contraindicated for use in pregnant women, similar to the original label of Delalutin. Further, AMAG has orphan drug exclusivity until Feb. 2018, Schwartz says. He views today's pullback as overdone and keeps an Outperform rating on the name. Its Makena injection is a prescription hormone medicine used to lower the risk of preterm birth in women. Shares of AMAG are down 11%, or $6.23, to $51.42 in midday trading.
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Reports Q1 revenue $11.9B, consensus $11.46B. "We had a good start to 2024, with revenue growth, important advances in our pipeline and the closure of several strategically important transactions. Our focus remains on strengthening the company's long-term growth profile. As a part of our continued evolution, we're executing a strategic productivity initiative that will allow us to be more agile, drive efficiency across the company, and prioritize investing in opportunities where we see the greatest potential to get the most promising medicines to patients as quickly as possible," said Christopher Boerner, Ph.D., board chair and chief executive officer, Bristol Myers Squibb. "