Shares of AMAG Pharmaceuticals, Inc. (AMAG - Free Report) were 17% down after the company announced top-line results from PROLONG (Progestin’s Role in Optimizing Neonatal Gestation), a study evaluating Makena in patients with a history of a prior spontaneous singleton preterm delivery. In fact, shares of AMAG have declined 44.8% in the past year, against the industry’s decline of 20.6%.
The PROLONG study did not show a statistically significant difference between the treatment and placebo arms for the co-primary endpoints. About 11% of women who were administered Makena delivered their babies 35 weeks into their pregnancy or earlier. That was not significantly better than 11.5% of the placebo participants. Further, the percentage of patients who met criteria for the pre-specified neonatal morbidity and mortality composite index experienced an even smaller difference compared to placebo patients. The PROLONG study was conducted as part of an approval commitment under the FDA’s “Subpart H” accelerated approval process.
We remind investors that Makena is a progestin approved to reduce the risk of preterm birth in women pregnant with a single baby who have a history of singleton spontaneous preterm birth. In February 2018, the FDA also approved a new administration option for Makena- subcutaneous auto-injector drug-device combination product to reduce the risk of preterm birth in certain at-risk women. The company has developed an auto-injector device for subcutaneous administration of Makena (Makena SQ), including chemistry, manufacturing and controls development, in partnership with Antares Pharma, Inc. (ATRS - Free Report) . Makena SQ auto-injector will ensure easier administration by healthcare providers and less painful injections for patients.
The company plans to conduct additional sub-group analyses of the PROLONG data, primarily focusing on patients at the highest risk of preterm delivery and the subset of patients enrolled in the United States. The company will work with the publications committee to further assess the data, submit the findings to the FDA, and prepare the data for peer reviewed publication.
AMAG Pharmaceuticals, Inc. Price
Zacks Rank & Stocks to Consider
AMAG currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the same space are Celgene Corporation and BioDelivery Sciences International, Inc. (BDSI - Free Report) , each carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Celgene’s earnings per share estimates have increased from $10.34 to $10.73 for 2019 and from $12.28 to $12.76 for 2020 in the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 2.65%.
BioDelivery Sciences’ loss per share estimates have narrowed from 25 cents to 18 cents for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with average of 8.57%.
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