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AMAG Files for FDA Approval of Subcutaneous Form of Makena

Zacks

AMAG Pharmaceuticals, Inc. AMAG announced the submission of a supplemental New Drug Application (sNDA) to the FDA for the subcutaneous auto-injector form of its marketed drug Makena in the U.S. Makena is currently approved as an intramuscular (IM) injection to reduce the risk of preterm birth in women who are pregnant with one baby.

A look at AMAG’s share price movement over the past one year shows that the stock has outperformed the Zacks classified Medical-Biomedical/Genetics industry. Specifically, AMAG’s stock dropped 9.8% during this period, while the industry lost 11.5%.

The company filed the sNDA based on data from a definitive pharmacokinetic (PK) study, which evaluated bioavailability of Makena as a subcutaneous auto-injector in comparison to the IM injection version in 120 healthy post-menopausal women. The study demonstrated bioequivalence for Makena administered subcutaneously via the auto-injector compared to the IM injection in a key pharmacokinetic parameter.


We remind investors that Makena subcutaneous auto-injector is being developed in partnership with Antares Pharma, Inc.

Makena is a progestin indicated to reduce the risk of preterm birth in women pregnant with a single baby who have a history of singleton spontaneous preterm birth. Makena's market share expanded to 42% in 2016, generating 63% of the total revenue of the company

As per a survey conducted by AMAG among women who are currently receiving, or previously received, or are eligible to receive IM injections, Makena subcutaneous auto-injector is preferable over IM injection due to the decreased administration time for the injection, the shorter needle and the lack of visibility of the needle during the injection process. This data is also included in the sNDA.

Zacks Rank & Stocks to Consider

AMAG Pharmaceuticals currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Grifols, S.A. GRFS, Infinity Pharmaceuticals, Inc. INFI and Corcept Therapeutics Incorporated CORT. Grifols and Infinity sport a Zacks Rank #1 (Strong Buy) while Corcept carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Grifols' earnings per share estimates increased from $1.04 to $1.15 for 2017 over the last 60 days. The company’s shares have appreciated 22.3% so far this year.

Shares of Infinity have gained 62.2% this year so far, while the company’s loss estimates for 2017 narrowed almost 6% in the past 60 days.

Corcept’s earnings estimates increased about 4% for 2017 over the last 60 days. Also, the company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 45%. Its share price has increased 52.9% year to date.

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