AMAG Pharmaceuticals (AMAG) Stock: Gaining Big On FDA Approval

AMAG Pharmaceuticals, Inc. AMAG Stock NewsAMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) is having an overwhelmingly strong day in the market today, and for good reason. In a press release issued early this morning, Antares Pharma, Inc. (NASDAQ: ATRS) announced that the FDA has approved a New Drug Application or NDA, that includes an AMAG Pharmaceuticals treatment. Today, we’ll talk about the approval, what we’re seeing from the stock, and what we’ll be watching for ahead.

AMAG Gains On FDA Approval

As mentioned above, AMAG Pharmaceuticals is having an overwhelmingly strong day in the market today after an FDA approval was announced. In a press release issued this morning, Antares Pharma announced that the United States Food and Drug Administration has approved their supplemental NDA for Makena®. The treatment is delivered through the ATRS QuickShot® device which was specifically designed for the rapid injection of highly viscous drug products.

In September, AMAG and ATRS entered into a license, development and supply agreement to develp a variation of their VIBEX QuickShot subcutaneous injector for use with Makena. According to the terms of the agreement, AMAG will manufacture and supply all drug products to ATRS. From there Antares will manufacture the device and is responsible for assembly and packaging of the final product that will then be sold to AMAG at cost plus margin. AMAG Pharmaceuticals will be in charge of commercialization and distribution of the final product with ATRS receiving high single digit to low double digit royalties on net sales as well as sales based milestones. In a statement, Robert F. Apple, President and CEO of ATRS, had the following to offer:

Today’s announcement represents the first FDA approval of a drug-device combination product utilizing our QuickShot auto injector. This first pass approval was made possible through an excellent working collaboration with our device team and the development group at AMAG… The Makena QuickShot device was designed to enhance performance on the attributes we believe are most critical to healthcare providers and patient acceptance, including decrease time to administer and use of a shorter, thinner nonvisible needle for subcutaneous injection, while potentially providing an alternative to the existing intramuscular methods of administration. We look forward to our continuing partnership with AMAG as it transitions from development to a commercial supply relationship.

What We’re Seeing From The Stock 

As investors, one of the first lessons that we learn is that the news moves the market. In this particular case, the news proved to be overwhelmingly positive. So, it’s no surprise to see that AMAG Pharmaceuticals is making a run for the top. As is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (10:16), AMAG is trading at $17.68 per share after a gain of $3.77 per share or 27.16% thus far today.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on AMAG. In particular, we’re interested in following the story surrounding the Makena QuickShot and excited to see what the sales figures are as this thing goes commercial. Nonetheless, we’ll continue to follow the story and bring the news to you as it breaks!

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