Antares Pharma Inc (NASDAQ: ATRS) is having an overwhelmingly strong day in the market today, and for good reason. The company announced that the United States Food and Drug Administration has approved a New Drug Application they submitted, leading to excitement among investors and sending the stock screaming for the top. Today, we’ll talk about the approval, what we’re seeing from the stock, and what we’ll be watching for with regard to ATRS ahead.
ATRS Announces FDA Approval
As mentioned above, Antares Pharma is having an overwhelmingly strong day int he market today after announcing that the FDA has approved a regulatory submission made by the company. In a press release issued early this morning, the company announced that the United States Food and Drug Administration, also known as FDA, has approved the New Drug Application surrounding the Makena® subcutaneous auto injector drug-device combination.
ATRS reminded investors that the Makena subcutaneous auto injector drug device combination was designed as a ready-to-administer treatment to reduce the risk of preterm birth in women who are pregnant with one baby and who spontaneously delivered one preterm baby in the past. The drug-device combination product uses QuickShot® by ATRS, a device that was developed to deliver a rapid injection of highly viscous drug products like progesterone in oil, through a fine gauge nonvisible needle. In a statement, Robert F. Apple, President and CEO at 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 decreased 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 ATRS
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. After all, there are few bits of news that are looked at in as positive of light as news of an FDA approval. So, it’s no surprise to see that excited investors are sending the the stock toward the top. Currently (8:20), ATRS is trading at $2.27 per share after a gain of $0.29 per share or 14.65% 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 ATRS. In particular, we’re interested in following the plans to commercialize the Makena QuickShot, now that the NDA has been approved, and excited to see revenue come in as a result. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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