Antares Pharma Inc (NASDAQ: ATRS) is having an incredibly strong start to the trading session this morning, and for good reason. The company announced that the FDA has approved its new drug application, a move that will launch the company into commercial stages. Of course, the news excited investors, sending the stock on a run for the top. Today, we’ll talk about:
- The FDA approval;
- what we’re seeing from ATRS; and
- what we’ll be watching for ahead.
ATRS Announces FDA Approval
As mentioned above, Antares Pharma is having an incredibly strong start to the trading session this morning after announcing that it has received FDA approval. In a press release issued late yesterday, the company announced that the United States Food and Drug Adminstration has approved Teva Pharmaceutical Industries’ (TEVA) epinephrine auto injector drug-device combination product. The product has been indicated for emergency treatment of severe allergic reactions, including those that are life threatening in adults and certain pediatric patients.
ATRS and TEVA partnered surrounding the treatment. The treatment is now approved as a generic product to the EpiPen®. Within the drug device, TEVA uses the ATRS VIBEX® device. The device has been approved with an AP rating. This means that it is therapeutically equivalent and fully substitutable to the EpiPen at the pharmacy. In a statement, Robert F. Apple, President and CEO at ATRS, had the following to offer:
We are extremely pleased with the FDA’s decision to approve Teva’s ANDA for the first and only fully substitutable generic version of Mylan’s branded EpiPen, the most widely used epinephrine auto injector on the market… This approval means patients living with severe, sometimes life-threatening allergic reactions, (anaphylaxis), who require immediate access to life-sparing epinephrine should have access to a generic alternative. We and our partner Teva worked diligently together to obtain the approval of this very complex drug/device rescue pen combination product utilizing our VIBEX auto injector platform and we look forward to Teva making it commercially available to patients.
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 the case of Antares Pharma, the news proved to be overwhelmingly positive. After all, this drug approval is a key step toward commercialization for the company. Not to mention, the generic version of the overwhelmingly high priced EpiPen will likely garner quite a bit of demand. So, it comes as no surprise that excited investors are pushing the stock upward in the market this morning. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:51), ATRS is trading at $3.45 per share after a gain of $0.15 per share or 4.55% thus far today.
Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!
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 story surrounding the company’s partnership with Teva and the sales the generic EpiPen will generate. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
Never Miss The News Again
Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!