Antares Pharma Inc (NASDAQ: ATRS) is having an incredibly strong start to the trading session this morning, and for good reason. The comapny announced that it has received FDA approval. 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 as a result; 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 in the pre-market hours this morning after announcing the receipt of an FDA approval. In a press release issued early this mroning, the company said that the FDA has approved XYOSTED™.
As a result of the approval, XYOSTED™ is the first FDA approved subcutaneous testosterone enanthate product. The treatment has been approved for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable QuickShot auto injector. In the release, ATRS said that the treatment is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absense of endogenous testosterone.
In a statement, Robert F. Apple, CEO at ATRS, had the following to offer:
Today’s FDA approval of XYOSTED is a significant milestone for Antares. XYOSTED expands our branded portfolio of combination drug/device products and continues to highlight our passion and commitment to providing high quality therapies that improve patient care… XYOSTED, the first subcutaneous auto injector product designed for testosterone replacement therapy will soon be available for adult males diagnosed with a deficiency or absence of endogenous testosterone. Published data from the XYOSTED phase three studies have shown our product to be easy to use and virtually pain free while providing steady testosterone levels.” He concluded, “We believe XYOSTED significantly enhances a testosterone deficient patient’s option for treatment, and I am proud of our team’s success in developing and bringing to market this novel product. We will now begin the process of onboarding sales representatives and expect to make XYOSTED available to patients before the end of this year.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news leads to moves. In the case of Antares, the news proved to be overwhelmingly positive. After all, FDA approval means that the company can now commercialize its XYOSTED treatment to patients in the United States, the largest target market for this product. So, it comes as no surprise to see that excited investors are pushing the stock up in the market this morning. At the moment (8:43), ATRS is trading at $3.55 per share after a gain of $0.19 per share or 5.65% 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 story surrounding the commercialization of XYOSTED now that the company has received FDA approval. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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