Antares Pharma Inc (NASDAQ: ATRS) is headed up in the pre-market hours this morning after announcing a regulatory update surrounding XYOSTEDTM (testosterone enanthate subcutaneous injection). Of course, the update was a positive one, leading to excitement-fueled gains as the stock makes it clear into the green in the pre-market hours. Today, we’ll talk about:
- The regulatory update;
- what we’re seeing from ATRS as a result; and
- what we’ll be watching for ahead.
ATRS Announces Regulatory Update
As mentioned above, Antares Pharma is having a strong start to the trading session this morning after the company announced a regulatory update. In a press release issued early this morning, the company announced that the United States Food and Drug Administration (FDA) acknowledged the receipt of the company’s re-submission to a recent Complete Response Letter received surrounding XYOSTED. In the release, ATRS said that the FDA has considered the re-submission a complete, class 2 response and has assigned a user fee goal date of September 29, 2018. In a statement, Robert F. Apple, President and CEO at ATRS, had the following to offer:
We are pleased that the FDA accepted our response to the XYOSTED CRL, and look forward to working closely with the Agency throughout the next review cycle.
What We’re Seeing From The Stock
With the strong news surrounding the re-submission of the XYOSTED NDA, it’s no surprise that investors are excited about Antares Pharma this morning. Of course, the excitement can be seen in the price of the stock as the stock makes its way toward the top. As is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (2:16), ATRS is trading at $2.16 per share after a gain of $0.07 per share (3.35%) thus far today.
What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on ATRS. We are particularly interested in following the news surrounding XYOSTED to see if the treatment does indeed achieve FDA approval. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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