Agile Therapeutics Inc (NASDAQ: AGRX) is flying early on in the trading session this morning, and for good reason. The company announced the results from a clinical study after meeting its primary endpoint. Of course, the news excited investors, pushing the stock on a run for the top. Today, we’ll talk about:
- The clinical data;
- what we’re seeing from AGRX stock as a result; and
- what we’ll be watching for ahead.
AGRX Announces Clinical Update
As mentioned above, Agile Therapeutics is having an incredibly strong start to the trading session this morning after the company announced positive clinical results.
In a press release issued early this morning, the company announced topline results from its comparative wear study. During the study, the company assessed Twirla in comparison to Xulane.
In the reulease, AGRX said that Twirla met its primary endpoint and demonstrated non-inferior adhesion to Xulane.
The study was the result of a recommendation by the FDA’s Office of New Drugs (OND). The OND recommended that the company complete a comparative wear study as part of a potential path toward the regulatory approval of the treatment in the United States.
In the release, the company said that the primary endpoint of the study was the mean difference in adhesion scrose between Twirla and Xulane. According to a Type A meeting with the FDA, Twirla was considered to be statistically non-inferior to Xulane if the upper 95% confidence limit of the mean difference was less than +0.15. During the study, a mean difference of -0.25 and upper 95% confidence limit of -0.16 were demonstrated, meeting this endpoint.
In a statement, Dr. Elizabeth Garner, Senior Vice-President and CMO at AGRX, had the following to offer:
We believe that the topline data from our comparative wear study provide important insights into the adhesion performance of Twirla that we can share with the FDA to support that Twirla demonstrates adequate in vivo adhesion. While the results from the study will need to be reviewed by the FDA as part of our planned NDA resubmission, we are very pleased with the results. We greatly appreciate the hard work and dedication from our clinical team and wish to thank the research professionals and staff at TKL Research, and most importantly, the women who participated in the trial.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. When it comes to Agile Therapeutics, the news proved to be overwhelmingly positive. After all, the strong clinical data brings the company one step closer to a New Drug Application for the regulatory approval of Twirla within the United States. So, it’s not surprising to see that excited investors are pushing the stock on a run for the top. As is just about always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:01), AGRX is trading at $1.03 per share after a gain of $0.14 per share or 15.73% 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 AGRX. In particular, we’re interested in following the story surrounding the company’s continued work to bring Twirla to market in the United States and around the world. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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