Agile Therapeutics Inc (NASDAQ: AGRX) is having an incredibly strong start to the trading session this morning, and for good reason. The company announced that it has received a response from the FDA with regard to a dispute resolution request. Of course, the news excited investors, sending the stock screaming for the top. Today, we’ll talk about:
- The FDA news;
- what we’re seeing from the stock; and
- what we’ll be watching for ahead.
AGRX Flies On Regulatory News
As mentioned above, Agile Therapeutics is having an incredibly strong start to the trading session this morning after announcing a regulatory update. In a press release issued early this morning, the company said that it received a response from the FDA’s Office of New Drugs with regard to its formal dispute resolution request.
Previously, the company appealed the FDA’s decision with regard to Twirla that prevented approval. While the OND has formally denied the company’s appeal, it did provide a path forward without the need to reformulate the product or conduct a bioequivalence study between formulations as previously suggested by DBRUP.
In the release, AGRX said that the OND suggested that the company conduct a wear study to evaluate whether Twirla demonstrates a generally similar adhesion performance to Xulane®, the generic version of the previously marketed Ortho Evra® contraceptive patch, a product the FDA considers to have acceptable adhesion. If this result is demonstrated, OND stated that the study would support the conclusion of adequate Twirla adhesion. OND has recommended that the Company first meet with DBRUP to gain agreement on the specific design and success criteria of a wear study for Twirla. Generally, wear studies are conducted by generic companies during the Phase 1 development of transdermal products and are significantly smaller in scope and shorter in duration than typical Phase 3 contraceptive clinical trials. The wear study suggested by OND provides a path forward but does not address efficacy. Rather, if the wear study is successful, Twirla’s safety and efficacy, including the Pearl Index, will need to be reviewed by FDA after the Company resubmits the NDA for Twirla. This is an issue that DBRUP plans to bring to Advisory Committee after the adhesion issue has been resolved.
In a statement, Al altomari, Chairman and CEO at AGRX, had the following to offer:
We appreciate the constructive discussions we’ve had with the FDA during this formal dispute resolution process. We are pleased that OND has provided a path forward, and we plan to meet with the Division to discuss the specifics of the proposed wear study as soon as possible. We look forward to resubmitting the NDA for Twirla after completion of our wear trial and welcome the opportunity to discuss the potential safety and efficacy of Twirla at an Advisory Committee Meeting… After we agree on the parameters of the wear study, we anticipate providing a further business update, which will review our cash guidance and planned resubmission timeline.
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 Agile Therapeutics, the news proved to be overwhelmingly positive. After all, while the company didn’t get the response it wanted, it will be able to skip multiple steps that investors expected to be required before moving to commercialization. So, it comes as no surprise that excited investors are sending the stock screaming for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:45), AGRX is trading at $0.97 per share after a gain of $0.51 per share or 109.57% 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 Twirla and the company’s attemp to bring it to market. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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