Clementia Pharmaceuticals Inc (NASDAQ: CMTA) is having a great start to the trading session this morning, and for good reason. The company announced that it plans to file a New Drug Application. Of course, the news excited investors who are sending the stock screaming for the top. Today, we’ll talk about:
- The New Drug Application;
- what we’re seeing from CMTA stock as a result; and
- what we’ll be watching for ahead.
CMTA Announces Coming NDA Filing
As mentioned above, Clementia Pharmaceuticals is having an incredibly strong start to the trading session this morning after announcing that it plans to file a New Drug Application with the FDA. In a press release, the company said tht it plans to submit an NDA for palovarotene in the United States in the second half of 2019.
In the release, CMTA said that the plans come following recent interactions with the FDA, including a Type B meeting as part of the treatment’s Breakthrough Therapy Designation. The company also said that the FDA has agreed that available data would support the nDA filing for the prevention of heterotopic ossification associated with flare up symptoms in patients with fibrodysplasia ossificans progressiva (FOP). In a statement, Clarissa Desjardins, Ph.D., founder and CEO at CMTA, had the following to offer:
The identification of a path to an NDA submission in the second half of 2019 is a significant milestone for Clementia and for patients with this ultra-rare and devastating genetic bone disease… We are thankful for the collaboration with the FDA’s Division of Bone, Reproductive and Urologic Products, potentially bringing the first approved treatment option to individuals affected by FOP. We are also grateful to the patients and their families, as well as the investigators and clinical sites, without whom none of this work would have been possible.
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 often leads to moves. In the case of Clementia Pharmaceuticals, the news proved to be overwhelmingly positive. After all, the submission of the NDA has the potential to lead to an opportunity for the company to generate revenue through marketing its treatment in the United States. So, it comes as no surprise to see that excited investors are sending the stock on a run for the top in the market this morning. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:05), CMTA is trading at $14.09 per share after a gain of $3.75 per share or 36.27% 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 CMTA. In particular, we’re interested in following the story surrounding the company’s continued work to bring palovarotene to market in the United States. 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!