KemPharm Inc (NASDAQ: KMPH) is having a great start to the trading session in the pre-market hours this morning, and for good reason. The company announced the results of a meeting with the FDA, eluding to a coming NDA submission.
As you could imagine, the news excited investors, pushing the stock on a run for the top. Today, we’ll talk about:
- The coming NDA;
- what we’re seeing from KMPH stock as a result; and
- what we’ll be watching for ahead.
KMPH Climbs On Coming NDA
As mentioned above, KemPharm is having a great day in the market today after announcing that it has concluded a meeting with the FDA. The news came by way of press release early this morning.
In the announcement the company said it concluded the pre-New Drug Application (NDA) meeting with the FDA for KP415. This is the investigational ADHD product candidate that contains serdexmethylphenidate and d-methylphenidate that is being develped by KMPH.
The company said that the purpose of the meeting was to discuss the company’s NDA for KP415 and to confirm the clinical and non-clinical requirements for submission. In the release, KMPH said that based on the FDA’s feedback, it believes that its regulatory data package will be sufficient for submission.
In a statement, Travis C. Mickle, Ph.D., President and CEO At KMPH, had the following to offer:
We are pleased with the collaborative tone of our meeting with the FDA, and we now have a solid understanding of the Agency’s requirements for our submission.
Based on feedback received during this meeting and from previous correspondences, we are confident in moving forward with our NDA package for KP415, which is on track for submission in late Q2 or early Q3 2019.
One of the topics discussed with the FDA was the data analysis of the KP415.E01 efficacy trial. The complete KP415.E01 data package will be included in the NDA and provides additional analyses beyond the previously announced top line data that further support our belief that KP415 elicits an onset of action at 30 minutes and a duration of effect of 13 hours. In addition, the FDA stated that no additional efficacy study or data is required to assess KP415’s efficacy in treating ADHD.
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 KemPharm, the news proved to be overwhelmingly positive.
After all, a NDA submission will bring the company one step closer to commercialization. In fact, should the NDA be approved, the company will be able to market its ADHD product in the United States. So, it’s not surprising to see that excited investors are sending the stock on a run for the top.
As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:54), KMPH is trading at $1.80 per share after a gain of $0.11 per share or 6.51% 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 KMPH. In particular, we’re interested in following the story surrounding the coming NDA for the ADHD treatment. Nonetheless, we’ll keep a close eye on the story and bring the news to you as it breaks!
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