Neos Therapeutics Inc (NASDAQ: NEOS) is having an incredibly strong start to the trading session today, and for good reason. The company is the center of attention, as today is a key PDUFA date for the company. Of course, this is leading to excitement and gains, prompting our partners at Trade Ideas to alert us to the movement. At the moment (9:53), NEOS is trading at $9.12 per share after a gain of $0.47 per share (5.49%) thus far today.
NEOS PDUFA Date Is Today
As mentioned above, Neos Therapeutics is having a relatively strong morning in the market this morning as today is the PDUFA date for the company. Six months ago today, the company resubmitted the application for Cotempla XR-ODT, which is the brand name for methylphenidate extended-release orally disintegrating tablets. The treatment is designed to treat ADHD.
The application was first submitted in 2015. However, the FDA had a few concerns about the treatment. NEOS is confident that it has addressed those concerns and that Cotempla will be approved. There's one thing we do know - we're going to find out whether the treatment is approved or denied by the end of the day today.
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What We'll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on NEOS. In particular, we're interested in learning whether or not Cotempla will be approved by the FDA. Of course, if the drug is approved, the stock will likely fly, while a denial of marketing authorization will likely tank the stock. We'll continue to follow the story closely and bring the news to you as it breaks!
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