BioXcel Therapeutics Inc (NASDAQ: BTAI) is having an incredibly strong start to the trading session this morning, and for good reason. The company announced positive proof-of-concept data, exciting investors and sending the stock screaming for the top. Today, we’ll talk about:
- The proof-of-concept data;
- what we’re seeing from the stock; and
- what we’ll be watching for with regard to BTAI ahead.
BTAI Announces Proof Of Concept Data
As mentioned above, BioXcel Therapeutics is having a strong day in the trading session this morning after announcing proof-of-concept data from its Phase 1 study of IV dexmedetomidine (Dex). The treatment is currently under development as an option for agitation in patients with Senile Dementia and Alzheimer’s Type (SDAT).
In the release, BTAI said that the positive data from the trial provides the evidence it needs to support the continued clinical development of BXCL501 under the Fast Track regulatory process.
In the release, the company said that the SDAT trial met its primary endpoint by identifying a safe dose of IV Dex that produced a mild arousable sedation, defined by a RASS2 score of -1. During the study of 14 patients, the drug proved to be well tolerated and had no clinically significant adverse events.
In a statement, Vincent O’Neill, MD, CMO at BTAI, had the following to offer:
The results of this study further validate our belief that BXCL501 represents a product with the potential to treat acute agitation arising from a number of neuropsychiatric indications. IV Dex has now demonstrated that this selective and safe alpha 2a receptor agonist can benefit patients across multiple pathologies where acute agitation is an issue. We look forward to evaluating BXCL501, which recently received Fast Track designation from the U.S. Food and Drug Administration (FDA), in our ongoing first-in-human pharmacokinetic (bioavailability) study for which we expect top-line data in the first half of 2019.
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 BioXcel, the news proved to be overwhelmingly positive. After all, the strong data means that the company will be moving BXCL501 further along the line in the development process. So, it’s not surprising to see that excited investors are pushing 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 (11:15), BTAI is trading at $4.52 per share after a gain of $0.93 per share or 25.91% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the iWatch Markets team will continue to keep a close eye on BTAI. In particular, we’re interested in following the story surrounding the development of BXCL501 as the treatment seems to be yielding strong results. With the Fast Track designation, development could be far faster and value could be driven here. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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