BioXcel Therapeutics Inc ( BTAI ) shares are trading higher. The AI biopharmaceutical company on Monday announced positive meeting comments from the U.S. Food and Drug Administration (FDA).

What Happened: BioXcel Therapeutics ( BTAI ) said the FDA provided positive pre-sNDA feedback that gives the company confidence that the planned sNDA (supplemental New Drug Application) regulatory package will be sufficient to support its sNDA submission.

The company said it remains on track to submit an sNDA for the at-home use of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the first quarter of 2026.

“We are pleased with the pre-sNDA meeting feedback we received from the FDA, which confirmed agreement on the content and format for our planned sNDA submission, and reflects a shared commitment to addressing the urgent needs of patients living with bipolar disorder or schizophrenia,” said Vimal Mehta, CEO of BioXcel Therapeutics ( BTAI ).

“This marks an important milestone in our mission to bring a safe and effective outpatient treatment to patients suffering from agitation, potentially transforming the treatment paradigm.”

BXCL501 was granted Fast Track Designation for the acute treatment of agitation associated with bipolar disorders or schizophrenia. The company noted that there are no FDA-approved therapies for the acute treatment of agitation in the at-home setting.

How To Buy BTAI Stock

By now you're likely curious about how to participate in the market for BioXcel Therapeutics ( BTAI ) – be it to purchase shares, or even attempt to bet against the company.

Buying shares is typically done through a brokerage account. You can find a list of possible trading platforms here. Many will allow you to buy “fractional shares,” which allows you to own portions of stock without buying an entire share.

If you're looking to bet against a company, the process is more complex. You'll need access to an options trading platform, or a broker who will allow you to “go short” a share of stock by lending you the shares to sell. The process of shorting a stock can be found at this resource. Otherwise, if your broker allows you to trade options, you can either buy a put option, or sell a call option at a strike price above where shares are currently trading – either way it allows you to profit off of the share price decline.

BTAI Price Action: BioXcel shares were up 14.59% at $6.28 at the time of publication Monday, according to Benzinga Pro.

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