The update comes as the company wraps up its pivotal Serenity At-Home Phase 3 trial and analysts grow more optimistic on BXCL501’s commercial potential.
Retail chatter surged around BioXcel Therapeutics early Monday after the company said it received positive preliminary FDA comments ahead of an Aug. 20 meeting to discuss expanding Igalmi’s label for at-home use in agitation tied to bipolar disorder and schizophrenia.
The FDA’s remarks focused on aligning with the company over the format and content of the upcoming supplemental new drug application (sNDA) submission. BioXcel said it is evaluating the comments and expects to provide an update following the meeting.
Currently, Igalmi is approved for hospital or supervised clinical use, and a green light for outpatient administration would open a new, significantly larger commercial opportunity.
The regulatory update comes on the heels of BioXcel completing its Serenity At-Home Phase 3 trial earlier this month, with the last patient visits finalized across 22 U.S. sites.
The pivotal study enrolled more than 200 patients and is designed to assess the safety of a 120 mcg self-administered dose of BXCL501 for acute agitation episodes in home settings. Top-line data are expected later this quarter and will form the backbone of the planned sNDA filing.
The FDA has previously granted BXCL501 Breakthrough Therapy designation for dementia-related agitation and Fast Track status for schizophrenia, bipolar disorder, and dementia.
BioXcel has also received two favorable recommendations from its Data Safety Monitoring Board, supporting the drug’s advancement toward regulatory review.
Last Friday, H.C. Wainwright boosted its price target on the stock to $10 from $8 while sticking with a Buy rating, pointing to growing excitement around BXCL501.
The brokerage firm called the upcoming Serenity trial readout “low-risk” and expects the company to file for an expanded label by the end of the year, with the FDA potentially signing off in the second half of 2026.
On Aug. 6, BioXcel said a new paper in Frontiers in Pharmacology highlighted dexmedetomidine, the key ingredient in BXCL501.
The study showed it could significantly influence stress-related behaviors in preclinical models, raising the possibility that the drug’s use might extend beyond calming acute agitation to helping manage longer-term psychiatric conditions.
On Stocktwits, retail sentiment for BioXcel was described as ‘extremely bullish’ with ‘extremely high’ message volume, making it the platform’s most trending stock.
One user urged that “$BTAI could be pushed over $50 this week” if investors “stick together,” adding that the community had the power to make it happen.
Another user noted that if the Aug. 20 meeting went positively, it would signal that Phase 3 data had already come back strong as expected.
BioXcel’s stock has declined 8.4% so far in 2025.
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