Street Calls of the Week
BioXcel Therapeutics, Inc. (NASDAQ:BTAI) announced Thursday that it has received preliminary comments from the U.S. Food and Drug Administration (FDA) in advance of a pre-supplemental New Drug Application (pre-sNDA) meeting scheduled for August 20, 2025. The company is currently reviewing the FDA’s feedback and stated it plans to provide an update next week.
According to the press release statement, the main objective of the upcoming pre-sNDA meeting is to align with the FDA on the format and content required for BioXcel’s planned sNDA submission. This includes discussions on clinical data, nonclinical information, and chemistry, manufacturing, and controls (CMC) requirements.
BioXcel Therapeutics is a pharmaceutical company based in New Haven, Connecticut. Its common stock is listed on the Nasdaq Capital Market under the ticker symbol BTAI.
The information in this article is based on a press release statement included in a recent SEC filing.
In other recent news, BioXcel Therapeutics has completed the final patient visit for its pivotal Phase 3 SERENITY At-Home clinical trial for IGALMI, which is expected to provide crucial data on treating agitation in bipolar disorder and schizophrenia in home settings. This milestone has prompted H.C. Wainwright to reiterate its Buy rating on BioXcel Therapeutics with a price target of $8. Meanwhile, Mizuho has significantly reduced its price target for the company to $2 from $16, maintaining a Neutral rating due to updated financial models and recent financings. Additionally, a study published in Frontiers in Pharmacology has highlighted that dexmedetomidine, the active ingredient in IGALMI, reduces stress-induced behaviors in preclinical models, suggesting broader applications beyond its current use. These developments come as BioXcel continues to explore the potential of its neuroscience-focused treatments.
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