Penny stocks, especially in the early-stage biotech sector, often tend to be volatile and highly risky, but they also offer the potential for massive rewards. One such company is BioXcel Therapeutics (BTAI), which stands out right now for its late-stage pipeline progress, rising market potential, and approaching FDA milestone, making it a top penny stock to keep an eye on for 2026.
BioXcel Therapeutics is a biopharmaceutical company that employs artificial intelligence (AI) and machine learning to discover and develop breakthrough treatments, with a focus on neuroscience. By using AI, the company aims to lower the cost and time needed for drug development when compared to traditional methods. Its lead product is IGALMI, which is an FDA-approved sublingual film formulation of BXCL501 used for the immediate treatment of severe agitation in people with schizophrenia and bipolar disorder.
BioXcel conducted a Phase 3 SERENITY At-Home trial with 246 patients to assess the safety of BXCL501 in a real-world, home-use environment, collecting data on over 2,600 agitation episodes. The results revealed no discontinuations due to tolerability in the treatment arm, no drug-related major adverse events, and no new or unexpected safety signals. These encouraging results have motivated the business to submit a supplemental New Drug Application (sNDA) to the FDA this month, requesting clearance for IGALMI at-home use. BioXcel expects it will be approved this year and is gearing up for the next round of pre-launch and commercial launch activities.
Beyond bipolar disorder and schizophrenia, BioXcel is moving on with its TRANQUILITY In-Care Phase 3 program, which aims to treat agitation linked with Alzheimer’s dementia. The company has received FDA comments on the clinical protocol and is currently examining proposals from contract research organizations in preparation for trial launch.
Currently, BioXcel believes that the at-home agitation market represents between 57 million and 77 million episodes annually in the U.S., exceeding earlier estimates of 23 million episodes. If approved, at-home IGALMI could address a significant unmet need by moving treatment from institutional settings to patients’ homes, which benefits the patients.
