Bioxcel Therapeutics Soars to Record High on Strong Schizophrenia Test Results

Shares of biotech company Bioxcel Therapeutics soared 14% on Monday and hit an all-time intraday high of $71.50 after revealing bullish Phase 3 results for an agitation treatment in patients with schizophrenia.

The company’s drug reduced agitation in patients with schizophrenia and bipolar disorder in two pivotal studies. Bioxcel is planning to ask for Food and Drug Administration approval in the first quarter of 2021.

BXCL501, the Company’s proprietary sublingual thin film of dexmedetomidine, met the primary and secondary endpoints of SERENITY I and SERENITY II, demonstrating a robust treatment effect in the trials. Results demonstrated that BXCL501 was well tolerated, with rapid and durable reductions in agitation.

The company’s press release states, “In patients with schizophrenia (SERENITY I) and a second study of bipolar disorder (SERENITY II), highly statistically significant and clinically meaningful reductions in the Positive and Negative Syndrome Scale, Excitatory Component (“PEC”) score at two hours, the primary endpoint, were reported for both high and low dose cohorts of BXCL501 compared to placebo (p<0.0001). Both studies also met the key secondary endpoint, demonstrating improvement in PEC scores beginning as early as 20 minutes in patients with bipolar disorder, at both dose levels, and as early as 20 minutes in patients with schizophrenia for the 180 mcg dose level. Exploratory efficacy endpoints confirmed the primary endpoint, with duration of response lasting at least four hours after treatment." "These compelling Phase 3 results show that (the drug called) BXCL501, if approved, has the potential to become an important new treatment option for patients suffering from acute agitation," Bioxcel Chief Executive Vimal Mehta stated. "We are extremely pleased that rapid and robust reductions in agitation were demonstrated in both patient populations despite differing neuropsychiatric diagnoses. We believe these results suggest that BXCL501 may have potential to treat agitation across a wide range of conditions. As we initiate steps toward regulatory submissions in these first two indications, we are also rapidly advancing the investigation of BXCL501 in additional disorders with significant unmet medical need including dementia, hyperactive delirium and opioid withdrawal symptoms," he added. Disclaimer: We have no position in BioXcel Therapeutics Inc. (NASDAQ: BTAI) and have not been compensated for this article.