Shares of BTAI stock plummeted Thursday after BioXcel Therapeutics' Igalmi missed the mark in patients with agitation due to schizophrenia or bipolar disorders.
Igalmi is already approved for this use. But BioXcel is hoping to gain approval for at-home use of Igalmi. Today, a health care professional must administer the under-the-tongue pill and watch for potential loss of consciousness.
Two hours after receiving Igalmi, 52% of patients showed improvement on a scale that measures poor impulse control, tension, hostility, uncooperativeness and excitement. In comparison, 36% of placebo recipients improved on the same scale. Meanwhile, the results weren't statistically significant.
On the stock market today, BTAI stock plunged 25.5% to close at 9.32.
BTAI Stock Drops Below 50-Day Line
The study called Serenity is a two-part examination of Igalmi. BioXcel unveiled results of the first part on Thursday. It included patients in a monitored medical setting. BioXcel expects these patients to have higher levels of agitation than the home-based patients planned for the second part of the study.
BioXcel says the results are likely enough for it to go forward with the at-home portion of the test. But that didn't bolster BTAI stock, which dropped below its 50-day moving average, according to MarketSmith.com.
"We are pleased with the outcome and progression of our land-and-expand strategy, which we believe moves us closer to addressing up to an additional 23 million annual agitation episodes in bipolar disorder and schizophrenia patients in the at-home setting," Chief Executive Vimal Mehta said in a written statement.
He noted approval for at-home use would potentially double Igalmi's market opportunity.
Though the results weren't statistically significant, BioXcel says Igalmi outperformed the placebo as early as one hour following treatment. Four hours following treatment, there were still more Igalmi patients than placebo recipients with symptom improvement.
BTAI stock has a strong IBD Digital Relative Strength Rating of 97, putting it in the top 3% of all stocks when it comes to 12-month performance.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
