Intra-Cellular Therapies stock rocketed and broke out Tuesday after its drug, Caplyta, topped expectations in a depression treatment study.
Caplyta is already approved as a schizophrenia treatment and to treat depressive episodes in people with bipolar disorder. Now, Intra-Cellular says Caplyta could treat a common form of depression known as major depressive disorder.
Over six weeks, patients who took Caplyta showed a 4.9-point reduction vs. the placebo group on a 60-point scale measuring depression symptoms. The results were statistically significant, lining Intra-Cellular up well ahead of a second Phase 3 study expected later this quarter.
The results from Study 501 suggest Caplyta is likely to outperform in two additional studies given similar trial designs, Needham analyst Ami Fadia said in a client note.
"This should drive significant momentum in the stock today in the double-digit range," she said.
On today's stock market, Intra-Cellular Therapies stock surged 23.3% to close at 79.84. Shares broke out of a consolidation with a buy point at 76.11, according to MarketSurge.com, and quickly climbed above the 5% chase zone.
Intra-Cellular Therapies Stock Hits Record High
The results of the study, dubbed Study 501, beat the company's own expectations, Mizuho Securities analyst Graig Suvannavejh said in a report. Management called for a 2- to 4-point improvement on the scale, known as the Montgomery-Asberg Depression Rating Scale, or MADRS.
Other antipsychotics approved as depression treatments have shown smaller improvements of 0.9 points to 3.2 points, he said. They include AbbVie's Vraylar at the low end, and Rexulti at the high end. Otsuka Pharmaceutical and Lundberg jointly developed Rexulti.
"With favorable safety and tolerability profile generally consistent with prior (Caplyta) trials and no new safety signals, we're very pleased with the data outcome," he said.
Suvannavejh kept his buy rating on Intra-Cellular Therapies stock.
Follow Allison Gatlin on X, the platform formerly known as Twitter, at @IBD_AGatlin.
