Intra-Cellular Therapies said Tuesday that its depression treatment succeeded in a key study, and ITCI stock broke definitively above its 200-day line for the first time since December.
The company tested its drug, known as lumateperone, in patients with two forms of depression. Patients who received lumateperone had a 5.7-point reduction on a 60-point scale of depression severity. RBC Capital Markets analyst Brian Abrahams called the results "very impressive."
"The bar based on our (key opinion leader) feedback was 3-5 points, and today's data handily clears that," he said in a note to clients.
On today's stock market, ITCI stock surged 16.4% to close at 55.73. That put shares above their 200-day moving average, according to MarketSmith.com.
ITCI Stock: Patients With 'Mixed Features'
Intra-Cellular is tackling two forms of depression — major depressive disorder and bipolar depression. In both populations, there are patients who have "mixed features." This means patients with MDD can also have manic symptoms. Patients with bipolar depression mania can exhibit depressive symptoms.
Lumateperone treatment led to statistically significant results in both groups of patients. RBC's Abrahams says the FDA will likely have to take a serious look at Intra-Cellular's request for approval and consider formally expanding it to include patients with mixed features.
"We would not be surprised to see the study results appear on the label, which could still enable Intra-Cellular to detail it in mixed features to physicians," he said.
He noted ITCI stock investors are likely paying close attention to the results in major depressive disorder. Intra-Cellular is also testing lumateperone as an added treatment in that form of depression. Results in that study are due in the first half of 2024. The MDD market is key for Intra-Cellular. The company notes 21 million adults in the U.S. experience this form of depression each year.
"Though (study) designs do differ," Abrahams noted.
He kept his outperform rating and 71 price target on ITCI stock.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
