Intra-Cellular Therapies ITCI announced that it has submitted a supplemental new drug application (sNDA) to the FDA aiming to expand the approved uses of its lead drug, Caplyta (lumateperone), to include treating major depressive disorder (MDD) in adults as an adjunctive therapy to antidepressants.

The sNDA submission is supported by positive results from two late-stage studies, Studies 501 and 502, that evaluated 42 mg of lumateperone as an adjunctive therapy to antidepressants for MDD. Both studies met the primary and key secondary efficacy endpoints, demonstrating Caplyta’s robust antidepressant efficacy and favorable safety and tolerability profile.

MDD is a common, albeit serious mood disorder that causes a persistent feeling of sadness or loss of interest. Approximately 21 million adults suffer from MDD each year in the United States. Notably, about two-thirds of patients do not achieve remission with initial treatment with antidepressants, implying a significant unmet medical need. Per Intra-Cellular, Caplyta has the potential to become a first-choice treatment for the adjunctive treatment of MDD, thereby further expanding the eligible patient population.

Subject to its approval for the MDD indication, Caplyta would be indicated for the treatment of three different major psychiatry indications affecting more than 30 million adult patients in the United States. In the past three months, shares of Intra-Cellular have gained 17.8% against the industry’s 5.1% decline.

Image Source: Zacks Investment Research

Caplyta – ITCI’s Key Growth Driver

Intra-Cellular’s Caplyta is already approved for the treatment of schizophrenia in adults in the United States. Later, its indication was expanded to treat bipolar depression in adults. Caplyta is currently the only approved treatment, both as monotherapy and adjunctive therapy with lithium or valproate, for depressive episodes associated with bipolar I or II disorder in adults.

In 2022, the FDA approved two new dosage strengths of Caplyta, 10.5 mg and 21 mg for patients concomitantly taking strong or moderate CYP3A4 inhibitors and 21 mg for patients with moderate or severe hepatic impairment. These new dosage strengths expanded the eligible patient population for Caplyta.

After the launch of its bipolar depression indication, Caplyta sales have increased, with the drug witnessing robust initial prescription growth. Intra-Cellular has also seen an increase in Caplyta prescriptions for the treatment of schizophrenia. Total Caplyta prescriptions grew 85% in 2023 compared with 2022. Net product sales of Caplyta in the first nine months of 2024 was $481.3 million, representing an increase of 46% compared with the year-ago figure on the back of strong prescription uptake.

ITCI’s Other Pipeline Programs

A third phase III study, Study 505, is also evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. This additional registrational study is intended to support the regulatory filing seeking label expansion of the drug for this indication if needed.

Lumateperone is also currently being evaluated in separate late-stage studies for other central nervous system (CNS) indications in adult patients.

Intra-Cellular is further evaluating a deuterated form of lumateperone, ITI-1248-ODT-SL, formulated as an oral disintegrating tablet for sublingual administration, making it convenient for patients who have difficulty swallowing conventional tablets. Based on encouraging phase I data, Intra-Cellular has initiated phase II programs evaluating ITI-1284-ODT-SL for the treatment of generalized anxiety disorder, psychosis in Alzheimer's disease and agitation in patients with Alzheimer’s disease.

ITCI’s clinical-stage pipeline also comprises other promising candidates beyond lumateperone, which are currently being developed for other CNS indications as well as cancer. 

Intra-Cellular Therapies Inc. Price and Consensus

Intra-Cellular Therapies Inc. price-consensus-chart | Intra-Cellular Therapies Inc. Quote

ITCI’s Zacks Rank & Stocks to Consider

Intra-Cellular currently carries a Zacks Rank #3 (Hold).

Some better-ranked pharma stocks are Allogene Therapeutics ALLO, Pfizer PFE and Gilead Sciences GILD, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 60 days, Allogene Therapeutics’ estimates for loss per share have narrowed from $1.40 to $1.35 for 2024, and that for 2025 has narrowed from $1.46 to $1.34. ALLO shares have lost 7.8% in the past three months.

Allogene Therapeutics’ earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 9.42%.

In the past 60 days, Pfizer’s earnings estimates have risen from $2.62 to $2.91 per share for 2024, while that for 2025 has increased from $2.84 to $2.91. PFE shares have lost 10.3% in the past three months.

Pfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.

In the past 60 days, Gilead Sciences’ earnings estimates have risen from $3.79 to $4.32 per share for 2024, while that for 2025 has increased from $7.24 to $7.38. GILD shares have risen 17.4% in the past three months.

Gilead Sciences’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 15.46%.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Pfizer Inc. (PFE) : Free Stock Analysis Report

Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report

Intra-Cellular Therapies Inc. (ITCI) : Free Stock Analysis Report

Allogene Therapeutics, Inc. (ALLO) : Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research