Johnson & Johnson (J&J) is taking over central nervous system disorders player Intra-Cellular Therapies Inc. for $132 per share in a deal that puts the total equity value at about $14.6 billion.

The arrangement brings J&J Caplyta (lumateperone), a once-daily oral therapy approved to treat adults with schizophrenia, as well as depressive episodes associated with bipolar I or II disorder, as a monotherapy and adjunctive therapy with lithium or valproate. Included, too, is ITI-1284, a phase II-stage candidate undergoing tests in generalized anxiety disorder (GAD) and Alzheimer’s disease (AD)-related psychosis and agitation. Intra-Cellular, of Bedminster, N.J., also provides a clinical-stage pipeline that complements J&J’s efforts.

In December 2024, Intra-Cellular made known the submission of an sNDA to the U.S. FDA for Caplyta as an adjunctive treatment for adults with major depressive disorder (MDD). In two global, double-blind, placebo-controlled phase III studies, Caplyta when used with antidepressants, turned up a statistically significant and clinically meaningful improvement in depressive symptoms, as measured by both clinician-rated and patient-reported outcomes. The safety profile proved consistent with the existing body of clinical data for the drug, and no new safety signals surfaced. If regulators say yes, Caplyta would become the first drug approved for MDD and depressive symptoms associated with bipolar I and II in more than 15 years. Phase III experiments are underway as well in bipolar I disorder with manic episodes or manic episodes with mixed features. Positive top-line findings on the efficacy and safety of the drug for preventing relapse in adults schizophrenia were shared in November 2024. Caplyta’s first approval for schizophrenia came in December 2019.

The precise mechanism is unknown, but the drug shows high serotonin 5-HT2A receptor occupancy and lower amounts of dopamine D2 receptor occupancy at therapeutic doses. In short-term clinical studies across all three green-lighted indications, Caplyta yielded results similar to placebo in weight change, metabolic effects, and extrapyramidal symptoms – problems that often make patients quit taking their meds. The most common reported adverse events were somnolence/sedation, dizziness, nausea and dry mouth. Caplyta can be taken at any time of day with or without food and does not require titration, which means adult patients can take the effective dose at the start of treatment.

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More than 1 billion people worldwide have been diagnosed with a neuropsychiatric or neurodegenerative disorder as the global population gets older. In the U.S., about 2.4 million adults live with schizophrenia. About 6.1 million adults are afflicted with bipolar disorder. An estimated 21 million adults struggle with MDD, and some 6.8 million face GAD. AD has struck about 6 million.

Under the terms of the agreement, J&J, of New Brunswick, N.J., will acquire all outstanding shares of Intra-Cellular, funding the deal through a combination of cash on hand and debt. The deal is expected to close later this year, subject to the usual regulatory go-aheads and yes votes from Intra-Cellular stockholders. Intra-Cellular’s stock (NASDAQ:ITCI) will no longer list on the Nasdaq market. J&J will provide further guidance on the impact of the deal during its fourth-quarter earnings call Jan. 22. Citi is serving as financial advisor to J&J, with Cravath, Swaine & Moore providing legal advice. Centerview Partners LLC and Jefferies are financially guiding Intra-Cellular, and Davis Polk & Wardwell LLP is giving legal advice.

TD Cowen analyst Joseph Thorne, based on the deal, put his Caplyta peak sales estimate at $4.8 billion across schizophrenia, bipolar disorder and MDD in 2039. “We believe this combined with the company's net cash and minimal pipeline value supports the deal price,” he wrote in a report. Evercore ISI’s Umer Raffat said of the deal in his dispatch that “JNJ isn’t getting a steal, but [Intra-Cellular] is commercial stage and very accretive.

Intra-Cellular recently guided to at least $5 billion in peak Caplyta sales. Intra-Cellular’s stock was trading at $127.48, up $32.61, or 34%. J&J’s stock (NYSE:JNJ) was selling for $143.39, up $1.34.