Johnson & Johnson JNJ announced positive top-line data from a pivotal phase III study evaluating Caplyta (lumateperone) for treating manic episodes, with or without mixed features, in adults with bipolar I disorder.
More on JNJ’s Latest Study Data With Caplyta
Data from the study showed that treatment with Caplyta led to a statistically significant and rapid reduction in manic symptoms versus placebo at week three, with significant improvement seen as early as day three – the primary endpoint of the study.
In the study, patients who were treated with once-daily Caplyta (42 mg) achieved a 4.8-point greater reduction in Young Mania Rating Scale (YMRS) total score versus placebo at week three. Treatment with Caplyta also demonstrated significant improvement in overall illness severity, as measured by the Clinical Global Impression-Severity score.
Per the company, a greater clinical response was observed with Caplyta. The proportion of patients achieving at least a 50% reduction in YMRS total score was more than twice as high with Caplyta as with placebo, at 45.8% versus 20.9%, respectively.
The safety and tolerability profile was similar to Caplyta’s established profile.
The latest results are from Study 451, the first of two pivotal phase III studies evaluating Caplyta in bipolar I mania. Management noted that the second pivotal phase III study – Study 452 – has been completed, with data analysis underway.
Year to date, shares of J&J have rallied 32.3% compared with the industry’s rise of 14.3%.
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JNJ’s Other Updates With Caplyta
Caplyta, an atypical antipsychotic, is presently approved for the treatment of schizophrenia, depression in both bipolar I and II, as well as major depressive disorder.
The acquisition of Intra-Cellular Therapies in 2025 added Caplyta to JNJ’s neuroscience portfolio.
Caplyta generated sales of $631 million in the first half of 2026, backed by new patient starts and continuing patient growth following its FDA approval in the adjunctive major depressive disorder indication in November 2025.
J&J also received FDA approval in April 2026 for the prevention of relapse in schizophrenia. Besides bipolar mania, the company is also developing Caplyta for pediatric psychiatric indications, creating additional potential growth avenues.
Caplyta is presently not approved for the treatment of manic episodes associated with bipolar I disorder.
J&J believes Caplyta has the potential to deliver peak sales of $5 billion.
J&J Zacks Rank & Stocks to Consider
JNJ currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Repligen RGEN and Precigen PGEN, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have risen 10.3% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents per share to earnings of 25 cents. Earnings estimates for 2027 have increased from 25 cents to 86 cents during the same time. PGEN’s shares have rallied 84.2% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.
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This article originally published on Zacks Investment Research (zacks.com).