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Johnson & Johnson bipolar drug meets goals in another late-stage trial
Johnson & Johnson said its drug Caplyta beat a placebo in another late-stage trial for bipolar mania, and it plans to use the results in a U.S. regulatory filing.
Quick Read
- Johnson & Johnson said Caplyta beat a placebo on its main goals in another late-stage trial in adults with bipolar mania.
- In topline results, 43.9% of treated patients improved by at least 50% on a mania scale, against 23.7% on placebo.
- J&J plans to use this trial and an earlier one to support a U.S. regulatory filing.
- The shares edged down and sit 0.6% below their 52-week high.
What did Johnson & Johnson report?
Johnson & Johnson (NYSE: JNJ) said its drug Caplyta, also called lumateperone, met its main goals in another late-stage trial. The study tested the drug in adults having manic episodes linked to bipolar disorder.
Why it matters: Topline results, the early headline summary of a trial, showed 43.9% of patients on Caplyta improving by at least 50% on the Young Mania Rating Scale. That compared with 23.7% of patients on a placebo, or dummy pill, the company said.
Caplyta also beat the placebo on a further key goal, a doctor's rating of overall illness severity, J&J said. Improvement showed up within days and lasted through the end of the treatment period.
How was the trial run, and what about side effects?
The trial was global and randomized. It was also blinded, meaning neither patients nor doctors knew who got the drug. It compared a daily dose of Caplyta with a placebo over a few weeks.
J&J said few patients dropped out and the safety profile matched earlier data. The most common side effects included dizziness, dry mouth and sleepiness or sedation.
How did the shares react?
Johnson & Johnson shares edged down 0.1% on Wednesday and closed at $280.41. That left them 0.6% below their 52-week high of $282.11, the highest price in the past year.
The broader market moved more. The S&P 500 rose 1.3%.
J&J accounts for 0.75% of the combined value of the 500 largest U.S. companies. Its small dip took $1 from $100,000 spread across them by size.
What comes next?
What’s next: J&J said it plans to pair these results with an earlier late-stage study to support a U.S. regulatory filing. The company gave no date for that submission in its announcement.
The open question is whether U.S. regulators accept the combined data for this use. Their review of the filing would answer it.
For readers
What it could mean for you: If you own Johnson & Johnson shares directly, the company's drug news reaches you in full, with no other holdings to offset it. So far the trial result barely moved the stock. The next marker may be the U.S. regulatory filing J&J says it plans. Any approval decision after that could matter more to the shares than these topline results. For a broad index fund, J&J is a small slice, so its drug news alone may move that fund little.
Questions and answers
What is Caplyta being tested for?
Johnson & Johnson is testing Caplyta, also called lumateperone, in adults having manic episodes linked to bipolar disorder. The latest late-stage trial met its main goals, the company said.
What side effects did Caplyta show in the bipolar trial?
J&J said the most common side effects included dizziness, dry mouth and sleepiness or sedation. Few patients dropped out, and the safety profile matched earlier data, the company said.
Has Johnson & Johnson filed for approval of Caplyta in bipolar mania?
Not yet. J&J said it plans to use this trial and an earlier late-stage study to support a U.S. regulatory filing, and it gave no date for the submission.
The numbers
| Johnson & Johnson (JNJ) price | $280.41 |
|---|---|
| Johnson & Johnson (JNJ) change | −0.13% |
| Johnson & Johnson (JNJ) market value | $680 billion |
| Johnson & Johnson (JNJ) 52-week high | $282.11 |
| S&P 500 change | +1.31% |
| 10-year Treasury yield | 4.98% |
Wednesday’s close
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