The U.S. Food and Drug Administration approved Weltruza as an extended-release injectable suspension for adults with schizophrenia.
- Approval rests on the late-stage SOLARIS study, where investigators reported better overall symptoms, a clear drop in illness severity, and gains in personal and social functioning.
- Weltruza uses SteadyTeq, a slow-release technology from French partner Medincell.
- European regulators accepted a marketing application for Weltruza in May 2026; that review is still open.
NYSE-listed shares of Teva Pharmaceutical Industries (TEVA) rallied on Friday, touching fresh 52-week highs, after the company won U.S. FDA approval for a once-monthly schizophrenia injection, extending a strong year for the stock.
TEVA stock rose as high as $42.02 and was up 6% at the time of writing.
FDA Clears First Once-Monthly Olanzapine Shot
The U.S. Food and Drug Administration approved Weltruza (olanzapine) for extended-release injectable suspension for adults with schizophrenia. Teva said it is the first and only once-monthly shot of olanzapine given under the skin.
The drug will come in three strengths—318 mg, 425 mg, and 531 mg—matching the usual daily oral doses of 10 mg, 15 mg, and 20 mg. Patients will not need starter doses, extra oral pills, or observation after each injection. Teva expects U.S. availability in the coming weeks.
TEVA’s Late-Stage Trial Showed Symptom Gains
Approval rests on the late-stage SOLARIS study. Investigators reported better overall symptoms, a clear drop in illness severity, and gains in personal and social functioning. Side effects matched those of oral olanzapine. The most common were weight gain, sleepiness, headache, constipation, and reactions at the injection site. Dropouts linked to common side effects were similar to placebo.
Olanzapine has been a widely used daily pill for schizophrenia for more than 30 years. Missed doses can raise the risk of relapse. About 2.1 million people in the United States have a schizophrenia diagnosis. Chris Fox, who leads Teva’s U.S. commercial business, said the shot was built around that adherence problem. Chief Medical Officer Eric Hughes said the under-the-skin design removes the need for monitoring after every dose.
Medincell- TEVA Partnership, U.S. Launch Timing, And Europe Review
Weltruza uses SteadyTeq, a slow-release technology from French partner Medincell. It is the second U.S. product from that alliance, after Uzedy, a long-acting risperidone shot approved in 2023.
European regulators accepted a marketing application for Weltruza in May 2026; that review is still open.
How Did TEVA Retail Traders React?
On Stocktwits, retail sentiment around TEVA stayed within neutral territory over the past 24 hours, while message volume rose from normal to high levels.
A Stocktwits user said that the stock pays to hold and voiced optimism for a further rally to $45.
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TEVA stock has gained 34% year-to-date.
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