Investing.com -- Teva Pharma Industries Ltd ADRs (NYSE: TEVA) climbed 4.5% in premarket trading on Friday following regulatory approval for its latest neuroscience therapy.

The U.S. Food and Drug Administration granted approval for WELTRUZA™ (olanzapine) extended-release injectable suspension, marking the first and only once-monthly subcutaneous long-acting injectable formulation of olanzapine for adults with schizophrenia. The treatment removes key operational hurdles long associated with antipsychotic regimens, requiring no initial loading doses, oral co-treatment supplementation, or post-injection clinical observation.

The regulatory milestone provides immediate operational validation for Teva's strategic pivot toward high-margin, innovative neuroscience assets. By eliminating mandatory post-injection monitoring, WELTRUZA directly targets a core structural barrier in daily adherence for the estimated 2.1 million Americans living with schizophrenia.

Approval was anchored by data from the pivotal Phase 3 SOLARIS trial, which demonstrated broad clinical efficacy across psychiatric benchmarks. Results highlighted statistically significant reductions in disease severity and sustained improvements in social functioning, paired with a systemic safety profile matching standard oral olanzapine.

To deliver controlled sustained release over a 30-day window, the drug leverages Medincell's proprietary SteadyTeq™ copolymer technology. Teva plans to launch the asset commercially across three strength tiers (318 mg, 425 mg, and 531 mg) in the U.S. market over the coming weeks.

The U.S. green light also reinforces Teva's international expansion trajectory in long-acting therapeutics. European regulators accepted the company's Marketing Authorization Application for the same formulation in May 2026, where trial data remains under active review.

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