U.S. approval of WILTROZA triggers $4 million payment to Medincell
Key Facts
Teva announced that WILTROZA had received U.S. Food and Drug Administration approval to treat schizophrenia in adults, triggering a $4 million approval payment to its partner Medincell, according to the company's announcement dated October 9, 2026. The drug uses Medincell's technology licensed to Teva under a partnership that includes financial entitlements tied to development, commercialization and sales. Medincell said the agreement entitles it to development and commercial milestone payments totaling up to $112 million, including the payment due upon U.S. approval. The company is also entitled to royalties on the drug's global net sales, described as being in the "mid- to high-single digits." Other payments are contingent on achieving the development and commercial milestones specified in the agreement, alongside returns tied to actual sales.
WILTROZA is a long-acting olanzapine formulation administered once monthly, with approved strengths of 318 mg, 425 mg and 531 mg, according to the U.S. prescribing information. A healthcare professional administers the injection under the skin of the abdomen, while the prescribing information requires confirmation that the patient tolerates oral olanzapine before starting treatment. Medincell says the regimen requires no loading doses or supplemental oral treatment at initiation and no mandatory post-injection monitoring. The requirement to establish oral olanzapine tolerability beforehand forms part of the instructions for starting treatment, alongside these features of administering the monthly injection. Common side effects of olanzapine in patients with schizophrenia include weight gain, drowsiness, headache and constipation, according to the drug's official website.
Teva said the approval was based on results from the pivotal Phase 3 SOLARIS trial, which tested the formulation's efficacy as part of its clinical development program. In an earlier announcement of efficacy results, the companies said the study "met its primary endpoint," with statistically significant reductions compared with placebo. Those reductions extended across all dose groups tested in the study, and the companies also described the results as clinically meaningful. According to the FDA-approved prescribing information, patients receiving WILTROZA showed statistically significant improvements in schizophrenia symptoms and disease severity. Improvements compared with placebo also extended to patients' personal and social functioning, alongside the symptom and disease-severity measures covered by the approved results.
The WILTROZA approval follows an earlier commercial application of Medincell's technology in schizophrenia treatment, the long-acting risperidone formulation marketed as UZEDY. That formulation received its first U.S. approval for this use in April 2023, according to Medincell's annual disclosure. In the second quarter of 2026, UZEDY net sales reached a record $77 million, according to the company's announcement. That represented a 43% increase from the same quarter a year earlier, in the latest sales figures included in its announcement. In the headline of its announcement on those results, Medincell noted that Teva raised its 2026 guidance alongside the announcement of record quarterly UZEDY sales.
In the market, Teva shares rose 3.5% in premarket trading following the U.S. approval, according to a report published by Investing.com on the day the decision was announced. The website linked the share move to the FDA's approval of WILTROZA, in a response ahead of the trading session's opening. In a separate report published by the website the same day, Oppenheimer raised its price target for the company's shares to $52. The firm's previous price target was $50 before the adjustment following the drug's approval. Oppenheimer maintained its "Outperform" rating on Teva shares while raising the price target, according to the report.
On the regulatory front, the FDA had accepted the application for long-acting olanzapine in February 2026, ahead of the approval decision announced in October. The European Medicines Agency also accepted the formulation's marketing authorization application in May 2026, according to Medincell's annual results. As the next commercial step in the United States, Teva plans to make WILTROZA available in the weeks following the approval announcement, according to its partner's statement. Medincell scheduled an investor webcast for October 9, 2026, the day U.S. approval was announced for the drug using its licensed technology. The company provided access to the live webcast and its replay through its website as part of investor communications accompanying the announcement.