Teva Announces New Olanzapine LAI (TEV-'749) Post Hoc Data Highlighting High Rates of Stabilization and Long-Term Efficacy as Once-Monthly Subcutaneous Injectable for the Treatment of Schizophrenia in Adults

Phase 3 SOLARIS post hoc results support long-term stabilization, low relapse and feasible switching to Teva’s monthly olanzapine LAI candidate.

Rhea-AI Summary

Teva (TEVA) reported new post hoc and switching data for investigational once-monthly subcutaneous olanzapine LAI TEV-'749 from the Phase 3 SOLARIS program in adult schizophrenia.

In the long-term open-label stage, 231 of 411 participants (56%; 61%, 54% and 54% in the 318-, 425- and 531-mg groups) achieved stabilization. Among those stabilized, 10 of 231 (4%; 6%, 1% and 5%) relapsed, and 39 of 183 patients (21%; 26%, 13% and 26%) treated for at least six months met PANSS-based remission criteria. Pharmacokinetic simulations indicated that initiating TEV-'749 one day after the last oral or short-acting intramuscular olanzapine dose produced olanzapine exposure within established oral therapeutic ranges. Metabolic outcomes showed a profile consistent with daily oral olanzapine without a clear dose-dependent pattern.

TEV-'749 is not yet approved. An FDA PDUFA decision is expected in Q4 2026, and the EMA accepted the marketing application in May 2026.

Positive

• 56% (231/411) of long-term SOLARIS participants on TEV-'749 achieved stabilization
• Only 4% (10/231) of stabilized TEV-'749 patients experienced relapse in long-term follow-up
• 21% (39/183) of patients treated ≥6 months on TEV-'749 met PANSS-based remission criteria
• Switching simulations kept olanzapine exposure within established oral therapeutic ranges
• Metabolic profile of TEV-'749 was consistent with daily oral olanzapine, with no clear dose-dependent pattern
• Regulatory catalysts: FDA PDUFA decision expected in Q4 2026 and EMA marketing application accepted in May 2026

Negative

• None.

Market Context

1.71% was TEVA’s pre-headline gain at the prior close, while peer context included RDY at 0.08% and ...

Analysis

1.71% was TEVA’s pre-headline gain at the prior close, while peer context included RDY at 0.08% and TAK at 0.59%; these figures describe the market backdrop, not a reaction to the clinical data.

Key Figures

Stabilization rate: 56% (231 of 411 participants) Relapse rate: 4% (10 of 231 participants) Remission rate: 21% (39 of 183 participants) +1 more

Stabilization rate

56% (231 of 411 participants)

Phase 3 SOLARIS open-label safety stage

Relapse rate

4% (10 of 231 participants)

Among participants who achieved stabilization

Remission rate

21% (39 of 183 participants)

Participants treated with TEV-'749 for six or more months

FDA decision timing

Q4 2026

Expected PDUFA decision for TEV-'749

Key Terms

post hoc, long-acting injectable, panss, pdufa, +1 more

5 terms

post hoc technical

"In a post hoc analysis of the open-label safety stage"

Post hoc means “after the fact” and describes conclusions or analyses made only after seeing results rather than set up beforehand. Investors should treat post hoc findings like noticing a pattern after the game has been played — they can suggest possibilities but are prone to coincidence or bias and often require rigorous, preplanned testing to be trusted. Overreliance on post hoc reasoning can lead to bad bets or misreading a company’s prospects.

long-acting injectable medical

"as a once-monthly subcutaneous long-acting injectable (LAI)"

A long-acting injectable is a medication formulated to be given by shot that releases its active ingredient slowly over weeks or months so a patient needs fewer doses. For investors, these products can change a drug’s market value by improving patient convenience and adherence, extending patent life or pricing opportunities, and requiring different manufacturing and regulatory steps compared with daily pills — much like swapping many small payments for a single, larger subscription.

panss medical

"Positive and Negative Syndrome Scale [PANSS] item score"

A PANSS is a standardized clinical rating scale used in psychiatry to measure the severity of symptoms in disorders like schizophrenia, scoring both “positive” signs (added symptoms such as hallucinations or delusions) and “negative” signs (lost functions such as social withdrawal) plus general symptoms. Investors care because PANSS scores are a key way regulators and doctors judge whether a treatment meaningfully improves patients, so changes on this scale can determine a drug’s approval prospects, prescribing uptake, and commercial value — like a test score that helps predict market success.

pdufa regulatory

"A PDUFA decision from the FDA is expected"

PDUFA is the Prescription Drug User Fee Act, the U.S. law under which drug companies pay fees that fund the FDA's review of new medicines. In company news the term usually appears as the PDUFA date, the target deadline by which the FDA aims to decide on a drug application; that date tells investors when to expect the approval or rejection decision for the product.

population pharmacokinetic medical

"Population Pharmacokinetic Simulations of Inpatient Switching"

A population pharmacokinetic analysis is a statistical method that models how a drug is absorbed, distributed, metabolized and eliminated across a group of people, quantifying the typical drug concentrations and the variation between individuals. It identifies patient characteristics (age, weight, kidney function, etc.) that explain differences in drug levels and helps predict how dosing or patient mix will affect blood concentrations, information investors use to assess development, labeling and safety risks.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• In a post hoc analysis of the open-label safety stage of the Phase 3 SOLARIS trial, more than half of participants receiving TEV-'749 achieved stabilization, few relapsed and more than one-fifth of participants receiving TEV-'749 for ≥ 6 months met criteria for remission 
• Treatment switch analyses provide clinical insights into maintaining established therapeutic ranges of olanzapine when initiating TEV-'749 from existing regimens
• Ahead of the Q4 FDA anticipated approval decision, the growing body of science around TEV-'749 demonstrates Teva’s commitment to patient-centered innovation in neuroscience, including a differentiated long-acting injectable franchise
  
  

PARSIPPANY, N.J., Sept. 18, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the presentation of new olanzapine LAI (TEV-'749) post hoc data from the pivotal SOLARIS Phase 3 trial as well as analyses supporting treatment switch strategies. The SOLARIS data highlighted the acute and long-term durability, efficacy and safety of TEV-'749 as a once-monthly subcutaneous long-acting injectable (LAI) formulation of olanzapine for the treatment of schizophrenia in adults. The findings were presented at Psych Congress, held September 15 – 19, 2026, in New Orleans, LA.

“These findings further validate the long-term clinical profile of TEV-'749 and its potential to be a once-monthly subcutaneous injectable olanzapine treatment that can help support stabilization for people living with schizophrenia,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “For those currently taking daily oral olanzapine and may be interested in switching to an LAI, these data suggest that TEV-'749 can support long-term symptom control, helping to potentially fill an unmet need for this patient community.”

Olanzapine is the most widely prescribed atypical antipsychotic for schizophrenia as a daily oral treatment.¹ However, daily options may make it difficult to sustain long-term symptom improvement due to challenges with adherence, increasing the risk for instability and relapse.²

Long-Term Data Show High Stabilization and Low Rates of Relapse

In a post hoc analysis of the long-term treatment open-label period of the Phase 3 SOLARIS trial, more than half of all participants receiving TEV-'749 achieved stabilization, more than one-fifth of long-term trial participants met criteria for remission (defined as maintaining a Positive and Negative Syndrome Scale [PANSS] item score of 3 or lower for at least six consecutive months across eight specific remission items), and few that had reached stabilization relapsed.

• Among 411 participants, 231 (56% [61%, 54%, and 54% with 318-, 425-, and 531-mg dose groups, respectively]) achieved stabilization
• Among 231 participants who achieved stabilization, only 10 (4% [6%, 1%, and 5%]) experienced relapse
• Among 183 participants who were treated with TEV-'749 for six or more months, 39 (21% [26%, 13%, and 26%]) achieved remission
  
  

“These TEV-'749 data are compelling because the vast majority of patients who start or respond well to olanzapine are treated with a daily oral pill of olanzapine,” said Christoph Correll, MD, Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY. “We know that long-acting injectable treatment options may support stability and reduce risk of relapse, and TEV-'749 has the potential to offer many of these individuals the efficacy of olanzapine in a once-monthly formulation.”

Data Support Direct Switching from Daily Pills or Short-Acting Injections to Once-Monthly TEV-'749

In separate analyses simulating potential switching scenarios in the inpatient, initiation of TEV-'749 one day after the last dose of oral or short-acting intramuscular olanzapine resulted in predictable olanzapine exposures that remained within established oral therapeutic ranges. The findings offer clinical insights into how healthcare providers may switch patients to TEV-'749 who are currently taking other olanzapine formulations.

Finally, an analysis of metabolic outcomes found that the metabolic profile of TEV-'749 was consistent with daily oral olanzapine formulations, with no clear dose-dependent pattern observed. These data add to the broader safety and tolerability findings from the SOLARIS program.

Below is the full set of olanzapine LAI (TEV-'749) posters being presented by Teva at Psych Congress 2026:

• (De novo) Durability of Response With Subcutaneous Long-Acting Injectable Olanzapine (TV-44749) in Schizophrenia: Post Hoc Analysis of the Phase 3 SOLARIS Trial
• (De novo) Population Pharmacokinetic Simulations of Inpatient Switching From Oral or Short-Acting Intramuscular Olanzapine to TV-44749
• (De novo) Subcutaneous Long-Acting Injectable Olanzapine (TV-44749) in Adults With Schizophrenia: Efficacy Results From the Phase 3 SOLARIS Trial
• (De novo) Characterization of the Body Weight and Metabolic Profile of Subcutaneous Long-Acting Injectable Olanzapine (TV-44749): Results From the Phase 3 SOLARIS Trial
• (Modified encore) Joint Population Pharmacokinetic Model of Oral, Intramuscular, and Subcutaneous (TV-44749) Olanzapine to Support TV-44749 Dosing and Switching Strategies
  
  

TEV-'749 is an investigational once-monthly subcutaneous LAI of the second-generation antipsychotic olanzapine. It is not approved by any regulatory authority for any use at this time.

TEV-'749 utilizes SteadyTeq™, a copolymer technology proprietary to Medincell that provides a controlled steady, sustained release of olanzapine.

A PDUFA decision from the FDA is expected for TEV-'749 in Q4 2026. In the EU, the European Medicines Agency accepted the Marketing Authorization Application for TEV-'749 in May 2026.

About Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS)
SOLARIS was a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of olanzapine extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 18-64 years) with schizophrenia.¹ For period one of the study (first 8 weeks), 675 patients were randomized to receive a subcutaneous injection of once-monthly olanzapine LAI (low, medium or high dose) or placebo in a 1:1:1:1 ratio.¹ For period two (next 48 weeks), patients who completed period one on placebo were re-randomized and equally allocated to one of the three olanzapine LAI treatment groups, while patients who completed period one on active olanzapine LAI remained on their established dose strength.¹ The end-of-treatment and follow-up visits were 4 and 8 weeks after administration of the last treatment dose, respectively.¹ The primary objective of the Phase 3 SOLARIS study was to evaluate the efficacy of olanzapine LAI in adult patients with schizophrenia, as measured by PANSS.¹ A key secondary objective was to further evaluate the efficacy of olanzapine LAI based on additional parameters in adult patients with schizophrenia, as measured by CGI-S and PSP.¹ A secondary objective of period two of the study was to evaluate the safety and tolerability of olanzapine LAI in adult patients with schizophrenia.¹ 

About Schizophrenia
Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts.² Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability.^2,3,4 Approximately 1% of the world’s population will develop schizophrenia in their lifetime, and 2.2 million people in the U.S. are currently diagnosed with the condition.^3,4 Although schizophrenia can occur at any age, the average age of onset tends to be in the late teens to the early 20s for men, and the late 20s to early 30s for women.⁴ The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often occur in the context of psychiatric emergency and require hospitalization.⁴ Approximately 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology.^5,6,7 Patients are often unaware of their illness and its consequences, contributing to treatment nonadherence, high discontinuation rates, and ultimately, significant direct and indirect healthcare costs from subsequent relapses and hospitalizations.^2,3,4,5,6,7

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop olanzapine LAI (TEV-‘749) for the treatment of adult patients diagnosed with schizophrenia and to obtain regulatory FDA approval; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize our innovative medicines and biosimilar portfolio, whether organically or through business development; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors,” and “Forward-Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

1. Data on file. [CSR/SOLARIS]. West Chester, PA: Teva Neuroscience, Inc.
2. Substance Abuse and Mental Health Services Administration. Schizophrenia. https://www.samhsa.gov/mental-health/schizophrenia. Accessed February 2026.
3. Velligan DI, Rao S. The Epidemiology and Global Burden of Schizophrenia. J Clin Psychiatry. 2023;84(1):MS21078COM5. https://doi.org/10.4088/JCP.MS21078COM5.
4. Wander C. (2020). Schizophrenia: Opportunities to Improve Outcomes and Reduce Economic Burden Through Managed Care. The Am J Manag Care. 26(3 Suppl), S62–S68. https://doi.org/10.37765/ajmc.2020.43013.
5. Emsley, R., & Kilian, S. (2018). Efficacy and safety profile of paliperidone palmitate injections in the management of patients with schizophrenia: an evidence-based review. Neuropsychiatric Dis. Treat., 14, 205–223.
6. Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50.
7. Andreasen, N. C., et al. (2013). Relapse duration, treatment intensity, and brain tissue loss in schizophrenia: a prospective longitudinal MRI study. The Am J Psychiatry, 170(6), 609–615.
   
   

Teva Media Inquiries:
TevaCommunicationsNorthAmerica@tevapharm.com

Teva Investor Relations Inquiries
TevaIR@Tevapharm.com

About Medincell

Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine active pharmaceutical ingredients with our proprietary BEPO^® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO^® technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY^® (BEPO^® technology is licensed to Teva under the name SteadyTeq™). We collaborate with leading pharmaceutical companies and foundations to improve global health through new treatment options. Based in Montpellier, Medincell currently employs more than 140 people representing more than 25 different nationalities.

Contact: communication@medincell.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is TEV-'749 and how is it administered?

TEV-'749 is an investigational once-monthly subcutaneous long-acting injectable (LAI) formulation of the second-generation antipsychotic olanzapine for adults with schizophrenia. It uses SteadyTeq™, Medincell’s proprietary copolymer technology designed to provide controlled, steady, sustained release of olanzapine from a small, bioresorbable subcutaneous depot.

What were the key design features of the Phase 3 SOLARIS study?

SOLARIS was a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial in adults aged 18–64 years with schizophrenia. In period one (8 weeks), 675 patients were randomized 1:1:1:1 to once-monthly subcutaneous olanzapine LAI (low, medium or high dose) or placebo. In period two (48 weeks), prior placebo patients were re-randomized to one of the three active doses, while those already on active treatment stayed on their dose. Primary efficacy was measured by PANSS, with CGI-S and PSP as key additional efficacy measures and safety/tolerability assessed in period two.

What did the switching analyses show for patients moving from oral or short-acting olanzapine to TEV-'749?

In simulation analyses of potential inpatient switching scenarios, initiating TEV-'749 one day after the last dose of oral or short-acting intramuscular olanzapine produced predictable olanzapine exposures that remained within established oral therapeutic ranges. The company states that these findings offer clinical insights into how healthcare providers may switch patients from existing olanzapine formulations to TEV-'749.

What is the current regulatory status of TEV-'749 in the U.S. and EU?

TEV-'749 is currently not approved by any regulatory authority. In the United States, an FDA Prescription Drug User Fee Act (PDUFA) decision is expected in the fourth quarter of 2026. In the European Union, the European Medicines Agency accepted the Marketing Authorization Application for TEV-'749 in May 2026.