The European Medicines Agency Accepts Teva’s Marketing Authorization Application for Olanzapine Long-Acting Injectable (TEV-‘749) for the Treatment of Schizophrenia in Adults

Rhea-AI Summary

Teva (NYSE:TEVA) and Medincell announced that the European Medicines Agency has accepted the Marketing Authorization Application for olanzapine long-acting injectable TEV-‘749 to treat schizophrenia in adults.

TEV-‘749 is a subcutaneous, once-every-four-weeks formulation supported by a Phase 3 program and is not yet approved anywhere.

Positive

• EMA accepts Marketing Authorization Application for TEV-‘749 in adult schizophrenia
• Subcutaneous long-acting injectable dosing once every four weeks targets adherence
• Phase 3 SOLARIS and broader program show efficacy and systemic safety profile
• Exposure to olanzapine consistent with daily oral olanzapine in clinical development
• Uses Medincell’s SteadyTeq technology for controlled, steady, prolonged drug release

Negative

• TEV-‘749 is not approved by any regulatory authority worldwide yet

News Market Reaction – TEVA

-0.47%

-0.47% Session close to close

In the May 21 session, TEVA declined 0.47%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights EMA acceptance of the Marketing Authorization Application for TEV-‘749,...

Analysis

This announcement highlights EMA acceptance of the Marketing Authorization Application for TEV-‘749, a once‑every‑four‑weeks subcutaneous olanzapine LAI for adults with schizophrenia, a condition affecting 0.3–1.5% of Europe’s population with a 15–20‑year life expectancy gap. It builds on Teva’s recent growth and pipeline updates, including strong UZEDY sales and an investment-grade upgrade. Investors should watch regulatory review milestones, additional clinical data, and how this asset fits into Teva’s broader Pivot to Growth strategy.

Key Figures

Schizophrenia prevalence: 0.3–1.5% of population in Europe Life expectancy reduction: 15–20 years Dosing frequency: Once every four weeks +3 more

6 metrics

Schizophrenia prevalence 0.3–1.5% of population in Europe Epidemiology context in EMA MAA release

Life expectancy reduction 15–20 years Life expectancy gap for people with schizophrenia in Europe

Dosing frequency Once every four weeks TEV-‘749 subcutaneous long-acting injection schedule

Administration route Subcutaneous Formulation of olanzapine long-acting injectable TEV-‘749

Regulatory status Not approved by any authority Current global approval status of TEV-‘749

Phase 3 study SOLARIS Phase 3 SOLARIS study supports EMA submission

Historical Context

5 past events · Latest: May 18 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
May 18	Credit rating upgrade	Positive	-0.8%	Fitch raised Teva’s corporate rating to investment grade BBB- with stable outlook.
May 18	Clinical registry data	Neutral	-0.8%	IMPACT-TD data highlighted underdiagnosis of tardive dyskinesia in younger adults.
May 04	Conference appearance	Positive	+1.4%	Announcement of BofA Health Care Conference presentation by Teva’s CMO.
Apr 30	ESG and access report	Positive	-0.9%	Healthy Future Report detailed ESG progress and meeting $7.5B bond targets.
Apr 29	Product sales update	Positive	+11.9%	Strong UZEDY Q1 sales and regulatory milestones for olanzapine LAI were reported.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Out of the last five news events, price aligned with the apparent sentiment three times and diverged twice, with one major positive commercial update drawing a strong upside move.

Recent Company History

Recent news for TEVA has highlighted both strategic and operational progress. On Apr 29, strong UZEDY® sales and regulatory updates for olanzapine LAI coincided with a +11.89% move. Sustainability achievements and meeting $7.5 billion in sustainability-linked bond targets on Apr 30 saw a modest decline, while a BofA conference appearance on May 4 aligned with a +1.44% gain. Fitch’s upgrade to investment grade on May 18 was followed by a slight pullback. Today’s EMA acceptance for TEV-‘749 adds to this pipeline and growth narrative.

Key Terms

european medicines agency, marketing authorization application, subcutaneous, long-acting injectable, +4 more

8 terms

european medicines agency regulatory

"the European Medicines Agency (EMA) has accepted the Marketing Authorization Application"

The European Medicines Agency is the central drug regulator that evaluates and authorizes medicines for use across the European Union and related countries, similar to a referee or safety inspector who checks that a medicine is safe and effective before it can be sold. Its decisions matter to investors because approvals, rejections, or safety warnings directly affect a drug maker’s ability to sell products, generate revenue, and face legal or reputational risks, which in turn influence stock value.

marketing authorization application regulatory

"has accepted the Marketing Authorization Application (MAA) for olanzapine long-acting injectable"

A marketing authorization application is a formal request submitted to a government regulator asking permission to sell a prescription medicine or medical product in a country or region. Think of it like asking for a business license after showing evidence the product is safe and works; investors care because approval determines whether the product can generate sales, how soon revenue starts, and how much regulatory risk and uncertainty remains.

subcutaneous medical

"designed to deliver the efficacy of olanzapine in a subcutaneous formulation"

Subcutaneous means situated or applied just beneath the skin. In finance, the term can describe processes or investments that are hidden or not immediately visible, much like something placed under the skin that isn't easily seen from the outside. Recognizing subcutaneous activities helps investors understand underlying factors that may influence markets or asset values over time.

long-acting injectable medical

"olanzapine long-acting injectable (TEV-‘749) for the treatment of schizophrenia"

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.

phase 3 medical

"The submission to the EMA is supported by an extensive clinical development program, including the Phase 3 SOLARIS study."

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

schizophrenia medical

"for the treatment of schizophrenia in adults."

A chronic brain disorder that changes how a person thinks, perceives reality, feels and interacts with others, often causing hallucinations, false beliefs and trouble organizing thoughts or daily life. It matters to investors because the condition creates demand for long‑term treatments, diagnostics and support services; developing effective therapies can be costly, risky and highly regulated, but successful drugs or devices can open large, steady markets—think of it like fixing a deep, complex software bug that many users rely on.

regulatory authority regulatory

"TEV-‘749 is not approved by any regulatory authority worldwide at this time."

A regulatory authority is a government or independent agency that creates, interprets and enforces the rules companies must follow in a particular industry. Like a referee or traffic controller, its decisions—approving products, issuing fines, imposing restrictions or providing guidance—can change a company’s costs, operations and growth outlook, so investors monitor those actions for potential impacts on revenue, legal risk and valuation.

copolymer medical

"a copolymer technology proprietary to Medincell that provides a controlled, steady, prolonged release"

A copolymer is a plastic or polymer made by linking two or more different types of small building blocks (monomers) into long chains, combining characteristics of each ingredient. Think of it like stringing different colored beads to create a material that is stronger, more flexible, or resistant to heat or chemicals than a single-ingredient plastic. Investors care because copolymer choice affects product performance, manufacturing cost, regulatory approval, patent protection and market differentiation, all of which influence revenue and risk.

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

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• The olanzapine long-acting injectable (TEV-’749) is designed to deliver the efficacy of olanzapine in a subcutaneous formulation¹ administered every four weeks.
• If approved, TEV-‘749 could help fill a significant unmet need in available schizophrenia treatment options by addressing the lack of a viable long-acting olanzapine formulation.
• Teva is committed to advancing this innovative treatment option, strengthening its scientific leadership in complex neurological conditions as part of its Pivot to Growth strategy.
  
  

TEL AVIV, Israel and PARIS, May 21, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) and Medincell (Euronext: MEDCL), today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for olanzapine long-acting injectable (TEV-‘749) for the treatment of schizophrenia in adults. TEV-‘749 aims to address treatment adherence in real-world settings and contribute to long-term disease management in people living with schizophrenia.¹

“Treatment adherence remains a challenge for people living with schizophrenia including those who rely on oral forms of Olanzapine. TEV-‘749, our investigational subcutaneously delivered olanzapine LAI, has the potential to help provide stability by offering the proven efficacy and safety of olanzapine as a once-every four weeks treatment,” said Eric Hughes, MD, PhD, Executive Vice President, and Chief Medical Officer at Teva. “For too long, treatment options have been limited by the lack of a viable long-acting olanzapine formulation, and we look forward to working with the EMA to help address this gap in care.”

“Daily oral olanzapine is one of the most commonly prescribed antipsychotics in Europe for people living with schizophrenia, and long-acting injectables are already well established in managing serious psychiatric conditions across the region,” said Christophe Douat, CEO of Medincell. “We believe a practical long-acting olanzapine option that fits more naturally into patients’ lives can help address a real and persistent need in schizophrenia.”

Schizophrenia affects 0.3 - 1.5% of the population in Europe², yet those living with the condition often face profound challenges of social isolation, unstable employment ³, and a life expectancy reduced by 15–20 years ⁴.

TEV-‘749 is not approved by any regulatory authority worldwide at this time. The submission to the EMA is supported by an extensive clinical development program, including the Phase 3 SOLARIS study. Across clinical development, TEV-‘749 demonstrated efficacy, a systemic safety profile, and exposure consistent with oral olanzapine.

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

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 0.3 - 1.5% of the population in Europe 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.

Teva Media Inquiries:
Comms@tevaeu.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.

Medincell Media Inquiries:
Contact: communication@medincell.com

Teva Cautionary Note Regarding Forward-Looking Statements

This Press Release may contain 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,” “aim” 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 approvals; our ability to successfully compete in the marketplace, including our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; our significant indebtedness; our business and operations in general; compliance, regulatory and litigation matters; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the first 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.

References

__________

¹ Data on file. Parsippany, NJ: Teva Neuroscience, Inc.
² European Brain Council. Rethinking Schizophrenia. 2024. Available at https://www.braincouncil.eu/projects/rethinking-schizophrenia/#:~:text=Rethinking%20Schizophrenia%20is%20a%20research,that%20of%20the%20general%20population. Last accessed March 2026³ Teva What lies beneath: Uncovering the hidden drivers and impact of Stigma in Schizophrenia White Paper 2025. Available at https://www.tevapharm.com/globalassets/tevapharm-vision-files/teva-white-paper-uncovering-hidden-drivers-and-impact-stigma-in-schizophrenia.pdf Last accessed March 2026
⁴ Thornicroft G. British Journal of Psychiatry. 2011;199(6):441-442.

FAQ

What did Teva (TEVA) announce about TEV-‘749 and the EMA in May 2026?

Teva announced that the EMA accepted its Marketing Authorization Application for TEV-‘749 to treat adult schizophrenia. According to Teva, this subcutaneous long-acting olanzapine injection is designed for once-every-four-weeks dosing to support treatment adherence and long-term management.

What is TEV-‘749 and how is it administered for schizophrenia treatment?

TEV-‘749 is an investigational long-acting injectable olanzapine formulation for adults with schizophrenia. According to Teva, it is administered subcutaneously once every four weeks and aims to deliver olanzapine efficacy with controlled, steady, prolonged release using Medincell’s SteadyTeq technology.

Is Teva’s TEV-‘749 for schizophrenia currently approved by any regulator?

TEV-‘749 is not approved by any regulatory authority worldwide at this time. According to Teva, the EMA’s acceptance of its Marketing Authorization Application is based on an extensive clinical development program, including the Phase 3 SOLARIS study showing efficacy and a systemic safety profile.

How could TEV-‘749 impact treatment adherence in adults with schizophrenia?

TEV-‘749 may help address treatment adherence by offering once-every-four-weeks olanzapine injections. According to Teva, it is intended to provide proven olanzapine efficacy and safety in a long-acting format, potentially supporting stability and long-term disease management in real-world settings.

What clinical data support Teva’s Marketing Authorization Application for TEV-‘749?

The application is supported by an extensive clinical development program, including the Phase 3 SOLARIS trial. According to Teva, TEV-‘749 demonstrated efficacy, a systemic safety profile, and olanzapine exposure consistent with oral olanzapine across its clinical development.

What drug delivery technology does TEV-‘749 use to release olanzapine?

TEV-‘749 uses Medincell’s proprietary SteadyTeq copolymer technology for drug delivery. According to Teva, SteadyTeq enables a controlled, steady, prolonged release of olanzapine, supporting its once-every-four-weeks subcutaneous dosing schedule for adults living with schizophrenia.