Teva Pharmaceuticals Submits New Drug Application to FDA for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly Treatment of Schizophrenia in Adults

Rhea-AI Summary

Teva (NYSE: TEVA) submitted a New Drug Application (NDA) to the FDA on December 9, 2025 for olanzapine extended-release injectable suspension (TEV-'749), an investigational once-monthly subcutaneous long-acting injectable (LAI) for adults with schizophrenia.

The NDA is supported by Phase 3 SOLARIS trial data, including Week 56 results that the company says met efficacy and safety endpoints and showed a profile consistent with oral olanzapine. The formulation uses SteadyTeq copolymer technology, proprietary to Medincell. Olanzapine LAI is not approved by any regulatory authority at this time.

Positive

• NDA submitted to FDA on December 9, 2025
• Phase 3 SOLARIS reported Week 56 efficacy and safety endpoint validation
• Once-monthly subcutaneous formulation may support real-world adherence
• SteadyTeq technology enables controlled sustained olanzapine release

Negative

• Olanzapine LAI is not approved by any regulatory authority
• Regulatory approval timeline and outcome remain uncertain
• Product relies on third-party SteadyTeq technology from Medincell

Key Figures

Trial phase Phase 3 SOLARIS trial forming basis of NDA

Follow-up duration Week 56 SOLARIS efficacy, safety and tolerability results

Participant age range 18 to 64 years Adults with schizophrenia in Phase 3 SOLARIS trial

Dosing frequency Once monthly Subcutaneous olanzapine LAI regimen for schizophrenia

Market Reality Check

$29.80 Last Close

Volume Volume 7,147,582 vs 20-day average 11,100,456, indicating muted trading interest ahead of the NDA news. low

Technical Shares at $28.33, trading above 200-day MA of $18.14 and within 1.43% of the 52-week high $28.74.

Peers on Argus

While TEVA was down 0.46%, key peers were mixed: UTHR -1.93%, RDY -1.56%, NBIX -1.06%, TAK -0.14%, and VTRS +0.91%, suggesting stock-specific factors around the NDA rather than a uniform sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 25	Biosimilar approvals	Positive	+0.9%	EU approvals for two denosumab biosimilars supporting biosimilars portfolio expansion.
Nov 21	Investor conferences	Neutral	+2.3%	Announcements of upcoming healthcare conference presentations by senior management.
Nov 19	AI innovation launch	Positive	-1.6%	Launch of Teva Rise open innovation platform to integrate AI and smart manufacturing.
Nov 07	Real-world outcomes	Positive	+1.2%	Interim real-world AUSTEDO data showing improved TD symptoms and daily functioning.
Nov 05	Earnings and outlook	Positive	+20.2%	Q3 2025 growth, stronger AUSTEDO outlook, and raised non-GAAP EPS guidance.

Pattern Detected

Recent news, especially clinical and portfolio milestones, has more often coincided with positive price reactions than negative ones, with only one notable divergence.

Recent Company History

Over the last few months, Teva has reported multiple growth and pipeline milestones. Q3 2025 results on Nov 5 showed sustained revenue growth and a stronger outlook, driving a 20.23% move. Subsequent news highlighted real-world AUSTEDO data, an AI-focused innovation platform, and European approvals for two denosumab biosimilars, generally aligning with modestly positive price reactions. Today’s NDA submission for olanzapine LAI builds on that pattern of advancing differentiated CNS assets within its broader growth strategy.

Market Pulse Summary

This announcement marks the submission of an NDA to the FDA for TEV-'749, a once‑monthly subcutaneous olanzapine long‑acting injectable for adults with schizophrenia, backed by Phase 3 SOLARIS Week 56 data. It extends a series of positive schizophrenia‑portfolio updates seen in prior SOLARIS readouts. Investors may watch for FDA review milestones, additional safety disclosures, and how this candidate integrates with Teva’s broader long‑acting injectable strategy over time.

Key Terms

new drug application regulatory

"announced the submission of a New Drug Application (NDA) to the U.S."

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

NDA regulatory

"announced the submission of a New Drug Application (NDA) to the U.S."

An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.

U.S. Food and Drug Administration regulatory

"New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

FDA regulatory

"New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

extended-release injectable medical

"olanzapine extended-release injectable suspension (TEV-'749) for the treatment"

An extended-release injectable is a medicine given by shot that slowly releases its active ingredient over an extended period (days to months) instead of all at once, like a timed-release battery that powers a device steadily. For investors, it matters because this delivery method can improve patient convenience and adherence, support longer-lasting sales per dose, and create additional regulatory and manufacturing hurdles that affect a drug’s commercial prospects and competitive position.

long-acting injectable medical

"Olanzapine long-acting injectable (LAI) has the potential to offer"

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.

subcutaneous medical

"once-monthly subcutaneous formulation, for a broad patient population"

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.

Phase 3 medical

"based on results from the Phase 3 SOLARIS trial, including Week 56 results"

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.

AI-generated analysis. Not financial advice.

• Olanzapine long-acting injectable (LAI) has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation, for a broad patient population¹
• Olanzapine LAI is designed to help support real-world adherence and improved stability, with the goal of addressing a critical treatment gap for people living with schizophrenia¹
• Teva is committed to advancing this innovative treatment option and further build on its differentiated LAI franchise
  

PARSIPPANY, N.J. and TEL AVIV, Israel, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults. The NDA for olanzapine LAI is based on results from the Phase 3 SOLARIS trial, including Week 56 results studying its efficacy, safety and tolerability in participants aged 18 to 64 living with schizophrenia.¹ The results validated olanzapine LAI in meeting efficacy and safety endpoints in a broad adult population of people living with schizophrenia.

“The innovation of olanzapine LAI comes from its delivery of olanzapine, a foundational treatment for schizophrenia, as a once-monthly subcutaneous formulation,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “Teva is committed to working closely with the FDA on the review of this olanzapine LAI application as we seek to help address the critical unmet needs of people living with schizophrenia.”

Olanzapine LAI is an investigational once-monthly subcutaneous LAI of the second-generation antipsychotic olanzapine. In the SOLARIS trial, it demonstrated an efficacy and safety profile consistent with currently available oral olanzapine formulations. It is not approved by any regulatory authority for any use at this time.

Olanzapine LAI utilizes SteadyTeq™, a copolymer technology proprietary to Medincell that provides a controlled steady, sustained release of olanzapine.

About Subcutaneous OLAnzapine Extended-Release Injection Study (SOLARIS)
SOLARIS is 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 (TEV-'749) (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 were randomized and equally allocated to one of the three olanzapine LAI (TEV-'749) treatment groups.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 (TEV-'749) in adult patients with schizophrenia.¹ A key secondary objective was to further evaluate the efficacy of olanzapine LAI (TEV-'749) based on additional parameters in adult patients with schizophrenia.¹ A secondary objective of period two of the study was to evaluate the safety and tolerability of olanzapine LAI (TEV-'749) 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 3.5 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.

Teva 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,” “project,” “guidance,” “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 and obtain regulatory approval for olanzapine extended-release injectable suspension LAI (TEV-'749) for the treatment of schizophrenia in adults; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; 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; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section 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. Parsippany, NJ: Teva Neuroscience, Inc.
2. Substance Abuse and Mental Health Services Administration. Schizophrenia. https://www.samhsa.gov/mental-health/schizophrenia.
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 Inquires
TevaIR@tevapharm.com

FAQ

What did Teva announce about TEV-'749 (olanzapine LAI) on December 9, 2025?

Teva announced it submitted a NDA to the FDA on December 9, 2025 for TEV-'749, an investigational once-monthly subcutaneous olanzapine formulation for adults with schizophrenia.

What clinical evidence supports Teva's NDA for TEV-'749 (TEVA)?

The NDA is supported by Phase 3 SOLARIS trial data, including Week 56 results that met stated efficacy and safety endpoints and showed consistency with oral olanzapine.

Is olanzapine LAI (TEV-'749) approved for use now for TEVA investors?

No. Olanzapine LAI is investigational and not approved by any regulatory authority at this time.

What is the dosing format and frequency for TEV-'749 (TEVA)?

TEV-'749 is described as an investigational once-monthly subcutaneous long-acting injectable of olanzapine.

What proprietary technology does TEV-'749 use and who provides it?

The formulation uses SteadyTeq, a copolymer controlled-release technology proprietary to Medincell.

How might TEV-'749 affect adherence for people living with schizophrenia (TEVA)?

Teva states the once-monthly LAI is designed to support real-world adherence and improved stability for a broad adult population.