U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly Treatment of Schizophrenia in Adults

Teva (NYSE: TEVA) announced FDA acceptance of its New Drug Application for TEV-'749, an investigational once-monthly subcutaneous olanzapine extended-release injectable suspension on Feb 20, 2026.

Rhea-AI Summary

Teva (NYSE: TEVA) announced FDA acceptance of its New Drug Application for TEV-'749, an investigational once-monthly subcutaneous olanzapine extended-release injectable suspension on Feb 20, 2026.

The NDA is supported by Phase 3 SOLARIS Week 56 results showing efficacy and safety consistent with existing olanzapine formulations and no evidence requiring post-injection monitoring; TEV-'749 uses Medincell's SteadyTeq sustained-release copolymer technology.

Positive

• FDA NDA accepted on Feb 20, 2026
• Phase 3 SOLARIS Week 56 showed efficacy and safety consistency
• Once-monthly subcutaneous dosing formulation
• No post-injection monitoring observed in SOLARIS results
• Uses SteadyTeq sustained-release copolymer technology

Negative

• Investigational product not approved by any regulatory authority
• SOLARIS trial population limited to ages 18 to 64

Argus Feb 20 session

-0.32% close to close Open Argus

Details

News Market Reaction – TEVA

On Feb 20, the day this news came out, TEVA closed 0.32% below the previous close.

Data tracked by StockTitan Argus for the Feb 20 session.

Key Figures

Post-injection monitoring: 3-hour period Trial duration: Week 56 results Participant age range: 18 to 64 years

Post-injection monitoring

3-hour period

Current REMS requirement for existing long-acting olanzapine

Trial duration

Week 56 results

Phase 3 SOLARIS trial efficacy and safety assessment

Participant age range

18 to 64 years

Adults with schizophrenia in Phase 3 SOLARIS

Previous Clinical trial Reports

5 past events · Latest: Dec 09

Same Type 5 events

1. Dec 09

   NDA submission TEV-'749

   24h Move

   +0.8%

   FDA NDA submission for once-monthly olanzapine LAI TEV-'749.

2. Sep 20

   SOLARIS safety data

   24h Move

   +2.8%

   Long-term SOLARIS data with no PDSS and consistent safety profile.

3. Sep 09

   Fast Track emrusolmin

   24h Move

   +2.0%

   FDA Fast Track designation for emrusolmin in Multiple System Atrophy.

4. May 30

   Schizophrenia portfolio data

   24h Move

   +2.9%

   UZEDY real-world outcomes and SOLARIS data with no PDSS for TEV-'749.

5. Mar 31

   SOLARIS satisfaction survey

   24h Move

   +1.9%

   High satisfaction rates with once-monthly subcutaneous TEV-'749 in SOLARIS.

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

Key Terms

new drug application (nda), long-acting injectable (lai), risk evaluation and mitigation strategy (rems), phase 3, +2 more

6 terms

new drug application (nda) regulatory

"announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA)"

A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.

long-acting injectable (lai) medical

"olanzapine long-acting injectable (LAI) suspension (TEV-'749) has the potential"

A long-acting injectable (LAI) is a medicine formulated to be given as a shot that releases its active ingredient slowly over weeks or months, reducing how often patients must take it. For investors, LAIs can mean steadier demand, better treatment adherence, and longer product lifecycles compared with daily pills—similar to switching from refilling a weekly grocery list to a monthly subscription—factors that can affect sales predictability and competitive position.

risk evaluation and mitigation strategy (rems) regulatory

"no long-acting olanzapine formulation without an FDA-required Risk Evaluation and Mitigation Strategy (REMS)"

A Risk Evaluation and Mitigation Strategy (REMS) is a formal safety program required by regulators for certain medicines or medical products to ensure benefits outweigh serious risks. It sets rules—such as training for prescribers, special distribution systems, or monitoring—to reduce harm. For investors, REMS can limit how widely and quickly a product can be sold, raise compliance costs, and affect legal risk, similar to how safety checks can slow and add expense to running a vehicle fleet.

phase 3 medical

"In the Phase 3 SOLARIS trial, TEV-'749 administered as a once-monthly"

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.

subcutaneous medical

"once-monthly subcutaneous injection demonstrated an efficacy and safety profile"

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.

atypical antipsychotic medical

"LAI of the second-generation atypical antipsychotic olanzapine. It is not approved"

Atypical antipsychotics are a class of medicines used to treat psychiatric conditions such as schizophrenia and bipolar disorder; they work on multiple brain chemical systems to reduce symptoms like hallucinations, mood swings and agitation. For investors they matter because trial results, regulatory approvals, safety warnings or new uses can quickly change prescribing patterns and sales — think of them as a product line whose demand and price can shift with clinical data or safety news.

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

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Add on Google Not now

• Olanzapine long-acting injectable (LAI) suspension (TEV-'749) has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation¹
• If approved, TEV-'749 could help address a significant unmet need in available schizophrenia treatment options by addressing the lack of viable long-acting olanzapine formulations¹
• Teva is committed to advancing this innovative treatment option and further building on its differentiated LAI franchise and scientific leadership in complex neurological conditions as it drives forward its Pivot to Growth strategy
  

PARSIPPANY, N.J. and TEL AVIV, Israel and PARIS, Feb. 20, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Medincell (Euronext: MEDCL), announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults. TEV-'749 is designed to improve real-world treatment adherence and help patients maintain long-term stability, with the goal of addressing a critical treatment gap for people living with schizophrenia.

Currently, there is no long-acting olanzapine formulation without an FDA-required Risk Evaluation and Mitigation Strategy (REMS), which mandates administration in a certified healthcare facility and requires a 3-hour post-injection monitoring period. In the Phase 3 SOLARIS trial, TEV-'749 administered as a once-monthly subcutaneous injection demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations and showed no evidence for the need for post-injection monitoring.

“Treatment adherence remains a major challenge and unmet need for people living with schizophrenia, including many 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-monthly treatment,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “For too long, the lack of a viable long-acting olanzapine formulation has limited the options available to these individuals, and we look forward to working with the FDA on the review of this NDA for TEV-'749 to help address this gap in care.”

“Daily olanzapine is one of the most widely prescribed antipsychotics for people living with schizophrenia, and this long‑acting formulation may better fit into their lives,” said Christophe Douat, CEO of Medincell. “As experience with long‑acting injectables continues to grow, they are increasingly recognized as an important treatment option in serious psychiatric conditions. The potential reach of a practical long‑acting option is significant.”

The NDA for TEV-'749 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 demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations.¹

TEV-'749 is an investigational once-monthly subcutaneous LAI of the second-generation atypical 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.

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.

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,” “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 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 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 Annual Report on Form 10-K for the year ended December 31, 2025, including in the section captioned “Risk Factors.” 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. 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 Inquires
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 did Teva announce about TEV-'749 on Feb 20, 2026 (TEVA)?

Teva announced FDA acceptance of the NDA for TEV-'749, an investigational once-monthly olanzapine LAI. According to the company, the filing is supported by Phase 3 SOLARIS Week 56 results showing efficacy and safety consistent with current olanzapine formulations.

Is TEV-'749 approved for treating schizophrenia in adults (TEVA)?

No, TEV-'749 is investigational and not approved by any regulatory authority. According to the company, the NDA has been accepted by the FDA and will undergo regulatory review before any approval decision.

What did the Phase 3 SOLARIS Week 56 results say about TEV-'749 (TEVA)?

SOLARIS Week 56 showed an efficacy and safety profile consistent with currently available olanzapine formulations. According to the company, the trial also found no evidence indicating the need for post-injection monitoring.

Will TEV-'749 require the 3-hour post-injection monitoring that current olanzapine LAIs require (TEVA)?

SOLARIS results indicated no evidence for the need for post-injection monitoring for TEV-'749. According to the company, the once-monthly subcutaneous formulation showed no signals necessitating the FDA-required REMS monitoring used with other olanzapine LAIs.

What technology does TEV-'749 use and why does it matter for TEVA shareholders?

TEV-'749 uses Medincell's SteadyTeq copolymer for controlled sustained release of olanzapine. According to the company, this technology enables once-monthly dosing and underpins the formulation's potential differentiation in long-acting schizophrenia treatments.