Teva to Discontinue Phase 2 TOPAS-MSA Study of emrusolmin (TEV-‘286) Following Interim Futility Analysis

The interim assessment identified no safety concerns, and a final decision on the broader emrusolmin program remains open.

Rhea-AI Summary

Teva (TEVA) will discontinue its Phase 2 TOPAS-MSA study of emrusolmin in adults with multiple system atrophy following an interim futility analysis. The prespecified analysis met the predefined stopping criterion, indicating a low probability of meeting the primary efficacy endpoint if the study continued. An independent data monitoring committee recommended discontinuation. This was a predictive interim assessment, not the final efficacy analysis; no safety concerns were identified.

Teva plans a comprehensive analysis of TOPAS-MSA and available open-label extension data, with findings to be shared after that analysis. The decision concerns TOPAS-MSA and is not a final decision on the broader emrusolmin program, which is being developed with MODAG. Teva will work with investigators to follow study protocols during discontinuation.

1 point · 0 major

NegativeiHow this balance works

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

How the balance worksHow Sentiment works

0 major · 1 point

Hollow bars mark forward-looking points. How the balance works

Positive

• Minor pointInterim analysis identified no safety concerns in the Phase 2 TOPAS-MSA study.

Negative

• Moderate point. Forward-looking: it has not happened yet and may not happen.TOPAS-MSA will be discontinued after interim analysis indicated low probability of meeting its primary efficacy endpoint.

Argus 15 min delay 12 alerts

-3.04% vs previous close $40.81 last price 1.6x rel. volume Open Argus

Details

Market Reaction – TEVA

$39.50 – $42.00 Day Range

$47.60B Mkt Cap at Last Price

On Nov 2, the day this news came out, the latest delayed price for TEVA is 3.04% below the previous close. Our momentum scanner has recorded 12 alerts for this stock so far that day. The latest delayed price is $40.81. Relative volume is above average at 1.6x what this stock usually trades by this time of day.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.

Key Figures

Planned enrollment: Approximately 350 participants Emrusolmin dose: 300 mg Treatment period: Approximately 48 weeks

Planned enrollment

Approximately 350 participants

TOPAS-MSA study design

Emrusolmin dose

300 mg

Planned treatment arm in TOPAS-MSA

Treatment period

Approximately 48 weeks

Planned TOPAS-MSA treatment period

Key Terms

futility analysis, primary efficacy endpoint, open-label extension, orphan drug designation, +1 more

5 terms

futility analysis medical

"based on a prespecified interim futility analysis"

A futility analysis is a planned mid-course check in a clinical trial to determine whether continuing the study is unlikely to show a meaningful benefit. Think of it like pausing a long road trip to see if you’re close enough to your destination to justify the remaining time and fuel; if not, the trial may be stopped early to limit costs and risk. For investors, futility results can sharply change a company’s timeline, spending needs and the likelihood of regulatory approval, which in turn affects valuation.

primary efficacy endpoint medical

"meeting its primary efficacy endpoint if continued"

The primary efficacy endpoint is the single main result a clinical trial is designed to measure to decide whether a treatment works, chosen before the study starts. Think of it as the official scoreboard metric judges use to declare a win or loss; investors watch it because meeting or missing this pre-set goal usually drives regulatory approval odds, market expectations, and a company’s stock value.

open-label extension medical

"available data from the open-label extension study"

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

orphan drug designation regulatory

"granted Orphan Drug designation to emrusolmin for MSA"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

fast track designation regulatory

"Fast Track designation in September 2025"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

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

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

• Predictive Interim analysis indicates low probability of study meeting its primary efficacy endpoint if continued
• Comprehensive analysis and evaluation of available open-label extension data will follow
• No safety concerns were identified in the interim analysis
  
  

PARSIPPANY, N.J., Nov. 02, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that it will discontinue the Phase 2 TOPAS-MSA study (NCT06568237) evaluating emrusolmin (TEV-‘286) in adults with multiple system atrophy (MSA). The decision follows a recommendation from the independent data monitoring committee (IDMC), based on a prespecified interim futility analysis. The analysis met the predefined futility criterion, indicating a low probability of the study meeting its primary efficacy endpoint if continued. This was an interim predictive assessment and not the study’s final efficacy analysis. No safety concerns were identified in the interim analysis.

Emrusolmin is being developed in partnership with MODAG GmbH. A comprehensive analysis of the TOPAS-MSA data and available data from the open-label extension study of emrusolmin in MSA (NCT07197866) will follow. The decision announced today concerns TOPAS-MSA and does not represent a final decision on the broader emrusolmin program.

“While we are disappointed by the outcome of this interim analysis for the Phase 2 study, we remain deeply committed to learning everything we can from these data,” said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer at Teva. “We are deeply grateful to the patients, families, investigators, and study teams who contributed their time and commitment to this research. Our hope is that the science and learnings can deepen our understanding of MSA and help us determine a path forward for emrusolmin.”

Teva will work with the TOPAS-MSA study investigators to ensure the study protocols are followed while the Phase 2 study is discontinued. Teva plans to share the TOPAS-MSA findings with the scientific community following completion of its comprehensive analysis.

Teva to Host Q3 Earnings Call on November 3, 2026
Teva will host its third-quarter 2026 earnings conference call on November 3, 2026 at 8:00 a.m. ET. Register here. A live webcast of the call will be available on Teva's website at: https://ir.tevapharm.com/Events-and-Presentations.

About the TOPAS-MSA Program
TOPAS-MSA (NCT06568237; TV56286-NDG-20039) is a randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy and safety of emrusolmin in adults with multiple system atrophy (MSA). The study was designed to enroll approximately 350 participants to receive emrusolmin 300 mg or placebo for approximately 48 weeks, followed by a four-week follow-up period. The primary endpoint is change from baseline to Week 48 in the modified Unified Multiple System Atrophy Rating Scale Part I score.

The separate Phase 2 open-label extension (OLE) study (NCT07197866; TV56286-NDG-20041) is designed to evaluate the long-term safety and tolerability of emrusolmin in eligible participants who completed the 48-week treatment period of TOPAS-MSA.

About emrusolmin
emrusolmin, also known as TEV-'286, is an investigational, orally administered small molecule designed to target alpha-synuclein aggregation, one of the core pathogenic mechanisms believed to be involved in MSA. Emrusolmin is being developed in partnership with MODAG GmbH. The U.S. Food and Drug Administration granted Orphan Drug designation to emrusolmin for MSA in 2022 and Fast Track designation in September 2025.

About Multiple System Atrophy (MSA)
MSA is a rare neurodegenerative disorder classified clinically as "atypical parkinsonism" and belongs to the group of synucleinopathies. MSA is characterized histopathologically by abnormal deposits of the α-synuclein protein, mainly in oligodendroglial cells (glial cytoplasmic inclusions) and also in certain nerve cells. Typically, there is a dysfunction of the autonomic nervous system, i.e., disturbances of bladder function, erectile function, intestinal mobility, or the regulation of blood pressure in combination with a movement disorder. The movement disorder often presents with either Parkinson-like symptoms or a disturbance of cerebellar function, such as ataxia, gait and speech problems. In the US, EU, and Japan, MSA affects about 40,000 people (prevalence of 4 per 100,000), with about 6,000 new cases diagnosed each year (incidence of 0.6 per 100,000). Post-diagnosis life expectancy is about 6-10 years. Due to the relatively small number of affected patients and lack of effective therapy, MSA qualifies for orphan status, allowing a shorter development path. This unmet medical need for MSA disease modification is the driver to develop new therapies that could potentially impact the lives of patients.

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment 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 Teva’s future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. All statements other than statements of historical fact are, or may be deemed to be, forward-looking statements. In some cases, you can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “developing,” “target,” “may,” “expand,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future performance. Important factors that could cause or contribute to such differences include risks and uncertainties relating to: our ability to develop emrusolmin (TEV-’286) for the treatment of MSA 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 to execute on our organizational transformation and to achieve expected cost savings; our significant indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments; and other factors discussed in this press release, 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,” “Other Information” and “Cautionary Note Regarding 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.

Teva Media Inquiries:
TevaCommunicationsNorthAmerica@tevapharm.com
Teva Investor Relations Inquiries:
TevaIR@Tevapharm.com

FAQ

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

Why is Teva discontinuing the TOPAS-MSA emrusolmin study?

A prespecified interim analysis met the predefined futility criterion, indicating a low probability of meeting the primary efficacy endpoint if TOPAS-MSA continued. The independent data monitoring committee recommended discontinuation. This predictive assessment was not the study’s final efficacy analysis.

Has Teva ended the broader emrusolmin development program?

No final decision on the broader emrusolmin program has been made. The discontinuation decision concerns TOPAS-MSA. Teva plans to analyze the study data and available data from the separate open-label extension before sharing the TOPAS-MSA findings with the scientific community.

What was the primary endpoint in Teva’s TOPAS-MSA study?

The primary endpoint was change from baseline to Week 48 in the modified Unified Multiple System Atrophy Rating Scale Part I score, a measure used to assess the disease. The randomized, double-blind study was designed to compare emrusolmin with placebo.

What does Teva’s separate emrusolmin open-label extension study evaluate?

The separate Phase 2 extension study is designed to evaluate long-term safety and tolerability of emrusolmin. It covers eligible participants who completed the 48-week treatment period of TOPAS-MSA.