PRINCETON, N.J., Oct. 02, 2026 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (Nasdaq: IART), a leading global medical technology company, today provided certain unaudited preliminary third quarter results and an update to its full-year 2026 guidance.

“Our third quarter results were impacted by the July flooding event at our Cincinnati facility,” said Stuart Essig, Chairman and Chief Executive Officer. “Our teams have made significant progress executing recovery plans and supporting customers. As we have gained additional visibility into the recovery timeline and production ramp, we now have a clearer understanding of the expected impact on our third quarter results and full-year outlook.”

Mr. Essig continued, “While we are lowering our full-year revenue and adjusted EPS outlook for 2026, we continue to expect strong cash generation, including greater than $85 million of operating cash flow in the third quarter and approximately $190 million to $200 million for the full year. Importantly, we remain encouraged by the progress we are making across the broader business, including improving product availability, the return of key products to market, and strengthening commercial execution.”

Update on Cincinnati Facility

As previously disclosed in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, and discussed on the second quarter earnings call, flooding at the Cincinnati facility in July 2026 caused damage to portions of the facility, equipment, inventory and other assets and resulted in operational disruption to the site. The facility manufactures and supports several products within the Company’s Specialty Surgical Technologies portfolio.

Since the event, Integra has continued to execute its business continuity and recovery plans. The Company has utilized available inventory, activated established alternate sources of supply for certain products, and advanced restoration activities at the Cincinnati facility. These actions are intended to support customers and mitigate disruption while recovery efforts continue.

Based on its current assessment, Integra estimates that the flooding related supply disruption negatively impacted third quarter revenue by approximately $7 million and is expected to negatively impact fourth quarter revenue by approximately $15 million to $20 million. The Company expects a return to full manufacturing operations at the site during the second quarter of 2027.

Integra maintains property and business interruption insurance covering the Cincinnati facility. Based on its current assessment, the Company expects insurance recoveries to mitigate a substantial portion of the earnings impact associated with the disruption throughout the recovery period and until the facility returns to full manufacturing capacity. The Company continues to work with its insurance carrier to assess and document recoverable losses associated with the event, including both property damage and business interruption claims.

Preliminary Third Quarter Results and Updated Full-Year Guidance

For the third quarter of 2026, the Company expects to report revenue of approximately $410 million to $412 million and adjusted earnings per diluted share of $0.55 to $0.59. The preliminary results as set forth above are unaudited and remain subject to completion of the Company’s financial closing procedures.

For the full year 2026, the Company is updating its reported revenue outlook from a range of $1.654 billion to $1.695 billion to a range of $1.634 billion to $1.654 billion. The Company is updating its adjusted earnings per diluted share guidance from a range of $2.40 to $2.50 to a range of $2.30 to $2.40 and expects operating cash flow for the year to be approximately $190 million to $200 million.

The third quarter preliminary results and updated full-year guidance reflect revised assumptions regarding the expected impact of the July flooding event at the Cincinnati facility, as well as updated assumptions for the broader business for the remainder of the year.

The Company will report its third quarter 2026 financial results during a conference call in October 2026. A press release with the date, time and webcast information will be provided closer to the reporting date. The Company will provide additional information regarding its third quarter financial results and outlook for full-year 2026 at that time.

About Integra LifeSciences

Integra LifeSciences (Nasdaq: IART) is a global medical technology leader dedicated to restoring lives. We are advancing transformational care through impactful innovation in neurosurgery and tissue reconstruction, specialized fields that demand exceptional expertise and precision. Our portfolio of highly differentiated, gold-standard technologies is trusted by healthcare professionals to deliver transformative care. For the latest news and information about Integra LifeSciences and its products, please visit www.integralife.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ from predicted results. Forward-looking factors that may be discussed include, but are not limited to: our preliminary unaudited results for the third quarter ended September 30, 2026; the preliminary estimated impact of the flooding event at our Cincinnati, Ohio manufacturing facility (the “Cincinnati facility”), including on revenue, adjusted earnings per diluted share and our financial condition and results of operations more generally; our fiscal 2026 guidance and our ability to deliver on such financial guidance; our expectations and progress in our recovery efforts, including timing and costs; and expected insurance coverage and recoveries. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Integra’s business and market, including: our ongoing assessment of the flooding event at the Cincinnati facility, related financial impacts, recovery efforts, potential asset impairments, unforeseen costs and insurance recoveries; and other risks identified under the heading “Risk Factors” included in item 1A of Integra’s Annual Report on Form 10-K for the year ended December 31, 2025, and information contained in subsequent filings with the Securities and Exchange Commission. Actual results could differ materially from anticipated or preliminary results or estimates. These forward-looking statements are made only as the date thereof, and Integra undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

Investor Relations:
Chris Ward
(609) 772-7736
chris.ward@integralife.com   

Media Contact:
Laurene Isip
(609) 208-8121
laurene.isip@integralife.com

PRINCETON, N.J., Oct. 02, 2026 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (Nasdaq: IART), a leading global medical technology company, today provided certain unaudited preliminary third quarter results and an update to its full-year 2026 guidance.

“Our third quarter results were impacted by the July flooding event at our Cincinnati facility,” said Stuart Essig, Chairman and Chief Executive Officer. “Our teams have made significant progress executing recovery plans and supporting customers. As we have gained additional visibility into the recovery timeline and production ramp, we now have a clearer understanding of the expected impact on our third quarter results and full-year outlook.”

Mr. Essig continued, “While we are lowering our full-year revenue and adjusted EPS outlook for 2026, we continue to expect strong cash generation, including greater than $85 million of operating cash flow in the third quarter and approximately $190 million to $200 million for the full year. Importantly, we remain encouraged by the progress we are making across the broader business, including improving product availability, the return of key products to market, and strengthening commercial execution.”

Update on Cincinnati Facility

As previously disclosed in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, and discussed on the second quarter earnings call, flooding at the Cincinnati facility in July 2026 caused damage to portions of the facility, equipment, inventory and other assets and resulted in operational disruption to the site. The facility manufactures and supports several products within the Company’s Specialty Surgical Technologies portfolio.

Since the event, Integra has continued to execute its business continuity and recovery plans. The Company has utilized available inventory, activated established alternate sources of supply for certain products, and advanced restoration activities at the Cincinnati facility. These actions are intended to support customers and mitigate disruption while recovery efforts continue.

Based on its current assessment, Integra estimates that the flooding related supply disruption negatively impacted third quarter revenue by approximately $7 million and is expected to negatively impact fourth quarter revenue by approximately $15 million to $20 million. The Company expects a return to full manufacturing operations at the site during the second quarter of 2027.

Integra maintains property and business interruption insurance covering the Cincinnati facility. Based on its current assessment, the Company expects insurance recoveries to mitigate a substantial portion of the earnings impact associated with the disruption throughout the recovery period and until the facility returns to full manufacturing capacity. The Company continues to work with its insurance carrier to assess and document recoverable losses associated with the event, including both property damage and business interruption claims.

Preliminary Third Quarter Results and Updated Full-Year Guidance

For the third quarter of 2026, the Company expects to report revenue of approximately $410 million to $412 million and adjusted earnings per diluted share of $0.55 to $0.59. The preliminary results as set forth above are unaudited and remain subject to completion of the Company’s financial closing procedures.

For the full year 2026, the Company is updating its reported revenue outlook from a range of $1.654 billion to $1.695 billion to a range of $1.634 billion to $1.654 billion. The Company is updating its adjusted earnings per diluted share guidance from a range of $2.40 to $2.50 to a range of $2.30 to $2.40 and expects operating cash flow for the year to be approximately $190 million to $200 million.

The third quarter preliminary results and updated full-year guidance reflect revised assumptions regarding the expected impact of the July flooding event at the Cincinnati facility, as well as updated assumptions for the broader business for the remainder of the year.

The Company will report its third quarter 2026 financial results during a conference call in October 2026. A press release with the date, time and webcast information will be provided closer to the reporting date. The Company will provide additional information regarding its third quarter financial results and outlook for full-year 2026 at that time.

About Integra LifeSciences

Integra LifeSciences (Nasdaq: IART) is a global medical technology leader dedicated to restoring lives. We are advancing transformational care through impactful innovation in neurosurgery and tissue reconstruction, specialized fields that demand exceptional expertise and precision. Our portfolio of highly differentiated, gold-standard technologies is trusted by healthcare professionals to deliver transformative care. For the latest news and information about Integra LifeSciences and its products, please visit www.integralife.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ from predicted results. Forward-looking factors that may be discussed include, but are not limited to: our preliminary unaudited results for the third quarter ended September 30, 2026; the preliminary estimated impact of the flooding event at our Cincinnati, Ohio manufacturing facility (the “Cincinnati facility”), including on revenue, adjusted earnings per diluted share and our financial condition and results of operations more generally; our fiscal 2026 guidance and our ability to deliver on such financial guidance; our expectations and progress in our recovery efforts, including timing and costs; and expected insurance coverage and recoveries. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Integra’s business and market, including: our ongoing assessment of the flooding event at the Cincinnati facility, related financial impacts, recovery efforts, potential asset impairments, unforeseen costs and insurance recoveries; and other risks identified under the heading “Risk Factors” included in item 1A of Integra’s Annual Report on Form 10-K for the year ended December 31, 2025, and information contained in subsequent filings with the Securities and Exchange Commission. Actual results could differ materially from anticipated or preliminary results or estimates. These forward-looking statements are made only as the date thereof, and Integra undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

Investor Relations:
Chris Ward
(609) 772-7736
chris.ward@integralife.com   

Media Contact:
Laurene Isip
(609) 208-8121
laurene.isip@integralife.com

Vilnius, Lithuania, Oct. 02, 2026 (GLOBE NEWSWIRE) —

As at the end of September 2026, the net asset value (NAV) of SUTNTIB AB Tewox decreased to EUR 44,775,595, compared to the previously determined NAV of EUR 45,190,557 at the end of August 2026.

The share price decreased to EUR 1.0696, from EUR 1.0795 at the end of August 2026. The pro-forma internal rate of return (IRR) decreased to 3.24%, compared to previously announced IRR of 3.51% at the end of August 2026.

Contact person for further information:

Paulius Nevinskas
Manager of the Investment Company
paulius.nevinskas@lordslb.lt
https://lordslb.lt/tewox_bonds/

Vilnius, Lithuania, Oct. 02, 2026 (GLOBE NEWSWIRE) —

As at the end of September 2026, the net asset value (NAV) of SUTNTIB AB Tewox decreased to EUR 44,775,595, compared to the previously determined NAV of EUR 45,190,557 at the end of August 2026.

The share price decreased to EUR 1.0696, from EUR 1.0795 at the end of August 2026. The pro-forma internal rate of return (IRR) decreased to 3.24%, compared to previously announced IRR of 3.51% at the end of August 2026.

Contact person for further information:

Paulius Nevinskas
Manager of the Investment Company
paulius.nevinskas@lordslb.lt
https://lordslb.lt/tewox_bonds/

Strengthens Executive Leadership Team to Accelerate Growth Plans as Company Seeks to Scale Innovative Drone Platforms Across Defense and Civilian Markets

FT. LAUDERDALE, FL, Oct. 02, 2026 (GLOBE NEWSWIRE) — / CORRECTING / Duke Robotics Corp. (Nasdaq: DUKR; DUKRW) (“Duke Robotics” or the “Company”), a leader in advanced robotics and drone-based solutions for civilian and defense markets, today announced the appointment of Avi Levin as Chief Financial Officer, effective October 1, 2026. Mr. Levin succeeds Shlomo Zakai, who is expected to continue providing financial and corporate consulting services to the Company to support a seamless transition of financial operations.

The appointment comes as Duke Robotics enters an accelerated growth phase following its recent Nasdaq uplisting and the arrival of Chief Executive Officer Yiftach Kleinman. As the Company looks to scale commercial adoption of its drone platforms across defense and civilian markets, and expand its offerings, the Company believes Mr. Levin will play a key role in developing Duke’s financial strategy, capital allocation, and corporate initiatives to support its growing operational footprint and strategic expansion plans.

“Since assuming the role of Chief Executive Officer, my focus has been to accelerate our operational tempo and assemble the executive leadership required to execute our growth strategy,” said Yiftach Kleinman, Chief Executive Officer of Duke Robotics. “Duke is at a pivotal inflection point. In the civilian sector, our utility grid solutions are commercially validated and addressing an urgent need for power infrastructure resilience amid rising geopolitical challenges and surging energy demand associated with, among other things, artificial intelligence. In defense, our battle-tested platforms are advancing toward broader commercialization. Bringing on an executive of Avi’s caliber is central to pursuing this market opportunity. He brings a rare combination of deep capital markets experience, proven public company CFO leadership, and strategic transaction expertise that we believe will be instrumental in scaling our business. On behalf of our Board of Directors and the entire Company, I also want to thank Shlomo Zakai for his dedicated financial stewardship through our Nasdaq uplisting, and we look forward to his continued support.”

Mr. Levin is an accomplished financial executive and certified public accountant with more than two decades of corporate finance, capital markets, and institutional leadership experience across the United States and Israel. Throughout his career, he has raised more than $130 million through private placements and public offerings with Nasdaq-listed issuers. He previously served as Chief Financial Officer of Ability Inc. (NASDAQ: ABIL), where he helped lead three Nasdaq offerings, raising an aggregate of $78 million. He also served as Chief Financial Officer of RAD Data Communications, a leading global telecommunications provider, where he managed a 49-person global finance and IT organization across 11 subsidiaries and led the company’s official Nasdaq IPO readiness initiative. Mr. Levin also served as Chief Financial Officer of enterprise AI software provider BlackSwan Technologies where he was part of their institutional financing round. Most recently, he served as a senior financial advisor and executive consultant, advising late-stage technology companies on U.S. capital raising, IPO readiness, and strategic transactions.

Earlier in his career, Mr. Levin worked in New York City at Credit Suisse (now part of UBS), where he worked on initial public offerings, follow-on equity offerings, and debt financings for NYSE-listed companies. He previously held corporate finance and controller positions at Broadridge Financial Solutions (NYSE: BR), where his responsibilities included acquisition accounting and post-merger integration, and served as Financial Reporting Manager at Overseas Shipholding Group (now International Seaways, NYSE: INSW). He began his career in the audit practice of PricewaterhouseCoopers (PwC) in its San Jose, California and Tel Aviv offices. Mr. Levin holds a Master of Business Administration (MBA) from the NYU Stern School of Business and a Bachelor of Arts in Economics and Accounting from Ben-Gurion University of the Negev. He is a Certified Public Accountant (CPA) in both the United States and Israel.

“I am thrilled to join Duke Robotics at such an exciting stage in its development,” said Avi Levin, incoming Chief Financial Officer. “Duke has developed innovative, proprietary drone technologies that I believe address clear and urgent operational needs across critical industries. With a strong public company platform on Nasdaq and energized leadership under Yiftach, the Company is positioned to pursue its growth strategy. I look forward to partnering closely with Yiftach, our Board of Directors, and our talented team to strengthen our financial foundation, support our strategic expansion, and drive long-term value for our shareholders.”

About Duke Robotics
Duke Robotics Corp. (Nasdaq: DUKR; DUKRW) develops advanced stabilization and autonomous robotic drone systems for both civilian and defense markets. The Company’s Insulator Cleaning Drone (IC Drone) is a first-of-its-kind, drone-enabled system for cleaning and monitoring high-voltage electric utility insulators. Leveraging Duke’s technologies, the IC Drone provides a safer, more efficient, and cost-effective alternative method. AEROTRACE™ is the Company’s AI-powered aerial monitoring and intelligence platform for infrastructure operators, designed to deliver actionable insights for asset assessment and proactive maintenance. In defense, through a collaboration agreement with Elbit Systems Land Ltd. (“Elbit”), the Bird of Prey weapons drone system is an agile, fully stabilized remote weapon system designed for non-line-of-sight and stand-off engagements, marketed by Elbit under the brand name Bird of Prey (formerly known as TIKAD). For additional Company information, please visit https://dukeroboticsys.com and follow us on Twitter (X) and LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements. Words such as “future” and similar expressions, or future or conditional verbs such as “will,” are intended to identify such forward-looking statements. Forward-looking statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on our beliefs, assumptions, and information currently available to us. For example, we are using forward-looking statements when we discuss the leadership transition and its anticipated benefits, the anticipated timing of Mr. Levin’s commencement of employment, the expected ongoing advisory role of Mr. Zakai, the anticipated benefits of Mr. Levin’s financial leadership and transaction background to the Company’s strategy and capital structure, the Company’s ability to accelerate operational execution and pipeline expansion, and the Company’s opportunities across the defense and energy-infrastructure sectors and beyond. Our actual results may differ materially from those expressed or implied due to known or unknown risks and uncertainties. These include, but are not limited to, risks related to the successful integration of new leadership, the successful market adoption of our technologies, the continued development and refinement of our technology, our ability to effectively collaborate with Elbit Systems, fluctuations in foreign currency exchange rates, operational challenges associated with marketing activities in new markets, economic conditions that may affect defense spending and infrastructure investment, geopolitical factors that could impact business operations, regulatory challenges in various regions, and competition from technological advances. For additional information on these and other risks and uncertainties, please see our filings with the Securities and Exchange Commission, including the discussion under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and any subsequent filings with the Securities and Exchange Commission. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Company Contact:
Duke Robotics Corp.
invest@dukeroboticsys.com

Investor Relations Contact:
Arx Investor Relations
North American Equities Desk
duke@arxhq.com

Duke Robotics Corp. is issuing this corrected release primarily to remove an incorrect reference to the annual revenues of RAD Data Communications from the description of Chief Financial Officer Avi Levin’s prior experience and to make certain other immaterial corrections to Mr. Levin’s biographical information.

Strengthens Executive Leadership Team to Accelerate Growth Plans as Company Seeks to Scale Innovative Drone Platforms Across Defense and Civilian Markets

FT. LAUDERDALE, FL, Oct. 02, 2026 (GLOBE NEWSWIRE) — / CORRECTING / Duke Robotics Corp. (Nasdaq: DUKR; DUKRW) (“Duke Robotics” or the “Company”), a leader in advanced robotics and drone-based solutions for civilian and defense markets, today announced the appointment of Avi Levin as Chief Financial Officer, effective October 1, 2026. Mr. Levin succeeds Shlomo Zakai, who is expected to continue providing financial and corporate consulting services to the Company to support a seamless transition of financial operations.

The appointment comes as Duke Robotics enters an accelerated growth phase following its recent Nasdaq uplisting and the arrival of Chief Executive Officer Yiftach Kleinman. As the Company looks to scale commercial adoption of its drone platforms across defense and civilian markets, and expand its offerings, the Company believes Mr. Levin will play a key role in developing Duke’s financial strategy, capital allocation, and corporate initiatives to support its growing operational footprint and strategic expansion plans.

“Since assuming the role of Chief Executive Officer, my focus has been to accelerate our operational tempo and assemble the executive leadership required to execute our growth strategy,” said Yiftach Kleinman, Chief Executive Officer of Duke Robotics. “Duke is at a pivotal inflection point. In the civilian sector, our utility grid solutions are commercially validated and addressing an urgent need for power infrastructure resilience amid rising geopolitical challenges and surging energy demand associated with, among other things, artificial intelligence. In defense, our battle-tested platforms are advancing toward broader commercialization. Bringing on an executive of Avi’s caliber is central to pursuing this market opportunity. He brings a rare combination of deep capital markets experience, proven public company CFO leadership, and strategic transaction expertise that we believe will be instrumental in scaling our business. On behalf of our Board of Directors and the entire Company, I also want to thank Shlomo Zakai for his dedicated financial stewardship through our Nasdaq uplisting, and we look forward to his continued support.”

Mr. Levin is an accomplished financial executive and certified public accountant with more than two decades of corporate finance, capital markets, and institutional leadership experience across the United States and Israel. Throughout his career, he has raised more than $130 million through private placements and public offerings with Nasdaq-listed issuers. He previously served as Chief Financial Officer of Ability Inc. (NASDAQ: ABIL), where he helped lead three Nasdaq offerings, raising an aggregate of $78 million. He also served as Chief Financial Officer of RAD Data Communications, a leading global telecommunications provider, where he managed a 49-person global finance and IT organization across 11 subsidiaries and led the company’s official Nasdaq IPO readiness initiative. Mr. Levin also served as Chief Financial Officer of enterprise AI software provider BlackSwan Technologies where he was part of their institutional financing round. Most recently, he served as a senior financial advisor and executive consultant, advising late-stage technology companies on U.S. capital raising, IPO readiness, and strategic transactions.

Earlier in his career, Mr. Levin worked in New York City at Credit Suisse (now part of UBS), where he worked on initial public offerings, follow-on equity offerings, and debt financings for NYSE-listed companies. He previously held corporate finance and controller positions at Broadridge Financial Solutions (NYSE: BR), where his responsibilities included acquisition accounting and post-merger integration, and served as Financial Reporting Manager at Overseas Shipholding Group (now International Seaways, NYSE: INSW). He began his career in the audit practice of PricewaterhouseCoopers (PwC) in its San Jose, California and Tel Aviv offices. Mr. Levin holds a Master of Business Administration (MBA) from the NYU Stern School of Business and a Bachelor of Arts in Economics and Accounting from Ben-Gurion University of the Negev. He is a Certified Public Accountant (CPA) in both the United States and Israel.

“I am thrilled to join Duke Robotics at such an exciting stage in its development,” said Avi Levin, incoming Chief Financial Officer. “Duke has developed innovative, proprietary drone technologies that I believe address clear and urgent operational needs across critical industries. With a strong public company platform on Nasdaq and energized leadership under Yiftach, the Company is positioned to pursue its growth strategy. I look forward to partnering closely with Yiftach, our Board of Directors, and our talented team to strengthen our financial foundation, support our strategic expansion, and drive long-term value for our shareholders.”

About Duke Robotics
Duke Robotics Corp. (Nasdaq: DUKR; DUKRW) develops advanced stabilization and autonomous robotic drone systems for both civilian and defense markets. The Company’s Insulator Cleaning Drone (IC Drone) is a first-of-its-kind, drone-enabled system for cleaning and monitoring high-voltage electric utility insulators. Leveraging Duke’s technologies, the IC Drone provides a safer, more efficient, and cost-effective alternative method. AEROTRACE™ is the Company’s AI-powered aerial monitoring and intelligence platform for infrastructure operators, designed to deliver actionable insights for asset assessment and proactive maintenance. In defense, through a collaboration agreement with Elbit Systems Land Ltd. (“Elbit”), the Bird of Prey weapons drone system is an agile, fully stabilized remote weapon system designed for non-line-of-sight and stand-off engagements, marketed by Elbit under the brand name Bird of Prey (formerly known as TIKAD). For additional Company information, please visit https://dukeroboticsys.com and follow us on Twitter (X) and LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements. Words such as “future” and similar expressions, or future or conditional verbs such as “will,” are intended to identify such forward-looking statements. Forward-looking statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on our beliefs, assumptions, and information currently available to us. For example, we are using forward-looking statements when we discuss the leadership transition and its anticipated benefits, the anticipated timing of Mr. Levin’s commencement of employment, the expected ongoing advisory role of Mr. Zakai, the anticipated benefits of Mr. Levin’s financial leadership and transaction background to the Company’s strategy and capital structure, the Company’s ability to accelerate operational execution and pipeline expansion, and the Company’s opportunities across the defense and energy-infrastructure sectors and beyond. Our actual results may differ materially from those expressed or implied due to known or unknown risks and uncertainties. These include, but are not limited to, risks related to the successful integration of new leadership, the successful market adoption of our technologies, the continued development and refinement of our technology, our ability to effectively collaborate with Elbit Systems, fluctuations in foreign currency exchange rates, operational challenges associated with marketing activities in new markets, economic conditions that may affect defense spending and infrastructure investment, geopolitical factors that could impact business operations, regulatory challenges in various regions, and competition from technological advances. For additional information on these and other risks and uncertainties, please see our filings with the Securities and Exchange Commission, including the discussion under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and any subsequent filings with the Securities and Exchange Commission. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Company Contact:
Duke Robotics Corp.
invest@dukeroboticsys.com

Investor Relations Contact:
Arx Investor Relations
North American Equities Desk
duke@arxhq.com

Duke Robotics Corp. is issuing this corrected release primarily to remove an incorrect reference to the annual revenues of RAD Data Communications from the description of Chief Financial Officer Avi Levin’s prior experience and to make certain other immaterial corrections to Mr. Levin’s biographical information.

  • The published review examines dopamine’s role in tic generation and how approved and investigational drugs may affect dopamine to reduce tics as well as synthesizes clinical trial evidence that ecopipam reduces tic severity, provides sustained benefit over time and helps prevent relapse without some of the complications associated with antipsychotic agents.¹
  • Ecopipam is an investigational, selective D1 (dopamine) receptor antagonist targeting dopaminergic signaling in the brain’s direct motor pathway implicated in Tourette syndrome.
  • Unlike D2 antipsychotics that target D2 receptors in the indirect pathway, ecopipam selectively targets D1 receptors in the direct motor pathway, offering a differentiated approach that may reduce tic severity while potentially avoiding common adverse events associated with D2-targeting therapies.1

PARSIPPANY, N.J., Oct. 02, 2026 (GLOBE NEWSWIRE) — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the Journal of Child Neurology published a comprehensive review examining dopamine pathways in Tourette syndrome and the therapeutic potential of ecopipam, a first-in-class investigational selective D1 (dopamine) receptor antagonist for the treatment of pediatric patients with Tourette syndrome.1,2 The review evaluates current treatment limitations and details how selectively targeting D1 receptors in the brain’s direct motor pathway may offer a differentiated, non-antipsychotic approach for managing tics in pediatric patients.1

“Tourette syndrome affects up to 1 in 130 children globally and can have a profound impact on a child’s daily life, education and social development,” said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer at Teva. “The review published in the Journal of Child Neurology reinforces the potential of ecopipam’s selective dopamine D1 receptor approach. This is the kind of innovative programs we are pursuing at Teva—advancing differentiated science to address meaningful unmet needs.”

The comprehensive review details the neurobiological rationale for D1 receptor antagonism compared with existing therapies. In Tourette syndrome, elevated dopaminergic activity in the basal ganglia is proposed to contribute to the expression of involuntary tics. Because D1 receptors are primarily expressed by neurons in the direct motor pathway, ecopipam is hypothesized to block excess dopaminergic activity in this pathway, thereby normalizing downstream basal ganglia signaling and movement patterns. In contrast, traditional antipsychotics target D2 receptors, which are primarily associated with the indirect pathway.

This mechanistic distinction is supported by clinical data synthesized across the ecopipam development program. In a Phase 3 trial (n=216, including 167 pediatric), continued ecopipam treatment cut the risk of tic relapse by 50% versus placebo in pediatric participants (HR: 0.5; P=0.008), building on Phase 2b and 12-month open-label data showing sustained reductions in tic severity. Across clinical trials, the most common adverse events included somnolence, headache, insomnia, fatigue and anxiety while ecopipam was not associated with clinically relevant weight gain, adverse metabolic effects or drug-induced movement disorders. The potential importance of this efficacy and tolerability profile is underscored by real-world treatment persistence data, which show that treatment discontinuation rates among patients newly treated with D2 receptor antagonists were 61.2% by 3 months and 82.1% by 18 months.1

“Treatment of Tourette syndrome can be complex, as clinicians must balance tic improvement with the side effect profiles of current therapies,” said Donald L. Gilbert, M.D., M.S., senior author of the review and Pediatric Movement Disorders and Tourette Syndrome Specialist, Division of Neurology, Cincinnati Children’s Hospital Medical Center. “Ecopipam selectively targets the dopamine D1 receptor, and the data reviewed in this publication – demonstrating reduced tic severity and sustained benefit without significant weight gain, metabolic complications or movement disorders – supports continued research into D1 receptor antagonism for Tourette syndrome.”

For more information on the review published online in the Journal of Child Neurology, click here.

About Tourette Syndrome 
Tourette syndrome is a chronic neuro-developmental disorder characterized by involuntary motor and vocal tics beginning in childhood, often between 5 and 10 years of age.3 For people living with Tourette syndrome, symptoms can be frequent, visible and disruptive, affecting everyday life.3

About Ecopipam and Its Clinical Program 
Ecopipam is a first-in-class investigational therapy designed to block dopamine signaling at the D1 receptor. D1 receptor hypersensitivity may contribute to repetitive and compulsive behaviors associated with Tourette syndrome. 

Ecopipam was granted Priority Review by the FDA with Orphan Drug designation for the treatment of pediatric patients with Tourette syndrome. Orphan Drug designation is reserved for patient populations of 200,000 or fewer. 

The D1AMOND Phase 2b Trial was a 12-week randomized, double-blind, placebo-controlled trial that studied 153 pediatric participants across 68 sites in North America and Europe. The primary efficacy endpoint was the change in the YGTSS-TTS, i.e., sum of the motor and vocal tic scores, from baseline to end of therapy.4 The associated Phase 2b open-label extension enrolled 121 pediatric subjects from the Phase 2b trial and followed them for up to 12 months’ duration to evaluate the long-term safety and tolerability of ecopipam.5 The subsequent D1AMOND Phase 3 Trial was a double-blind, placebo-controlled, randomized withdrawal trial enrolling a total of 216 pediatric and adult participants into an open-label stabilization period and randomizing 104 participants (90 pediatric, 14 adult) across 77 sites in North America and Europe. The objective of this study was to evaluate the maintenance of efficacy of ecopipam in pediatric and adult responders utilizing the YGTSS-TTS change from randomization or increased Tourette-specific care to determine relapse.6 While this Phase 3 trial included adult participants, the accepted NDA and resulting indication sought by Teva are exclusively for pediatric patients. 

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 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 successfully develop, obtain regulatory approval for and commercialize ecopipam; our ability to successfully compete in the marketplace including our ability to develop and commercialize ecopipam for the treatment of pediatric patients with Tourette syndrome; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and to profitably commercialize our 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” 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.

References:

  1. Karkanias, G. B., Flatt, J. A., Korb, R. T., Munschauer, F. E., Wanaski, S. P., Cunniff, T. M., & Gilbert, D. L. (2026). Targeting Dopamine Pathways for the Treatment of Tourette Syndrome. Journal of Child Neurology. https://doi.org/10.1177/08830738261491159
  2. U.S. Food and Drug Administration (FDA) Approval Records: Haloperidol (1969), Pimozide (1984), Aripiprazole (2014); Pringsheim, T., et al. (2019). The pharmacological management of tic disorders: an updated practice guideline. Neurology. 
  3. CDC | Tourette Syndrome | Data and Statistics on Tourette Syndrome, 2024; Mayo Clinic | Tourette Syndrome – Diagnosis and treatment, 2025. 
  4. Gilbert DL, Dubow JS, Cunniff TM, et al. Ecopipam for Tourette Syndrome: A Randomized Trial. Pediatrics. 2023;151(2):e2022059574. doi:10.1542/peds.2022-059574 
  5. Gilbert DL, Kim DJB, Miller MM, et al. Safety and Effect of 12-Month Ecopipam Treatment in Pediatric Patients with Tourette Syndrome. Mov Disord Clin Pract. 2025;12(8):1157-1166. doi:10.1002/mdc3.70091. 
  6. Gilbert DL, Atkinson SD, Kim DJB, et al. Efficacy and Safety of Ecopipam for Tourette Syndrome: A Phase 3 Randomized Clinical Trial. JAMA Neurol. 2026;83(7):645–653. doi:10.1001/jamaneurol.2026.1431

Teva Media Inquiries:
tevacommunicationsnorthamerica@tevapharm.com

Teva Investor Relations Inquiries:
TevaIR@tevapharm.com

  • The published review examines dopamine’s role in tic generation and how approved and investigational drugs may affect dopamine to reduce tics as well as synthesizes clinical trial evidence that ecopipam reduces tic severity, provides sustained benefit over time and helps prevent relapse without some of the complications associated with antipsychotic agents.¹
  • Ecopipam is an investigational, selective D1 (dopamine) receptor antagonist targeting dopaminergic signaling in the brain’s direct motor pathway implicated in Tourette syndrome.
  • Unlike D2 antipsychotics that target D2 receptors in the indirect pathway, ecopipam selectively targets D1 receptors in the direct motor pathway, offering a differentiated approach that may reduce tic severity while potentially avoiding common adverse events associated with D2-targeting therapies.1

PARSIPPANY, N.J., Oct. 02, 2026 (GLOBE NEWSWIRE) — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the Journal of Child Neurology published a comprehensive review examining dopamine pathways in Tourette syndrome and the therapeutic potential of ecopipam, a first-in-class investigational selective D1 (dopamine) receptor antagonist for the treatment of pediatric patients with Tourette syndrome.1,2 The review evaluates current treatment limitations and details how selectively targeting D1 receptors in the brain’s direct motor pathway may offer a differentiated, non-antipsychotic approach for managing tics in pediatric patients.1

“Tourette syndrome affects up to 1 in 130 children globally and can have a profound impact on a child’s daily life, education and social development,” said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer at Teva. “The review published in the Journal of Child Neurology reinforces the potential of ecopipam’s selective dopamine D1 receptor approach. This is the kind of innovative programs we are pursuing at Teva—advancing differentiated science to address meaningful unmet needs.”

The comprehensive review details the neurobiological rationale for D1 receptor antagonism compared with existing therapies. In Tourette syndrome, elevated dopaminergic activity in the basal ganglia is proposed to contribute to the expression of involuntary tics. Because D1 receptors are primarily expressed by neurons in the direct motor pathway, ecopipam is hypothesized to block excess dopaminergic activity in this pathway, thereby normalizing downstream basal ganglia signaling and movement patterns. In contrast, traditional antipsychotics target D2 receptors, which are primarily associated with the indirect pathway.

This mechanistic distinction is supported by clinical data synthesized across the ecopipam development program. In a Phase 3 trial (n=216, including 167 pediatric), continued ecopipam treatment cut the risk of tic relapse by 50% versus placebo in pediatric participants (HR: 0.5; P=0.008), building on Phase 2b and 12-month open-label data showing sustained reductions in tic severity. Across clinical trials, the most common adverse events included somnolence, headache, insomnia, fatigue and anxiety while ecopipam was not associated with clinically relevant weight gain, adverse metabolic effects or drug-induced movement disorders. The potential importance of this efficacy and tolerability profile is underscored by real-world treatment persistence data, which show that treatment discontinuation rates among patients newly treated with D2 receptor antagonists were 61.2% by 3 months and 82.1% by 18 months.1

“Treatment of Tourette syndrome can be complex, as clinicians must balance tic improvement with the side effect profiles of current therapies,” said Donald L. Gilbert, M.D., M.S., senior author of the review and Pediatric Movement Disorders and Tourette Syndrome Specialist, Division of Neurology, Cincinnati Children’s Hospital Medical Center. “Ecopipam selectively targets the dopamine D1 receptor, and the data reviewed in this publication – demonstrating reduced tic severity and sustained benefit without significant weight gain, metabolic complications or movement disorders – supports continued research into D1 receptor antagonism for Tourette syndrome.”

For more information on the review published online in the Journal of Child Neurology, click here.

About Tourette Syndrome 
Tourette syndrome is a chronic neuro-developmental disorder characterized by involuntary motor and vocal tics beginning in childhood, often between 5 and 10 years of age.3 For people living with Tourette syndrome, symptoms can be frequent, visible and disruptive, affecting everyday life.3

About Ecopipam and Its Clinical Program 
Ecopipam is a first-in-class investigational therapy designed to block dopamine signaling at the D1 receptor. D1 receptor hypersensitivity may contribute to repetitive and compulsive behaviors associated with Tourette syndrome. 

Ecopipam was granted Priority Review by the FDA with Orphan Drug designation for the treatment of pediatric patients with Tourette syndrome. Orphan Drug designation is reserved for patient populations of 200,000 or fewer. 

The D1AMOND Phase 2b Trial was a 12-week randomized, double-blind, placebo-controlled trial that studied 153 pediatric participants across 68 sites in North America and Europe. The primary efficacy endpoint was the change in the YGTSS-TTS, i.e., sum of the motor and vocal tic scores, from baseline to end of therapy.4 The associated Phase 2b open-label extension enrolled 121 pediatric subjects from the Phase 2b trial and followed them for up to 12 months’ duration to evaluate the long-term safety and tolerability of ecopipam.5 The subsequent D1AMOND Phase 3 Trial was a double-blind, placebo-controlled, randomized withdrawal trial enrolling a total of 216 pediatric and adult participants into an open-label stabilization period and randomizing 104 participants (90 pediatric, 14 adult) across 77 sites in North America and Europe. The objective of this study was to evaluate the maintenance of efficacy of ecopipam in pediatric and adult responders utilizing the YGTSS-TTS change from randomization or increased Tourette-specific care to determine relapse.6 While this Phase 3 trial included adult participants, the accepted NDA and resulting indication sought by Teva are exclusively for pediatric patients. 

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 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 successfully develop, obtain regulatory approval for and commercialize ecopipam; our ability to successfully compete in the marketplace including our ability to develop and commercialize ecopipam for the treatment of pediatric patients with Tourette syndrome; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and to profitably commercialize our 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” 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.

References:

  1. Karkanias, G. B., Flatt, J. A., Korb, R. T., Munschauer, F. E., Wanaski, S. P., Cunniff, T. M., & Gilbert, D. L. (2026). Targeting Dopamine Pathways for the Treatment of Tourette Syndrome. Journal of Child Neurology. https://doi.org/10.1177/08830738261491159
  2. U.S. Food and Drug Administration (FDA) Approval Records: Haloperidol (1969), Pimozide (1984), Aripiprazole (2014); Pringsheim, T., et al. (2019). The pharmacological management of tic disorders: an updated practice guideline. Neurology. 
  3. CDC | Tourette Syndrome | Data and Statistics on Tourette Syndrome, 2024; Mayo Clinic | Tourette Syndrome – Diagnosis and treatment, 2025. 
  4. Gilbert DL, Dubow JS, Cunniff TM, et al. Ecopipam for Tourette Syndrome: A Randomized Trial. Pediatrics. 2023;151(2):e2022059574. doi:10.1542/peds.2022-059574 
  5. Gilbert DL, Kim DJB, Miller MM, et al. Safety and Effect of 12-Month Ecopipam Treatment in Pediatric Patients with Tourette Syndrome. Mov Disord Clin Pract. 2025;12(8):1157-1166. doi:10.1002/mdc3.70091. 
  6. Gilbert DL, Atkinson SD, Kim DJB, et al. Efficacy and Safety of Ecopipam for Tourette Syndrome: A Phase 3 Randomized Clinical Trial. JAMA Neurol. 2026;83(7):645–653. doi:10.1001/jamaneurol.2026.1431

Teva Media Inquiries:
tevacommunicationsnorthamerica@tevapharm.com

Teva Investor Relations Inquiries:
TevaIR@tevapharm.com

  • Based on a post hoc analysis, a majority of participants (~70%) experienced clinically meaningful tic reduction within 8 weeks of starting ecopipam
  • An interim 18-month analysis of an ongoing open-label extension study demonstrated a mean reduction in tic severity scores (45.6%) with no new safety signals observed
  • Additional analyses found that common concurrent psychiatric conditions did not negatively impact ecopipam’s efficacy or safety, adding to the growing body of evidence supporting ecopipam’s application currently under FDA Priority Review

PARSIPPANY, N.J., Oct. 02, 2026 (GLOBE NEWSWIRE) — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new data for ecopipam, a first-in-class investigational selective D1 (dopamine) receptor antagonist for the treatment of pediatric patients with Tourette syndrome. Presented at the International Congress of Parkinson’s Disease and Movement Disorders (MDS) in Seoul, South Korea (October 4–8, 2026), the data include a post hoc analysis of safety and efficacy during the initial 8 weeks of treatment with ecopipam, long-term efficacy and safety from an interim analysis of an ongoing open-label extension (OLE) study, post hoc subgroup analyses and preclinical receptor selectivity findings.

“Tourette syndrome is a complex neurodevelopmental disorder that presents significant daily challenges for children and their families,” said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer of Teva. “These promising new data for ecopipam reinforce our confidence in its potential in pediatric Tourette syndrome care. If approved, ecopipam would be the first new therapy for Tourette syndrome in more than 10 years and the first with a novel mechanism of action in more than 50 years.”

Key Findings from Studies Include:

  • Tic Severity Reduction Observed Within Two Months of Treatment: In a pooled post hoc analysis of 292 patients across Phase 2b and Phase 3 trials, a clinically meaningful improvement in the Yale Global Tic Severity Scale Total Tic Score (YGTSS-TTS) (score ≥25%) was observed in 69.8% of participants within the first eight weeks of treatment with ecopipam. The most commonly reported adverse events (AEs) were somnolence and headache, and the most commonly reported cross-trial AEs were most often observed within the first eight weeks of ecopipam exposure.
  • Clinically Meaningful Reduction in Tic Severity Sustained >1 year: An interim analysis of an ongoing 36-month OLE study included patients who completed the phase 3 study and the phase 2b OLE study receiving ecopipam titrated over 3-4 weeks then maintained at a target dose for up to 36 months. The study evaluated 118 children, adolescents and adults with Tourette syndrome who received at least one dose of ecopipam (median treatment exposure of 14.9 months). Ecopipam maintained clinically meaningful tic suppression through 18 months according to the YGTSS-TTS. The most commonly reported AEs were nasopharyngitis, upper respiratory tract infection, anxiety, diarrhea, influenza, pyrexia and insomnia.
  • Co-Occurring Psychiatric Conditions Did Not Impact Efficacy or Safety of Ecopipam: A post hoc analysis evaluated 216 participants (aged ≥6 years) from the Phase 3 trial, comparing outcomes between those with (n=129) and without (n=87) common co-occurring psychiatric conditions, including ADHD, OCD, anxiety and depression. During the 12-week open-label period, the presence of co-occurring conditions did not negatively impact reductions in tic severity, with mean YGTSS-TTS score reductions consistent across participants with ≥1 co-occurring conditions and those without. Overall safety and tolerability profiles were similarly consistent between both groups.

“Many children with Tourette syndrome do not receive treatment, and among those who do, treatment is often discontinued within a year because symptoms remain inadequately controlled or side effects become difficult to tolerate,” said Donald L. Gilbert, M.D., M.S., Pediatric Movement Disorders and Tourette Syndrome Specialist, Division of Neurology, Cincinnati Children’s Hospital Medical Center. “Children living with Tourette syndrome urgently need treatment options that work rapidly, remain effective over time and have a demonstrated tolerability profile. These findings are encouraging because they suggest that, if approved, ecopipam may offer patients and families a meaningful new option.”

About Tourette Syndrome
Tourette syndrome is a chronic neuro-developmental disorder characterized by involuntary motor and vocal tics beginning in childhood, often between 5 and 10 years of age.2 For people living with Tourette syndrome, symptoms can be frequent, visible and disruptive, affecting everyday life.2

About Ecopipam and Its Clinical Program
Ecopipam is a first-in-class investigational therapy designed to block dopamine signaling at the D1 receptor. D1 receptor hypersensitivity may contribute to repetitive and compulsive behaviors associated with Tourette syndrome.

Ecopipam was granted Priority Review by the FDA with Orphan Drug designation for the treatment of pediatric patients with Tourette syndrome. Orphan Drug designation is reserved for patient populations of 200,000 or fewer.

The D1AMOND Phase 2b Trial was a 12-week randomized, double-blind, placebo-controlled trial that studied 153 pediatric participants across 68 sites in North America and Europe. The primary efficacy endpoint was the change in the YGTSS-TTS, i.e., sum of the motor and vocal tic scores, from baseline to end of therapy.3 The associated Phase 2b open-label extension enrolled 121 pediatric subjects from the Phase 2b trial and followed them for up to 12 months’ duration to evaluate the long-term safety and tolerability of ecopipam.4 The subsequent D1AMOND Phase 3 Trial was a double-blind, placebo-controlled, randomized withdrawal trial enrolling a total of 216 pediatric and adult participants into an open-label stabilization period and randomizing 104 participants (90 pediatric, 14 adult) across 77 sites in North America and Europe. The objective of this study was to evaluate the maintenance of efficacy of ecopipam in pediatric and adult responders utilizing the YGTSS-TTS change from randomization or increased Tourette-specific care to determine relapse.5 While this Phase 3 trial included adult participants, the accepted NDA and resulting indication sought by Teva are exclusively for pediatric patients.

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 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 successfully develop, obtain regulatory approval for and commercialize ecopipam; our ability to successfully compete in the marketplace including our ability to develop and commercialize ecopipam for the treatment of pediatric patients with Tourette syndrome; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and to profitably commercialize our 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” 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.

References:

  1. U.S. Food and Drug Administration (FDA) Approval Records: Haloperidol (1969), Pimozide (1984), Aripiprazole (2014); Pringsheim, T., et al. (2019). The pharmacological management of tic disorders: an updated practice guideline. Neurology.
  2. CDC | Tourette Syndrome | Data and Statistics on Tourette Syndrome, 2024; Mayo Clinic | Tourette Syndrome – Diagnosis and treatment, 2025.
  3. Gilbert DL, Dubow JS, Cunniff TM, et al. Ecopipam for Tourette Syndrome: A Randomized Trial. Pediatrics. 2023;151(2):e2022059574. doi:10.1542/peds.2022-059574
  4. Gilbert DL, Kim DJB, Miller MM, et al. Safety and Effect of 12-Month Ecopipam Treatment in Pediatric Patients with Tourette Syndrome. Mov Disord Clin Pract. 2025;12(8):1157-1166. doi:10.1002/mdc3.70091.
  5. Gilbert DL, Atkinson SD, Kim DJB, et al. Efficacy and Safety of Ecopipam for Tourette Syndrome: A Phase 3 Randomized Clinical Trial. JAMA Neurol. 2026;83(7):645–653. doi:10.1001/jamaneurol.2026.1431

Teva Media Inquiries:
TevaCommunicationsNorthAmerica@tevapharm.com

Teva Investor Relations Inquiries:
TevaIR@Tevapharm.com

  • Based on a post hoc analysis, a majority of participants (~70%) experienced clinically meaningful tic reduction within 8 weeks of starting ecopipam
  • An interim 18-month analysis of an ongoing open-label extension study demonstrated a mean reduction in tic severity scores (45.6%) with no new safety signals observed
  • Additional analyses found that common concurrent psychiatric conditions did not negatively impact ecopipam’s efficacy or safety, adding to the growing body of evidence supporting ecopipam’s application currently under FDA Priority Review

PARSIPPANY, N.J., Oct. 02, 2026 (GLOBE NEWSWIRE) — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new data for ecopipam, a first-in-class investigational selective D1 (dopamine) receptor antagonist for the treatment of pediatric patients with Tourette syndrome. Presented at the International Congress of Parkinson’s Disease and Movement Disorders (MDS) in Seoul, South Korea (October 4–8, 2026), the data include a post hoc analysis of safety and efficacy during the initial 8 weeks of treatment with ecopipam, long-term efficacy and safety from an interim analysis of an ongoing open-label extension (OLE) study, post hoc subgroup analyses and preclinical receptor selectivity findings.

“Tourette syndrome is a complex neurodevelopmental disorder that presents significant daily challenges for children and their families,” said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer of Teva. “These promising new data for ecopipam reinforce our confidence in its potential in pediatric Tourette syndrome care. If approved, ecopipam would be the first new therapy for Tourette syndrome in more than 10 years and the first with a novel mechanism of action in more than 50 years.”

Key Findings from Studies Include:

  • Tic Severity Reduction Observed Within Two Months of Treatment: In a pooled post hoc analysis of 292 patients across Phase 2b and Phase 3 trials, a clinically meaningful improvement in the Yale Global Tic Severity Scale Total Tic Score (YGTSS-TTS) (score ≥25%) was observed in 69.8% of participants within the first eight weeks of treatment with ecopipam. The most commonly reported adverse events (AEs) were somnolence and headache, and the most commonly reported cross-trial AEs were most often observed within the first eight weeks of ecopipam exposure.
  • Clinically Meaningful Reduction in Tic Severity Sustained >1 year: An interim analysis of an ongoing 36-month OLE study included patients who completed the phase 3 study and the phase 2b OLE study receiving ecopipam titrated over 3-4 weeks then maintained at a target dose for up to 36 months. The study evaluated 118 children, adolescents and adults with Tourette syndrome who received at least one dose of ecopipam (median treatment exposure of 14.9 months). Ecopipam maintained clinically meaningful tic suppression through 18 months according to the YGTSS-TTS. The most commonly reported AEs were nasopharyngitis, upper respiratory tract infection, anxiety, diarrhea, influenza, pyrexia and insomnia.
  • Co-Occurring Psychiatric Conditions Did Not Impact Efficacy or Safety of Ecopipam: A post hoc analysis evaluated 216 participants (aged ≥6 years) from the Phase 3 trial, comparing outcomes between those with (n=129) and without (n=87) common co-occurring psychiatric conditions, including ADHD, OCD, anxiety and depression. During the 12-week open-label period, the presence of co-occurring conditions did not negatively impact reductions in tic severity, with mean YGTSS-TTS score reductions consistent across participants with ≥1 co-occurring conditions and those without. Overall safety and tolerability profiles were similarly consistent between both groups.

“Many children with Tourette syndrome do not receive treatment, and among those who do, treatment is often discontinued within a year because symptoms remain inadequately controlled or side effects become difficult to tolerate,” said Donald L. Gilbert, M.D., M.S., Pediatric Movement Disorders and Tourette Syndrome Specialist, Division of Neurology, Cincinnati Children’s Hospital Medical Center. “Children living with Tourette syndrome urgently need treatment options that work rapidly, remain effective over time and have a demonstrated tolerability profile. These findings are encouraging because they suggest that, if approved, ecopipam may offer patients and families a meaningful new option.”

About Tourette Syndrome
Tourette syndrome is a chronic neuro-developmental disorder characterized by involuntary motor and vocal tics beginning in childhood, often between 5 and 10 years of age.2 For people living with Tourette syndrome, symptoms can be frequent, visible and disruptive, affecting everyday life.2

About Ecopipam and Its Clinical Program
Ecopipam is a first-in-class investigational therapy designed to block dopamine signaling at the D1 receptor. D1 receptor hypersensitivity may contribute to repetitive and compulsive behaviors associated with Tourette syndrome.

Ecopipam was granted Priority Review by the FDA with Orphan Drug designation for the treatment of pediatric patients with Tourette syndrome. Orphan Drug designation is reserved for patient populations of 200,000 or fewer.

The D1AMOND Phase 2b Trial was a 12-week randomized, double-blind, placebo-controlled trial that studied 153 pediatric participants across 68 sites in North America and Europe. The primary efficacy endpoint was the change in the YGTSS-TTS, i.e., sum of the motor and vocal tic scores, from baseline to end of therapy.3 The associated Phase 2b open-label extension enrolled 121 pediatric subjects from the Phase 2b trial and followed them for up to 12 months’ duration to evaluate the long-term safety and tolerability of ecopipam.4 The subsequent D1AMOND Phase 3 Trial was a double-blind, placebo-controlled, randomized withdrawal trial enrolling a total of 216 pediatric and adult participants into an open-label stabilization period and randomizing 104 participants (90 pediatric, 14 adult) across 77 sites in North America and Europe. The objective of this study was to evaluate the maintenance of efficacy of ecopipam in pediatric and adult responders utilizing the YGTSS-TTS change from randomization or increased Tourette-specific care to determine relapse.5 While this Phase 3 trial included adult participants, the accepted NDA and resulting indication sought by Teva are exclusively for pediatric patients.

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 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 successfully develop, obtain regulatory approval for and commercialize ecopipam; our ability to successfully compete in the marketplace including our ability to develop and commercialize ecopipam for the treatment of pediatric patients with Tourette syndrome; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and to profitably commercialize our 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” 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.

References:

  1. U.S. Food and Drug Administration (FDA) Approval Records: Haloperidol (1969), Pimozide (1984), Aripiprazole (2014); Pringsheim, T., et al. (2019). The pharmacological management of tic disorders: an updated practice guideline. Neurology.
  2. CDC | Tourette Syndrome | Data and Statistics on Tourette Syndrome, 2024; Mayo Clinic | Tourette Syndrome – Diagnosis and treatment, 2025.
  3. Gilbert DL, Dubow JS, Cunniff TM, et al. Ecopipam for Tourette Syndrome: A Randomized Trial. Pediatrics. 2023;151(2):e2022059574. doi:10.1542/peds.2022-059574
  4. Gilbert DL, Kim DJB, Miller MM, et al. Safety and Effect of 12-Month Ecopipam Treatment in Pediatric Patients with Tourette Syndrome. Mov Disord Clin Pract. 2025;12(8):1157-1166. doi:10.1002/mdc3.70091.
  5. Gilbert DL, Atkinson SD, Kim DJB, et al. Efficacy and Safety of Ecopipam for Tourette Syndrome: A Phase 3 Randomized Clinical Trial. JAMA Neurol. 2026;83(7):645–653. doi:10.1001/jamaneurol.2026.1431

Teva Media Inquiries:
TevaCommunicationsNorthAmerica@tevapharm.com

Teva Investor Relations Inquiries:
TevaIR@Tevapharm.com

Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.