{"success":true,"data":{"pressRelease":{"id":"133651","rtpr_id":"nGNX6nQ8Mw","ticker":"TEVA","exchange":"","all_tickers":["TEVA"],"title":"Teva Announces Positive Topline Results from Phase 2a Study in Celiac Disease for Its Anti-IL-15 Antibody, Further Validating Its Pipeline-in-a-Product Potential","author":"Globe Newswire","published_at":"2026-09-02T11:03:00.405Z","article_body":"* Teva-discovered TEV ‘408, a novel anti-IL-15 monoclonal antibody,\ndemonstrated statistically significant and clinically meaningful prevention of\ngluten-induced intestinal damage vs placebo following a single subcutaneous\ndose.\n* TEV ‘408 was well-tolerated with no safety signals observed to date.\n* Together with the vitiligo program, the celiac disease topline results\nfurther support TEV ‘408 as a potential pipeline-in-a-product opportunity in\nmultiple diseases.\nTeva will hold an investor call and live webcast today,\nWednesday, September 2, 2026, at 8:00 a.m. ET to discuss these data.\n\nTEL AVIV, Israel, Sept. 02, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical\nIndustries Ltd. (NYSE and TASE: TEVA) today announced positive topline results\nfrom an ongoing Phase 2a study of TEV ‘408, an investigational\nanti-interleukin-15 monoclonal antibody, in adults with celiac disease. The\nstudy met its primary endpoint, demonstrating statistically significant and\nclinically meaningful prevention of gluten-induced intestinal damage versus\nplacebo at week 8. TEV ‘408 was well-tolerated, with no safety signals\nobserved to date.\n\n“A strict gluten-free diet has long been the only option for people living\nwith celiac disease. Yet, even with strict adherence to a gluten-free diet,\nmany continue to experience symptoms, intestinal damage and a significant\nimpact on their daily lives,” said Eric Hughes, MD, PhD, Executive Vice\nPresident, Global R&D and Chief Medical Officer at Teva\n(https://www.globenewswire.com/Tracker?data=bUU1YOWqwIp5Ao3WdTGFgy9LTWzaIV7tKYw4GZRVjbVgenoXWkGS5DplHF8bYxGou1UleTEAp903n1x7a6CirozIwchPj69v0ngeJJGGSiGeYqmf4x49QPGPUZOzb6XVeIEVrqVKydUb_wZlhkpcotl_SbVoTr12maM3G_YlcAeyqXDOlIpjv0Ku7lmpEXIEslMiRu0QCJyzXHX4sk1W7C2gQie3NAUS0kP9rtNJAgrAHsYeMvUQC9K9QPqGCUilas4GvhRQVYSvFGhezLzEnWaw8oJVQTCOt4FutIWSr4Y=).\n“These results underscore the potential to move beyond managing gluten\nexposure and address celiac disease at its biological source. They also\nstrengthen our confidence in targeting the IL-15 pathway as an approach to\nreducing immune-driven intestinal damage.”\n\nThe ongoing randomized, placebo-controlled study enrolled 50 adult\nparticipants with celiac disease on a gluten-free diet (GFD) with minimal\nintestinal damage at baseline as measured by the villous height-to-crypt depth\nratio (Vh:Cd ≥2.0) and symptoms. Two weeks after receiving a single dose of\nTEV ‘408, participants began a six-week daily gluten challenge (GC). The\nstudy assessed biopsy-based measures of intestinal damage and inflammation\nalong with patient-reported symptoms. At week 8 (the end of the GC) TEV\n‘408:\n* Showed statistically significant and clinically meaningful prevention of\ngluten-induced intestinal damage versus placebo, as measured by the trial’s\nprimary endpoint of Vh:Cd ratio with a least squares (LS) mean change from\nbaseline of -0.43 compared with -0.88 for placebo (treatment difference of\n0.45, 95% CI: (0.06, 0.84), p<0.05).\n* Showed a favorable effect on intestinal inflammation as measured by density\nof intraepithelial lymphocytes (IELs) compared with placebo; the LS Mean\nchange from baseline in the density of IELs, was an increase of 27.60 for\nplacebo compared to 0.37 for TEV ‘408 treated participants (treatment\ndifference of -27.23, 95% CI: (-39.67, -14.79)).\n* Demonstrated lower GI symptom scores versus placebo, as assessed using the\nCeliac Disease Symptom Diary (CDSD), a patient-reported outcome (PRO).\n* Was well-tolerated with no emerging safety signals.\nAdditional analyses from the ongoing Phase 2a study are underway. Teva plans\nto present further data from the study at a future scientific meeting.\n\nTeva Investor Call\nTeva will hold an investor call and live webcast today, Wednesday, September\n2, 2026, at 8:00 a.m. ET/ 2:00 p.m. CET to discuss these data. To participate,\nplease register in advance here\n(https://www.globenewswire.com/Tracker?data=UodgELr4u5UJZZQEGKe1MS61pGqX-ODhjAWzhJ8lO4H6m5Dbl07Lh8JeIlbqeJuvVesDDDgbfj_pzKzNyq2zn-5DS9Qwle5iCYX8LG6DAjfkn5m4Cy97exnE40A8X_s65mr-VF9Xkq6XR9t_oq3rcRgI9RLbKvFBc8YbDLb734QF4TotYf_ABFoP_7Y7xWeNoqAcgjgBbtz0yRsv3ms3Vbxg0Pz5ivR8ebv2XNOXv301LM96s36MFHqbx5kk5S-NoigjAEgnF1GWlm6wLgSJw51nEh3HDSgkn9Rd_Ho3H4JxNQTYgfraNT1gIHb-z6igyhLwIqn-pXAbSWbGyot_Q40Z2z9yeJ6_bSPH_5KomgRnLKhPKtmpObrC0cK9i5UAOp8WPH5y74Ka0Zf7MzMUL9nI_A6MkUToHaSmNZH85Fs9YqYeQoqJzLxp6zin8R6HFjwKGD1-DtdyXTscyNWhLk_e89MxTM305VbQQMPkVO4flAt1JMaJXy0_R1TQFiRYeO_uthhj7GqHhwBFAt21VAnOvGJnrzuxCLlONICVGpy-sDEU0iHi-_4cYyDN37402i_XmowBsyUBJMjwiHfuZeV0OmcxT88TZvsKXNrGlX4DtyYU2wZC3qaKEcok-zfedYoMl60-uGmkh0mrfp5BfyEQAEgLphkXq3Uo3v7OQi8eseEterA3uT4p7kl816nb79rYKd450Wg1KKR6cxkLaqlLIe9bWxxm3KhjaSav0PSaSkVuhlkLz6tVBnr7LeAA-G10P_cINgNVO61nckPD8kJN7F5hEoCtbBGCftSzgq5W7d5FHnYGfrUIuut7AOM7F2ScLEjjmp1SManqDhQXB2nQKqpEXfdhAjB9Z_2D8-qHhxH6WXGWhFwF8DwpScQE8WtYm3PBruXAUvHrtMeRvpaISoH6LfOnsimEJ-bw67rMRpF1sO99urRRLockie7oMJ42_Bmi27einLY6OY208G_7zWcqsawG6uCYUl-x55S-nSDGZwHgTyo_92kUWKJz9OnOl59o53oluy0XkVmWJPomsHlS9ggpVWprywJBGYgMPDxV271ae3brkcATqUQ8FXK7AXpnjNNtqt46NU_tic4rJGMj3664nXdqtA0K-IUOhe6duuAW2IJyZ_XfIQj07pT0mxyHpgLOUgWTHV4H9KQndyFVbUwSLsJxVLzntZz2tsA-CZO5TpBT0ZOFHQ6HT2WmkqJ8xmhpWjNBtv7ezK2Anq_X_RgnlyUx6IffezMndAjGgV7ZPTwXBSh-bcm2hfk5YMej_u-W81tdZSVzAEHBSBgBscXKZaQnGzONx7d9sq9XExz_9Uk-v5836546).\nTo access a live webcast of the presentation, visit Teva’s Investor\nRelations website\n(https://www.globenewswire.com/Tracker?data=9213gz_hdFsgcSoiT_YlgDyoDmJZZD_NO-meNVb_lEOX5X8CggmUJGAqLsrn_f65awim2LMRWlozM-oVJiIuwQUgVHVnppjhpvPSNs5SH9eF2VCXtL6nm1zzeJnaRgvcNblIcHL7Nwm00tvtuFbBkxNtHt9tHr-wUrzr18p5w1MXKQAHrr-CP2Hdg85z8XjaiuiAP0oORU1wBV5LdVL5a4t0OAfieZbn4rDnQKOH2TanTxBL9qXDt2K22UrDVaDrrH268n3eQAtOuQ4S-V29WKRetUerBtz19o8ev_1o3VbJqfjSTvEfdTvfR268Lhw5Cqj4TUCZ44i0gCuFD0UObWBWM661agG2zAva7GYgz0YkZIdUasXCnDZcEXoEMV7FIz_falsXB4qFjW0xsbuzCypFEoDulaqiD4Jg4dfTkbfWXKeuQQRU_meShLXoaqCwwIZLeTdLFAC7fQrQNMEF6hR_LENv32ueUO4MudsGVN00Wiud-z5xMDvqTmR0dLdtYy10YHiac87USxuhllsihHrVAvciUwGAt2WNXibp-m_TG00k7RG3ylL6c4SDUDtrZRhWMlQGLhPm2HeG1WgrDHJVtxKVTPs6t96DTLWPxWqwuxDlvgoQ1rSc96zDixmFxoCivj15pebu_9Wl2C_-m2LXMxAY1NvyQPM1aFtkbJZYQqdoP43PBIVZOG8uV-3R).\nAn archived version of the webcast will be available 24 hours after the end of\nthe live discussion.\n\nAbout TEV ‘408\nTEV ‘408, discovered by Teva, is an investigational human monoclonal\nantibody designed to inhibit interleukin-15 (IL-15), a cytokine involved in\nimmune-mediated pathways. TEV ‘408 has a high affinity and potency (in\nvitro) with a prolonged half-life that supports the potential for convenient\nsubcutaneous dosing.\n\nTEV ‘408 is being studied as a potential therapy for celiac disease in a\nPhase 2a study and was granted Fast Track designation in that indication by\nthe U.S. FDA in May 2025. By blocking IL-15 activity, TEV ‘408 aims to\nreduce the IL-15-driven intestinal inflammation and damage that are\ncharacteristic of celiac disease.\n\nTEV ‘408 is also being evaluated in a Phase 1b study as a treatment for\nvitiligo. Following encouraging results from the ongoing Phase 1b study in\nvitiligo\n(https://www.globenewswire.com/Tracker?data=GmImqDnrv9rzMD8z2G_XlD_m86NvhGezmzDbxV-HwOc-lZNhiQFqNe6mFpbgEBTAqsHOhfWm4xjYllHYuR5Rdg5xaH8B0y0LnPXARsSc8XC02Zyg8Bd4IFNeBX9HqOU39A4Zhfuvort4DmVutKvM_v6D07pvy8yhy9ZxxFoKCdpUirLn_0nVaAGGz-ON3z06x7AxJ8AQO-y4CqQsk6ZFqcNxsGU66JFt6qoxu17wvdtTzB84LvXUFOzLM23N1avA4-WBcrPkLecl7GTwDLl3G05m3OE3DuNgSWUw0HcxlDI=),\nTeva is advancing the investigational asset into a Phase 2b study in vitiligo.\nBy blocking IL-15 activity, TEV ‘408 aims to reduce the immune-mediated\ndestruction of melanocytes (pigment-producing cells) resulting in white\npatches on the skin characteristic of vitiligo.\n\nTeva entered a strategic funding agreement with Royalty Pharma in January\n2026. Under the agreement, Teva is eligible to receive up to $500 million to\naccelerate the clinical development of TEV ‘408. If approved and launched,\nTeva will pay a milestone to Royalty Pharma and a royalty on worldwide net\nsales of TEV ‘408.\n\nAbout Celiac Disease\n(https://www.globenewswire.com/Tracker?data=ug9Qf3YCZxUSY3yukXyEGgWAVgBzXGevF-mNLC5yCuGXdgLVfejfuOtMuqeIdhqD2JJugmmj7ttcmK8FU8wZrGKmFAwJXwq_M3DDKtHMomhP3vjrAWfrEHn9ySPjELkAg9k5X6vOEJeryCy-o61RtuhJn3bGgPLvVFV_1se8G9o=)\nCeliac disease is a serious autoimmune disease in which exposure to gluten\ntriggers an immune response that damages the small intestine. It affects\napproximately 1% of the global population, or more than three million people\nin the U.S. alone, although many individuals remain undiagnosed. Celiac\ndisease can cause chronic digestive symptoms, fatigue, nutrient deficiencies,\nand other health complications that can significantly impact daily life.\n\nThere are currently no approved therapies for celiac disease. A strict\ngluten-free diet (GFD) remains the standard of care, yet even with careful\nadherence, patients may continue to experience symptoms, reduced quality of\nlife, and ongoing intestinal inflammation or damage due to inadvertent gluten\nexposure. For people living with celiac disease, managing the condition often\nrequires constant vigilance around meals, travel, work, and social activities,\ncreating significant daily burden. The limitations of current management\napproaches underscore the need for therapies that address the underlying\ndrivers of disease and improve outcomes for patients.\n\nAbout Teva\n(https://www.globenewswire.com/Tracker?data=9213gz_hdFsgcSoiT_YlgHGDCxfQGamOexc_uCTMucD-j9RKu-CZ_AkUDZeJOdQ27IWMmo2EfB_5GfUvHu3NQA==)\nTeva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into\na leading innovative biopharmaceutical company, enabled by a world-class\ngenerics business. For over 120 years, Teva’s commitment to bettering health\nhas never wavered. From innovating in the fields of neuroscience and\nimmunology to providing complex generic medicines, biosimilars and pharmacy\nbrands worldwide, Teva is dedicated to addressing patients’ needs, now and\nin the future. At Teva, We Are All In For Better Health. To learn more about\nhow, visit www.tevapharm.com.\n\nCautionary Note Regarding Forward-Looking Statements\nThis press release contains forward-looking statements within the meaning of\nthe Private Securities Litigation Reform Act of 1995, which are based on\nmanagement’s current beliefs and expectations and are subject to substantial\nrisks and uncertainties, both known and unknown, that could cause our future\nresults, performance or achievements to differ significantly from that\nexpressed or implied by such forward-looking statements. You can identify\nthese forward-looking statements by the use of words such as “should,”\n“expect,” “anticipate,” “estimate,” “target,” “may,”\n“intend,” “plan,” “believe” and other words and terms of similar\nmeaning and expression in connection with any discussion of future operating\nor financial performance. Important factors that could cause or contribute to\nsuch differences include risks relating to: our ability to successfully\ndevelop and commercialize TEV-’408 for the treatment of celiac disease and\nfor the treatment of vitiligo; our ability to successfully compete in the\nmarketplace, including our ability to develop and commercialize additional\npharmaceutical products; our ability to successfully execute on our Pivot to\nGrowth strategy, including to expand our innovative and biosimilar medicines\npipeline and profitably commercialize our innovative medicines and biosimilar\nportfolio, whether organically or through business development; and other\nfactors discussed in our Quarterly Report on Form 10-Q for the second quarter\nof 2026 and in our Annual Report on Form 10-K for the year ended December 31,\n2025, including in the sections captioned “Risk Factors,” and\n“Forward-Looking Statements.” Forward-looking statements speak only as of\nthe date on which they are made, and we assume no obligation to update or\nrevise any forward-looking statements or other information contained herein,\nwhether as a result of new information, future events or otherwise. You are\ncautioned not to put undue reliance on these forward-looking statements.\n\nTeva Media Inquiries: TevaCommunicationsNorthAmerica@tevapharm.com\nTeva Investor Relations Inquiries: TevaIR@Tevapharm.com\n\nA photo accompanying this announcement is available at\nhttps://www.globenewswire.com/NewsRoom/AttachmentNg/2392ceaa-b1f3-44a8-bd7e-4c775053e093\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/c2001734-949b-4cc2-8021-b4b64eda1f13)\nTeva Announces Positive Topline Results from Phase 2a Study in Celiac Disease\nfor Its Anti-IL-15 Antibody \n(https://www.globenewswire.com/NewsRoom/AttachmentNg/2392ceaa-b1f3-44a8-bd7e-4c775053e093/en)\nTeva Announces Positive Topline Results from Phase 2a Study in Celiac Disease\nfor Its Anti-IL-15 Antibody, Further Validating Its Pipeline-in-a-Product\nPotential\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX6nQ8Mw","title":"Teva Announces Positive Topline Results from Phase 2a Study in Celiac Disease for Its Anti-IL-15 Antibody, Further Validating Its Pipeline-in-a-Product Potential","author":"Globe Newswire","ticker":"TEVA","created":"2026-09-02T11:03:00.405Z","tickers":["TEVA"],"exchange":"","article_body":"* Teva-discovered TEV ‘408, a novel anti-IL-15 monoclonal antibody,\ndemonstrated statistically significant and clinically meaningful prevention of\ngluten-induced intestinal damage vs placebo following a single subcutaneous\ndose.\n* TEV ‘408 was well-tolerated with no safety signals observed to date.\n* Together with the vitiligo program, the celiac disease topline results\nfurther support TEV ‘408 as a potential pipeline-in-a-product opportunity in\nmultiple diseases.\nTeva will hold an investor call and live webcast today,\nWednesday, September 2, 2026, at 8:00 a.m. ET to discuss these data.\n\nTEL AVIV, Israel, Sept. 02, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical\nIndustries Ltd. (NYSE and TASE: TEVA) today announced positive topline results\nfrom an ongoing Phase 2a study of TEV ‘408, an investigational\nanti-interleukin-15 monoclonal antibody, in adults with celiac disease. The\nstudy met its primary endpoint, demonstrating statistically significant and\nclinically meaningful prevention of gluten-induced intestinal damage versus\nplacebo at week 8. TEV ‘408 was well-tolerated, with no safety signals\nobserved to date.\n\n“A strict gluten-free diet has long been the only option for people living\nwith celiac disease. Yet, even with strict adherence to a gluten-free diet,\nmany continue to experience symptoms, intestinal damage and a significant\nimpact on their daily lives,” said Eric Hughes, MD, PhD, Executive Vice\nPresident, Global R&D and Chief Medical Officer at Teva\n(https://www.globenewswire.com/Tracker?data=bUU1YOWqwIp5Ao3WdTGFgy9LTWzaIV7tKYw4GZRVjbVgenoXWkGS5DplHF8bYxGou1UleTEAp903n1x7a6CirozIwchPj69v0ngeJJGGSiGeYqmf4x49QPGPUZOzb6XVeIEVrqVKydUb_wZlhkpcotl_SbVoTr12maM3G_YlcAeyqXDOlIpjv0Ku7lmpEXIEslMiRu0QCJyzXHX4sk1W7C2gQie3NAUS0kP9rtNJAgrAHsYeMvUQC9K9QPqGCUilas4GvhRQVYSvFGhezLzEnWaw8oJVQTCOt4FutIWSr4Y=).\n“These results underscore the potential to move beyond managing gluten\nexposure and address celiac disease at its biological source. They also\nstrengthen our confidence in targeting the IL-15 pathway as an approach to\nreducing immune-driven intestinal damage.”\n\nThe ongoing randomized, placebo-controlled study enrolled 50 adult\nparticipants with celiac disease on a gluten-free diet (GFD) with minimal\nintestinal damage at baseline as measured by the villous height-to-crypt depth\nratio (Vh:Cd ≥2.0) and symptoms. Two weeks after receiving a single dose of\nTEV ‘408, participants began a six-week daily gluten challenge (GC). The\nstudy assessed biopsy-based measures of intestinal damage and inflammation\nalong with patient-reported symptoms. At week 8 (the end of the GC) TEV\n‘408:\n* Showed statistically significant and clinically meaningful prevention of\ngluten-induced intestinal damage versus placebo, as measured by the trial’s\nprimary endpoint of Vh:Cd ratio with a least squares (LS) mean change from\nbaseline of -0.43 compared with -0.88 for placebo (treatment difference of\n0.45, 95% CI: (0.06, 0.84), p<0.05).\n* Showed a favorable effect on intestinal inflammation as measured by density\nof intraepithelial lymphocytes (IELs) compared with placebo; the LS Mean\nchange from baseline in the density of IELs, was an increase of 27.60 for\nplacebo compared to 0.37 for TEV ‘408 treated participants (treatment\ndifference of -27.23, 95% CI: (-39.67, -14.79)).\n* Demonstrated lower GI symptom scores versus placebo, as assessed using the\nCeliac Disease Symptom Diary (CDSD), a patient-reported outcome (PRO).\n* Was well-tolerated with no emerging safety signals.\nAdditional analyses from the ongoing Phase 2a study are underway. Teva plans\nto present further data from the study at a future scientific meeting.\n\nTeva Investor Call\nTeva will hold an investor call and live webcast today, Wednesday, September\n2, 2026, at 8:00 a.m. ET/ 2:00 p.m. CET to discuss these data. To participate,\nplease register in advance here\n(https://www.globenewswire.com/Tracker?data=UodgELr4u5UJZZQEGKe1MS61pGqX-ODhjAWzhJ8lO4H6m5Dbl07Lh8JeIlbqeJuvVesDDDgbfj_pzKzNyq2zn-5DS9Qwle5iCYX8LG6DAjfkn5m4Cy97exnE40A8X_s65mr-VF9Xkq6XR9t_oq3rcRgI9RLbKvFBc8YbDLb734QF4TotYf_ABFoP_7Y7xWeNoqAcgjgBbtz0yRsv3ms3Vbxg0Pz5ivR8ebv2XNOXv301LM96s36MFHqbx5kk5S-NoigjAEgnF1GWlm6wLgSJw51nEh3HDSgkn9Rd_Ho3H4JxNQTYgfraNT1gIHb-z6igyhLwIqn-pXAbSWbGyot_Q40Z2z9yeJ6_bSPH_5KomgRnLKhPKtmpObrC0cK9i5UAOp8WPH5y74Ka0Zf7MzMUL9nI_A6MkUToHaSmNZH85Fs9YqYeQoqJzLxp6zin8R6HFjwKGD1-DtdyXTscyNWhLk_e89MxTM305VbQQMPkVO4flAt1JMaJXy0_R1TQFiRYeO_uthhj7GqHhwBFAt21VAnOvGJnrzuxCLlONICVGpy-sDEU0iHi-_4cYyDN37402i_XmowBsyUBJMjwiHfuZeV0OmcxT88TZvsKXNrGlX4DtyYU2wZC3qaKEcok-zfedYoMl60-uGmkh0mrfp5BfyEQAEgLphkXq3Uo3v7OQi8eseEterA3uT4p7kl816nb79rYKd450Wg1KKR6cxkLaqlLIe9bWxxm3KhjaSav0PSaSkVuhlkLz6tVBnr7LeAA-G10P_cINgNVO61nckPD8kJN7F5hEoCtbBGCftSzgq5W7d5FHnYGfrUIuut7AOM7F2ScLEjjmp1SManqDhQXB2nQKqpEXfdhAjB9Z_2D8-qHhxH6WXGWhFwF8DwpScQE8WtYm3PBruXAUvHrtMeRvpaISoH6LfOnsimEJ-bw67rMRpF1sO99urRRLockie7oMJ42_Bmi27einLY6OY208G_7zWcqsawG6uCYUl-x55S-nSDGZwHgTyo_92kUWKJz9OnOl59o53oluy0XkVmWJPomsHlS9ggpVWprywJBGYgMPDxV271ae3brkcATqUQ8FXK7AXpnjNNtqt46NU_tic4rJGMj3664nXdqtA0K-IUOhe6duuAW2IJyZ_XfIQj07pT0mxyHpgLOUgWTHV4H9KQndyFVbUwSLsJxVLzntZz2tsA-CZO5TpBT0ZOFHQ6HT2WmkqJ8xmhpWjNBtv7ezK2Anq_X_RgnlyUx6IffezMndAjGgV7ZPTwXBSh-bcm2hfk5YMej_u-W81tdZSVzAEHBSBgBscXKZaQnGzONx7d9sq9XExz_9Uk-v5836546).\nTo access a live webcast of the presentation, visit Teva’s Investor\nRelations website\n(https://www.globenewswire.com/Tracker?data=9213gz_hdFsgcSoiT_YlgDyoDmJZZD_NO-meNVb_lEOX5X8CggmUJGAqLsrn_f65awim2LMRWlozM-oVJiIuwQUgVHVnppjhpvPSNs5SH9eF2VCXtL6nm1zzeJnaRgvcNblIcHL7Nwm00tvtuFbBkxNtHt9tHr-wUrzr18p5w1MXKQAHrr-CP2Hdg85z8XjaiuiAP0oORU1wBV5LdVL5a4t0OAfieZbn4rDnQKOH2TanTxBL9qXDt2K22UrDVaDrrH268n3eQAtOuQ4S-V29WKRetUerBtz19o8ev_1o3VbJqfjSTvEfdTvfR268Lhw5Cqj4TUCZ44i0gCuFD0UObWBWM661agG2zAva7GYgz0YkZIdUasXCnDZcEXoEMV7FIz_falsXB4qFjW0xsbuzCypFEoDulaqiD4Jg4dfTkbfWXKeuQQRU_meShLXoaqCwwIZLeTdLFAC7fQrQNMEF6hR_LENv32ueUO4MudsGVN00Wiud-z5xMDvqTmR0dLdtYy10YHiac87USxuhllsihHrVAvciUwGAt2WNXibp-m_TG00k7RG3ylL6c4SDUDtrZRhWMlQGLhPm2HeG1WgrDHJVtxKVTPs6t96DTLWPxWqwuxDlvgoQ1rSc96zDixmFxoCivj15pebu_9Wl2C_-m2LXMxAY1NvyQPM1aFtkbJZYQqdoP43PBIVZOG8uV-3R).\nAn archived version of the webcast will be available 24 hours after the end of\nthe live discussion.\n\nAbout TEV ‘408\nTEV ‘408, discovered by Teva, is an investigational human monoclonal\nantibody designed to inhibit interleukin-15 (IL-15), a cytokine involved in\nimmune-mediated pathways. TEV ‘408 has a high affinity and potency (in\nvitro) with a prolonged half-life that supports the potential for convenient\nsubcutaneous dosing.\n\nTEV ‘408 is being studied as a potential therapy for celiac disease in a\nPhase 2a study and was granted Fast Track designation in that indication by\nthe U.S. FDA in May 2025. By blocking IL-15 activity, TEV ‘408 aims to\nreduce the IL-15-driven intestinal inflammation and damage that are\ncharacteristic of celiac disease.\n\nTEV ‘408 is also being evaluated in a Phase 1b study as a treatment for\nvitiligo. Following encouraging results from the ongoing Phase 1b study in\nvitiligo\n(https://www.globenewswire.com/Tracker?data=GmImqDnrv9rzMD8z2G_XlD_m86NvhGezmzDbxV-HwOc-lZNhiQFqNe6mFpbgEBTAqsHOhfWm4xjYllHYuR5Rdg5xaH8B0y0LnPXARsSc8XC02Zyg8Bd4IFNeBX9HqOU39A4Zhfuvort4DmVutKvM_v6D07pvy8yhy9ZxxFoKCdpUirLn_0nVaAGGz-ON3z06x7AxJ8AQO-y4CqQsk6ZFqcNxsGU66JFt6qoxu17wvdtTzB84LvXUFOzLM23N1avA4-WBcrPkLecl7GTwDLl3G05m3OE3DuNgSWUw0HcxlDI=),\nTeva is advancing the investigational asset into a Phase 2b study in vitiligo.\nBy blocking IL-15 activity, TEV ‘408 aims to reduce the immune-mediated\ndestruction of melanocytes (pigment-producing cells) resulting in white\npatches on the skin characteristic of vitiligo.\n\nTeva entered a strategic funding agreement with Royalty Pharma in January\n2026. Under the agreement, Teva is eligible to receive up to $500 million to\naccelerate the clinical development of TEV ‘408. If approved and launched,\nTeva will pay a milestone to Royalty Pharma and a royalty on worldwide net\nsales of TEV ‘408.\n\nAbout Celiac Disease\n(https://www.globenewswire.com/Tracker?data=ug9Qf3YCZxUSY3yukXyEGgWAVgBzXGevF-mNLC5yCuGXdgLVfejfuOtMuqeIdhqD2JJugmmj7ttcmK8FU8wZrGKmFAwJXwq_M3DDKtHMomhP3vjrAWfrEHn9ySPjELkAg9k5X6vOEJeryCy-o61RtuhJn3bGgPLvVFV_1se8G9o=)\nCeliac disease is a serious autoimmune disease in which exposure to gluten\ntriggers an immune response that damages the small intestine. It affects\napproximately 1% of the global population, or more than three million people\nin the U.S. alone, although many individuals remain undiagnosed. Celiac\ndisease can cause chronic digestive symptoms, fatigue, nutrient deficiencies,\nand other health complications that can significantly impact daily life.\n\nThere are currently no approved therapies for celiac disease. A strict\ngluten-free diet (GFD) remains the standard of care, yet even with careful\nadherence, patients may continue to experience symptoms, reduced quality of\nlife, and ongoing intestinal inflammation or damage due to inadvertent gluten\nexposure. For people living with celiac disease, managing the condition often\nrequires constant vigilance around meals, travel, work, and social activities,\ncreating significant daily burden. The limitations of current management\napproaches underscore the need for therapies that address the underlying\ndrivers of disease and improve outcomes for patients.\n\nAbout Teva\n(https://www.globenewswire.com/Tracker?data=9213gz_hdFsgcSoiT_YlgHGDCxfQGamOexc_uCTMucD-j9RKu-CZ_AkUDZeJOdQ27IWMmo2EfB_5GfUvHu3NQA==)\nTeva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into\na leading innovative biopharmaceutical company, enabled by a world-class\ngenerics business. For over 120 years, Teva’s commitment to bettering health\nhas never wavered. From innovating in the fields of neuroscience and\nimmunology to providing complex generic medicines, biosimilars and pharmacy\nbrands worldwide, Teva is dedicated to addressing patients’ needs, now and\nin the future. At Teva, We Are All In For Better Health. To learn more about\nhow, visit www.tevapharm.com.\n\nCautionary Note Regarding Forward-Looking Statements\nThis press release contains forward-looking statements within the meaning of\nthe Private Securities Litigation Reform Act of 1995, which are based on\nmanagement’s current beliefs and expectations and are subject to substantial\nrisks and uncertainties, both known and unknown, that could cause our future\nresults, performance or achievements to differ significantly from that\nexpressed or implied by such forward-looking statements. You can identify\nthese forward-looking statements by the use of words such as “should,”\n“expect,” “anticipate,” “estimate,” “target,” “may,”\n“intend,” “plan,” “believe” and other words and terms of similar\nmeaning and expression in connection with any discussion of future operating\nor financial performance. Important factors that could cause or contribute to\nsuch differences include risks relating to: our ability to successfully\ndevelop and commercialize TEV-’408 for the treatment of celiac disease and\nfor the treatment of vitiligo; our ability to successfully compete in the\nmarketplace, including our ability to develop and commercialize additional\npharmaceutical products; our ability to successfully execute on our Pivot to\nGrowth strategy, including to expand our innovative and biosimilar medicines\npipeline and profitably commercialize our innovative medicines and biosimilar\nportfolio, whether organically or through business development; and other\nfactors discussed in our Quarterly Report on Form 10-Q for the second quarter\nof 2026 and in our Annual Report on Form 10-K for the year ended December 31,\n2025, including in the sections captioned “Risk Factors,” and\n“Forward-Looking Statements.” Forward-looking statements speak only as of\nthe date on which they are made, and we assume no obligation to update or\nrevise any forward-looking statements or other information contained herein,\nwhether as a result of new information, future events or otherwise. You are\ncautioned not to put undue reliance on these forward-looking statements.\n\nTeva Media Inquiries: TevaCommunicationsNorthAmerica@tevapharm.com\nTeva Investor Relations Inquiries: TevaIR@Tevapharm.com\n\nA photo accompanying this announcement is available at\nhttps://www.globenewswire.com/NewsRoom/AttachmentNg/2392ceaa-b1f3-44a8-bd7e-4c775053e093\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/c2001734-949b-4cc2-8021-b4b64eda1f13)\nTeva Announces Positive Topline Results from Phase 2a Study in Celiac Disease\nfor Its Anti-IL-15 Antibody \n(https://www.globenewswire.com/NewsRoom/AttachmentNg/2392ceaa-b1f3-44a8-bd7e-4c775053e093/en)\nTeva Announces Positive Topline Results from Phase 2a Study in Celiac Disease\nfor Its Anti-IL-15 Antibody, Further Validating Its Pipeline-in-a-Product\nPotential\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-09-02T11:03:00.457436429Z","server_sent_at_ms":1788346980457},"received_at":"2026-09-02T11:03:00.578Z","source_url":"https://www.globenewswire.com/news-release/2026/09/02/3354990/0/en/teva-announces-positive-topline-results-from-phase-2a-study-in-celiac-disease-for-its-anti-il-15-antibody-further-validating-its-pipeline-in-a-product-potential.html"},"analysis":{"id":"122523","press_release_id":"133651","analysis_json":{"industry":{"label":"Pharmaceuticals","sector":"Health Care"},"redFlags":["Small Phase 2a sample size (n=50); treatment-difference confidence interval lower bound (0.06) sits close to zero","Results are topline only; full dataset not yet presented at a scientific meeting or peer-reviewed","Enrollment restricted to patients with minimal baseline intestinal damage, which may limit generalizability","Commercialization is years away and Teva owes a royalty/milestone to Royalty Pharma on any future net sales"],"eventType":"clinical_trial","narrative":"Teva announced positive topline results from its ongoing Phase 2a study of TEV '408, an investigational anti-IL-15 monoclonal antibody, in adults with celiac disease, with the study meeting its primary endpoint of preventing gluten-induced intestinal damage versus placebo at week 8.\n\nIn the 50-participant placebo-controlled study, TEV '408 showed a least-squares mean Vh:Cd change of -0.43 versus -0.88 for placebo (treatment difference 0.45, p<0.05), with favorable effects on intestinal inflammation and lower GI symptom scores; the single subcutaneous dose was well-tolerated with no safety signals observed to date.\n\nThe results support Teva's pipeline-in-a-product thesis: TEV '408 also has FDA Fast Track designation in celiac disease (May 2025), is advancing into a Phase 2b vitiligo study after positive Phase 1b data, and targets an indication where no approved therapies currently exist.\n\nUnder a January 2026 strategic funding agreement, Royalty Pharma will provide up to $500 million to accelerate TEV '408 development, with Teva owing a milestone and royalty on worldwide net sales if the drug is approved and launched.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"First positive interventional readout positioning TEV '408 as a potential first-ever approved celiac therapy, with a second shot on goal in vitiligo and up to $500M in Royalty Pharma backing."},"keyFigures":{"drugName":"TEV '408 (anti-IL-15 monoclonal antibody)","phaseOfTrial":"Phase 2a","customDimensions":{"primary_endpoint":"Vh:Cd ratio LS mean change from baseline of -0.43 for TEV '408 vs -0.88 for placebo","enrolled_participants":50,"fda_fast_track_designation":"granted May 2025 in celiac disease","iel_density_ls_mean_change":"increase of 27.60 for placebo vs 0.37 for TEV '408","royalty_pharma_funding_cap":"$500 million","iel_density_treatment_difference":-27.23,"primary_endpoint_treatment_difference":"0.45, 95% CI: (0.06, 0.84), p<0.05"}},"quotedText":"address celiac disease at its biological source","namedEntities":{"people":[{"name":"Eric Hughes, MD, PhD","role":"Executive Vice President, Global R&D and Chief Medical Officer at Teva"}],"products":["TEV '408"],"companies":[{"name":"Teva Pharmaceutical Industries Ltd.","ticker":"TEVA","relationship":"filer"},{"name":"Royalty Pharma","relationship":"funding partner (January 2026 strategic funding agreement, up to $500 million)"},{"name":"U.S. FDA","relationship":"regulator (Fast Track designation, May 2025)"}],"dollarAmounts":[{"amount":"$500 million","context":"maximum funding Teva is eligible to receive under the January 2026 Royalty Pharma strategic funding agreement to accelerate TEV '408 clinical development"},{"amount":"three million","context":"estimated number of people in the U.S. living with celiac disease"}]},"materialImpact":{"score":4,"reasoning":"TEV '408 met its Phase 2a primary endpoint with statistical significance in celiac disease, an indication with no approved therapies, materially validating Teva's lead innovative pipeline-in-a-product asset. Impact is capped below 5 because this is a small Phase 2a readout (n=50) with approval still years away, not an FDA binary event."},"tickerRelevance":{"others":[],"primary":"TEVA"},"globalImportance":52,"audienceRelevance":58,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"large-cap global pharma, household name","eventGravity":"positive Phase 2a readout on lead innovative pipeline asset","pipelineValidation":"second indication (vitiligo Phase 2b) supports pipeline-in-a-product framing","marketCapAdjustment":"meaningful pipeline catalyst but not near-term revenue for a diversified pharma","retailFavoriteBoost":"moderate; TEVA widely held but not a meme favorite","indicationWhitespace":"no approved therapies for celiac disease (~1% global prevalence)"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":4,"narrative":"Teva announced positive topline results from its ongoing Phase 2a study of TEV '408, an investigational anti-IL-15 monoclonal antibody, in adults with celiac disease, with the study meeting its primary endpoint of preventing gluten-induced intestinal damage versus placebo at week 8.\n\nIn the 50-participant placebo-controlled study, TEV '408 showed a least-squares mean Vh:Cd change of -0.43 versus -0.88 for placebo (treatment difference 0.45, p<0.05), with favorable effects on intestinal inflammation and lower GI symptom scores; the single subcutaneous dose was well-tolerated with no safety signals observed to date.\n\nThe results support Teva's pipeline-in-a-product thesis: TEV '408 also has FDA Fast Track designation in celiac disease (May 2025), is advancing into a Phase 2b vitiligo study after positive Phase 1b data, and targets an indication where no approved therapies currently exist.\n\nUnder a January 2026 strategic funding agreement, Royalty Pharma will provide up to $500 million to accelerate TEV '408 development, with Teva owing a milestone and royalty on worldwide net sales if the drug is approved and launched.","key_figures":{"drugName":"TEV '408 (anti-IL-15 monoclonal antibody)","phaseOfTrial":"Phase 2a","customDimensions":{"primary_endpoint":"Vh:Cd ratio LS mean change from baseline of -0.43 for TEV '408 vs -0.88 for placebo","enrolled_participants":50,"fda_fast_track_designation":"granted May 2025 in celiac disease","iel_density_ls_mean_change":"increase of 27.60 for placebo vs 0.37 for TEV '408","royalty_pharma_funding_cap":"$500 million","iel_density_treatment_difference":-27.23,"primary_endpoint_treatment_difference":"0.45, 95% CI: (0.06, 0.84), p<0.05"}},"named_entities":{"people":[{"name":"Eric Hughes, MD, PhD","role":"Executive Vice President, Global R&D and Chief Medical Officer at Teva"}],"products":["TEV '408"],"companies":[{"name":"Teva Pharmaceutical Industries Ltd.","ticker":"TEVA","relationship":"filer"},{"name":"Royalty Pharma","relationship":"funding partner (January 2026 strategic funding agreement, up to $500 million)"},{"name":"U.S. FDA","relationship":"regulator (Fast Track designation, May 2025)"}],"dollarAmounts":[{"amount":"$500 million","context":"maximum funding Teva is eligible to receive under the January 2026 Royalty Pharma strategic funding agreement to accelerate TEV '408 clinical development"},{"amount":"three million","context":"estimated number of people in the U.S. living with celiac disease"}]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-02T11:10:47.964Z","global_importance":52,"audience_relevance":58,"importance_components":{"tickerTier":"large-cap global pharma, household name","eventGravity":"positive Phase 2a readout on lead innovative pipeline asset","pipelineValidation":"second indication (vitiligo Phase 2b) supports pipeline-in-a-product framing","marketCapAdjustment":"meaningful pipeline catalyst but not near-term revenue for a diversified pharma","retailFavoriteBoost":"moderate; TEVA widely held but not a meme favorite","indicationWhitespace":"no approved therapies for celiac disease (~1% global prevalence)"}},"durationMs":72373,"modelName":"glm-4.7"}}