{"success":true,"data":{"pressRelease":{"id":"70302","rtpr_id":"nGNE7Jp8fN","ticker":"SASY","exchange":"Euronext Paris","all_tickers":["SASY"],"title":"REG-Press Release: Sanofi’s Wayrilz approved in Japan to treat immune thrombocytopenia","author":"Globe Newswire","published_at":"2026-06-23T05:15:00.062Z","article_body":"Sanofi’s Wayrilz approved in Japan to treat immune thrombocytopenia\n* Wayrilz is a BTK inhibitor that works through multi-immune modulation to\nhelp address the underlying causes of immune thrombocytopenia (ITP)\n* Approval based on the LUNA 3 phase 3 study that demonstrated rapid and\ndurable platelet response and improvements in other symptoms\n* ITP is a rare disease of complex immune dysregulation leading to lower\nplatelet counts, bleeding, and reduced quality of life\nParis, June 23, 2026. The Ministry of Health, Labour and Welfare in Japan has\ngranted marketing and manufacturing authorization to Wayrilz (rilzabrutinib),\na novel oral reversible Bruton’s tyrosine kinase inhibitor (BTKi), for the\ntreatment of persistent or chronic immune thrombocytopenia (ITP) in patients\nwho do not respond sufficiently to other treatments or in whom tolerability is\nconsidered to be problematic. Wayrilz can help address the underlying causes\nof the disease, through multi-immune modulation, targeting key pathways across\nthe immune system.\n\nThe approval is based on the LUNA 3 phase 3 study (clinical study identifier:\nNCT04562766)\n(https://www.clinicaltrials.gov/study/NCT04562766?cond=ITP%20-%20Immune%20Thrombocytopenia&term=Sanofi&intr=rilzabrutinib&rank=2),\nin which Wayrilz met the primary and secondary endpoints, showing a positive\nimpact on sustained platelet counts and other symptoms.\n\n\"For ITP patients, achieving platelet counts close to normal and living\nwithout worrying about bleeding is extremely important. Additionally, in\nrecent years, there has been growing interest in various other symptoms\nassociated with ITP such as fatigue,” said Hisashi Kato, MD, PhD, Department\nof Blood Transfusion and Cell Therapy, The University of Osaka Hospital,\nSuita, Japan. “Wayrilz is a novel BTKi that works through multi-immune\nmodulation to help address the root cause of ITP pathophysiology. It is\nexpected to become a new therapeutic option that may help patients with\ndisease management, including not only improvement in platelet counts but also\nconsidering patients' quality of life.\"\n\n“People living with immune thrombocytopenia who continue to experience\nsymptoms, despite trying existing treatments, face a great unmet need,” said\nManuela Buxo, Executive Vice President, Global Head of Specialty Care at\nSanofi. “Wayrilz has a differentiated mechanism of action that enables\nmulti-immune modulation to address the underlying pathophysiology of ITP and\noffers new hope to patients who have not responded to prior therapy. This\nmilestone underscores Sanofi’s commitment to bringing innovative treatment\noptions to rare disease patients around the world.”\n\nThe LUNA 3 phase 3 study evaluated the efficacy and safety of Wayrilz compared\nto placebo in adults (n=202) with persistent or chronic ITP. Patients who\nachieved platelet count response at 12 weeks were eligible to continue the\nfull 24-week double-blind period (64% of patients in the Wayrilz arm and 32%\nof patients in the placebo arm). Patients receiving Wayrilz experienced the\nfollowing compared to patients receiving placebo:\n* Statistically significant durable platelet response at week 25 (23% of\npatients in Wayrilz arm vs. 0% in placebo arm; p<0.0001) \n* Faster time to first platelet response (36 days in Wayrilz arm vs. not\nreached in placebo arm; p<0.0001)\n* Longer duration of platelet response (least square mean of 7 weeks in\nWayrilz arm vs. 0.7 weeks in placebo arm)\nPatients receiving Wayrilz reported an overall 10.6-point improvement in the\noverall quality of life domain compared to a 2.3-point increase in the placebo\narm, based on The Immune Thrombocytopenia Patient Assessment Questionnaire, a\nclinical tool designed to measure ITP symptoms and impacts. The results of\nthis analysis are descriptive and were not powered for statistical\nsignificance.\n\nThe most common adverse reactions (incidence ≥10%) were diarrhea, nausea,\nheadache, abdominal pain, and COVID-19.\n\nWayrilz is being studied across multiple other rare diseases, including\nIgG4-related disease (IgG4-RD), warm autoimmune hemolytic anemia (wAIHA), and\nsickle cell disease. These additional indications are currently under\ninvestigation and have not been approved by regulatory authorities. Japan has\ngranted Wayrilz orphan drug designation for ITP, IgG4-RD, and wAIHA.\n\nAbout ITP\nITP is a disease of complex immune dysregulation that causes low platelet\ncounts (<100,000/μL), resulting in a variety of bleeding symptoms and high\nrisk of thromboembolism. Beyond bruising and bleeding, which can include\npotentially life-threatening episodes like intracranial hemorrhage, people\nliving with ITP may experience reduced quality of life, including physical\nfatigue and cognitive impairment.\n\nAbout Wayrilz\nWayrilz (rilzabrutinib) is a novel oral reversible covalent BTK inhibitor that\nhas the potential to be an effective new medicine for several rare\nimmune-mediated or inflammatory diseases by working to restore immune balance\nvia multi-immune modulation. The enzyme BTK, expressed in B cells,\nmacrophages, and other innate immune cells, plays a critical role in multiple\nimmune-mediated disease processes and inflammatory pathways. With the\napplication of the TAILORED COVALENCY(®) technology, Wayrilz can selectively\ninhibit the BTK target. Wayrilz is now approved for the treatment of ITP in\nthe US, the EU, the UAE, the UK and Japan.\n\nAbout Sanofi \nSanofi is an R&D driven, AI-powered biopharma company committed to improving\npeople’s lives and delivering compelling growth. We apply our deep\nunderstanding of the immune system to invent medicines and vaccines that treat\nand protect millions of people around the world, with an innovative pipeline\nthat could benefit millions more. Our team is guided by one purpose: we chase\nthe miracles of science to improve people’s lives; this inspires us to drive\nprogress and deliver positive impact for our people and the communities we\nserve, by addressing the most urgent healthcare, environmental, and societal\nchallenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY\n\nMedia Relations\nSandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com\nEvan Berland | +1 215 432 0234 | evan.berland@sanofi.com\nLéo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com\nVictor Rouault | +1 617 356 4751 | victor.rouault@sanofi.com\nTimothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com\nLéa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com\nEkaterina Pesheva | +1 410 926 6780 | ekaterina.pesheva@sanofi.com \nLaura Romby| +33 6 74 16 74 29 | laura.romby@sanofi.com\n\nInvestor Relations\nThomas Kudsk Larsen |+44 7545 513 693 | thomas.larsen@sanofi.com\nAlizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com\nKeita Browne | +1 781 249 1766 | keita.browne@sanofi.com\nNathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com\nNina Goworek | +1 908 569 7086 | nina.goworek@sanofi.com\nThibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com\nYun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com\n\nSanofi Forward-Looking Statements\nThis press release contains forward-looking statements within the meaning of\napplicable securities laws, including the Private Securities Litigation Reform\nAct of 1995, as amended. Forward-looking statements are statements that are\nnot historical facts. These statements include projections and estimates and\ntheir underlying assumptions regarding the marketing and other potential of\nthe product; regarding potential future events and revenues from the product.\nWords such as “expect,” “anticipate,” “believe,” “intend,”\n“estimate,” “plan,” “can,” “contemplate,” “could,” “is\ndesigned to,” “may,” “might,” “potential,” “objective,”\n\"attempt,\" “target,” “project,” \"strategy,\" \"strive,\" \"desire,\"\n“predict,” “forecast,” “ambition,” “guideline,” \"seek,\"\n“should,” “will,” \"goal,\" or the negative of these and similar\nexpressions are intended to identify forward-looking statements. Although\nSanofi’s management believes that the expectations reflected in such\nforward-looking statements are reasonable, investors are cautioned that\nforward-looking information and statements are subject to various risks and\nuncertainties, many of which are difficult to predict and generally beyond the\ncontrol of Sanofi, that could cause actual results and developments to differ\nmaterially from those expressed in, or implied or projected by, the\nforward-looking information and statements. These risks, uncertainties and\nassumptions include among other things, unexpected regulatory actions or\ndelays, or government regulation generally, that could affect the availability\nor commercial potential of the product, the fact that product may not be\ncommercially successful; authorities’ decisions regarding whether and when\nto approve a product candidate; political pressure in the United States to\nmandate lower drug prices including “most favored nation” pricing for\nState Medicaid programs; the uncertainties inherent in research and\ndevelopment, including future clinical data and analysis of existing clinical\ndata relating to the product, including post marketing, unexpected safety,\nquality or manufacturing issues; competition in general; risks associated with\nintellectual property and any related pending or future litigation and the\nultimate outcome of such litigation, and volatile economic and market\nconditions, and the impact that global crises may have on us, our customers,\nsuppliers, vendors, and other business partners, and the financial condition\nof any one of them, as well as on our employees and on the global economy as a\nwhole. The risks and uncertainties also include the uncertainties discussed or\nidentified in the public filings with the SEC and the French Markets Authority\n(AMF) made by Sanofi, including those listed under “Risk Factors” and\n“Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s\nannual report on Form 20-F for the year ended December 31, 2025 or contained\nin our periodic reports on Form 6-K. Other than as required by applicable law,\nSanofi does not undertake any obligation to update or revise any\nforward-looking information or statements. In light of these risks,\nuncertainties and assumptions, you should not place undue reliance on any\nforward-looking statements contained herein.\n\nAll trademarks mentioned in this press release are the property of the Sanofi\ngroup.\n\nAttachment\n*     Press_Release\n(https://ml-eu.globenewswire.com/Resource/Download/4325af4c-23d8-4a34-a5f7-3031c1a15997)","article_body_html":"","raw_payload":{"data":{"id":"nGNE7Jp8fN","title":"REG-Press Release: Sanofi’s Wayrilz approved in Japan to treat immune thrombocytopenia","author":"Globe Newswire","ticker":"SASY","created":"2026-06-23T05:15:00.062Z","tickers":["SASY"],"exchange":"Euronext Paris","article_body":"Sanofi’s Wayrilz approved in Japan to treat immune thrombocytopenia\n* Wayrilz is a BTK inhibitor that works through multi-immune modulation to\nhelp address the underlying causes of immune thrombocytopenia (ITP)\n* Approval based on the LUNA 3 phase 3 study that demonstrated rapid and\ndurable platelet response and improvements in other symptoms\n* ITP is a rare disease of complex immune dysregulation leading to lower\nplatelet counts, bleeding, and reduced quality of life\nParis, June 23, 2026. The Ministry of Health, Labour and Welfare in Japan has\ngranted marketing and manufacturing authorization to Wayrilz (rilzabrutinib),\na novel oral reversible Bruton’s tyrosine kinase inhibitor (BTKi), for the\ntreatment of persistent or chronic immune thrombocytopenia (ITP) in patients\nwho do not respond sufficiently to other treatments or in whom tolerability is\nconsidered to be problematic. Wayrilz can help address the underlying causes\nof the disease, through multi-immune modulation, targeting key pathways across\nthe immune system.\n\nThe approval is based on the LUNA 3 phase 3 study (clinical study identifier:\nNCT04562766)\n(https://www.clinicaltrials.gov/study/NCT04562766?cond=ITP%20-%20Immune%20Thrombocytopenia&term=Sanofi&intr=rilzabrutinib&rank=2),\nin which Wayrilz met the primary and secondary endpoints, showing a positive\nimpact on sustained platelet counts and other symptoms.\n\n\"For ITP patients, achieving platelet counts close to normal and living\nwithout worrying about bleeding is extremely important. Additionally, in\nrecent years, there has been growing interest in various other symptoms\nassociated with ITP such as fatigue,” said Hisashi Kato, MD, PhD, Department\nof Blood Transfusion and Cell Therapy, The University of Osaka Hospital,\nSuita, Japan. “Wayrilz is a novel BTKi that works through multi-immune\nmodulation to help address the root cause of ITP pathophysiology. It is\nexpected to become a new therapeutic option that may help patients with\ndisease management, including not only improvement in platelet counts but also\nconsidering patients' quality of life.\"\n\n“People living with immune thrombocytopenia who continue to experience\nsymptoms, despite trying existing treatments, face a great unmet need,” said\nManuela Buxo, Executive Vice President, Global Head of Specialty Care at\nSanofi. “Wayrilz has a differentiated mechanism of action that enables\nmulti-immune modulation to address the underlying pathophysiology of ITP and\noffers new hope to patients who have not responded to prior therapy. This\nmilestone underscores Sanofi’s commitment to bringing innovative treatment\noptions to rare disease patients around the world.”\n\nThe LUNA 3 phase 3 study evaluated the efficacy and safety of Wayrilz compared\nto placebo in adults (n=202) with persistent or chronic ITP. Patients who\nachieved platelet count response at 12 weeks were eligible to continue the\nfull 24-week double-blind period (64% of patients in the Wayrilz arm and 32%\nof patients in the placebo arm). Patients receiving Wayrilz experienced the\nfollowing compared to patients receiving placebo:\n* Statistically significant durable platelet response at week 25 (23% of\npatients in Wayrilz arm vs. 0% in placebo arm; p<0.0001) \n* Faster time to first platelet response (36 days in Wayrilz arm vs. not\nreached in placebo arm; p<0.0001)\n* Longer duration of platelet response (least square mean of 7 weeks in\nWayrilz arm vs. 0.7 weeks in placebo arm)\nPatients receiving Wayrilz reported an overall 10.6-point improvement in the\noverall quality of life domain compared to a 2.3-point increase in the placebo\narm, based on The Immune Thrombocytopenia Patient Assessment Questionnaire, a\nclinical tool designed to measure ITP symptoms and impacts. The results of\nthis analysis are descriptive and were not powered for statistical\nsignificance.\n\nThe most common adverse reactions (incidence ≥10%) were diarrhea, nausea,\nheadache, abdominal pain, and COVID-19.\n\nWayrilz is being studied across multiple other rare diseases, including\nIgG4-related disease (IgG4-RD), warm autoimmune hemolytic anemia (wAIHA), and\nsickle cell disease. These additional indications are currently under\ninvestigation and have not been approved by regulatory authorities. Japan has\ngranted Wayrilz orphan drug designation for ITP, IgG4-RD, and wAIHA.\n\nAbout ITP\nITP is a disease of complex immune dysregulation that causes low platelet\ncounts (<100,000/μL), resulting in a variety of bleeding symptoms and high\nrisk of thromboembolism. Beyond bruising and bleeding, which can include\npotentially life-threatening episodes like intracranial hemorrhage, people\nliving with ITP may experience reduced quality of life, including physical\nfatigue and cognitive impairment.\n\nAbout Wayrilz\nWayrilz (rilzabrutinib) is a novel oral reversible covalent BTK inhibitor that\nhas the potential to be an effective new medicine for several rare\nimmune-mediated or inflammatory diseases by working to restore immune balance\nvia multi-immune modulation. The enzyme BTK, expressed in B cells,\nmacrophages, and other innate immune cells, plays a critical role in multiple\nimmune-mediated disease processes and inflammatory pathways. With the\napplication of the TAILORED COVALENCY(®) technology, Wayrilz can selectively\ninhibit the BTK target. Wayrilz is now approved for the treatment of ITP in\nthe US, the EU, the UAE, the UK and Japan.\n\nAbout Sanofi \nSanofi is an R&D driven, AI-powered biopharma company committed to improving\npeople’s lives and delivering compelling growth. We apply our deep\nunderstanding of the immune system to invent medicines and vaccines that treat\nand protect millions of people around the world, with an innovative pipeline\nthat could benefit millions more. Our team is guided by one purpose: we chase\nthe miracles of science to improve people’s lives; this inspires us to drive\nprogress and deliver positive impact for our people and the communities we\nserve, by addressing the most urgent healthcare, environmental, and societal\nchallenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY\n\nMedia Relations\nSandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com\nEvan Berland | +1 215 432 0234 | evan.berland@sanofi.com\nLéo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com\nVictor Rouault | +1 617 356 4751 | victor.rouault@sanofi.com\nTimothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com\nLéa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com\nEkaterina Pesheva | +1 410 926 6780 | ekaterina.pesheva@sanofi.com \nLaura Romby| +33 6 74 16 74 29 | laura.romby@sanofi.com\n\nInvestor Relations\nThomas Kudsk Larsen |+44 7545 513 693 | thomas.larsen@sanofi.com\nAlizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com\nKeita Browne | +1 781 249 1766 | keita.browne@sanofi.com\nNathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com\nNina Goworek | +1 908 569 7086 | nina.goworek@sanofi.com\nThibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com\nYun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com\n\nSanofi Forward-Looking Statements\nThis press release contains forward-looking statements within the meaning of\napplicable securities laws, including the Private Securities Litigation Reform\nAct of 1995, as amended. Forward-looking statements are statements that are\nnot historical facts. These statements include projections and estimates and\ntheir underlying assumptions regarding the marketing and other potential of\nthe product; regarding potential future events and revenues from the product.\nWords such as “expect,” “anticipate,” “believe,” “intend,”\n“estimate,” “plan,” “can,” “contemplate,” “could,” “is\ndesigned to,” “may,” “might,” “potential,” “objective,”\n\"attempt,\" “target,” “project,” \"strategy,\" \"strive,\" \"desire,\"\n“predict,” “forecast,” “ambition,” “guideline,” \"seek,\"\n“should,” “will,” \"goal,\" or the negative of these and similar\nexpressions are intended to identify forward-looking statements. Although\nSanofi’s management believes that the expectations reflected in such\nforward-looking statements are reasonable, investors are cautioned that\nforward-looking information and statements are subject to various risks and\nuncertainties, many of which are difficult to predict and generally beyond the\ncontrol of Sanofi, that could cause actual results and developments to differ\nmaterially from those expressed in, or implied or projected by, the\nforward-looking information and statements. These risks, uncertainties and\nassumptions include among other things, unexpected regulatory actions or\ndelays, or government regulation generally, that could affect the availability\nor commercial potential of the product, the fact that product may not be\ncommercially successful; authorities’ decisions regarding whether and when\nto approve a product candidate; political pressure in the United States to\nmandate lower drug prices including “most favored nation” pricing for\nState Medicaid programs; the uncertainties inherent in research and\ndevelopment, including future clinical data and analysis of existing clinical\ndata relating to the product, including post marketing, unexpected safety,\nquality or manufacturing issues; competition in general; risks associated with\nintellectual property and any related pending or future litigation and the\nultimate outcome of such litigation, and volatile economic and market\nconditions, and the impact that global crises may have on us, our customers,\nsuppliers, vendors, and other business partners, and the financial condition\nof any one of them, as well as on our employees and on the global economy as a\nwhole. The risks and uncertainties also include the uncertainties discussed or\nidentified in the public filings with the SEC and the French Markets Authority\n(AMF) made by Sanofi, including those listed under “Risk Factors” and\n“Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s\nannual report on Form 20-F for the year ended December 31, 2025 or contained\nin our periodic reports on Form 6-K. Other than as required by applicable law,\nSanofi does not undertake any obligation to update or revise any\nforward-looking information or statements. In light of these risks,\nuncertainties and assumptions, you should not place undue reliance on any\nforward-looking statements contained herein.\n\nAll trademarks mentioned in this press release are the property of the Sanofi\ngroup.\n\nAttachment\n*     Press_Release\n(https://ml-eu.globenewswire.com/Resource/Download/4325af4c-23d8-4a34-a5f7-3031c1a15997)"},"type":"article","timestamp":"2026-06-23T05:15:00.158553364Z","server_sent_at_ms":1782191700158},"received_at":"2026-06-23T05:15:00.212Z","source_url":null},"analysis":{"id":"59695","press_release_id":"70302","analysis_json":{"industry":{"label":"Pharmaceuticals","sector":"Health Care"},"redFlags":[],"eventType":"regulatory","narrative":"Sanofi received marketing and manufacturing authorization in Japan for Wayrilz (rilzabrutinib) to treat persistent or chronic immune thrombocytopenia (ITP). This expands the drug's footprint to a fifth major market, following approvals in the US, EU, UAE, and UK.\n\nThe approval was supported by the Phase 3 LUNA 3 study, where Wayrilz achieved a statistically significant durable platelet response in 23% of patients versus 0% for placebo at week 25. Patients on the therapy also reported a 10.6-point improvement in quality of life scores.\n\nWayrilz is a novel oral reversible BTK inhibitor designed to address the underlying immune dysregulation of ITP. Sanofi noted that the most common adverse reactions were diarrhea, nausea, and headache.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Japan approval expands Wayrilz reach to fifth major market; Phase 3 data showed strong platelet response and QoL benefits."},"keyFigures":{"drugName":"Wayrilz (rilzabrutinib)","phaseOfTrial":"Phase 3","customDimensions":{"qol_improvement":"10.6-point (Wayrilz) vs 2.3-point (placebo)","duration_of_response":"7 weeks (Wayrilz) vs 0.7 weeks (placebo)","time_to_first_response":"36 days (Wayrilz) vs not reached (placebo)","durable_platelet_response_w25":"23% (Wayrilz) vs 0% (placebo)"}},"quotedText":"Wayrilz has a differentiated mechanism of action that enables multi-immune modulation to address the underlying pathophysiology of ITP and offers new hope to patients who have not responded to prior therapy.","namedEntities":{"people":[{"name":"Hisashi Kato","role":"MD, PhD, Department of Blood Transfusion and Cell Therapy, The University of Osaka Hospital"},{"name":"Manuela Buxo","role":"Executive Vice President, Global Head of Specialty Care at Sanofi"}],"products":["Wayrilz","rilzabrutinib"],"companies":[{"name":"Sanofi","ticker":"SNY","relationship":"issuer"},{"name":"Sanofi","ticker":"SAN","relationship":"issuer"}],"dollarAmounts":[]},"materialImpact":{"score":4,"reasoning":"Approval in Japan is a significant expansion for Wayrilz, adding a key pharmaceutical market to the existing US, EU, UAE, and UK approvals. The Phase 3 data showed strong statistical significance in durable platelet responses compared to placebo."},"tickerRelevance":{"others":[{"ticker":"SNY","relevance":"issuer"},{"ticker":"SAN","relevance":"issuer"}],"primary":"SASY"},"globalImportance":45,"audienceRelevance":35,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"large-cap-pharma","eventGravity":"regulatory-approval","sectorWeight":"Health Care"}},"event_type":"regulatory","event_type_secondary":null,"sentiment":"bullish","material_impact_score":4,"narrative":"Sanofi received marketing and manufacturing authorization in Japan for Wayrilz (rilzabrutinib) to treat persistent or chronic immune thrombocytopenia (ITP). This expands the drug's footprint to a fifth major market, following approvals in the US, EU, UAE, and UK.\n\nThe approval was supported by the Phase 3 LUNA 3 study, where Wayrilz achieved a statistically significant durable platelet response in 23% of patients versus 0% for placebo at week 25. Patients on the therapy also reported a 10.6-point improvement in quality of life scores.\n\nWayrilz is a novel oral reversible BTK inhibitor designed to address the underlying immune dysregulation of ITP. Sanofi noted that the most common adverse reactions were diarrhea, nausea, and headache.","key_figures":{"drugName":"Wayrilz (rilzabrutinib)","phaseOfTrial":"Phase 3","customDimensions":{"qol_improvement":"10.6-point (Wayrilz) vs 2.3-point (placebo)","duration_of_response":"7 weeks (Wayrilz) vs 0.7 weeks (placebo)","time_to_first_response":"36 days (Wayrilz) vs not reached (placebo)","durable_platelet_response_w25":"23% (Wayrilz) vs 0% (placebo)"}},"named_entities":{"people":[{"name":"Hisashi Kato","role":"MD, PhD, Department of Blood Transfusion and Cell Therapy, The University of Osaka Hospital"},{"name":"Manuela Buxo","role":"Executive Vice President, Global Head of Specialty Care at Sanofi"}],"products":["Wayrilz","rilzabrutinib"],"companies":[{"name":"Sanofi","ticker":"SNY","relationship":"issuer"},{"name":"Sanofi","ticker":"SAN","relationship":"issuer"}],"dollarAmounts":[]},"model_name":"qwen3_6_27b_awq","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-06-23T05:17:06.672Z","global_importance":45,"audience_relevance":35,"importance_components":{"tickerTier":"large-cap-pharma","eventGravity":"regulatory-approval","sectorWeight":"Health Care"}},"durationMs":126456,"modelName":"george-droid-qwen-72b"}}