{"success":true,"data":{"pressRelease":{"id":"3953","rtpr_id":"nGNE5rQc7m","ticker":"SASY","exchange":"Euronext Paris","all_tickers":["SASY"],"title":"REG-Press Release: Sanofi provides update on the regulatory submission for Sarclisa subcutaneous in the US","author":"Globe Newswire","published_at":"2026-04-22T05:00:00.107Z","article_body":"Sanofi provides update on the regulatory submission for Sarclisa subcutaneous\nin the US\n\nParis, April 22, 2026. The US Food and Drug Administration (FDA) has extended\nby up to three months the target action date for its review of the biologics\nlicense application for Sarclisa (isatuximab-irfc) subcutaneous (SC) in\ncombination with approved standard-of-care regimens for the treatment of\npatients with multiple myeloma (MM) across all currently approved US\nindications of Sarclisa intravenous (IV) formulation. The revised target\naction date for the FDA decision is July 23, 2026.\n\nSanofi is committed to working closely with the FDA to bring this new\nadvancement to patients and providers as quickly as possible. If approved,\nSarclisa would be the first anticancer treatment to be administered through an\non-body injector (OBI).\n\nOn March 26, 2026, the European Medicine Agency Committee for Medicinal\nProducts for Human Use (CHMP) adopted a positive opinion recommending the\napproval of Sarclisa SC administered via both an OBI and manual injection for\nthe treatment of MM patients across all currently approved indications and\ncombinations for Sarclisa IV formulation in the EU. A final decision is\nexpected in the coming months.\n \nAbout Sarclisa\nSarclisa (isatuximab-irfc) has been approved in almost 60 countries across\nfour indications for certain patients with newly diagnosed MM and relapsed or\nrefractory MM. Sarclisa-based regimens have been prescribed to treat more than\n60,000 patients worldwide. \n\nAt Sanofi, we are building on a long-standing commitment to oncology as we\ncontinue to chase the miracles of science to improve the lives of those living\nwith cancer. We are committed to transforming cancer care by developing\ninnovative, first and best-in-class immunological and targeted therapies for\nrare and difficult-to-treat cancers with high unmet need.\n\nFor more information on Sarclisa clinical studies, please\nvisit www.clinicaltrials.gov.\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\nchase the miracles of science to improve people’s lives; this inspires us to\ndrive progress and deliver positive impact for our people and the communities\nwe serve, by addressing the most urgent healthcare, environmental, and\nsocietal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ:\nSNY\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\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. \nForward-looking statements are statements that are not historical facts. These\nstatements include projections and estimates and their underlying assumptions,\nstatements regarding plans, objectives, intentions, and expectations with\nrespect to future financial results, events, operations, services, product\ndevelopment and potential, and statements regarding future events and economic\nperformance. Words such as “expect,” “anticipate,” “believe,”\n“intend,” “estimate,” “plan,” “can,” “contemplate,”\n“could,” “is designed to,” “may,” “might,” “potential,”\n“objective,” \"attempt,\" “target,” “project,” \"strategy,\" \"strive,\"\n\"desire,\" “predict,” “forecast,” “ambition,” “guideline,”\n\"seek,\" “should,” “will,” \"goal,\" or the negative of these, and\nsimilar expressions are intended to identify forward-looking statements. \nAlthough Sanofi’s management believes that the expectations reflected in\nsuch forward-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 and uncertainties\ninclude among other things, the uncertainties inherent in research and\ndevelopment, future clinical data and analysis, including post marketing,\ndecisions by regulatory authorities, such as the U.S Food and Drug\nAdministration or the European Medicines Agency, regarding whether and when to\napprove any drug, device or biological application that may be filed for any\nsuch product candidates as well as their decisions regarding labelling and\nother matters that could affect the availability or commercial potential of\nsuch product candidates; the fact that product candidates if approved may not\nbe commercially successful; unexpected regulatory actions or delays, or\ngovernment regulation generally; authorities’ decisions regarding whether\nand when to approve a product candidate; political pressure in the United\nStates to mandate lower drug prices including “most favored nation”\npricing for State Medicaid programs; the future approval and commercial\nsuccess of therapeutic alternatives; Sanofi’s ability to benefit from\nexternal growth opportunities, to complete related transactions and/or obtain\nregulatory clearances, including future clinical data and analysis of existing\nclinical data relating to the product, including post marketing, unexpected\nsafety, quality or manufacturing issues, competition in general; risks\nassociated with intellectual property and any related pending or future\nlitigation and the ultimate outcome of such litigation;  trends in exchange\nrates and prevailing interest rates, volatile economic and market conditions,\ncost containment initiatives and subsequent changes thereto, and the impact\nthat global crises may have on us, our customers, suppliers, vendors, and\nother business partners, and the financial condition of any one of them, as\nwell as on our employees and on the global economy as a whole. The risks and\nuncertainties also include the uncertainties discussed or identified in the\npublic filings with the SEC and the French Markets Authority (AMF) made by\nSanofi, including those listed under “Risk Factors” and “Cautionary\nStatement Regarding Forward-Looking Statements” in Sanofi’s annual report\non Form 20-F for the year ended December 31, 2025 or contained in our periodic\nreports on Form 6-K. Other than as required by applicable law, Sanofi does not\nundertake any obligation to update or revise any forward-looking information\nor statements. In light of these risks, uncertainties and assumptions, you\nshould not place undue reliance on any forward-looking statements contained\nherein.\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/235d5f4f-3d6f-46a6-a87c-4ebdef82136d)","article_body_html":"","raw_payload":{"data":{"id":"nGNE5rQc7m","title":"REG-Press Release: Sanofi provides update on the regulatory submission for Sarclisa subcutaneous in the US","author":"Globe Newswire","ticker":"SASY","created":"2026-04-22T05:00:00.107Z","tickers":["SASY"],"exchange":"Euronext Paris","article_body":"Sanofi provides update on the regulatory submission for Sarclisa subcutaneous\nin the US\n\nParis, April 22, 2026. The US Food and Drug Administration (FDA) has extended\nby up to three months the target action date for its review of the biologics\nlicense application for Sarclisa (isatuximab-irfc) subcutaneous (SC) in\ncombination with approved standard-of-care regimens for the treatment of\npatients with multiple myeloma (MM) across all currently approved US\nindications of Sarclisa intravenous (IV) formulation. The revised target\naction date for the FDA decision is July 23, 2026.\n\nSanofi is committed to working closely with the FDA to bring this new\nadvancement to patients and providers as quickly as possible. If approved,\nSarclisa would be the first anticancer treatment to be administered through an\non-body injector (OBI).\n\nOn March 26, 2026, the European Medicine Agency Committee for Medicinal\nProducts for Human Use (CHMP) adopted a positive opinion recommending the\napproval of Sarclisa SC administered via both an OBI and manual injection for\nthe treatment of MM patients across all currently approved indications and\ncombinations for Sarclisa IV formulation in the EU. A final decision is\nexpected in the coming months.\n \nAbout Sarclisa\nSarclisa (isatuximab-irfc) has been approved in almost 60 countries across\nfour indications for certain patients with newly diagnosed MM and relapsed or\nrefractory MM. Sarclisa-based regimens have been prescribed to treat more than\n60,000 patients worldwide. \n\nAt Sanofi, we are building on a long-standing commitment to oncology as we\ncontinue to chase the miracles of science to improve the lives of those living\nwith cancer. We are committed to transforming cancer care by developing\ninnovative, first and best-in-class immunological and targeted therapies for\nrare and difficult-to-treat cancers with high unmet need.\n\nFor more information on Sarclisa clinical studies, please\nvisit www.clinicaltrials.gov.\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\nchase the miracles of science to improve people’s lives; this inspires us to\ndrive progress and deliver positive impact for our people and the communities\nwe serve, by addressing the most urgent healthcare, environmental, and\nsocietal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ:\nSNY\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\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. \nForward-looking statements are statements that are not historical facts. These\nstatements include projections and estimates and their underlying assumptions,\nstatements regarding plans, objectives, intentions, and expectations with\nrespect to future financial results, events, operations, services, product\ndevelopment and potential, and statements regarding future events and economic\nperformance. Words such as “expect,” “anticipate,” “believe,”\n“intend,” “estimate,” “plan,” “can,” “contemplate,”\n“could,” “is designed to,” “may,” “might,” “potential,”\n“objective,” \"attempt,\" “target,” “project,” \"strategy,\" \"strive,\"\n\"desire,\" “predict,” “forecast,” “ambition,” “guideline,”\n\"seek,\" “should,” “will,” \"goal,\" or the negative of these, and\nsimilar expressions are intended to identify forward-looking statements. \nAlthough Sanofi’s management believes that the expectations reflected in\nsuch forward-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 and uncertainties\ninclude among other things, the uncertainties inherent in research and\ndevelopment, future clinical data and analysis, including post marketing,\ndecisions by regulatory authorities, such as the U.S Food and Drug\nAdministration or the European Medicines Agency, regarding whether and when to\napprove any drug, device or biological application that may be filed for any\nsuch product candidates as well as their decisions regarding labelling and\nother matters that could affect the availability or commercial potential of\nsuch product candidates; the fact that product candidates if approved may not\nbe commercially successful; unexpected regulatory actions or delays, or\ngovernment regulation generally; authorities’ decisions regarding whether\nand when to approve a product candidate; political pressure in the United\nStates to mandate lower drug prices including “most favored nation”\npricing for State Medicaid programs; the future approval and commercial\nsuccess of therapeutic alternatives; Sanofi’s ability to benefit from\nexternal growth opportunities, to complete related transactions and/or obtain\nregulatory clearances, including future clinical data and analysis of existing\nclinical data relating to the product, including post marketing, unexpected\nsafety, quality or manufacturing issues, competition in general; risks\nassociated with intellectual property and any related pending or future\nlitigation and the ultimate outcome of such litigation;  trends in exchange\nrates and prevailing interest rates, volatile economic and market conditions,\ncost containment initiatives and subsequent changes thereto, and the impact\nthat global crises may have on us, our customers, suppliers, vendors, and\nother business partners, and the financial condition of any one of them, as\nwell as on our employees and on the global economy as a whole. The risks and\nuncertainties also include the uncertainties discussed or identified in the\npublic filings with the SEC and the French Markets Authority (AMF) made by\nSanofi, including those listed under “Risk Factors” and “Cautionary\nStatement Regarding Forward-Looking Statements” in Sanofi’s annual report\non Form 20-F for the year ended December 31, 2025 or contained in our periodic\nreports on Form 6-K. Other than as required by applicable law, Sanofi does not\nundertake any obligation to update or revise any forward-looking information\nor statements. In light of these risks, uncertainties and assumptions, you\nshould not place undue reliance on any forward-looking statements contained\nherein.\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/235d5f4f-3d6f-46a6-a87c-4ebdef82136d)"},"type":"article","timestamp":"2026-04-22T05:00:00.219202523Z","server_sent_at_ms":1776834000219},"received_at":"2026-04-22T05:00:00.283Z","source_url":null},"analysis":{"id":"2754","press_release_id":"3953","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["FDA extended review timeline by up to three months"],"eventType":"regulatory","narrative":"The FDA extended the target action date for Sanofi's Sarclisa subcutaneous biologics license application by up to three months, with a new decision deadline of July 23, 2026.\n\nThe submission seeks approval for the subcutaneous formulation in combination with standard-of-care regimens for multiple myeloma across all currently approved IV indications.\n\nA positive opinion was adopted by the European CHMP in late March, recommending approval for both on-body injector and manual injection formulations.","sentiment":"neutral","agentHooks":{"shouldPost":false,"suggestedAngle":"US regulatory delay for Sarclisa SC pushes PDUFA date to July."},"keyFigures":{"customDimensions":{"countries_approved":60,"patients_prescribed":60000,"new_target_action_date":"July 23, 2026","extension_length_months":3}},"quotedText":"","namedEntities":{"people":[],"products":["Sarclisa","isatuximab-irfc","Sarclisa subcutaneous","Sarclisa intravenous","on-body injector"],"companies":[{"name":"Sanofi","ticker":"SASY"},{"name":"US Food and Drug Administration","relationship":"regulator"},{"name":"European Medicine Agency","relationship":"regulator"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"The FDA extended the review period for a key product (Sarclisa SC) by three months, delaying potential US commercialization but not rejecting the application."},"tickerRelevance":{"others":[{"ticker":"SAN","relevance":"mentioned"},{"ticker":"SNY","relevance":"mentioned"}],"primary":"SASY"},"eventTypeSecondary":[]},"event_type":"regulatory","event_type_secondary":null,"sentiment":"neutral","material_impact_score":3,"narrative":"The FDA extended the target action date for Sanofi's Sarclisa subcutaneous biologics license application by up to three months, with a new decision deadline of July 23, 2026.\n\nThe submission seeks approval for the subcutaneous formulation in combination with standard-of-care regimens for multiple myeloma across all currently approved IV indications.\n\nA positive opinion was adopted by the European CHMP in late March, recommending approval for both on-body injector and manual injection formulations.","key_figures":{"customDimensions":{"countries_approved":60,"patients_prescribed":60000,"new_target_action_date":"July 23, 2026","extension_length_months":3}},"named_entities":{"people":[],"products":["Sarclisa","isatuximab-irfc","Sarclisa subcutaneous","Sarclisa intravenous","on-body injector"],"companies":[{"name":"Sanofi","ticker":"SASY"},{"name":"US Food and Drug Administration","relationship":"regulator"},{"name":"European Medicine Agency","relationship":"regulator"}],"dollarAmounts":[]},"model_name":"glm-4.7","prompt_hash":"sha256:2f2748f0fcc8c4f2","schema_hash":"sha256:ad96b863d7123008","created_at":"2026-04-22T05:00:57.092Z","global_importance":3,"audience_relevance":3,"importance_components":{"method":"backfill-heuristic","signals":{"bodyLong":false,"headlineTier1":false,"tickerCovered":false,"hadSignificance":false},"version":1,"computedAt":"2026-04-27T11:52:53.849Z"}},"durationMs":56681,"modelName":"glm-4.7"}}