Sanofi provides update on the regulatory submission for Sarclisa subcutaneous in the US   Paris, April 22, 2026. The US Food and Drug Administration (FDA) has extended by up to three months the target action date for its

PARIS:SAN

Press Release: Sanofi provides update on the regulatory submission for Sarclisa subcutaneous in the US

FDA Extends Sanofi's Sarclisa Subcutaneous Review Timeline

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 <section data-block="information">
 <h3>Information</h3>
 Sanofi provides update on the regulatory submission for Sarclisa subcutaneous in the US Paris, April 22, 2026. The US Food and Drug Administration (FDA) has extended by up to three months the target action date for its
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 <section data-block="ai-summary-paragraph">
 <h3>AI Summary</h3>
 The FDA has extended its review timeline for Sanofi&#039;s Sarclisa subcutaneous formulation by up to three months, with a new decision date set for July 23, 2026. If approved, Sarclisa will be the first anticancer treatment available through an on-body injector, indicating a significant innovation in cancer therapy delivery that could positively impact Sanofi&#039;s market position.
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 <section data-block="ai-summary-bullets">
 <h3>Key Points</h3>
 <ul><li>FDA extends Sarclisa SC review by up to three months.</li><li>New target action date for approval is July 23, 2026.</li><li>Sarclisa SC will be the first cancer treatment using an on-body injector.</li><li>European approval decision for Sarclisa SC is expected soon.</li><li>Sanofi&#039;s commitment to oncology emphasizes innovation and patient care.</li></ul>
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 <section data-block="companies-mentioned">
 <h3>Companies Mentioned</h3>
 <ul><li>Sanofi (SAN): Key player in oncology with innovative therapies that could enhance market position.</li></ul>
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 <section data-block="category">
 <h3>Corporate Developments</h3>
 This news fits the &#039;Corporate Developments&#039; category as it relates to regulatory submissions and product innovation, which are vital for Sanofi&#039;s growth strategy in oncology.
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 <section data-block="market-moving">
 <h3>Market-Moving</h3>
 <ul><li>FDA&#039;s decision on Sarclisa SC could dramatically affect Sanofi&#039;s revenue outlook.</li><li>Unique delivery system for Sarclisa SC may lead to competitive advantage in oncology.</li><li>Positive European approval can boost investor confidence and stock performance.</li></ul>
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 <section data-block="key-facts">
 <h3>Key Facts</h3>
 <ul><li>Sarclisa has been approved in nearly 60 countries.</li><li>Over 60,000 patients are treated with Sarclisa globally.</li><li>FDA&#039;s new target date for Sarclisa SC is July 23, 2026.</li><li>Sarclisa SC received a positive opinion from the EU on March 26, 2026.</li><li>On-body injector technology is a novel delivery method for oncology treatments.</li></ul>
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 <section data-block="trading-thesis">
 <h3>Trading Thesis</h3>
 Investors should consider an optimistic outlook for PARIS:SAN, expecting gains post-approval.
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<link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css"></link>Sanofi provides update on the regulatory submission for Sarclisa subcutaneous in the US Paris, April 22, 2026. The US Food and Drug Administration (FDA) has extended by up to three months the target action date for its review of the biologics license application for Sarclisa (isatuximab-irfc) subcutaneous (SC) in combination with approved standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all currently approved US indications of Sarclisa intravenous (IV) formulation. The revised target action date for the FDA decision is July 23, 2026. Sanofi is committed to working closely with the FDA to bring this new advancement to patients and providers as quickly as possible. If approved, Sarclisa would be the first anticancer treatment to be administered through an on-body injector (OBI). On March 26, 2026, the European Medicine Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Sarclisa SC administered via both an OBI and manual injection for the treatment of MM patients across all currently approved indications and combinations for Sarclisa IV formulation in the EU. A final decision is expected in the coming months.   About Sarclisa Sarclisa (isatuximab-irfc) has been approved in almost 60 countries across four indications for certain patients with newly diagnosed MM and relapsed or refractory MM. Sarclisa-based regimens have been prescribed to treat more than 60,000 patients worldwide.  At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need. For more information on Sarclisa clinical studies, please visit <a href="http://www.clinicaltrials.gov" rel="nofollow" target="_blank">www.clinicaltrials.gov</a>. About Sanofi  Sanofi is an R&amp;D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media Relations Sandrine Guendoul &#x7C; +33 6 25 09 14 25 &#x7C; <a href="mailto:sandrine.guendoul@sanofi.com" rel="nofollow" target="_blank">sandrine.guendoul@sanofi.com</a> Evan Berland &#x7C; +1 215 432 0234 &#x7C; <a href="mailto:evan.berland@sanofi.com" rel="nofollow" target="_blank">evan.berland@sanofi.com</a>   Léo Le Bourhis &#x7C; +33 6 75 06 43 81 &#x7C; <a href="mailto:leo.lebourhis@sanofi.com" rel="nofollow" target="_blank">leo.lebourhis@sanofi.com</a>   Victor Rouault &#x7C; +1 617 356 4751 &#x7C; <a href="mailto:victor.rouault@sanofi.com" rel="nofollow" target="_blank">victor.rouault@sanofi.com</a> Timothy Gilbert &#x7C; +1 516 521 2929 &#x7C; <a href="mailto:timothy.gilbert@sanofi.com" rel="nofollow" target="_blank">timothy.gilbert@sanofi.com</a> Léa Ubaldi &#x7C; +33 6 30 19 66 46 &#x7C; <a href="mailto:lea.ubaldi@sanofi.com" rel="nofollow" target="_blank">lea.ubaldi@sanofi.com</a> Ekaterina Pesheva &#x7C; +1 410 926 6780 &#x7C; ekaterina.pesheva@sanofi.com Investor Relations Thomas Kudsk Larsen &#x7C;+ 44 7545 513 693 &#x7C; <a href="mailto:thomas.larsen@sanofi.com" rel="nofollow" target="_blank">thomas.larsen@sanofi.com</a> Alizé Kaisserian &#x7C; + 33 6 47 04 12 11 &#x7C; <a href="mailto:alize.kaisserian@sanofi.com" rel="nofollow" target="_blank">alize.kaisserian@sanofi.com</a> Keita Browne &#x7C; + 1 781 249 1766 &#x7C; <a href="mailto:keita.browne@sanofi.com" rel="nofollow" target="_blank">keita.browne@sanofi.com</a> Nathalie Pham &#x7C; + 33 7 85 93 30 17 &#x7C; <a href="mailto:nathalie.pham@sanofi.com" rel="nofollow" target="_blank">nathalie.pham@sanofi.com</a> Nina Goworek &#x7C; +1 908 569 7086 &#x7C; <a href="mailto:nina.goworek@sanofi.com" rel="nofollow" target="_blank">nina.goworek@sanofi.com</a> Thibaud Châtelet &#x7C; + 33 6 80 80 89 90 &#x7C; <a href="mailto:thibaud.chatelet@sanofi.com" rel="nofollow" target="_blank">thibaud.chatelet@sanofi.com</a> Yun Li &#x7C; +33 6 84 00 90 72 &#x7C; <a href="mailto:yun.li3@sanofi.com" rel="nofollow" target="_blank">yun.li3@sanofi.com</a> Sanofi forward-looking statements This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future events and economic performance. Words such as "expect," "anticipate," "believe," "intend," "estimate," "plan," "can," "contemplate," "could," "is designed to," "may," "might," "potential," "objective," &#34;attempt,&#34; "target," "project," &#34;strategy,&#34; &#34;strive,&#34; &#34;desire,&#34; "predict," "forecast," "ambition," "guideline," &#34;seek,&#34; "should," "will," &#34;goal,&#34; or the negative of these, and similar expressions are intended to identify forward-looking statements. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the U.S Food and Drug Administration or the European Medicines Agency, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates; the fact that product candidates if approved may not be commercially successful; unexpected regulatory actions or delays, or government regulation generally; authorities' decisions regarding whether and when to approve a product candidate; political pressure in the United States to mandate lower drug prices including "most favored nation" pricing for State Medicaid programs; the future approval and commercial success of therapeutic alternatives; Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general; risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation;  trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the French Markets Authority (AMF) made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2025 or contained in our periodic reports on Form 6-K. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. In light of these risks, uncertainties and assumptions, you should not place undue reliance on any forward-looking statements contained herein. All trademarks mentioned in this press release are the property of the Sanofi group. 
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The FDA has extended its review timeline for Sanofi's Sarclisa subcutaneous formulation by up to three months, with a new decision date set for July 23, 2026. If approved, Sarclisa will be the first anticancer treatment available through an on-body injector, indicating a significant innovation in cancer therapy delivery that could positively impact Sanofi's market position.

Press Release: Sanofi provides update on the regulatory submission for Sarclisa subcutaneous in the US

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