<SEC-DOCUMENT>0001193125-25-170077.txt : 20250731
<SEC-HEADER>0001193125-25-170077.hdr.sgml : 20250731
<ACCEPTANCE-DATETIME>20250731073442
ACCESSION NUMBER:		0001193125-25-170077
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		6
CONFORMED PERIOD OF REPORT:	20250731
FILED AS OF DATE:		20250731
DATE AS OF CHANGE:		20250731

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Sanofi
		CENTRAL INDEX KEY:			0001121404
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		EIN:				133529324
		STATE OF INCORPORATION:			I0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-31368
		FILM NUMBER:		251169440

	BUSINESS ADDRESS:	
		STREET 1:		46 AVENUE DE LA GRANDE ARMEE
		CITY:			PARIS
		STATE:			I0
		ZIP:			75017
		BUSINESS PHONE:		33153774400

	MAIL ADDRESS:	
		STREET 1:		46 AVENUE DE LA GRANDE ARMEE
		CITY:			PARIS
		STATE:			I0
		ZIP:			75017

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SANOFI-AVENTIS
		DATE OF NAME CHANGE:	20040826

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SANOFI SYNTHELABO SA
		DATE OF NAME CHANGE:	20010104
</SEC-HEADER>
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<TYPE>6-K
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<DESCRIPTION>6-K
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P>
<P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center><DIV STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</DIV></center>
<P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>FORM <FONT STYLE="white-space:nowrap">6-K</FONT> </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>REPORT OF FOREIGN PRIVATE ISSUER </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>PURSUANT TO RULE <FONT STYLE="white-space:nowrap">13a-16</FONT> OR <FONT STYLE="white-space:nowrap">15d-16</FONT> </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934 </B></P>
<P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center><DIV STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</DIV></center>
<P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">For the month of July 2025 </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">Commission File Number: <FONT STYLE="white-space:nowrap">001-31368</FONT> </P>
<P STYLE="margin-top:20pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>SANOFI </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">(Translation of
registrant&#146;s name into English) </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">46, avenue de la Grande Arm&eacute;e, 75017 Paris, FRANCE </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">(Address of principal executive offices) </P> <P STYLE="margin-top:30pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">Indicate
by check mark whether the registrant files or will file annual reports under cover Form <FONT STYLE="white-space:nowrap">20-F</FONT> or Form <FONT STYLE="white-space:nowrap">40-F.</FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">Form <FONT STYLE="white-space:nowrap">20-F</FONT> &#9746;&#8195;&#8195;&#8195;Form <FONT STYLE="white-space:nowrap">40-F</FONT> &#9744; </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">1 </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">In July 2025, Sanofi published the press releases attached hereto as Exhibits 99.1 and 99.2 which are
incorporated herein by reference. </P> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>Exhibit Index </B></P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom"><U>Exhibit&nbsp;No.</U></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center"><U>Description</U>&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8194;</TD></TR>
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<TD VALIGN="top">Exhibit&nbsp;99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d48779dex991.htm">Press Release dated July&nbsp;25, 2025: Sanofi&#146;s Sarclisa approved in the EU for the treatment of transplant-eligible newly diagnosed multiple myeloma </A></TD></TR>
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<TD VALIGN="top">Exhibit&nbsp;99.2</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d48779dex992.htm">Press Release dated July&nbsp;30, 2025: Sanofi&#146;s SAR446523, a GPRC5D monoclonal antibody, earns orphan drug designation in the US for multiple myeloma </A></TD></TR>
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 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">2 </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">SIGNATURES </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:6%; font-size:9pt; font-family:Times New Roman">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized. </P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom">Dated: July&nbsp;31, 2025</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center">SANOFI&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;</TD></TR>
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<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">By&#8195;&#8195;</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">/s/ <U>Alexandra Roger&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;&#8195;</U></TD></TR>
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<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Name: Alexandra Roger</TD></TR>
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<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Title: Head of Legal Corporate&nbsp;&amp; Finance</TD></TR>
</TABLE>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">3 </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL" ALIGN="right"><B>Exhibit 99.1 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom"><FONT STYLE="font-family:Verdana; font-size:14pt"><B>Press Release</B></FONT></TD>
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</TABLE> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:18pt; font-family:Georgia" ALIGN="justify"><FONT COLOR="#7900e6"><I>Sanofi&#146;s Sarclisa approved in the EU for the treatment of transplant-eligible newly
diagnosed multiple myeloma </I></FONT></P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="3%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Verdana; font-size:10pt">Approval based on <FONT STYLE="white-space:nowrap">GMMG-HD7</FONT> phase 3 study demonstrating that Sarclisa with VRd
induction treatment significantly improved MRD negativity benefit and prolonged PFS compared to VRd alone </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Verdana; font-size:10pt">With the first global approval in TE NDMM, Sarclisa is now approved in the EU across all lines of therapy, regardless
of transplant eligibility </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify"><B>Paris, July</B><B></B><B>&nbsp;25, 2025.</B> Following the <FONT
STYLE="font-family:Verdana; font-size:10pt" COLOR="#7900e6"><U>positive opinion</U></FONT><FONT STYLE="font-family:Verdana"> by the European Medicines Agency&#146;s Committee for Medicinal Products for Human Use on June&nbsp;19, 2025, the European
Commission has approved Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant.
</FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:6%; font-size:10pt; font-family:Verdana" ALIGN="justify"><I>&#147;We have been on a mission to accelerate Sarclisa&#146;s clinical development program with the hope to bring this
important medicine to as many people as possible living with multiple myeloma,&#148; said </I><B><I>Olivier Nataf</I></B><I>, Global Head of Oncology at Sanofi. &#147;Today&#146;s decision represents a prime example of those efforts, and most
importantly, paves the way for Sarclisa to potentially become accessible to even more patients in the EU, regardless of transplant eligibility or line of therapy.&#148;</I> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The approval is based on results from <FONT STYLE="font-family:Verdana; font-size:10pt" COLOR="#7900e6"><U>part one</U></FONT><FONT
STYLE="font-family:Verdana"> of the <FONT STYLE="white-space:nowrap">two-part,</FONT> double-randomized, German-speaking Myeloma Multicenter Group <FONT STYLE="white-space:nowrap">(GMMG)-HD7</FONT> phase 3 study (clinical study identifier: </FONT><FONT
STYLE="font-family:Verdana; font-size:10pt" COLOR="#7900e6"><U>NCT03617731</U></FONT><FONT STYLE="font-family:Verdana">), which was designed to independently assess the effects of Sarclisa during the induction and maintenance phases. <FONT
STYLE="white-space:nowrap">Sarclisa-VRd</FONT> demonstrated a deep and rapid response in transplant-eligible (TE) NDMM patients compared to VRd alone, reflected by a statistically significant minimal residual disease (MRD) negativity benefit at the
end of the <FONT STYLE="white-space:nowrap">18-week</FONT> induction period, which was the primary endpoint of part one. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">These MRD results
were supported by the <FONT STYLE="font-family:Verdana; font-size:10pt" COLOR="#7900e6"><U>final progression-free survival (PFS) analysis of part one</U></FONT><FONT STYLE="font-family:Verdana"> (induction and transplant), which demonstrated a
statistically significant and clinically meaningful improvement in PFS in patients treated with <FONT STYLE="white-space:nowrap">Sarclisa-VRd</FONT> during induction, regardless of the maintenance therapy received. Additionally, the majority (53.1%)
of patients receiving <FONT STYLE="white-space:nowrap">Sarclisa-VRd</FONT> experienced continued MRD negativity (compared to 38% in the control arm), defined as MRD negativity persisting from post-induction to post-transplant, which was consistent
with the prolonged PFS benefit. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The results are part of the growing body of clinical evidence supporting the use of Sarclisa in the
front-line setting and reinforce the potential of <FONT STYLE="white-space:nowrap">Sarclisa-VRd</FONT> when used prior to transplant. Data from part two, the maintenance portion of the study, are forthcoming. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">With four approved indications globally, including two in the front-line setting, the approval further affirms Sarclisa as an established MM treatment
option, reflecting Sanofi&#146;s ambition to address critical unmet needs in MM care and make a meaningful difference in treatment outcomes at every stage of the disease. </P>
<P STYLE="margin-top:14pt; margin-bottom:0pt; font-size:12pt; font-family:Georgia" ALIGN="justify"><FONT COLOR="#7900e6"><I>About the <FONT STYLE="white-space:nowrap">GMMG-HD7</FONT> study </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify"><FONT STYLE="white-space:nowrap">GMMG-HD7</FONT> is a pivotal, randomized, open-label, multicenter, <FONT STYLE="white-space:nowrap">two-part</FONT>
phase 3 study evaluating Sarclisa in combination with VRd, also referred to as RVd (lenalidomide, bortezomib, and dexamethasone), versus VRd induction followed by post-transplant <FONT STYLE="white-space:nowrap">re-randomization</FONT> to Sarclisa
plus lenalidomide versus lenalidomide maintenance alone in TE NDMM patients. The GMMG-</P>
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initiated study is being conducted in close collaboration with Sanofi based on jointly defined research. Sanofi provided financial support to GMMG for this study. In December 2021, Sanofi and
GMMG shared results from part one, which met the primary endpoint of MRD negativity after induction therapy and before transplant in NDMM patients. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The study enrolled 662 patients with TE NDMM across 67 sites in Germany. In the first part of the study, all participants were equally randomized to
receive three <FONT STYLE="white-space:nowrap">42-day</FONT> induction cycles of VRd in both arms of the study, while Sarclisa was added to only one study arm. After induction treatment, all patients received intensification therapy with autologous
stem cell transplant. In the second part of the study, patients were <FONT STYLE="white-space:nowrap">re-randomized</FONT> post-transplant to receive Sarclisa plus lenalidomide or lenalidomide alone as maintenance therapy. During part one of the
study, Sarclisa was administered through an intravenous infusion at a dose of 10 mg/kg once weekly for the first four weeks of cycle one, then every other week for the rest of the induction period. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The <FONT STYLE="white-space:nowrap">GMMG-HD7</FONT> protocol defined two primary endpoints: MRD negativity following induction therapy in the first
part of the study, and PFS after the second randomization post-transplant in the second part, where Sarclisa was added to lenalidomide maintenance. The latter endpoint is expected to be available in due course. The key secondary endpoint for the
first part of the study was PFS from first randomization. Additional secondary endpoints included rates of complete response after induction, and intensification, overall survival, and safety. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">MRD negativity was assessed by next-generation flow cytometry (sensitivity of 1x10<SUP STYLE="font-size:75%; vertical-align:top">-5</SUP>) after
induction. In the latest results, PFS for both arms, regardless of maintenance therapy, were measured from the first randomization. </P> <P STYLE="margin-top:14pt; margin-bottom:0pt; font-size:12pt; font-family:Georgia" ALIGN="justify"><FONT
 COLOR="#7900e6"><I>About Sarclisa </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Sarclisa (isatuximab) is approved in more than 50 countries, including in the US, EU, Japan, and
China, across multiple lines of treatment for MM. Based on the <FONT STYLE="white-space:nowrap">ICARIA-MM</FONT> phase 3 study, Sarclisa is approved in the US and Japan in combination with pomalidomide and dexamethasone (Pd) for the treatment of
patients with relapsed or refractory multiple myeloma (R/R MM) who have received <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>two prior therapies, including lenalidomide and a proteasome inhibitor. Additionally, Sarclisa is approved in
the EU in combination with Pd for the treatment of patients with R/R MM who have received <FONT STYLE="font-family:Times New Roman">&#8805;</FONT>two prior therapies, including lenalidomide and a proteasome inhibitor and have relapsed on the last
therapy, and in China for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. Based on the IKEMA phase 3 study, Sarclisa is also approved in more than 50 countries in combination with
carfilzomib and dexamethasone, including in the US for the treatment of patients with R/R MM who have received one to three prior lines of therapy and in the EU for patients with MM who have received at least one prior therapy. In the US, EU, and
China, Sarclisa is approved in combination with VRd as a front-line treatment option in transplant-ineligible NDMM patients, based on the IMROZ phase 3 study. Sarclisa is also approved in the EU in combination with VRd as an induction treatment for
transplant-eligible NDMM patients, based on the <FONT STYLE="white-space:nowrap">GMMG-HD7</FONT> phase 3 study. In Japan, Sarclisa is approved in combination with VRd as a front-line treatment option regardless of transplant eligibility. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">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 <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">best-in-class</FONT></FONT> immunological and targeted therapies for rare and <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">difficult-to-treat</FONT></FONT> cancers with high unmet need. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">For more information
on Sarclisa clinical studies, please visit <FONT STYLE="font-family:Verdana; font-size:10pt" COLOR="#7900e6"><U>www.clinicaltrials.gov</U></FONT><FONT STYLE="font-family:Verdana">. </FONT></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia" ALIGN="justify"><FONT COLOR="#7900e6"><I>About the German-speaking Myeloma Multicenter Group </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">GMMG is the largest study group focusing on MM in Germany, with headquarters based in Heidelberg. Within the last 20+ years, the GMMG study group has
performed numerous studies including five randomized, multicenter phase 3 studies with 4,000 patients enrolled from about 90 participating and cotreating centers throughout Germany. The overall goal of GMMG is to generate improved therapies for
myeloma patients through the development and testing of novel and personalized, genome- and signaling driven treatment strategies. The GMMG has set itself </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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the goal of achieving further approvals for effective antibody-based drug combinations for the first-line treatment of myeloma patients, in which antibody-based treatment regimens have been
integrated into seven GMMG study concepts (CONCEPT, DANTE, DADA, HD6, HD7, HD8, HD9 and HD10). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT COLOR="#7900e6"><I>About Sanofi </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Sanofi is an R&amp;D driven, <FONT STYLE="white-space:nowrap">AI-powered</FONT> biopharma company committed to improving people&#146;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&#146;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. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT COLOR="#7900e6"><I>Media Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Sandrine Guendoul</B> |
+33 6 25 09 14 25 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>sandrine.guendoul@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Evan Berland</B> | +1 215 432 0234 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>evan.berland@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>L&eacute;o Le Bourhis</B> | +33 6 75 06 43 81 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>leo.lebourhis@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Victor
Rouault</B> | +33 6 70 93 71 40 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>victor.rouault@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Timothy Gilbert</B> | +1 516 521 2929 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>timothy.gilbert@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>L&eacute;a Ubaldi</B><B></B>&nbsp;| +33 6 30 19 66 46
|&nbsp;<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>lea.ubaldi@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT
 COLOR="#7900e6"><I>Investor Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Thomas Kudsk Larsen</B> | +44 7545 513 693 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>thomas.larsen@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Aliz&eacute;
Kaisserian</B> | +33 6 47 04 12 11 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>alize.kaisserian@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Felix Lauscher</B> | +1 908 612 7239 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>felix.lauscher@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Keita Browne</B> | +1 781 249 1766 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>keita.browne@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Nathalie
Pham</B> | +33 7 85 93 30 17 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>nathalie.pham@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Tarik Elgoutni</B> | +1 617 710 3587 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>tarik.elgoutni@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Thibaud Ch&acirc;telet</B> | +33 6 80 80 89 90 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>thibaud.chatelet@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Yun
Li</B>&nbsp;| +33 6 84 00 90 72 |&nbsp;<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>yun.li3@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV STYLE="line-height:4.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #cccccc">&nbsp;</DIV>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana"><B>Sanofi forward-looking statements </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana"><I>This press release contains
forward-looking statements as defined in 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 regarding the
marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words &#147;expects&#148;, &#147;anticipates&#148;, &#147;believes&#148;,
&#147;intends&#148;, &#147;estimates&#148;, &#147;plans&#148;, and similar expressions. Although Sanofi&#146;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, unexpected regulatory actions or delays, or government regulation generally, that could affect
the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, 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 future litigation and the ultimate outcome of such litigation, and
volatile economic and market conditions, 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 AMF made by Sanofi, including those listed under &#147;Risk Factors&#148; and &#147;Cautionary
Statement Regarding Forward-Looking Statements&#148; in Sanofi&#146;s annual report on Form <FONT STYLE="white-space:nowrap">20-F</FONT> for the year ended December&nbsp;31, 2024. Other than as required by applicable law, Sanofi does not undertake
any obligation to update or revise any forward-looking information or statements. </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana"><I>All trademarks mentioned in this press release are the property of the
Sanofi group. </I></P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:ARIAL" ALIGN="right"><B>Exhibit 99.2 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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</TABLE> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:18pt; font-family:Georgia" ALIGN="justify"><FONT COLOR="#7900e6"><I>Sanofi&#146;s SAR446523, a GPRC5D monoclonal antibody, earns orphan drug designation in the
US for multiple myeloma </I></FONT></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P ALIGN="justify" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Verdana; font-size:10pt">Designation granted for IgG1-based GPRC5D monoclonal antibody for the potential treatment of patients with relapsed or
refractory multiple myeloma </P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify"><B>Paris, July</B><B></B><B>&nbsp;30, 2025.</B> The US Food and Drug Administration (FDA) has
granted orphan drug designation to SAR446523, an IgG1-based Antibody-Dependent Cellular Cytotoxicity-enhanced (ADCC) monoclonal antibody (mAb) targeting <FONT STYLE="white-space:nowrap">G-protein</FONT> coupled receptor family C group 5 member D
(GPRC5D) for the potential treatment of patients with relapsed or refractory multiple myeloma (R/R MM). GPRC5D is highly expressed on plasma cells in MM patients, with low expression in healthy tissues. The FDA grants orphan drug designation to
investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the US. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:6%; font-size:10pt; font-family:Verdana" ALIGN="justify"><I>&#147;The orphan drug designation is a significant milestone in our ongoing efforts to develop innovative treatments in multiple
myeloma,&#148; said </I><B><I>Alyssa Johnsen, MD, PhD</I></B><I>, Global Therapeutic Area Head, Immunology and Oncology Development at Sanofi. &#147;This underscores our commitment to multiple myeloma, a disease for which we have acquired strong
expertise with the development of another widely used and approved immunotherapy treatment.&#148; </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">The safety and efficacy of SAR446523 has
not been evaluated by any regulatory authority and is still under investigation. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:11pt; font-family:Georgia"><FONT COLOR="#7900e6"><I>About SAR446523 </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">SAR446523 is an investigational IgG1-based mAb designed to target GPRC5D, which is highly expressed on plasma cells, with an engineered fragment
crystallizable domain to enhance antibody dependent cell-mediated cytotoxicity. This innovative approach aims to improve the efficacy of treatment for MM, a rare and challenging cancer of plasma cells. Subcutaneous SAR446523 is currently being
evaluated in an ongoing phase 1, <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-human</FONT></FONT> study in patients with R/R MM (clinical study identifier:
<FONT STYLE="font-family:Verdana; font-size:10pt" COLOR="#7900e6"><U>NCT06630806</U></FONT><FONT STYLE="font-family:Verdana">). SAR4465523 originates from Sanofi Research in
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">Vitry-sur-Seine,</FONT></FONT> France. </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:11pt; font-family:Georgia"><FONT COLOR="#7900e6"><I>About multiple myeloma
</I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Multiple myeloma is considered a rare disease, yet MM is the second most common hematologic malignancy with more than 180,000 people
diagnosed with MM each year, globally. Despite available treatments, MM remains an incurable malignancy with an estimated 62% five-year survival rate for newly diagnosed patients. There is a need for new frontline therapeutic options for all
patients, especially for those who are transplant ineligible, due to high attrition rates in subsequent lines of therapy. Since MM does not have a cure, most patients will relapse and stop responding to therapies they have received. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">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 <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">best-in-class</FONT></FONT> immunological and targeted therapies for rare and <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">difficult-to-treat</FONT></FONT> cancers with high unmet need. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">For more information
on MM clinical studies, please visit <FONT STYLE="font-family:Verdana; font-size:10pt" COLOR="#7900e6"><U>www.clinicaltrials.gov</U></FONT><FONT STYLE="font-family:Verdana">. </FONT></P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT COLOR="#7900e6"><I>About Sanofi </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Verdana" ALIGN="justify">Sanofi&nbsp;is an R&amp;D driven, <FONT STYLE="white-space:nowrap">AI-powered</FONT> biopharma company committed to improving people&#146;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.<I></I>&nbsp;Our team is guided by one purpose: we chase the miracles of science to improve people&#146;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. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT COLOR="#7900e6"><I>Media Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Sandrine Guendoul</B> |
+33 6 25 09 14 25 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>sandrine.guendoul@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Evan Berland</B> | +1 215 432 0234 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>evan.berland@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>L&eacute;o Le Bourhis</B> | +33 6 75 06 43 81 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>leo.lebourhis@sanofi.com </U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Victor
Rouault</B> | +33 6 70 93 71 40 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>victor.rouault@sanofi.com </U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Timothy Gilbert</B> | +1 516 521 2929 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>timothy.gilbert@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>L&eacute;a Ubaldi</B><B></B>&nbsp;| +33 6 30 19 66 46
|&nbsp;<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>lea.ubaldi@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Georgia"><FONT
 COLOR="#7900e6"><I>Investor Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Thomas Kudsk Larsen</B> |+44 7545 513 693 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>thomas.larsen@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Aliz&eacute;
Kaisserian</B><B></B>&nbsp;|&nbsp;+33 6 47 04 12 11 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>alize.kaisserian@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Felix Lauscher</B><B></B>&nbsp;|&nbsp;+1&nbsp;908&nbsp;612 7239 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>felix.lauscher@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Keita
Browne</B><B></B>&nbsp;|&nbsp;+1 781 249 1766 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>keita.browne@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Nathalie Pham</B><B></B>&nbsp;|&nbsp;+33 7 85 93 30 17 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>nathalie.pham@sanofi.com</U></FONT><FONT
STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Tarik Elgoutni </B>| +1 617 710 3587 |
<FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>tarik.elgoutni@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Thibaud
Ch&acirc;telet</B> | +33 6 80 80 89 90 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>thibaud.chatelet@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Verdana"><B>Yun Li </B>| +33 6 84 00 90 72 | <FONT STYLE="font-family:Verdana; font-size:8pt" COLOR="#7900e6"><U>yun.li@sanofi.com</U></FONT><FONT STYLE="font-family:Verdana">
</FONT></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV STYLE="line-height:4.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #cccccc">&nbsp;</DIV>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana"><B>Sanofi forward-looking statements </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana" ALIGN="justify"><I>This press release
contains forward-looking statements as defined in 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 performance.
Forward-looking statements are generally identified by the words &#147;expects&#148;, &#147;anticipates&#148;, &#147;believes&#148;, &#147;intends&#148;, &#147;estimates&#148;, &#147;plans&#148; and similar expressions. Although Sanofi&#146;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 FDA or the EMA, 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, the future approval and commercial success of therapeutic alternatives, Sanofi&#146;s ability to benefit from external growth opportunities, to complete
related transactions and/or obtain regulatory clearances, 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 AMF made by Sanofi, including those
listed under &#147;Risk Factors&#148; and &#147;Cautionary Statement Regarding Forward-Looking Statements&#148; in Sanofi&#146;s annual report on Form <FONT STYLE="white-space:nowrap">20-F</FONT> for the year ended December&nbsp;31, 2024. Other than
as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:7pt; font-family:Verdana"><I>All trademarks
mentioned in this press release are the property of the Sanofi group. </I></P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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