<SEC-DOCUMENT>0001171843-24-004539.txt : 20240808
<SEC-HEADER>0001171843-24-004539.hdr.sgml : 20240808
<ACCEPTANCE-DATETIME>20240807201231
ACCESSION NUMBER:		0001171843-24-004539
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20240807
FILED AS OF DATE:		20240808
DATE AS OF CHANGE:		20240807

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			NOVARTIS AG
		CENTRAL INDEX KEY:			0001114448
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			V8
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-15024
		FILM NUMBER:		241185590

	BUSINESS ADDRESS:	
		STREET 1:		LICHTSTRASSE 35
		CITY:			BASEL
		STATE:			V8
		ZIP:			CH 4056
		BUSINESS PHONE:		01141613241111

	MAIL ADDRESS:	
		STREET 1:		LICHTSTRASSE 35
		CITY:			BASEL
		STATE:			V8
		ZIP:			CH 4056
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<P STYLE="font-size: 18pt; text-align: center; margin: 0pt 0"><B>UNITED STATES</B></P>

<P STYLE="font-size: 18pt; text-align: center; margin: 0pt 0"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>Washington, D.C. 20549</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 18pt; text-align: center; margin: 0pt 0"><B>FORM 6-K</B></P>

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<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>REPORT OF FOREIGN PRIVATE ISSUER</B></P>

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<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>(Commission File No. 1-15024)</B></P>

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<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">____________________</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 18pt; text-align: center; margin: 0pt 0"><B>Novartis AG</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">(Name of Registrant)</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>Lichtstrasse 35</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>4056 Basel</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>Switzerland</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">(Address of Principal Executive Offices)</P>

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<P STYLE="font-size: 10pt; margin: 0pt 0 3pt">Indicate by check mark whether the registrant files or will file annual reports under
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    <TD STYLE="width: 50%; text-align: right; font-size: 10pt"><FONT STYLE="font-size: 10pt"><B>Form 20-F:&nbsp;&#9746;</B></FONT></TD>
    <TD STYLE="width: 3%; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="width: 47%; font-size: 10pt"><FONT STYLE="font-size: 10pt">Form 40-F:&nbsp;&#9744;</FONT></TD></TR>
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<P STYLE="font-size: 10pt; margin: 0pt 0 3pt">Indicate by check mark whether the registrant by furnishing the information contained
in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange
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    <TD STYLE="width: 33%"><p style="color: rgb(4,96,169); font: 9pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"><b>Novartis&nbsp;International&nbsp;AG<BR>
                           Novartis&nbsp;Global Communications</b><BR>
                           <font style="color: windowtext">CH-4002 Basel</font><BR>
                           <font style="color: windowtext">Switzerland</font></P>

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<p style="color: rgb(0, 0, 0); font-size: 12pt; margin-top: 0pt; margin-bottom: 0pt; text-indent: 0px"><font style="font-size: 10pt">&nbsp;</font></p>

<p style="font: 14pt Arial, Helvetica, Sans-Serif; margin: 0pt 0; color: rgb(141,31,27)"><b>MEDIA &amp; INVESTOR RELEASE</b></p>

<P STYLE="color: rgb(0, 0, 0); font-size: 12pt; margin-top: 0pt; margin-bottom: 0pt; text-indent: 0px"><FONT STYLE="font-size: 10pt"></FONT></P>

<P STYLE="color: rgb(0, 0, 0); font-size: 12pt; margin-top: 0pt; margin-bottom: 0pt; text-indent: 0px"><font style="font-size: 10pt">&nbsp;</font></p>

<P STYLE="font-weight: bold; margin: 0pt 0; font-size: 12pt">Novartis receives FDA accelerated approval for Fabhalta&reg; (iptacopan), the first and only
complement inhibitor for the reduction of proteinuria in primary IgA nephropathy (IgAN)</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><B>Ad hoc announcement pursuant to Art. 53 LR</B></P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%"><TR STYLE="vertical-align: top"><TD STYLE="width: 20px"></TD><TD STYLE="width: 20px">&#8226;</TD><TD><I>Fabhalta&nbsp;achieved
a 44% proteinuria reduction from baseline in Phase III&nbsp;APPLAUSE-IgAN&nbsp;interim analysis, compared with 9% in placebo arm, demonstrating
a clinically meaningful reduction of 38% vs. placebo (p&lt;0.0001)<SUP>1</SUP></I></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top"><TD STYLE="width: 20px"></TD><TD STYLE="width: 20px">&#8226;</TD><TD><I>Fabhalta
is an inhibitor of the alternative complement pathway, activation of which is thought to contribute to the pathogenesis of IgAN<SUP>1-4</SUP></I></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%"><TR STYLE="vertical-align: top"><TD STYLE="width: 20px"></TD><TD STYLE="width: 20px">&#8226;</TD><TD><I>Despite
current standard of care, up to 50% of IgAN patients with persistent proteinuria progress to kidney failure within 10 to 20 years of
diagnosis<SUP>5-11</SUP></I></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%"><TR STYLE="vertical-align: top"><TD STYLE="width: 20px"></TD><TD STYLE="width: 20px">&#8226;</TD><TD><I>This
marks the first approval from Novartis&rsquo; renal pipeline, which also includes atrasentan and zigakibart</I></TD></TR></TABLE>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="margin: 0pt 0; font-size: 10pt"><B>Basel, August 8, 2024&nbsp;</B>&ndash; Novartis today announced that the U.S. Food and Drug
Administration (FDA) has granted accelerated approval for Fabhalta<SUP>&reg;</SUP>&nbsp;(iptacopan), a first-in-class complement inhibitor
for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. This
is generally defined as a urine protein-to-creatinine ratio (UPCR) &ge;1.5 g/g<SUP>1</SUP>. Fabhalta specifically targets the alternative
complement pathway of the immune system. When overly activated in the kidneys, the complement system is thought to contribute to the pathogenesis
of IgAN<SUP>1-4</SUP>.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">This indication is granted under accelerated approval based on the pre-specified interim analysis
of the Phase III APPLAUSE-IgAN study measuring reduction in proteinuria at 9 months compared to placebo. It has not been established whether
Fabhalta slows kidney function decline in patients with IgAN. The continued approval of Fabhalta may be contingent upon verification and
description of clinical benefit from the ongoing Phase III APPLAUSE-IgAN study, evaluating whether Fabhalta slows disease progression
as measured by estimated glomerular filtration rate (eGFR) decline over 24 months<SUP>1</SUP>. The eGFR data are expected at study completion
in 2025 and are intended to support traditional FDA approval.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&ldquo;The heterogeneous and progressive nature of IgA nephropathy has made it challenging to
effectively treat this disease. Thankfully, the treatment landscape is rapidly evolving,&rdquo; said Professor Dana Rizk, Investigator
and APPLAUSE-IgAN Steering Committee Member and professor in the University of Alabama at Birmingham Division of Nephrology. &ldquo;Mounting
clinical evidence underscores the pivotal role of complement activation in IgA nephropathy. I am thrilled that this advancement is now
available to help enable a targeted treatment approach for IgAN patients.&rdquo;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">IgAN is a progressive, rare disease in which the immune system attacks the kidneys, often causing
glomerular inflammation and proteinuria<SUP>12</SUP>. Approximately 25 people per million worldwide are newly diagnosed with IgAN each
year<SUP>13</SUP>. Each person&rsquo;s disease journey is unique as IgAN progresses differently and treatment responses vary as well<SUP>12,14</SUP>.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

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<P STYLE="margin: 0pt 0; font-size: 10pt">Despite current standard of care, up to 50% of IgAN patients with persistent proteinuria progress
to kidney failure within 10 to 20 years of diagnosis. These patients often require maintenance dialysis and/or kidney transplantation<SUP>5-11</SUP>.
Effective, targeted therapies with different mechanisms of action can help physicians select the most appropriate treatment for patients<SUP>12,14</SUP>.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><B>Data supporting approval</B><BR>
The ongoing Phase III APPLAUSE-IgAN study is evaluating the efficacy and safety of twice-daily oral Fabhalta (200 mg) versus placebo in
adult IgAN patients on a stable dose of maximally-tolerated renin-angiotensin system (RAS) inhibitor therapy with or without a stable
dose of SGLT2i. The primary endpoint for the interim analysis was the percent reduction of proteinuria, a marker of kidney damage, measured
by comparing UPCR at 9 months to baseline<SUP>1,4</SUP>.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">Fabhalta achieved a 44% reduction in proteinuria at 9 months relative to baseline, compared
with a 9% reduction in the placebo arm, demonstrating a clinically meaningful and statistically significant 38% reduction vs. placebo
(p&lt;0.0001).&nbsp;The treatment effect on UPCR at 9 months was consistent across all subgroups, including age, sex, race and baseline
disease characteristics (such as baseline eGFR and proteinuria levels), and the use of SGLT2i<SUP>1</SUP>. Fabhalta demonstrated a favorable
safety profile, consistent with previously reported data<SUP>1,13</SUP>. In patients with IgAN, the most common adverse reactions (&ge;5%)
with Fabhalta were upper respiratory tract infection, lipid disorder, and abdominal pain. Fabhalta may cause serious infections caused
by encapsulated bacteria and is available only through a Risk Evaluation and Mitigation Strategy (REMS) that requires specific vaccinations<SUP>1</SUP>.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><B>Expanding commitment in IgAN</B><BR>
&ldquo;Today&rsquo;s approval of Fabhalta as a first-in-class medicine for IgA nephropathy is an important milestone in our journey to
evolve rare renal disease care by bringing new treatments to people in urgent need of options,&rdquo; said Victor Bult&oacute;, President
US, Novartis. &ldquo;We are deeply committed to those living with rare renal diseases and look forward to continued partnership with this
community as we further advance our broad portfolio.&rdquo;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">Novartis is advancing the late-stage development of two additional IgAN therapies with highly
differentiated mechanisms of action: atrasentan, an investigational oral endothelin A receptor antagonist that received FDA filing acceptance
in Q2 2024, and zigakibart, an investigational subcutaneously administered anti-APRIL monoclonal antibody that is currently in Phase III
development.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&ldquo;As a parent of a son living with the disease for 20 years, I understand firsthand the
fear and uncertainty that come with an IgAN diagnosis, and the devastating impact it can have on patients and their families,&rdquo; said
Bonnie Schneider, Director and Co-Founder, IgAN Foundation. &ldquo;Today&rsquo;s approval offers new hope for people living with IgA nephropathy
as it represents a treatment innovation that provides us with a new way to fight this multifaceted disease.&rdquo;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><B>About APPLAUSE-IgAN</B><BR>
APPLAUSE-IgAN (NCT04578834) is a Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate
the efficacy and safety of twice-daily oral Fabhalta (200 mg) in 518 adult primary IgAN patients<SUP>1,15</SUP>.&nbsp;&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">The two primary endpoints of the study for the interim and final analysis, respectively, are
proteinuria reduction at 9 months as measured by 24 hour UPCR, and the annualized total eGFR slope over 24 months<SUP>1,4</SUP>. At the
time of final analysis, the following secondary endpoints will also be assessed: proportion of participants reaching UPCR &lt;1 g/g without
receiving corticosteroids/immunosuppressants or other newly approved drugs or initiating new background therapy for treatment of IgAN
or initiating kidney replacement therapy (KRT), time from randomization to first occurrence of composite kidney failure endpoint event,
and change from baseline to 9 months in the fatigue scale as measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue
questionnaire<SUP>15,16</SUP>.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

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<P STYLE="margin: 0pt 0; font-size: 10pt">The main study population included 250 IgAN patients with an eGFR &ge;30 mL/min/1.73 m<SUP>2</SUP>&nbsp;and
UPCR &ge;1 g/g at baseline<SUP>15,16</SUP>. In addition, a smaller cohort of patients with severe renal impairment (eGFR 20&ndash;30 mL/min/1.73
m<SUP>2</SUP>&nbsp;at baseline) was also enrolled to provide additional information but will not contribute to the main efficacy analyses<SUP>1</SUP>.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><B>Novartis in rare kidney diseases</B><BR>
At Novartis, our journey in nephrology began more than 40 years ago when the development and introduction of cyclosporine helped reimagine
the field of transplantation and immunosuppression. We continue today with a broad renal R&amp;D portfolio targeting the underlying causes
of disease to preserve kidney function. We aim to help transform the lives of people living with kidney diseases enabling them to live
longer without the need for dialysis or transplantation.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">Discovered at Novartis, Fabhalta (iptacopan) is the first of our renal pipeline to receive FDA
approval. Novartis is also studying the investigational agents atrasentan and zigakibart for IgAN.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">Beyond IgAN, Fabhalta is in development for a range of additional rare diseases, including C3
glomerulopathy (C3G), atypical hemolytic uremic syndrome (aHUS), immune complex membranoproliferative glomerulonephritis (IC-MPGN) and
lupus nephritis (LN). Studies are ongoing to evaluate the safety and efficacy profiles in these investigational indications and support
potential regulatory submissions. Fabhalta submissions to the FDA and EMA for the treatment of C3G are planned by year-end.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><B>Disclaimer</B><BR>
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act
of 1995. Forward-looking statements can generally be identified by words such as &ldquo;potential,&rdquo; &ldquo;can,&rdquo; &ldquo;will,&rdquo;
&ldquo;plan,&rdquo; &ldquo;may,&rdquo; &ldquo;could,&rdquo; &ldquo;would,&rdquo; &ldquo;expect,&rdquo; &ldquo;anticipate,&rdquo; &ldquo;look
forward,&rdquo; &ldquo;believe,&rdquo; &ldquo;committed,&rdquo; &ldquo;investigational,&rdquo; &ldquo;pipeline,&rdquo; &ldquo;launch,&rdquo;
&ldquo;progress,&rdquo; &ldquo;accelerated,&rdquo; &ldquo;targets,&rdquo; &ldquo;continued,&rdquo; &ldquo;contingent,&rdquo; &ldquo;progressive,&rdquo;
&ldquo;evolving,&rdquo; &ldquo;enable,&rdquo; &ldquo;innovation,&rdquo; &ldquo;ongoing,&rdquo; &ldquo;evaluating,&rdquo; &ldquo;evolve,&rdquo;
&ldquo;committed,&rdquo; &ldquo;advance,&rdquo; &ldquo;advancing,&rdquo; &ldquo;commitment,&rdquo; &ldquo;to developing,&rdquo; &ldquo;to
provide, &ldquo;development,&rdquo; &ldquo;to address,&rdquo; or similar terms, or by express or implied discussions regarding potential
marketing approvals, new indications or labeling for Fabhalta or the other investigational or approved products described in this press
release, or regarding potential future revenues from such product. You should not place undue reliance on these statements. Such forward-looking
statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown
risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Fabhalta or
the other investigational or approved products described in this press release will be submitted or approved for sale or for any additional
indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially
successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties
inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions
or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general
public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary
intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business
conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues;
potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and
factors referred to in Novartis AG&rsquo;s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing
the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained
in this press release as a result of new information, future events or otherwise.&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

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<P STYLE="margin: 0pt 0; font-size: 10pt"><B>About Novartis</B><BR>
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people&rsquo;s lives so that
patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million
people worldwide.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">Reimagine medicine with us: Visit us at&nbsp;<B>https://www.novartis.com</B>&nbsp;and connect
with us on&nbsp;<B>LinkedIn</B>,&nbsp;<B>Facebook</B>,&nbsp;<B>X/Twitter</B>&nbsp;and&nbsp;<B>Instagram</B>.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><B>References</B></P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><FONT STYLE="font-size: 8pt">&nbsp;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%"><TR STYLE="vertical-align: top"><TD STYLE="width: 20px"></TD><TD STYLE="width: 20px"><FONT STYLE="font-size: 8pt">1.</FONT></TD><TD><FONT STYLE="font-size: 8pt">FABHALTA
                                            prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corp; August 2024.</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top"><TD STYLE="width: 20px"></TD><TD STYLE="width: 20px"><FONT STYLE="font-size: 8pt">2.</FONT></TD><TD><FONT STYLE="font-size: 8pt">Lafayette
                                            RA, Kelepouris E. lmmunoglobulin A nephropathy: advances in understanding of pathogenesis
                                            and treatment.&nbsp;<I>Am J Nephrol</I>. 2018;47(suppl 1):43-52.</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%"><TR STYLE="vertical-align: top"><TD STYLE="width: 20px"></TD><TD STYLE="width: 20px"><FONT STYLE="font-size: 8pt">3.</FONT></TD><TD><FONT STYLE="font-size: 8pt">Rizk
                                            DV, Maillard N, Julian BA, et al. The emerging role of complement proteins as a target for
                                            therapy of IgA nephropathy.&nbsp;<I>Front Immunol</I>. 2019;10:504.</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%"><TR STYLE="vertical-align: top"><TD STYLE="width: 20px"></TD><TD STYLE="width: 20px"><FONT STYLE="font-size: 8pt">4.</FONT></TD><TD><FONT STYLE="font-size: 8pt">Perkovic
                                            V, Kollins D, Renfurm R, et al. Efficacy and Safety of Iptacopan in Patients with IgA Nephropathy:
                                            Interim Results from the Phase 3 APPLAUSE-IgAN Study. Presented at the World Congress of
                                            Nephrology (WCN); April 15, 2024; Buenos Aires, Argentina.</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%"><TR STYLE="vertical-align: top"><TD STYLE="width: 20px"></TD><TD STYLE="width: 20px"><FONT STYLE="font-size: 8pt">5.</FONT></TD><TD><FONT STYLE="font-size: 8pt">Xie
                                            J et al.&nbsp;<I>PLoS One</I>. 2012;7;e38904.</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%"><TR STYLE="vertical-align: top"><TD STYLE="width: 20px"></TD><TD STYLE="width: 20px"><FONT STYLE="font-size: 8pt">6.</FONT></TD><TD><FONT STYLE="font-size: 8pt">Rodrigues
                                            J, et al.&nbsp;<I>Clin J Am Soc Nephrol</I>. 2017;12(4):677-686.</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%"><TR STYLE="vertical-align: top"><TD STYLE="width: 20px"></TD><TD STYLE="width: 20px"><FONT STYLE="font-size: 8pt">7.</FONT></TD><TD><FONT STYLE="font-size: 8pt">Pitcher
                                            D et al.&nbsp;<I>Clin J Am Soc Nephrol</I>. 2023;18(6):727-738.</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%"><TR STYLE="vertical-align: top"><TD STYLE="width: 20px"></TD><TD STYLE="width: 20px"><FONT STYLE="font-size: 8pt">8.</FONT></TD><TD><FONT STYLE="font-size: 8pt">Hastings
                                            MC et al.&nbsp;<I>Kidney Int Rep</I>. 2018;3(1):99-104.</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%"><TR STYLE="vertical-align: top"><TD STYLE="width: 20px"></TD><TD STYLE="width: 20px"><FONT STYLE="font-size: 8pt">9.</FONT></TD><TD><FONT STYLE="font-size: 8pt">Sim
                                            JJ et al. Poster TH-PO615 presented at: ASN Kidney Week 2023; November 2-5, 2023; Philadelphia,
                                            PA.</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%"><TR STYLE="vertical-align: top"><TD STYLE="width: 20px"></TD><TD STYLE="width: 20px"><FONT STYLE="font-size: 8pt">10.</FONT></TD><TD><FONT STYLE="font-size: 8pt">Bobart
                                            SA et al.&nbsp;<I>Nephrol Dial Transplant</I>. 2021;36(5):840-847.</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%"><TR STYLE="vertical-align: top"><TD STYLE="width: 20px"></TD><TD STYLE="width: 20px"><FONT STYLE="font-size: 8pt">11.</FONT></TD><TD><FONT STYLE="font-size: 8pt">Saha
                                            MK et al. Poster TH-PO1016 presented at: ASN Kidney Week 2019; November 5-10, 2019; Washington,
                                            DC.</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%"><TR STYLE="vertical-align: top"><TD STYLE="width: 20px"></TD><TD STYLE="width: 20px"><FONT STYLE="font-size: 8pt">12.</FONT></TD><TD><FONT STYLE="font-size: 8pt">Kidney
                                            Disease: Improving Global Outcomes (KDIGO) 2021 Clinical Practice Guideline for the Management
                                            of Glomerular Diseases.&nbsp;<I>Kidney Int</I>. 2021;100(4):S1-S276.</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%"><TR STYLE="vertical-align: top"><TD STYLE="width: 20px"></TD><TD STYLE="width: 20px"><FONT STYLE="font-size: 8pt">13.</FONT></TD><TD><FONT STYLE="font-size: 8pt">Zhang
                                            H, Rizk DV, Perkovic V, et al. Results of a Randomized Double-Blind Placebo-Controlled Phase
                                            2 Study Propose Iptacopan as an Alternative Complement Pathway Inhibitor for IgA Nephropathy.&nbsp;<I>Kidney
                                            Int</I>. 2024;105(1):189-199.</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%"><TR STYLE="vertical-align: top"><TD STYLE="width: 20px"></TD><TD STYLE="width: 20px"><FONT STYLE="font-size: 8pt">14.</FONT></TD><TD><FONT STYLE="font-size: 8pt">Boyd
                                            JK, Cheung CK, Molyneux K, Feehally J, Barratt J. An Update on the Pathogenesis and Treatment
                                            of IgA Nephropathy.&nbsp;<I>Kidney Int</I>. 2012;81(9):833-843.</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%"><TR STYLE="vertical-align: top"><TD STYLE="width: 20px"></TD><TD STYLE="width: 20px"><FONT STYLE="font-size: 8pt">15.</FONT></TD><TD><FONT STYLE="font-size: 8pt">ClinicalTrials.gov.
                                            NCT04578834. A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group,
                                            Phase III Study to Evaluate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy
                                            Patients. Available from:&nbsp;https://clinicaltrials.gov/ct2/show/NCT04578834. Accessed
                                            June 2024.</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%"><TR STYLE="vertical-align: top"><TD STYLE="width: 20px"></TD><TD STYLE="width: 20px"><FONT STYLE="font-size: 8pt">16.</FONT></TD><TD><FONT STYLE="font-size: 8pt">Rizk
                                            DV, Rovin BH, Zhang H, et al. Targeting the Alternative Complement Pathway with Iptacopan
                                            to Treat IgA Nephropathy: Design and Rationale of the APPLAUSE-IgAN Study.&nbsp;<I>Kidney
                                            Int Rep</I>. 2023;8(5):968-979.</FONT></TD></TR></TABLE>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
