<SEC-DOCUMENT>0001171843-25-006196.txt : 20250930
<SEC-HEADER>0001171843-25-006196.hdr.sgml : 20250930
<ACCEPTANCE-DATETIME>20250930171233
ACCESSION NUMBER:		0001171843-25-006196
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20250930
FILED AS OF DATE:		20250930
DATE AS OF CHANGE:		20250930

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			NOVARTIS AG
		CENTRAL INDEX KEY:			0001114448
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		EIN:				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:		251361461

	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
</SEC-HEADER>
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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>

<P STYLE="font-size: 18pt; text-align: center; margin: 0pt 0">&nbsp;</P>

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

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>PURSUANT TO RULE 13a-16 or 15d-16 OF</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>THE SECURITIES EXCHANGE ACT OF 1934</B></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>Report on Form 6-K dated September 30, 2025</b></P>

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

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

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">____________________</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 cover
of Form 20-F or Form 40-F:</P>

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    <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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    <TD STYLE="width: 33%"><FONT STYLE="font-size: 10pt"><IMG SRC="logo.jpg" ALT=""></FONT></TD>
    <TD STYLE="width: 47%"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD>
    <TD STYLE="white-space: nowrap; width: 20%">
        <p style="color: rgb(4,96,169); font: 9pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"><b>Novartis&nbsp;International&nbsp;AG<BR> </b><BR>
        <font style="color: windowtext">CH-4002 Basel</font><BR> <font style="color: windowtext">Switzerland</font></P>
        <p style="color: #0460A9; font: bold 9pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">&nbsp;</P>
        <p style="font: 9pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">https://www.novartis.com</P>
        <P STYLE="font: 9pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">http://x.com/NovartisNews</P> </TD></TR>
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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="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">PRESS RELEASE</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-size: 14pt; font-weight: bold; margin-top: 0pt; margin-bottom: 0pt; color: rgb(4,95,169)">Novartis receives FDA approval
for Rhapsido<font style="font-size: 10pt">&reg; </font>(remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous
urticaria (CSU)</p>

<p style="font-size: 10pt; font-weight: bold; margin-top: 0pt; margin-bottom: 0pt; color: #045FA9">&nbsp;</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><b>Ad hoc announcement pursuant to Art. 53 LR</b></p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><b>&nbsp;</b></p>

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    <td style="width: 0pt"></td>
    <td style="width: 20pt; text-align: left"><font style="font-family: Symbol; font-size: 10pt; color: #045FA9">&middot;</font></td>
    <td style="text-align: justify"><i>Rhapsido helps to inhibit release of histamine and proinflammatory mediators by targeting BTK, offering
        unique approach to CSU treatment</i><sup>1</sup></td> </tr>
  </table>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">&nbsp;</p>

<table cellpadding="0" cellspacing="0" style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; width: 100%">
  <tr style="vertical-align: top; text-align: justify">
    <td style="width: 0pt"></td>
    <td style="width: 20pt; text-align: left"><font style="font-family: Symbol; font-size: 10pt; color: #045FA9">&middot;</font></td>
    <td style="text-align: justify"><i>Well-controlled disease observed as fast as two weeks, with demonstrated safety profile that requires no
        lab monitoring</i><sup>1</sup></td> </tr>
  </table>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">&nbsp;</p>

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    <td style="width: 20pt; text-align: left"><font style="font-family: Symbol; font-size: 10pt; color: #045FA9">&middot;</font></td>
    <td style="text-align: justify"><i>1.7 million people in US live with CSU; more than half remain symptomatic despite increasing doses of antihistamines</i><sup>2,3</sup></td>
        </tr>
  </table>

<p style="margin-top: 0; margin-bottom: 0">&nbsp;</p>

<table cellpadding="0" cellspacing="0" style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; width: 100%">
  <tr style="vertical-align: top; text-align: justify">
    <td style="width: 0pt"></td>
    <td style="width: 20pt; text-align: left"><font style="font-family: Symbol; font-size: 10pt; color: #045FA9">&middot;</font></td>
    <td style="text-align: justify"><i>Remibrutinib also in clinical development for chronic inducible urticaria, food allergy, and hidradenitis
        suppurativa, expanding Novartis Immunology portfolio</i></td> </tr>
  </table>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">&nbsp;</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><b>Basel, September 30, 2025 </b>&ndash; Novartis announced today that
Rhapsido<font style="font-size: 10pt">&reg; </font>(remibrutinib) received US Food and Drug Administration (FDA) approval as an oral treatment
for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Rhapsido is a pill
taken twice daily and does not require injections or lab monitoring. It is the first FDA-approved Bruton&rsquo;s tyrosine kinase inhibitor
(BTKi) for CSU. Rhapsido helps to inhibit the release of histamine and other proinflammatory mediators by targeting BTK, offering a unique
approach to CSU treatment.<font style="font-size: 10pt"><sup>1</sup></font></p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">&nbsp;</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">&ldquo;CSU is a serious disease that can cause debilitating symptoms and
unpredictable flares. It&rsquo;s difficult to diagnose and manage,&rdquo; said Mark Lebwohl, MD, Dean for Clinical Therapeutics at the
Icahn School of Medicine at Mount Sinai and member of the steering committee for the remibrutinib REMIX Phase III clinical trial program.
&ldquo;Remibrutinib represents a new way of treating CSU. By blocking the activity of BTK, remibrutinib stops a key pathway of the immune
response in CSU. This is an exciting new option that has the potential to help a broad range of patients get fast relief.&rdquo;</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">&nbsp;</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">CSU is a mast cell-driven condition thought to be caused by immune dysregulation.
In people with CSU, the immune system can become activated through allergic (IgE) or autoimmune (IgG) pathways.<font style="font-size: 10pt"><sup>4</sup></font>
This causes certain immune cells&mdash;mast cells and basophils&mdash;to activate the BTK protein. While not fully understood, it is believed
that once activated, BTK leads to the release of histamine and other proinflammatory mediators that may cause the red, swollen, and itchy
hives commonly seen in CSU.<font style="font-size: 10pt"><sup>5,6</sup></font></p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">&nbsp;</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">CSU symptoms are unpredictable, recurring for six weeks or more without
an identified cause.<font style="font-size: 10pt"><sup>7</sup></font> Diagnosis can take up to 24 months.<font style="font-size: 10pt"><sup>8</sup></font>
Many CSU patients say their symptoms negatively impact their sleep, work, and mental health.<font style="font-size: 10pt"><sup>9,10,11</sup>
</font>Antihistamines are the first-line treatment, but over half of patients still have symptoms, even at higher doses.<font style="font-size: 10pt">2</font>
Injectable treatments exist for those who don't respond to antihistamines, yet fewer than 20% of eligible patients receive them.<font style="font-size: 10pt"><sup>12</sup></font></p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">&nbsp;</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"></p>

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<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">&ldquo;The approval of remibrutinib is an important development in CSU
care. It quickly reduces symptoms, offering patients control of the hives and itching that they experience on a daily basis,&rdquo; said
Giselle Mosnaim, MD, MS, an Allergist and Immunologist from Endeavor Health, Clinical Associate Professor at the University of Chicago
Pritzker School of Medicine and REMIX trial investigator. &ldquo;This is significant because it expands beyond existing injectable treatments
and gives patients an oral option that can easily be incorporated into their daily lives.&rdquo;</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">&nbsp;</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">&ldquo;Many CSU patients feel misunderstood and settle for treatments
that don&rsquo;t fully meet their needs,&rdquo; said Lynda Mitchell, CEO of Allergy &amp; Asthma Network. &ldquo;We support new treatment
options that empower patients to choose what works best for them. This convenient new oral therapy offers a promising new way to manage
CSU and potentially improve daily life for those living with this challenging condition.&rdquo;</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">&nbsp;</p>

<p style="font-size: 10pt; font-weight: bold; margin-top: 0pt; margin-bottom: 0pt">Clinical data supporting approval</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">The FDA approval of Rhapsido in CSU is based on results from the Phase
III REMIX-1 (<u>NCT05030311</u>) and REMIX-2 (<u>NCT05032157</u>) clinical trials in patients who remained symptomatic on second-generation
H1 antihistamines. Rhapsido demonstrated superiority in change from baseline versus placebo in itch (ISS7), hives (HSS7), and weekly urticaria
activity (UAS7) at Week 12.<font style="font-size: 10pt"><sup>13</sup></font> Significantly more patients treated with Rhapsido versus
placebo achieved well-controlled disease (UAS7&le;6) as early as Week 2 and at Week 12, and about one-third of patients achieved complete
absence of itch and hives at Week 12.<font style="font-size: 10pt"><sup>13</sup></font> Rhapsido has a demonstrated safety profile that
requires no lab monitoring.<font style="font-size: 10pt"><sup>13</sup></font> The most common adverse events (incidence &ge;3%) were nasal
congestion, sore throat, and runny nose (nasopharyngitis), bleeding, headache, nausea, and abdominal pain.<font style="font-size: 10pt"><sup>13</sup></font></p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">&nbsp;</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">Novartis has completed regulatory submissions for Rhapsido for the treatment
of CSU across many countries, including in the European Union, Japan, and China, with priority review granted in China.</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">&nbsp;</p>

<p style="font-size: 10pt; font-weight: bold; margin-top: 0pt; margin-bottom: 0pt">Transforming care in Immunology</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">&ldquo;This approval of Rhapsido as the first and only BTK inhibitor in
CSU is an important milestone in our journey to reshape care for overlooked immune-related conditions and offer more patients the potential
to find fast relief,&rdquo; said Victor Bult&oacute;, President, US, Novartis. &ldquo;Building on our legacy in advancing the treatment
of allergic, dermatologic, and rheumatologic conditions, we are deeply committed to further investing in innovative, patient- focused
therapies across immunology.&rdquo;</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">&nbsp;</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">Discovered and developed by Novartis to target the BTK pathway as a driver
of inflammation, remibrutinib is being investigated in ongoing clinical trials across a variety of immune-related conditions, including
chronic inducible urticaria (CIndU), hidradenitis suppurativa (HS), and food allergy.</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">&nbsp;</p>

<p style="font-size: 10pt; font-weight: bold; margin-top: 0pt; margin-bottom: 0pt">Disclaimer</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">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; or similar terms, or by express or implied discussions regarding potential marketing approvals,
new indications or labeling for the investigational or approved products described in this press release, or regarding potential future
revenues from such products.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 the 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.</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">&nbsp;</p>

<p style="font-size: 10pt; font-weight: bold; margin-top: 0pt; margin-bottom: 0pt"></p>

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<p style="font-size: 10pt; font-weight: bold; margin-top: 0pt; margin-bottom: 0pt">About Novartis</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">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 <font style="font-size: 10pt">nearly 300 </font>million people worldwide.</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">&nbsp;</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">Reimagine medicine with us: Visit us at <b>https://www.novartis.com</b>
and connect with us on <b>LinkedIn</b>, <b><u>Facebook</u></b>, <b><u>X/Twitter</u></b> and <b>Instagram</b>.</p>

<p style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt">&nbsp;</p>

<p style="font-size: 10pt; font-weight: bold; margin-top: 0pt; margin-bottom: 0pt">References</p>

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  <tr style="vertical-align: top; text-align: justify">
    <td style="width: 0pt"></td>
    <td style="width: 20pt; text-align: left">1.</td>
    <td style="text-align: justify">Rhapsido<sup>&reg;</sup> (remibrutinib) Prescribing Information. Novartis Pharmaceuticals Corp.</td> </tr>
  </table>

<table cellpadding="0" cellspacing="0" style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; width: 100%">
  <tr style="vertical-align: top; text-align: justify">
    <td style="width: 0pt"></td>
    <td style="width: 20pt; text-align: left">2.</td>
    <td style="text-align: justify">Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA&sup2;LEN
        task force report. <i>Allergy</i>. 2011;66:317-330. doi:10.1111/j.1398-9995.2010.02496.x</td> </tr>
  </table>

<table cellpadding="0" cellspacing="0" style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; width: 100%">
  <tr style="vertical-align: top; text-align: justify">
    <td style="width: 0pt"></td>
    <td style="width: 20pt; text-align: left">3.</td>
    <td style="text-align: justify">The World Bank. Population, total. Accessed June 2025. https://data.worldbank.org/indicator/SP.POP.TOTL</td>
        </tr>
  </table>

<table cellpadding="0" cellspacing="0" style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; width: 100%">
  <tr style="vertical-align: top; text-align: justify">
    <td style="width: 0pt"></td>
    <td style="width: 20pt; text-align: left">4.</td>
    <td style="text-align: justify">Kolkhir P, Mu&ntilde;oz M, Asero R, et al. Autoimmune chronic spontaneous urticaria. <i>J Allergy Clin Immunol</i>.
        2022;149(6):1819-1831. doi:10.1016/j.jaci.2022.04.010</td> </tr>
  </table>

<table cellpadding="0" cellspacing="0" style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; width: 100%">
  <tr style="vertical-align: top; text-align: justify">
    <td style="width: 0pt"></td>
    <td style="width: 20pt; text-align: left">5.</td>
    <td style="text-align: justify">Kolkhir, P., Gim&eacute;nez-Arnau, A.M., Kulthanan, K. et al. Urticaria. <i>Nat Rev Dis Primers.</i> 8, 61
        (2022). https://doi.org/10.1038/s41572-022-00389-z</td> </tr>
  </table>

<table cellpadding="0" cellspacing="0" style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; width: 100%">
  <tr style="vertical-align: top; text-align: justify">
    <td style="width: 0pt"></td>
    <td style="width: 20pt; text-align: left">6.</td>
    <td style="text-align: justify">Mendes-Bastos P, Brasileiro A, Kolkhir P, et al. Bruton's tyrosine kinase inhibition-An emerging therapeutic
        strategy in immune-mediated dermatological conditions. <i>Allergy</i>. 2022;77(8):2355-2366.</td> </tr>
  </table>

<table cellpadding="0" cellspacing="0" style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; width: 100%">
  <tr style="vertical-align: top; text-align: justify">
    <td style="width: 0pt"></td>
    <td style="width: 20pt; text-align: left">7.</td>
    <td style="text-align: justify">Maurer M, Costa C, Gimenez Arnau A, et al. Antihistamine-resistant chronic spontaneous urticaria remains undertreated:
        2-year data from the AWARE study. <i>Clin Exp Allergy</i>. 2020;50:1166-1175. doi: 10.1111/cea.13716</td> </tr>
  </table>

<table cellpadding="0" cellspacing="0" style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; width: 100%">
  <tr style="vertical-align: top; text-align: justify">
    <td style="width: 0pt"></td>
    <td style="width: 20pt; text-align: left">8.</td>
    <td style="text-align: justify">Friedman A, Kwatra SG, Yosipovitch G. A Practical Approach to Diagnosing and Managing Chronic Spontaneous
        Urticaria. <i>Dermatol Ther </i>(Heidelb). 2024;14(6):1371-1387. doi: 10.1007/s13555-024-01173-5</td> </tr>
  </table>

<table cellpadding="0" cellspacing="0" style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; width: 100%">
  <tr style="vertical-align: top; text-align: justify">
    <td style="width: 0pt"></td>
    <td style="width: 20pt; text-align: left">9.</td>
    <td style="text-align: justify">Mendelson M, Bernstein J, Gabriel S, et al. Patient-reported impact of chronic urticaria compared with psoriasis
        in the United States. <i>J Dermatolog Treat</i>. 2017; 28(3):229-236. doi:10.1080/09546634.2016.1227421</td> </tr>
  </table>

<table cellpadding="0" cellspacing="0" style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; width: 100%">
  <tr style="vertical-align: top; text-align: justify">
    <td style="width: 0pt"></td>
    <td style="width: 20pt; text-align: left">10.</td>
    <td style="text-align: justify">Maurer M, Abuzakouk M, B&eacute;rard F, et al. The burden of chronic spontaneous urticaria is substantial:
        Real-world evidence from ASSURE-CSU. <i>Allergy</i>. 2017;72(12):2005-2016. doi:10.1111/all.13209</td> </tr>
  </table>

<table cellpadding="0" cellspacing="0" style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; width: 100%">
  <tr style="vertical-align: top; text-align: justify">
    <td style="width: 0pt"></td>
    <td style="width: 20pt; text-align: left">11.</td>
    <td style="text-align: justify">Balp M-M, Krupsky K, Balkaran BL, et al. Oral presentation at: European Academy of Allergy and Clinical Immunology
        (EAACI) Hybrid Congress 2023; June 9&ndash;11, 2023; Hamburg, Germany.</td> </tr>
  </table>

<table cellpadding="0" cellspacing="0" style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; width: 100%">
  <tr style="vertical-align: top; text-align: justify">
    <td style="width: 0pt"></td>
    <td style="width: 20pt; text-align: left">12.</td>
    <td style="text-align: justify"><font style="color: #232323">Maurer M, Raap U, Staubach P, et al. Antihistamine-resistant chronic spontaneous
        urticaria: 1-year data from the AWARE study. Clin Exp Allergy.2019; 49: 655&ndash;662. https://doi.org/10.1111/cea.13309</font></td> </tr>
  </table>

<table cellpadding="0" cellspacing="0" style="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; width: 100%">
  <tr style="vertical-align: top; text-align: justify">
    <td style="width: 0pt"></td>
    <td style="width: 20pt; text-align: left">13.</td>
    <td style="text-align: justify">Metz M, Gim&eacute;nez-Arnau A, Hide M, et al. Long-term efficacy and safety of remibrutinib in patients with
        chronic spontaneous urticaria in the Phase 3 REMIX-1 and REMIX-2 studies. Presented as a late oral abstract session on clinical trials
        at EAACI 2024; May 31-June 3, 2024; Valencia, Spain.</td> </tr>
  </table>

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    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Name:&nbsp;</FONT></TD>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
