<SEC-DOCUMENT>0001171843-21-005398.txt : 20210803
<SEC-HEADER>0001171843-21-005398.hdr.sgml : 20210803
<ACCEPTANCE-DATETIME>20210803063035
ACCESSION NUMBER:		0001171843-21-005398
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20210803
FILED AS OF DATE:		20210803
DATE AS OF CHANGE:		20210803

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			NOVARTIS AG
		CENTRAL INDEX KEY:			0001114448
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		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:		211137882

	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>

<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>

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<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 August 3, 2021</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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<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font-size: 10pt; width: 100%">
<TR STYLE="vertical-align: top">
    <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>
</TABLE>
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<P STYLE="font-size: 10pt; margin: 0pt 0 3pt">Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(1):</P>

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<TR STYLE="vertical-align: top">
    <TD STYLE="width: 50%; text-align: right"><FONT STYLE="font-size: 10pt">Yes:&nbsp;&#9744;</FONT></TD>
    <TD STYLE="width: 3%">&nbsp;</TD>
    <TD STYLE="width: 47%"><FONT STYLE="font-size: 10pt"><B>No</B>:&nbsp;<B>&#9746;</B></FONT></TD></TR>
</TABLE>
<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 3pt">Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(7):&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font-size: 10pt">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 50%; text-align: right"><FONT STYLE="font-size: 10pt">Yes:&nbsp;&#9744;</FONT></TD>
    <TD STYLE="width: 3%">&nbsp;</TD>
    <TD STYLE="width: 47%"><FONT STYLE="font-size: 10pt"><B>No</B>:&nbsp;<B>&#9746;</B></FONT></TD></TR>
</TABLE>
<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<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
Act of 1934.&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font-size: 10pt">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 50%; text-align: right"><FONT STYLE="font-size: 10pt">Yes:&nbsp;&#9744;</FONT></TD>
    <TD STYLE="width: 3%">&nbsp;</TD>
    <TD STYLE="width: 47%"><FONT STYLE="font-size: 10pt"><B>No</B>:&nbsp;<B>&#9746;</B></FONT></TD></TR>
</TABLE>


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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"></FONT></P>

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<TR STYLE="vertical-align: top; text-align: left">
    <TD STYLE="width: 33%"><FONT STYLE="font-size: 10pt"><IMG SRC="logo.jpg" ALT=""></FONT></TD>
    <TD STYLE="width: 34%"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD>
    <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>

<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">http://www.novartis.com</P>
<P STYLE="font: 9pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">https://twitter.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; 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="text-align: left; 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="text-align: left; font-size: 10pt; font-weight: bold; margin-top: 4.45pt; margin-right: 0pt; margin-bottom: 0pt"><FONT STYLE="font-size: 12pt">Novartis
announces lift of partial clinical trial hold and plans to initiate a new, pivotal Phase 3 study of intrathecal OAV-101 in older patients
with SMA</FONT></P>

<P STYLE="font-size: 10pt; margin: 0.45pt 0 0"><B>&nbsp;</B></P>

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

<P STYLE="font-size: 10pt; margin: 0.2pt 0 0"><B>&nbsp;</B></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font-size: 10pt; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 1%"></TD><TD STYLE="width: 18pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="padding-right: 47.3pt"><I>FDA concluded that OAV-101 intrathecal (IT) clinical program may proceed based on data from nonclinical
toxicology study</I></TD></TR></TABLE>

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

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font-size: 10pt; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 1%"></TD><TD STYLE="width: 18pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="padding-right: 20.3pt"><I>New Phase 3 STEER study will evaluate efficacy, safety, and tolerability of OAV- 101 IT in treatment-na&iuml;ve
patients with SMA Type 2 aged between 2 and 18 years old, the first to study gene therapy in this patient population</I></TD></TR></TABLE>

<P STYLE="font-size: 10pt; margin: 0.05pt 0 0"><I>&nbsp;</I></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font-size: 10pt; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 1%"></TD><TD STYLE="width: 18pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="padding-right: 33.85pt"><I>STEER will build upon the OAV-101 IT STRONG study which demonstrated significant increases in HFMSE
scores and a clinically meaningful response in patients with SMA Type 2 aged between &ge;2 years and &lt;5 years old</I></TD></TR></TABLE>

<P STYLE="font-size: 10pt; margin: 0.2pt 0 0"><I>&nbsp;</I></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font-size: 10pt; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 1%"></TD><TD STYLE="width: 18pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="padding-right: 25.85pt"><I>OAV-101 IT under investigation as a one-time, single-dose, treatment option for older patients with
SMA</I></TD></TR></TABLE>

<P STYLE="font-size: 10pt; margin: 0.45pt 0 0"><I>&nbsp;</I></P>

<P STYLE="font-size: 10pt; margin-top: 0pt; margin-right: 0.3in; margin-bottom: 0pt"><B>Basel, August 3, 2021 </B>&mdash; Novartis today announced that the U.S. Food
and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients
may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. The decision to lift the hold was based on data
from Novartis&rsquo; comprehensive nonclinical toxicology study in non-human primates (NHP) that addressed all issues identified, including
questions of dorsal root ganglia (DRG) injury following IT administration.</P>

<P STYLE="font-size: 10pt; margin: 0.25pt 0 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin-top: 0pt; margin-right: 0.3in; margin-bottom: 0pt">Following this decision and input from the FDA and European Medicines Agency (EMA),
Novartis now plans to initiate STEER, a global pivotal Phase 3 registration-enabling study to evaluate the clinical efficacy, safety,
and tolerability of OAV-101 IT in treatment na&iuml;ve patients who are between two and 18 years of age, able to sit, but have never walked.
While disease progression is slower in patients with later-onset SMA, there are significant unmet needs.</P>

<P STYLE="font-size: 10pt; margin: 0.15pt 0 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin-top: 0pt; margin-right: 0.3in; margin-bottom: 0pt">&ldquo;We are very pleased that our comprehensive nonclinical data package has
addressed all issues identified related to DRG toxicity and the FDA has reached the decision that we may proceed with our OAV-101 IT clinical
trial program and initiate the STEER trial,&rdquo; said Shephard Mpofu, M.D., SVP, Chief Medical Officer, Novartis Gene Therapies. &ldquo;We
believe that all patients diagnosed with SMA should be able to benefit from the transformative impact of gene therapy and we remain confident
that investigational OAV-101 IT is a viable potential treatment path for older patients who often have ongoing unmet needs, and for whom
a one- time treatment could be especially compelling.&rdquo;</P>

<P STYLE="font-size: 10pt; margin: 0.25pt 0 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin-top: 0pt; margin-right: 0.3in; margin-bottom: 0pt">STEER will build upon the Phase 1/2 STRONG study
which showed that treatment with OAV- 101 IT led to significant increases in Hammersmith Functional Motor Scale-Expanded (HFMSE) scores
and a clinically meaningful response in older patients between &ge;2 years and &lt;5 years old with SMA Type 2.</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>


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<P STYLE="font-size: 10pt; margin-top: 0pt; margin-right: 0.3in; margin-bottom: 0pt">Additionally, STEER will add to the clinical data
and emerging real-world evidence for the use of gene therapy to treat SMA. Our intravenous formulation, Zolgensma<FONT STYLE="font-size: 10pt"><SUP>&reg;
</SUP></FONT>(onasemnogene abeparvovec) is approved in 41 countries. More than 1,400 patients have been treated with Zolgensma IV globally,
including in the European Union, South Korea and Canada, where regulatory approval includes dosing guidance for babies and young children
up to 21kg.</P>

<P STYLE="font-size: 10pt; margin: 0.35pt 0 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin-top: 0pt; margin-right: 0.3in; margin-bottom: 0pt">&ldquo;We are very pleased to see that a plan has been reached from Novartis, the
FDA and EMA working together to move this IT approach forward,&rdquo; said Kenneth Hobby, President, Cure SMA. &ldquo;This route of administration
has the potential to open up access for older patients to all the benefits of gene therapy. We have seen the interest among our symptomatic
patients and their families in gene therapy, and this study is an important step in understanding its potential to address unmet needs
that remain in the SMA community.&rdquo;</P>

<P STYLE="font-size: 10pt; margin: 0.05pt 0 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin-top: 0pt; margin-right: 0pt; margin-bottom: 0pt; color: #211F1F"><B>About STEER</B></P>

<P STYLE="font-size: 10pt; margin-top: 0pt; margin-right: 0.3in; margin-bottom: 0pt">STEER is a Phase 3 randomized, double-blind, sham-controlled study to evaluate
the clinical efficacy, safety, and tolerability of a one-time intrathecal (IT) dose of OAV-101 in treatment na&iuml;ve patients with Type
2 SMA who are between two and 18 years of age, able to sit, but have never walked. The primary objective of STEER is to evaluate the efficacy
and safety of one-time IT administration of OAV-101 compared to sham controls over a 52-week period, at the end of which patients in the
control arm will be treated with OAV-101. The therapeutic effect of OAV-101 will be evaluated using the Hammersmith Functional Motor Scale-
Expanded (HFMSE). Secondary objectives include evaluating safety and efficacy of OAV-101 using the Revised Upper Limb Module (RULM) scale.
More than 100 patients will be randomized to receive OAV-101 by IT injection or to receive a sham procedure. At the end of the 52-week
period, all eligible patients who received the sham procedure will receive OAV- 101 and all eligible patients who received OAV-101 will
receive the sham procedure.</P>

<P STYLE="font-size: 10pt; margin: 0.1pt 0 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin-top: 0pt; margin-right: 0.3in; margin-bottom: 0pt">A sham-controlled study is a method used in clinical trials to help determine
the effectiveness of a drug or treatment when a procedure is required, and has precedent in other Phase 3 studies measuring the efficacy
of treatments for later-onset SMA. The use of a sham procedure in STEER is included to provide a comparison group for an unbiased collection
and assessment of efficacy, safety and tolerability of OAV-101 IT for this older population where the disease progression is slower.</P>

<P STYLE="font-size: 10pt; margin: 0.5pt 0 0">&nbsp;</P>

<P STYLE="font-size: 10pt; font-weight: bold; margin-top: 0pt; margin-right: 0pt; margin-bottom: 0pt">About Spinal Muscular Atrophy (SMA)</P>

<P STYLE="font-size: 10pt; margin-top: 0pt; margin-right: 0.3in; margin-bottom: 0pt">SMA is a rare, genetic neuromuscular disease caused
by a lack of a functional <I>SMN1 </I>gene, resulting in the irreversible loss of motor neurons, affecting muscle functions, including
breathing, swallowing and basic movement.<FONT STYLE="font-size: 10pt"><SUP>1,2</SUP></FONT> The severity of SMA varies across a spectrum
of types that each correspond to the copy number of the <I>SMN2 </I>gene, which produces a small fraction (~10%) of functional SMN protein
compared with <I>SMN1</I>.<FONT STYLE="font-size: 10pt"><SUP>3</SUP></FONT> Left untreated, patients with SMA Type 2 are unable to walk
and will require a wheelchair, and more than 30% will die by age 25.<FONT STYLE="font-size: 10pt"><SUP>4</SUP> </FONT>Loss of motor neurons
cannot be reversed, so SMA patients with symptoms at the time of treatment will likely require some supportive respiratory, nutritional
and/or musculoskeletal care to maximize functional abilities.<FONT STYLE="font-size: 10pt"><SUP>4</SUP></FONT></P>

<P STYLE="font-size: 10pt; margin: 0.55pt 0 0">&nbsp;</P>

<P STYLE="font-size: 10pt; font-weight: bold; margin-top: 0pt; margin-right: 0pt; margin-bottom: 0pt">About Novartis Gene Therapies</P>

<P STYLE="font-size: 10pt; margin-top: 0pt; margin-right: 0.3in; margin-bottom: 0pt">Novartis Gene Therapies is reimagining medicine to transform the lives of people
living with rare genetic diseases. Utilizing cutting-edge technology, we are working to turn promising gene therapies into proven treatments,
beginning with our transformative intravenous gene therapy for spinal muscular atrophy (SMA). Our robust AAV-based pipeline is advancing
treatments for Rett syndrome and Friedreich&rsquo;s ataxia. We are powered by the world&rsquo;s largest, commercially-proven gene therapy
manufacturing footprint, enabling us to bring gene therapy to patients around the world at quality and scale.</P>

<P></P>

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<P STYLE="font-size: 10pt; margin-top: 0pt; margin-right: 0.3in; margin-bottom: 0pt">Novartis Gene Therapies has an exclusive, worldwide license with Nationwide
Children's Hospital to both the intravenous and intrathecal delivery of AAV9 gene therapy for the treatment of all types of SMA; has an
exclusive, worldwide license from REGENXBIO for any recombinant AAV vector in its intellectual property portfolio for the <I>in vivo </I>gene
therapy treatment of SMA in humans; an exclusive, worldwide licensing agreement with G&eacute;n&eacute;thon for <I>in vivo </I>delivery
of AAV9 vector into the central nervous system for the treatment of SMA; and a non-exclusive, worldwide license agreement with AskBio
for the use of its self- complementary DNA technology for the treatment of SMA.</P>

<P STYLE="font-size: 10pt; margin: 0.25pt 0 0">&nbsp;</P>

<P STYLE="font-size: 10pt; font-weight: bold; margin-top: 0.05pt; margin-right: 0pt; margin-bottom: 0pt">Disclaimer</P>

<P STYLE="font-size: 10pt; margin-top: 0pt; margin-right: 0.3in; 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;seek,&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
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<P><B>References</B></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font-size: 10pt; margin-top: 2.7pt; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 2%"></TD><TD STYLE="width: 18.05pt">1.</TD><TD>Anderton RS and Mastaglia FL. <I>Expert Rev Neurother</I>. 2015;15(8):895&ndash;908.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font-size: 10pt; margin-top: 2.7pt; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 2%"></TD><TD STYLE="width: 18.05pt">2.</TD><TD STYLE="padding-right: 26.4pt">Finkel RS, McDermott MP, Kaufmann P. et al. Observational study of spinal muscular atrophy type I and
implications for clinical trials. <I>Neurology</I>. 2014;83(9):810-7.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font-size: 10pt; margin-top: 2.7pt; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 2%"></TD><TD STYLE="width: 18.05pt">3.</TD><TD STYLE="padding-right: 29.1pt">Lorson CL, Rindt H, Shababi M. Spinal muscular atrophy: mechanisms and therapeutic strategies. <I>Hum
Mol Genet</I>. 2010;(15):R111-8.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font-size: 10pt; margin-top: 2.7pt; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 2%"></TD><TD STYLE="width: 18.05pt">4.</TD><TD STYLE="padding-right: 14.6pt">Darras BT, Finkel RS. &ldquo;Natural history of spinal muscular atrophy.&rdquo; In: Sumner CJ, Paushkin
S, Ko CP, eds. Spinal Muscular Atrophy: Disease Mechanisms and Therapy, 2nd ed. London, UK: Academic Press/Elsevier;2017:399&#8210;421.</TD></TR></TABLE>

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