argenx Enters Into Agreement To Acquire Priority Review Voucher
23 Novembro 2020 - 3:00AM
November 23, 2020
Breda, the Netherlands / Ghent, Belgium – argenx
(Euronext & Nasdaq: ARGX), a global immunology company
committed to improving the lives of people suffering from severe
autoimmune diseases and cancer, today announced that the company
has agreed to acquire a U.S. Food and Drug Administration (FDA)
Priority Review Voucher (PRV) from Bayer Healthcare
Pharmaceuticals, Inc for $98 million. A PRV entitles the holder to
FDA priority review of a single New Drug Application or Biologics
License Application (BLA), which reduces the target review time and
may potentially lead to an expedited approval.
argenx expects to redeem the PRV for a future
marketing application for its FcRn antagonist efgartigimod. It will
not be used for the BLA filing of intravenous efgartigimod in
generalized myasthenia gravis, which is on track to be submitted in
2020.
“Efgartigimod has the potential to offer a new
therapy option to patients with severe autoimmune diseases. We are
currently advancing both an intravenous and subcutaneous
formulation, which we believe will capture variability in patient
preferences around dosing schedule and convenience, and will allow
us to reach the most number of patients. Through this investment in
a PRV, we’ll be able to seek expedited review of a future marketing
application and build additional optionality into our development
plans for efgartigimod,” said Tim Van Hauwermeiren, Chief Executive
Officer of argenx.
The closing of the acquisition of the PRV is
subject to customary closing conditions, including clearance under
the Hart-Scott Rodino (HSR) Antitrust Improvements Act.
About Efgartigimod
Efgartigimod is an investigational antibody
fragment designed to reduce disease-causing immunoglobulin G (IgG)
antibodies and block the IgG recycling process. Efgartigimod binds
to the neonatal Fc receptor (FcRn), which is widely expressed
throughout the body and plays a central role in rescuing IgG
antibodies from degradation. Blocking FcRn reduces IgG antibody
levels representing a logical potential therapeutic approach for
several autoimmune diseases known to be driven by disease-causing
IgG antibodies, including: myasthenia gravis (MG), a chronic
disease that causes muscle weakness; pemphigus vulgaris (PV), a
chronic disease characterized by severe blistering of the skin;
immune thrombocytopenia (ITP), a chronic bruising and bleeding
disease; and chronic inflammatory demyelinating polyneuropathy
(CIDP), a neurological disease leading to impaired motor
function.
About argenxargenx is a global
immunology company committed to improving the lives of people
suffering from severe autoimmune diseases and cancer. Partnering
with leading academic researchers through its Immunology Innovation
Program (IIP), argenx aims to translate immunology breakthroughs
into a world-class portfolio of novel antibody-based medicines.
argenx is evaluating efgartigimod in multiple serious autoimmune
diseases, and cusatuzumab in hematological cancers in collaboration
with Janssen. argenx is also advancing several earlier stage
experimental medicines within its therapeutic franchises. argenx
has offices in Belgium, the United States, and Japan. For more
information, visit www.argenx.com and follow us on LinkedIn at
https://www.linkedin.com/company/argenx/.
For further information, please contact:
Beth DelGiacco, Vice President, Corporate Communications &
Investor Relations +1 518 424 4980bdelgiacco@argenx.com
Joke Comijn, Director Corporate Communications & Investor
Relations (EU)+32 (0)477 77 29 44+32 (0)9 310 34
19jcomijn@argenx.com
Forward-looking Statements
The contents of this announcement include statements that are,
or may be deemed to be, forward-looking statements. These
forward-looking statements can be identified by the use of
forward-looking terminology, including the terms believes,
estimates, anticipates, expects, intends, may, will, or should, and
include statements argenx makes concerning the closing of the
acquisition of the PRV; the expected benefits of the PRV; the
timing of the BLA filing of IV efgartigimod in generalized
myasthenia gravis; the timing and outcome of FDA feedback regarding
its proposed strategy for a bridging study between the intravenous
(IV) and subcutaneous (SC) formulations of efgartigimod in gMG; the
expected benefits of IV and SC formulations of efgartigimod; the
therapeutic potential of its product candidates; and the intended
results of its strategy. By their nature, forward-looking
statements involve risks and uncertainties and readers are
cautioned that any such forward-looking statements are not
guarantees of future performance. argenx’s actual results may
differ materially from those predicted by the forward-looking
statements as a result of various important factors, including the
ability to satisfy closing conditions for the acquisition of the
PRV, the occurrence of any event that could give rise to the
termination of the PRV acquisition agreement, the ability to
recognize the anticipated benefits of the PRV acquisition, the
effects of the COVID-19 pandemic, the inherent uncertainties
associated with preclinical and clinical trial and product
development activities and regulatory approval requirements;
argenx’s reliance on collaborations with third parties; estimating
the commercial potential of argenx’s product candidates; argenx’s
ability to obtain and maintain protection of intellectual property
for its technologies and drugs; argenx’s limited operating history;
and argenx’s ability to obtain additional funding for operations
and to complete the development and commercialization of its
product candidates. A further list and description of these risks,
uncertainties and other risks can be found in argenx’s U.S.
Securities and Exchange Commission (SEC) filings and reports,
including in argenx’s most recent annual report on Form 20-F filed
with the SEC as well as subsequent filings and reports filed by
argenx with the SEC. Given these uncertainties, the reader is
advised not to place any undue reliance on such forward-looking
statements. These forward-looking statements speak only as of the
date of publication of this document. argenx undertakes no
obligation to publicly update or revise the information in this
press release, including any forward-looking statements, except as
may be required by law.
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