Apellis Announces Pegcetacoplan MAA Review Has Been Reset to Day 180 of Initial Assessment by European Medicines Agency (EMA)
April 26 2024 - 6:15AM
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that
the European Medicines Agency (EMA) has reset the review of the
marketing authorization application (MAA) for intravitreal
pegcetacoplan for geographic atrophy to the last phase of the
initial assessment (day 180). The procedure is expected to be led
by the original rapporteurs, and EMA has stated their intent to
convene a new expert group meeting. Apellis anticipates an opinion
from the Committee for Medicinal Products for Human Use (CHMP) no
later than July 2024.
The update follows the judgment by the Court of
Justice of the European Union (CJEU) on March 14, 2024, which ruled
on the organization of EMA’s expert groups. The judgment has
implications on EMA's policy for handling competing interests of
experts.
This decision by EMA is strictly procedural in
response to the CJEU judgment and is not related to the
pegcetacoplan data package. Apellis will continue to work closely
with EMA on the review of the pegcetacoplan marketing
application.
About ApellisApellis
Pharmaceuticals, Inc. is a global biopharmaceutical company that
combines courageous science and compassion to develop life-changing
therapies for some of the most challenging diseases patients face.
We ushered in the first new class of complement medicine in 15
years and now have two approved medicines targeting C3. These
include the first-ever therapy for geographic atrophy, a leading
cause of blindness around the world. We believe we have only begun
to unlock the potential of targeting C3 across serious retinal,
rare, and neurological diseases. For more information, please visit
http://apellis.com or follow us
on Twitter and LinkedIn.
Apellis Forward-Looking
StatementStatements in this press release about future
expectations, plans and prospects, as well as any other statements
regarding matters that are not historical facts, may constitute
“forward-looking statements” within the meaning of The Private
Securities Litigation Reform Act of 1995. The words “anticipate,”
“believe,” “continue,” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “potential,” “predict,” “project,” “should,”
“target,” “will,” “would” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Actual
results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including whether pegcetacoplan will receive approval from
foreign regulatory agencies for GA when expected or at all,
including the impact on the likelihood and timing of such
approvals; and other factors discussed in the “Risk Factors”
section of Apellis’ Annual Report on Form 10-K with the Securities
and Exchange Commission on February 27, 2024 and the risks
described in other filings that Apellis may make with the
Securities and Exchange Commission. Any forward-looking statements
contained in this press release speak only as of the date hereof,
and Apellis specifically disclaims any obligation to update any
forward-looking statement, whether as a result of new information,
future events or otherwise.
Media Contact:
Lissa Pavlukmedia@apellis.com617.977.6764
Investor Contact:Meredith
Kayameredith.kaya@apellis.com617.599.8178
Apellis Pharmaceuticals (NASDAQ:APLS)
Historical Stock Chart
From Apr 2024 to May 2024
Apellis Pharmaceuticals (NASDAQ:APLS)
Historical Stock Chart
From May 2023 to May 2024