Merus Receives FDA extension of PDUFA for zenocutuzumab
November 05 2024 - 5:30AM
UK Regulatory
Merus Receives FDA extension of PDUFA for zenocutuzumab
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Nov.
05, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the
Company, we, or our), a clinical-stage oncology company developing
innovative, full-length multispecific antibodies
(Biclonics® and Triclonics®), today announced
that the United States Food and Drug Administration (FDA) has
extended the Prescription Drug User Fee Act (PDUFA) goal date for
zenocutuzumab (Zeno) Biologics License Application (BLA) currently
under priority review.
The US FDA has extended the PDUFA goal date to February 4, 2025
to enable sufficient time to review information recently submitted
by the Company in response to a CMC information request. No
additional clinical data have been requested.
Merus believes that obtaining a commercialization partnership
agreement is an important step in bringing Zeno to patients with
NRG1+ cancer, if approved.
About Merus N.V.
Merus is a clinical-stage oncology company developing innovative
full-length human bispecific and trispecific antibody therapeutics,
referred to as Multiclonics®. Multiclonics®
are manufactured using industry standard processes and have been
observed in preclinical and clinical studies to have several of the
same features of conventional human monoclonal antibodies, such as
long half-life and low immunogenicity. For additional information,
please visit Merus’ website, and LinkedIn.
Forward-Looking Statements
This press
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. All
statements contained in this press release that do not relate to
matters of historical fact should be considered forward-looking
statements, including without limitation, statements regarding the
content and timing of regulatory developments and updates for
zenocutuzumab; the BLA review, goal PDUFA date; and our belief that
obtaining a commercialization partnership agreement is an important
step in bringing Zeno to patients with NRG1+ cancer, if approved.
These forward-looking statements are based on management’s current
expectations. These statements are neither promises nor guarantees,
but involve known and unknown risks, uncertainties and other
important factors that may cause our actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements, including, but not limited to, the
following: our need for additional funding, which may not be
available and which may require us to restrict our operations or
require us to relinquish rights to our technologies or antibody
candidates; potential delays in regulatory approval, which would
impact our ability to commercialize our product candidates and
affect our ability to generate revenue; the lengthy and expensive
process of clinical drug development, which has an uncertain
outcome; the unpredictable nature of our early stage development
efforts for marketable drugs; potential delays in enrollment of
patients, which could affect the receipt of necessary regulatory
approvals; our reliance on third parties to conduct our clinical
trials and the potential for those third parties to not perform
satisfactorily; impacts of the volatility in the global economy,
including global instability, including the ongoing conflicts in
Europe and the Middle East; we may not identify suitable
Biclonics® or bispecific antibody candidates under our
collaborations or our collaborators may fail to perform adequately
under our collaborations; our reliance on third parties to
manufacture our product candidates, which may delay, prevent or
impair our development and commercialization efforts; protection of
our proprietary technology; our patents may be found invalid,
unenforceable, circumvented by competitors and our patent
applications may be found not to comply with the rules and
regulations of patentability; we may fail to prevail in potential
lawsuits for infringement of third-party intellectual property; and
our registered or unregistered trademarks or trade names may be
challenged, infringed, circumvented or declared generic or
determined to be infringing on other marks.
These and other important factors discussed under the caption
“Risk Factors” in our Quarterly Report on Form 10-Q for the period
ended September 30, 2024, filed with the Securities and Exchange
Commission, or SEC, on October 31, 2024, and our other reports
filed with the SEC, could cause actual results to differ materially
from those indicated by the forward-looking statements made in this
press release. Any such forward-looking statements represent
management’s estimates as of the date of this press release. While
we may elect to update such forward-looking statements at some
point in the future, we disclaim any obligation to do so, even if
subsequent events cause our views to change, except as required
under applicable law. These forward-looking statements should not
be relied upon as representing our views as of any date subsequent
to the date of this press release.
Multiclonics®, Biclonics® and
Triclonics® are registered trademarks of Merus N.V.
Merus NV (TG:2GH)
Historical Stock Chart
From Nov 2024 to Dec 2024
Merus NV (TG:2GH)
Historical Stock Chart
From Dec 2023 to Dec 2024