NewLink Genetics Announces FDA Accepts Partnered Biologics License Application (BLA) and Grants Priority Review for Ebola Vac...
17 Settembre 2019 - 11:05PM
NewLink Genetics Corporation (NASDAQ:NLNK) today announced that the
U.S. Food and Drug Administration (FDA) has accepted Merck’s
Biologics License Application (BLA) and granted priority review for
the investigational Ebola vaccine (V920), for the prevention of
disease caused by the Ebola Zaire virus. Merck’s rolling submission
was made pursuant to the FDA’s Breakthrough Therapy Designation for
V920, a designation awarded to our partner, Merck, in July 2016.
The Prescription Drug User Fee Act (PDUFA), or target action date,
is set for March 14, 2020. As NewLink has previously stated, the
FDA’s approval of this Ebola vaccine would trigger the issuance of
a priority review voucher owned by Merck and in which NewLink
Genetics has a substantial economic interest. Thereafter, NewLink
would have the right to monetize its share of interest in the
voucher. This Ebola vaccine candidate was originally developed
by the Public Health Agency of Canada (PHAC) and thereafter
licensed to NewLink Genetics.
“We are pleased with this morning’s announcement from our
partner, Merck. The global community, Merck and government partners
have worked relentlessly to further the development of the
investigational V920 Ebola vaccine,” said Brad Powers, a member of
the Office of the CEO. “We are thankful to those frontline
responders who work tirelessly to help fight this devastating
disease, and we believe this vaccine has the potential to impact
many lives.”
About NewLink Genetics Corporation
NewLink Genetics is a clinical stage biopharmaceutical company
focused on developing novel oncology product candidates to improve
the lives of patients with cancer where treatment options are
limited. NewLink Genetics' IDO pathway inhibitors, indoximod and
its prodrug, NLG802, are immuno-oncology drug candidates designed
to harness multiple components of the immune system to combat
cancer. For more information, please visit
www.NewLinkGenetics.com.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking
statements of NewLink Genetics that involve substantial risks and
uncertainties. All statements contained in this press release are
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. The words “will be,”
"may," “appear to,” “has potential to,” “look forward to,” “are
designed to,” or the negative of these terms or other similar
expressions, are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. These forward-looking statements include, among
others, statements about results of NewLink’s clinical trials for
product candidates and any other statements other than statements
of historical fact. Actual results or events could differ
materially from the plans, intentions and expectations disclosed in
the forward-looking statements that NewLink Genetics makes due to a
number of important factors, including those risks discussed in
"Risk Factors" and elsewhere in NewLink Genetics' Quarterly Report
on Form 10-Q for the quarter ended June 30, 2019 and other reports
filed with the U.S. Securities and Exchange Commission (SEC). The
forward-looking statements in this press release represent NewLink
Genetics’ views as of the date of this press release. NewLink
Genetics anticipates that subsequent events and developments will
cause its views to change. However, while it may elect to update
these forward-looking statements at some point in the future, it
specifically disclaims any obligation to do so. You should,
therefore, not rely on these forward-looking statements as
representing NewLink Genetics' views as of any date subsequent to
the date of this press release.##
Investor & Media Contact:
Lisa MillerDirector of Investor RelationsNewLink
Genetics515-598-2555lmiller@linkp.com
Source: NewLink Genetics Corporation
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