Denali Therapeutics Announces FDA Clinical Hold on DNL919 Investigational New Drug (IND) Application
January 13 2022 - 7:00AM
Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical
company developing a broad portfolio of product candidates
engineered to cross the blood-brain barrier (BBB) for
neurodegenerative diseases, today announced that after the close of
business (Eastern Time) on Wednesday, January 12, 2022, the company
was informed via e-mail communication from the U.S. Food and Drug
Administration (FDA) that the DNL919 (ATV:TREM2) Investigational
New Drug (IND) application has been placed on clinical hold. The
FDA indicated they will provide an official clinical hold letter to
Denali in approximately 30 days. Denali plans to provide additional
updates pending discussion with the FDA.
About Denali Therapeutics Denali
Therapeutics is a biopharmaceutical company developing a broad
portfolio of product candidates engineered to cross the blood-brain
barrier (BBB) for neurodegenerative diseases. Denali pursues new
treatments by rigorously assessing genetically validated targets,
engineering delivery across the BBB and guiding development through
biomarkers that demonstrate target and pathway engagement. Denali
is based in South San Francisco. For additional information, please
visit www.denalitherapeutics.com.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements expressed or implied
in this press release include, but are not limited to, statements
regarding Denali's business strategy and plans; plans timelines and
expectations relating to the development of DNL919 and the Antibody
Transport Vehicle (ATV), including plans to initiate first in-human
trials; the FDA’s communication plans related to the clinical hold
on the DNL919 Investigational New Drug Application (IND); and
Denali’s plans and expectations for discussions with the FDA and
the outcomes from the discussions. Actual results are subject to
risks and uncertainties and may differ materially from those
indicated by these forward-looking statements as a result of these
risks and uncertainties, including but not limited to, risks
related to: any and all risks to Denali’s business and operations
caused directly or indirectly by the evolving COVID-19 pandemic;
risk of the occurrence of any event, change or other circumstance
that could give rise to the termination of Denali’s agreements with
its collaborators; Denali’s early stages of clinical drug
development; Denali’s and its collaborators’ ability to complete
the development and, if approved, commercialization of its product
candidates; Denali’s and its collaborators’ ability to enroll
patients in its ongoing and future clinical trials; Denali’s
reliance on third parties for the manufacture and supply of its
product candidates for clinical trials; Denali’s dependence on
successful development of its blood-brain barrier platform
technology and its programs and product candidates; Denali’s and
its collaborators’ ability to conduct or complete clinical trials
on expected timelines; the risk of significant adverse events,
toxicities or other undesirable side effects; the risk that
preclinical profiles of Denali’s product candidate DNL919 may not
translate in clinical trials; the potential for clinical trials of
Denali’s product candidates to differ from preclinical, early
clinical, preliminary or expected results; the uncertainty that
product candidates including DNL919 will receive regulatory
approval necessary to initiate human clinical studies or be
commercialized; uncertainty in the FDA’s plans to communicate and
discuss the clinical hold on the DNL919 IND with Denali and the
risk that those discussions may be delayed; the uncertainty in the
outcome of Denali’s discussions with the FDA regarding the clinical
hold on the DNL919 IND; implementation of Denali’s strategic plans
for its business, product candidates and blood-brain barrier
platform technology; Denali’s ability to obtain additional capital
to finance its operations, as needed; Denali’s ability to
accurately forecast future financial results in the current
environment; general economic and market conditions; and other
risks and uncertainties. In light of these risks, uncertainties and
assumptions, the forward-looking statements in this press release
are inherently uncertain and may not occur, and actual results
could differ materially and adversely from those anticipated or
implied in the forward-looking statements. Accordingly, you should
not rely upon forward-looking statements as predictions of future
events. Information regarding risks and uncertainties may be found
in Denali’s Annual and Quarterly Reports filed on Forms 10-K and
10-Q filed with the Securities and Exchange Commission (SEC) on
February 26, 2021, and November 4, 2021, respectively, and Denali’s
future reports to be filed with the SEC. Denali does not undertake
any obligation to update or revise any forward-looking statements,
to conform these statements to actual results or to make changes in
Denali’s expectations, except as required by law.
Contact:
Laura Hansen, Ph.D. Vice President, Investor
Relations (650) 452-2747 hansen@dnli.com
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