Trading of Clovis Oncology, Inc. Common Stock Halted
April 12 2016 - 7:04AM
Business Wire
FDA’s Oncologic Drugs Advisory Committee to
Review Rociletinib New Drug Application for the Treatment of
Non-Small Cell Lung Cancer
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that NASDAQ
has halted trading of the Company’s common stock. The U.S. Food and
Drug Administration’s (FDA) Oncologic Drugs Advisory Committee
(ODAC) is meeting this morning to discuss the company’s New Drug
Application (NDA) for rociletinib for the treatment of patients
with mutant epidermal growth factor receptor (EGFR) non-small cell
lung cancer (NSCLC) who have been previously treated with an
EGFR-targeted therapy and have the EGFR T790M mutation.
About RociletinibRociletinib is the company’s novel,
oral, targeted covalent (irreversible) mutant-selective inhibitor
of EGFR in development for the treatment of NSCLC in patients with
initial activating EGFR mutations, as well as the dominant
resistance mutation T790M. Data from both the pivotal, single-arm
TIGER-X and TIGER-2 clinical trials served as the basis for the
U.S. and EU regulatory submissions for the treatment of advanced
mutant EGFR T790M-positive lung cancer. Rociletinib was granted
Breakthrough Therapy designation by the FDA in May 2014.
About Clovis OncologyClovis Oncology, Inc. is a
biopharmaceutical company focused on acquiring, developing and
commercializing innovative anti-cancer agents in the U.S., Europe
and additional international markets. Clovis Oncology targets
development programs at specific subsets of cancer populations, and
simultaneously develops diagnostic tools that direct a compound in
development to the population that is most likely to benefit from
its use. Clovis Oncology is headquartered in Boulder, Colorado.
To the extent that statements contained in this press release
are not descriptions of historical facts regarding Clovis Oncology,
they are forward-looking statements reflecting the current beliefs
and expectations of management made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Such forward-looking statements involve substantial risks and
uncertainties that could cause our clinical development programs,
future results, performance or achievements to differ significantly
from those expressed or implied by the forward-looking statements.
Such risks and uncertainties include, among others, the
uncertainties inherent in our clinical development programs for our
drug candidates, the corresponding development pathways of our
companion diagnostics, actions by the FDA, the EMA or other
regulatory authorities regarding whether to approve drug
applications that may be filed, as well as their decisions
regarding drug labeling, and other matters that could affect the
availability or commercial potential of our drug candidates or
companion diagnostics, including competitive developments. Clovis
Oncology does not undertake to update or revise any forward-looking
statements. A further description of risks and uncertainties can be
found in Clovis Oncology’s filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K and its
reports on Form 10-Q and Form 8-K.
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version on businesswire.com: http://www.businesswire.com/news/home/20160412005725/en/
Clovis Oncology, Inc.Breanna Burkart,
303-625-5023bburkart@clovisoncology.comorAnna Sussman,
303-625-5022asussman@clovisoncology.com
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