Verastem Oncology Announces Submission of a Marketing Authorization Application to the European Medicines Agency for COPIKTRA...
November 25 2019 - 7:00AM
Business Wire
Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company),
a biopharmaceutical company focused on developing and
commercializing medicines seeking to improve the survival and
quality of life of cancer patients, today announced the submission
of a Marketing Authorization Application to the European Medicines
Agency (EMA) for COPIKTRA® (duvelisib), an oral inhibitor of
phosphoinositide 3-kinase (PI3K), seeking approval for the
treatment of patients with relapsed or refractory chronic
lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and
relapsed or refractory follicular lymphoma (FL).
“We have seen the significant benefit of COPIKTRA as a treatment
option for patients throughout our clinical trials and experience
globally,” said Brian Stuglik, Chief Executive Officer of Verastem
Oncology. “The MAA submission for COPIKTRA in Europe is an
important milestone in our mission to offer new therapies to
patients in need and we are committed to working effectively with
the EMA through the regulatory process to bring COPIKTRA to
patients in Europe.”
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a commercial
biopharmaceutical company committed to the development and
commercialization of medicines to improve the lives of patients
diagnosed with cancer. We are driven by the strength, tenacity and
courage of those battling cancer – single-minded in our resolve to
deliver new therapies that not only keep cancer at bay, but improve
the lives of patients diagnosed with cancer. Because for us, it’s
personal.
Our first FDA approved product is now available for the
treatment of patients with certain types of indolent non-Hodgkin’s
lymphoma (iNHL). Our pipeline comprises product candidates that
seek to treat cancer by modulating the local tumor
microenvironment. For more information, please visit
www.verastem.com.
Forward looking statements notice
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including those related to the safety and efficacy of COPIKTRA;
whether and when the EMA may approve the Marketing Authorization
for COPIKTRA, which will depend on the assessment by the EMA of the
benefit-risk profile suggested by the totality of the efficacy and
safety information submitted, and if approved, whether COPIKTRA
will be commercially successful in Europe; and that COPIKTRA will
not result in new treatment options being offered to patients in
Europe. These risks, uncertainties and other factors could cause
actual results to differ materially from those referred to in the
forward-looking statements. The reader is cautioned not to rely on
these forward-looking statements.
Other risks and uncertainties include those identified under the
heading “Risk Factors” in the Company’s Quarterly Report on Form
10-Q for the quarterly period ended September 30, 2019, as filed
with the Securities and Exchange Commission (SEC) on October 30,
2019, its Annual Report on Form 10-K for the year ended December
31, 2018 as filed with the SEC on March 12, 2019, and in any
subsequent filings with the SEC. The forward-looking statements
contained in this press release reflect Verastem Oncology’s views
as of the date hereof, and the Company does not assume and
specifically disclaims any obligation to update any forward-looking
statements whether as a result of new information, future events or
otherwise, except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20191125005189/en/
Investors: John Doyle Vice President, Investor Relations &
Finance +1 781-469-1546 jdoyle@verastem.com Media: Lisa Buffington
Corporate Communications +1 781-292-4205
lbuffington@verastem.com
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