Stemline Therapeutics Announces Submission of European Marketing Authorization Application (MAA) for ELZONRIS™
January 07 2019 - 9:50AM
Stemline Therapeutics, Inc. (NASDAQ:STML), a biopharmaceutical
company focused on the development and commercialization of novel
oncology therapeutics, announced today that it has submitted the
marketing authorization application (MAA) for ELZONRIS
(tagraxofusp) to the European Medicines Agency (EMA). The MAA seeks
approval for treating patients with blastic plasmacytoid dendritic
cell neoplasm (BPDCN). In November 2018, the EMA granted the
ELZONRIS MAA accelerated assessment.
On December 21, 2018, ELZONRIS was approved by the U.S. Food and
Drug Administration (FDA) for the treatment of BPDCN in adult and
pediatric patients, two years and older, in both treatment-naïve
and previously-treated populations. ELZONRIS is the first treatment
approved for BPDCN and the first approved CD123-targeted
therapy.
“The submission of the ELZONRIS MAA is another major step
forward for providing this important targeted treatment to
patients, globally,” said Ivan Bergstein, M.D., CEO of Stemline
Therapeutics. “We look forward to working closely with the EMA to
ensure this treatment is available to patients as quickly as
possible. In parallel, our commercial team is continuing its
ongoing effort to raise awareness of both CD123 testing and BPDCN
worldwide. Potential European approval offers us an opportunity to
significantly increase the number of patients who may benefit from
ELZONRIS.”
About ELZONRIS™ELZONRIS (tagraxofusp), a
CD123-directed cytotoxin, was approved by the Food and Drug
Administration (FDA) on December 21, 2018 for the treatment of
adult and pediatric patients, two years and older, with blastic
plasmacytoid dendritic cell neoplasm (BPDCN). In November 2018, the
European Medicines Agency (EMA) granted ELZONRIS accelerated
assessment to the marketing authorization application (MAA), which
was submitted to the EMA in January 2019. ELZONRIS is also being
evaluated in additional clinical trials in other indications
including chronic myelomonocytic leukemia (CMML), myelofibrosis
(MF) and other CD123 positive diseases.
About BPDCNBlastic plasmacytoid dendritic cell
neoplasm (BPDCN) is an aggressive hematologic malignancy with
historically poor outcomes and an area of unmet medical need. The
BPDCN cell of origin is the plasmacytoid dendritic cell (pDC)
precursor. BPDCN typically presents in the bone marrow and/or skin
and may also involve lymph nodes and viscera. The diagnosis of
BPDCN is based on the immunophenotypic diagnostic triad of CD123,
CD4, and CD56. For more information, please visit the BPDCN disease
awareness website at www.bpdcninfo.com.
About Stemline TherapeuticsStemline
Therapeutics, Inc. is a biopharmaceutical company focused on the
development and commercialization of novel oncology therapeutics.
In December 2018, the FDA approved ELZONRIS, a targeted therapy
directed to CD123, for the treatment of adult and pediatric
patients, two years and older, with blastic plasmacytoid dendritic
cell neoplasm (BPDCN). In November 2018, the European Medicines
Agency (EMA) granted accelerated assessment to the marketing
authorization application (MAA) of ELZONRIS in patients with BPDCN,
which was submitted to the EMA in January 2019. ELZONRIS is also
being evaluated in clinical trials in additional indications
including chronic myelomonocytic leukemia (CMML), myelofibrosis
(MF) and others. Other Stemline clinical candidates include SL-801,
a novel oral small molecule reversible inhibitor of XPO1, which is
currently in a Phase 1 trial of patients with advanced solid tumors
and recent data was presented at the European Society of Medical
Oncology (ESMO) annual conference; and SL-701, an immunotherapeutic
which has completed a Phase 2 trial in patients with second-line
glioblastoma and recent data were presented at the Society for
Neuro-Oncology (SNO) annual conference.
Forward-Looking Statements Some of the
statements included in this press release may be forward-looking
statements that involve a number of risks and uncertainties. For
those statements, we claim the protection of the safe harbor for
forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995. The factors that could cause our
actual results to differ materially include: the success and timing
of our MAA submission to the EMA CHMP; the success and timing of
our clinical trials and preclinical studies for our product
candidates, including site initiation, institutional review board
approval, scientific review committee approval, patient accrual,
safety, tolerability and efficacy data observed, and input from
regulatory authorities including the risk that the FDA, EMA, or
other ex-U.S. national drug authority ultimately does not agree
with our data, find our data supportive of approval, or approve any
of our product candidates; the possibility that results of clinical
trials are not predictive of safety and efficacy results of our
product candidates in broader patient populations or of our
products if approved; our plans to develop and commercialize our
product candidates, including, but not limited to delays in
arranging satisfactory manufacturing capabilities and establishing
commercial infrastructure for ELZONRIS; product efficacy or safety
concerns resulting in product recalls or regulatory action; the
risk that estimates regarding the number of patients with the
diseases that our products and product candidates may treat are
inaccurate; our products not gaining acceptance among patients (and
providers or third party payers) for certain indications (due to
cost or otherwise); the risk that third party payors (including
governmental agencies) will not reimburse for the use of ELZONRIS
at acceptable rates or at all; the company’s ability to maintain or
increase sales of ELZONRIS; the company’s ability to develop and
commercialize ELZONRIS; the adequacy of our pharmacovigilance and
drug safety reporting processes; our available cash and
investments; our ability to obtain and maintain intellectual
property protection for our products and product candidates;
delays, interruptions, or failures in the manufacture and supply of
our products and product candidates; the performance of third-party
businesses, including, but not limited to, manufacturers, clinical
research organizations, clinical trial sponsors and clinical trial
investigators; and other risk factors identified from time to time
in our reports filed with the SEC. Any forward-looking statements
set forth in this press release speak only as of the date of this
press release. We do not intend to update any of these
forward-looking statements to reflect events or circumstances that
occur after the date hereof.
Contact:
Investors: Stemline Therapeutics, Inc.750
Lexington AvenueEleventh FloorNew York, NY 10022Tel:
646-502-2307Email: investorrelations@stemline.com
Stemline Therapeutics (NASDAQ:STML)
Historical Stock Chart
From Mar 2024 to Apr 2024
Stemline Therapeutics (NASDAQ:STML)
Historical Stock Chart
From Apr 2023 to Apr 2024