Stemline Therapeutics to Present at the 37th Annual J.P. Morgan Healthcare Conference
January 02 2019 - 7:30AM
Stemline Therapeutics, Inc. (NASDAQ:STML), a biopharmaceutical
company focused on the development and commercialization of novel
oncology therapeutics, announced today that Ivan Bergstein, M.D.,
Stemline’s CEO, will present at the 37th Annual J.P. Morgan
Healthcare Conference on Wednesday, January 9, 2019 at 5:00 PM PT
at the Westin St. Francis Hotel in San Francisco, CA. A live
webcast of the presentation can be viewed on the company's website
at www.stemline.com.
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 upcoming marketing authorization application
(MAA), which is expected to be submitted in the first quarter of
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 upcoming
marketing authorization application (MAA) of ELZONRIS in patients
with BPDCN, which is expected to be submitted in the first quarter
of 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
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