Stemline Therapeutics to Present at the Cowen 40th Annual Health Care Conference
February 26 2020 - 7:30AM
Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage
biopharmaceutical company focused on the development and
commercialization of novel oncology therapeutics, today announced
that management will present at the Cowen 40th Annual Health Care
Conference on Monday, March 2, 2020 at 12:00 PM ET at the Boston
Marriott Copley Place in Boston, MA. A live webcast of the
presentation can be viewed on the company’s website at
www.stemline.com.
About ELZONRIS®
ELZONRIS® (tagraxofusp), a targeted therapy directed to CD123,
is approved by the U.S. Food and Drug Administration (FDA) and
commercially available in the U.S. for the treatment of adult and
pediatric patients, two years or older, with blastic plasmacytoid
dendritic cell neoplasm (BPDCN). For full prescribing information
in the U.S., visit www.ELZONRIS.com. In Europe, a marketing
authorization application (MAA) is under review by the European
Medicines Agency (EMA).
ELZONRIS is also being evaluated in additional clinical trials
in other CD123+ indications, including chronic myelomonocytic
leukemia (CMML), myelofibrosis (MF), acute myeloid leukemia (AML),
and others are planned including a CD123+ all-comers trial.
About BPDCN BPDCN, formerly blastic NK-cell
lymphoma, is an aggressive hematologic malignancy, often with
cutaneous manifestations, with historically poor outcomes. BPDCN
typically presents in the bone marrow and/or skin and may also
involve lymph nodes and viscera. The BPDCN cell of origin is the
plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN
is based on the immunophenotypic diagnostic triad of CD123, CD4,
and CD56, as well as other markers. The World Health Organization
(WHO) termed this disease “BPDCN” in 2008; previous names included
blastic NK cell lymphoma and agranular CD4+/CD56+ hematodermic
neoplasm. For more information, please visit the BPDCN disease
awareness website at www.bpdcninfo.com.
About CD123CD123 is a cell surface target
expressed on a wide range of malignancies including blastic
plasmacytoid dendritic cell neoplasm (BPDCN), certain
myeloproliferative neoplasms (MPNs) including chronic
myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute
myeloid leukemia (AML) (and potentially enriched in certain AML
subsets), myelodysplastic syndrome (MDS), and chronic myeloid
leukemia (CML). CD123 has also been reported on multiple myeloma
(MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL),
Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL).
In addition, CD123+ cells have been detected in the tumor
microenvironment of several solid tumors as well as in certain
autoimmune disorders including cutaneous lupus and scleroderma.
About Stemline Therapeutics Stemline
Therapeutics, Inc. is a commercial-stage biopharmaceutical company
focused on the development and commercialization of novel oncology
therapeutics. ELZONRIS® (tagraxofusp), a targeted therapy
directed to CD123, is FDA-approved and commercially available in
the U.S. for the treatment of adult and pediatric patients, two
years and older, with blastic plasmacytoid dendritic cell neoplasm
(BPDCN). In Europe, a marketing authorization application (MAA) is
under review by the European Medicines Agency (EMA). ELZONRIS is
also being evaluated in clinical trials in additional indications
including chronic myelomonocytic leukemia (CMML), myelofibrosis
(MF) acute myeloid leukemia (AML), and additional trials and
indications are planned. Additional pipeline candidates include:
felezonexor (SL-801) (XPO1 inhibitor; Phase 1 in advanced solid
tumor patients ongoing) and SL-1001 (RET kinase inhibitor,
IND-enabling studies ongoing). For more information, please visit
the company’s website at www.stemline.com.
Forward-Looking StatementsSome 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 risk that our
actual revenue for the fourth quarter and year ended December
31, 2019 may differ materially from our estimated results for
these periods as a result of the completion of year-end closing
procedures or the audit of our financial statements; the success of
our U.S. launch and commercialization; the success of our MAA
submission to the EMA and potential launch in Europe; the success
and timing of our clinical trials and preclinical studies for our
product and product candidates, including ELZONRIS in additional
indications and our other pipeline 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 product and product candidates may treat are inaccurate;
inadequate market penetration of our products; our products not
gaining acceptance among patients (and providers or third party
payors) 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 produce, maintain or increase sales
of ELZONRIS; the company’s ability to develop and/or 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 product and product candidates; delays, interruptions, or
failures in the manufacture and supply of our product 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: Investor RelationsStemline
Therapeutics, Inc.750 Lexington AvenueEleventh FloorNew York, NY
10022Tel: 646-502-2307Email: investorrelations@stemline.com
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