Stemline Therapeutics to Participate in Panel on Myeloid Tumors at the 31st Annual ROTH Conference
March 18 2019 - 7:00AM
Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage
biopharmaceutical company focused on the development and
commercialization of novel oncology therapeutics, announced today
that Ivan Bergstein, M.D., Stemline’s CEO, was selected to
participate as a panelist on “The Brave New World of Myeloid
Tumors.” The panel will take place on Monday, March 18 at 3 PM PT
during the 31st Annual ROTH conference at the Ritz-Carlton Laguna
Niguel, CA.
About CD123CD123 is a cell surface target
expressed on a wide range of myeloid tumors 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 certain lymphoid
malignancies including 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 has
been detected on some solid tumors as well as autoimmune disorders
including cutaneous lupus and scleroderma.
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). For full prescribing
information in the U.S., visit www.ELZONRIS.com. In November 2018,
the European Medicines Agency (EMA) granted ELZONRIS accelerated
assessment to the marketing authorization application (MAA), which
was submitted to, and validated by, 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 acute myeloid leukemia (AML).
About BPDCN BPDCN is an aggressive hematologic
malignancy with historically poor outcomes and an area of unmet
medical need. 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, and other markers. For more
information, please visit the BPDCN disease awareness website at
www.bpdcninfo.com.
About Stemline Therapeutics Stemline
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 or 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 for the treatment of
patients with BPDCN, which was submitted to, and validated by, the
EMA in January 2019. ELZONRIS is also being evaluated in clinical
trials in additional indications including chronic myelomonocytic
leukemia (CMML), myelofibrosis (MF) and acute myeloid leukemia
(AML). Additional pipeline candidates include: SL-701
(immunotherapeutic; Phase 2 in glioblastoma patients completed),
SL-801 (XPO1 inhibitor; Phase 1 in advanced solid tumor patients
ongoing), SL-901 (novel kinase inhibitor; prior abbreviated
European Phase 1, IND-enabling studies ongoing), and SL-1001 (novel
RET kinase inhibitor, IND-enabling studies pending).
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 success of our MAA
submission to the EMA; 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;
inadequate market penetration of our products; 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 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 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: Investor RelationsStemline
Therapeutics, Inc.750 Lexington AvenueEleventh FloorNew York, NY
10022Tel: 646-502-2307Email:
investorrelations@stemline.com
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