Stemline Therapeutics Announces that FDA Accepts ELZONRIS™ Biologics License Application (BLA) and Grants Priority Review
August 13 2018 - 06:30AM
Stemline Therapeutics, Inc. (Nasdaq: STML), a clinical-stage
biopharmaceutical company developing novel oncology therapeutics,
announced today that the U.S. Food and Drug Administration (FDA)
has accepted for filing the Company’s Biologics License Application
(BLA) for ELZONRISTM (tagraxofusp; SL-401) for the treatment of
patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
The FDA also granted Priority Review for the BLA and has set a
target action date of February 21, 2019, under the Prescription
Drug User Fee Act (PDUFA).
The FDA grants Priority Review to product applications that, if
approved, would provide significant improvements in the safety or
effectiveness of the treatment, diagnosis, or prevention of serious
conditions when compared to standard applications.
ELZONRIS has also been granted Breakthrough Therapy Designation
(BTD) and Orphan Drug Designation (ODD) by the FDA.
Ivan Bergstein, M.D., Stemline’s CEO, commented, “The acceptance
of our BLA for filing and grant of Priority Review represent
tremendous milestones for Stemline and the BPDCN patient community.
We would like to thank the patients and their families who
participated in our clinical trials, as well as recognize the
tireless work of our investigators and entire Stemline team. Given
both Priority and Breakthrough status, our commercial organization
is positioning itself to rapidly launch ELZONRIS, if approved, to
ensure this important new treatment reaches patients as quickly as
possible.”
Conference Call and WebcastStemline
Therapeutics will host a conference call and audio webcast on
Monday, August 13, 2018 at 8:30 AM ET. Interested participants and
investors may access the conference call by dialing 844-389-8660
(U.S./Canada) or 478-219-0408 (International) and referencing
conference ID: 4762319. An audio webcast can also be accessed via
the Investor Relations tab of the Stemline Therapeutics website at
http://ir.stemline.com.
About ELZONRISTM (tagraxofusp;
SL-401)ELZONRISTM (tagraxofusp; SL-401) is a novel
targeted investigational therapy directed to CD123, a cell surface
receptor expressed on a range of malignancies. ELZONRIS
successfully completed a pivotal trial in patients with blastic
plasmacytoid dendritic cell neoplasm (BPDCN), and a Biologics
License Application (BLA) in this indication has been accepted for
filing and been granted Priority Review by the U.S. Food and Drug
Administration (FDA). ELZONRIS has also been granted Breakthrough
Therapy Designation (BTD) and Orphan Drug Designation by the FDA.
ELZONRIS is also being evaluated in clinical trials in additional
indications including chronic myelomonocytic leukemia (CMML),
myelofibrosis (MF), and others.
About BPDCNPlease visit the BPDCN disease
awareness website: www.bpdcninfo.com.
About Stemline TherapeuticsStemline
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
developing novel oncology therapeutics. Stemline is developing
three clinical stage product candidates, ELZONRISTM (tagraxofusp;
SL-401), SL-801, and SL-701. ELZONRIS is a targeted therapy
directed to the interleukin-3 receptor (CD123) present on a range
of malignancies. ELZONRIS has completed a pivotal trial in blastic
plasmacytoid dendritic cell neoplasm (BPDCN), for which it was
granted breakthrough therapy designation (BTD). The pivotal trial
met its primary endpoint, and a Biologics License Application (BLA)
has been accepted for filing and granted Priority Review by the
FDA. ELZONRIS is also being evaluated in clinical trials in
additional indications including chronic myelomonocytic leukemia
(CMML), myelofibrosis (MF), and others. SL-801 is a novel oral
small molecule reversible inhibitor of XPO1 that is currently in a
Phase 1 trial of patients with advanced solid tumors; dose
escalation is ongoing. SL-701, an immunotherapeutic, has completed
a Phase 2 trial in patients with second-line glioblastoma; data and
next steps for the program are being evaluated.
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 and timing
of our BLA submission to the FDA; 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 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; our plans to develop and commercialize our product
candidates; market acceptance of our products; reimbursement
available for our products; our available cash and investments; our
ability to obtain and maintain intellectual property protection for
our product candidates; our ability to obtain and maintain
intellectual property protection for our product candidates; our
ability to manufacture; the performance of third-party
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.
ContactInvestor RelationsStemline Therapeutics,
Inc.750 Lexington AvenueEleventh FloorNew York, NY 10022Tel:
646-502-2307Email: investorrelations@stemline.com
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