UroGen will Present Scientific Advances in Bladder Cancer at the Annual Meeting of the Society of Urologic Oncology
13 11월 2023 - 10:00PM
Business Wire
- Results from the pivotal Phase 3 ENVISION trial studying
primary chemoablation with UGN-102 (mitomycin) for intravesical
solution in patients with recurrent low-grade intermediate-risk
non-muscle-invasive bladder cancer (LG-IR-NMIBC) will be presented
as a late-breaking oral presentation
- The Phase 3 ATLAS trial comparing the efficacy and safety of
intravesical chemoablation with UGN-102 with or without subsequent
TURBT, to TURBT alone in patients with LG-IR-NMIBC will be
presented in a digital poster session
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated
to developing and commercializing novel solutions that treat
urothelial and specialty cancers, will highlight data from two key
Phase 3 trials evaluating UGN-102, an investigational treatment in
development for LG-IR-NMIBC at the 2023 Society of Urologic
Oncology (SUO) annual meeting, November 28-December 1 in Washington
D.C. These data presentations further UroGen’s mission of
developing and commercializing innovative treatments for urothelial
and specialty cancers that provide patients with novel non-surgical
options to fulfill the unmet needs that exist with current
standards of care.
“The ATLAS and ENVISION Phase 3 clinical trials broaden our
understanding of potentially using a new approach to treat
LG-IR-NMIBC,” says Mark Schoenberg, M.D., Chief Medical Officer of
UroGen. “We’re particularly excited that the SUO selected the
ENVISION study as one of only two late-breaking trials designated
for oral presentations, which we believe further reinforces its
potential in advancing bladder cancer treatment. We are optimistic
for what the future may hold for LG-IR-NMIBC patients who suffer
from this highly prevalent and recurrent disease.”
Key highlights of UGN-102 data accepted by SUO:
Abstract Title
Presentation Details
Primary chemoablation for recurrent
low-grade intermediate risk (LG IR) NMIBC: The ENVISION trial
Podium Oral Presentation: Urothelial
Cancer Session I
Thursday, Nov 30th,
12:04 p.m. – 12:09 p.m. EST
*Abstract available day of
presentation
Presenter:
Sandip Prasad, M.D.
Morristown Medical Center/Atlantic Health
System and Garden State Urology, Morristown, NJ
Treatment of low-grade intermediate risk
non-muscle invasive bladder cancer with UGN-102 + transurethral resection of bladder tumor (TURBT)
compared to TURBT monotherapy: the Phase 3 ATLAS trial
Poster #132
Poster Available: Thursday, Nov 30th,
2:15 p.m. - 3:15 p.m. EST
Presenter:
Sandip Prasad, M.D.
Morristown Medical Center/Atlantic Health
System and Garden State Urology, Morristown, NJ
About UGN-102
UGN-102 (mitomycin) for intravesical solution is an innovative
drug formulation of mitomycin, currently in Phase 3 development for
the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel®
technology, a sustained release, hydrogel-based formulation,
UGN-102 is designed to enable longer exposure of bladder tissue to
mitomycin, thereby enabling the treatment of tumors by non-surgical
means. UGN-102 is delivered to patients using a standard urinary
catheter in an outpatient setting. Assuming positive findings from
the durability of response endpoint from the ENVISION Phase 3
study, UroGen anticipates submitting an NDA for UGN-102 in
2024.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and
commercializing innovative solutions that treat urothelial and
specialty cancers because patients deserve better options. UroGen
has developed RTGel® reverse-thermal hydrogel, a proprietary
sustained-release, hydrogel-based platform technology that has the
potential to improve the therapeutic profiles of existing drugs.
UroGen’s sustained release technology is designed to enable longer
exposure of the urinary tract tissue to medications, making local
therapy a potentially more effective treatment option. JELMYTO®
(mitomycin) for pyelocalyceal solution and investigational
treatment UGN-102 (mitomycin) for intravesical solution for
patients with low-grade non-muscle invasive bladder cancer are
designed to ablate tumors by non-surgical means. UroGen is
headquartered in Princeton, NJ with operations in Israel. Visit
www.urogen.com to learn more or follow us on Twitter,
@UroGenPharma.
Forward-Looking Statements
This press release contains forward-looking statements as that
term is defined in the Private Securities Litigation Reform Act of
1995, including, without limitation, statements regarding: the
potential for UGN-102 to introduce a new non-surgical treatment
option for LG-IR-NMIBC and advance bladder cancer treatment;
optimism for the future of LG-IR-NMIBC patients; the anticipated
release of durability of response endpoint data from the ENVISION
Phase 3 study; UroGen’s plans to submit an NDA for UGN-102 and the
expected timing thereof; and the potential of UroGen’s proprietary
RTGel® technology to improve therapeutic profiles of existing drugs
and UroGen’s sustained release technology making local delivery
potentially more effective as compared to other treatment options.
These statements are subject to a number of risks, uncertainties
and assumptions, including, but not limited to: preliminary results
may not be indicative of results that may be observed in the
future; the timing and success of clinical trials and potential
safety and other complications thereof; unforeseen delays that may
impact the timing of progressing clinical trials and reporting
data; the ability to obtain regulatory approval within the
timeframe expected, or at all; there is no guarantee that the
current clinical development plan for UGN-102 will ultimately
support submission of an NDA, notwithstanding the current agreement
with the FDA; even if an NDA for UGN-102 is accepted by the FDA,
there is no guarantee that such NDA will be sufficient to support
approval of UGN-102; the ability to maintain regulatory approval;
complications associated with commercialization activities; the
labeling for any approved product; competition in UroGen’s
industry; the scope, progress and expansion of developing and
commercializing UroGen’s product candidates; the size and growth of
the market(s) therefor and the rate and degree of market acceptance
thereof vis-à-vis alternative therapies; UroGen’s ability to
attract or retain key management, members of the board of directors
and personnel; UroGen’s RTGel technology may not perform as
expected; UroGen may not successfully develop and receive
regulatory approval of any other product that incorporates RTGel
technology; UroGen’s financial condition and need for additional
capital in the future. In light of these risks and uncertainties,
and other risks and uncertainties that are described in the Risk
Factors section of UroGen’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2023, filed with the SEC on November
14, 2023 (which is available at http://www.sec.gov), the events and
circumstances discussed in such forward-looking statements may not
occur, and UroGen’s actual results could differ materially and
adversely from those anticipated or implied thereby. Any
forward-looking statements speak only as of the date of this press
release and are based on information available to UroGen as of the
date of this release.
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INVESTOR CONTACT: Vincent Perrone Senior Director, Investor
Relations vincent.perrone@urogen.com 609-460-3588 ext. 1093
MEDIA CONTACT: Cindy Romano Director, Corporate Communications
cindy.romano@urogen.com 609-460-3583 ext. 1083
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