Following Pre-NDA Meeting with the FDA, UroGen Announces Rolling NDA Submission for UGN-102 to Begin January 2024
October 03 2023 - 8:00AM
Business Wire
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated
to developing and commercializing novel solutions that treat
urothelial and specialty cancers, today announced that it has
reached agreement with the U.S. Food and Drug Administration (FDA)
on plans for submission of a New Drug Application (NDA) for UGN-102
(mitomycin) for intravesical solution. The FDA indicated that the
current clinical development plan for UGN-102, which includes
evaluation of duration of complete response (CR) at 12 months from
the pivotal ENVISION trial, will support submission of an NDA for
the treatment of low-grade intermediate-risk non-muscle invasive
bladder cancer (LG-IR-NMIBC). The FDA also agreed that the UGN-102
NDA can utilize a rolling review, allowing for early submission of
the Chemistry, Manufacturing and Controls (CMC) sections of the
NDA, which is planned for January 2024. If approved, UGN-102 has
the potential to introduce a new non-surgical treatment paradigm
for LG-IR-NMIBC, a subset of bladder cancer patients characterized
by high recurrence rates and the need for multiple surgeries.
“We are very pleased with the outcome of our pre-NDA meeting
where the FDA agreed with our plan to submit our NDA for UGN-102
once all patients reach 12 months post CR. Our dialogue with the
FDA during our recent pre-NDA meeting was very constructive and
underscores the strength of our clinical program for UGN-102,” said
Liz Barrett, President and CEO, UroGen. “With the announcement of
positive Phase 3 topline results from the ATLAS and ENVISION
studies earlier this year, this meeting was a significant step in
defining the path forward for NDA submission and potential approval
for UGN-102. UroGen is committed to developing innovative
treatments for those battling bladder cancer, one of the most
recurrent malignancies, and UGN-102 stands at the forefront of that
mission.”
The UGN-102 clinical development plan centers around the Phase 3
ENVISION pivotal trial and is supported by robust clinical data
from the ATLAS Phase 3 and OPTIMA Phase 2b trials.
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 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 path
forward for a UGN-102 NDA submission; the potential approval of
UGN-102; the potential for UGN-102 to introduce a new non-surgical
treatment paradigm for LG-IR-NMIBC; the anticipated commencement of
a rolling NDA for UGN-102 in January 2024; 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 June 30, 2023 filed with the SEC
in August 10, 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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version on businesswire.com: https://www.businesswire.com/news/home/20231003915532/en/
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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