UroGen Pharma Ltd. Ordinary Shares - URGN STOCK NEWS

UroGen Pharma (Nasdaq: URGN) announced long-term follow-up results for JELMYTO in treating low-grade upper tract urothelial cancer (LG-UTUC). The study showed that among patients who achieved complete response in the OLYMPUS trial (41 out of 71 patients), the median duration of response was 47.8 months with a median follow-up of 28.1 months.

The data, presented at the Society for Urologic Oncology annual meeting and published in the Journal of Urology, demonstrates JELMYTO's potential for long-term disease control. Of the original 41 complete responders, 20 participated in the long-term follow-up study, though this introduces some selection bias in the analysis.

UroGen Pharma (Nasdaq: URGN) announced promising Phase 3 ENVISION trial results for UGN-102, a mitomycin-based intravesical solution for treating recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC). The trial demonstrated an 82.3% duration of response at 12 months in patients who achieved complete response at 3 months, with durability extending to 80.9% at 15 and 18 months.

The study achieved its primary endpoint with a 79.6% complete response rate at 3 months post-treatment. The safety profile remained consistent with previous trials, with common side effects including dysuria, hematuria, and urinary tract infection. The FDA has set a PDUFA goal date of June 13, 2025, for UGN-102, which could potentially become the first FDA-approved treatment for LG-IR-NMIBC.

UroGen Pharma (URGN) announced new data presentations at the Society of Urologic Oncology 2024 annual meeting in Dallas, featuring updates on UGN-102, JELMYTO, and UGN-301. The presentations focus on treatments for low-grade intermediate-risk non-muscle-invasive bladder cancer and upper tract urothelial carcinoma. The data includes results from phase 3 trials of UGN-102, long-term outcomes of JELMYTO, and phase 1 studies of UGN-301 in various treatment scenarios.

UroGen Pharma (Nasdaq: URGN) reports new data from a long-term follow-up study of the OLYMPUS trial, showing a median duration of response (DOR) of 47.8 months for patients who achieved complete response with JELMYTO (mitomycin) for pyelocalyceal solution. JELMYTO is FDA approved for treating low-grade, upper tract urothelial cancer (LG-UTUC) in adults. The study, published in the Journal of Urology, included 41 patients from the OLYMPUS trial with a median follow-up of 28.1 months. Notably, 20 of these patients entered the long-term follow-up study. The data suggests robust durability in maintaining cancer control. The study's limitations include its post-hoc nature and selection bias. Further research is ongoing through the JELMYTO uTRACT Registry, with 19 sites activated and 191 patients enrolled as of July 10.

UroGen Pharma reported Q3 2024 financial results, highlighting FDA acceptance of UGN-102's New Drug Application with a PDUFA date of June 13, 2025. JELMYTO achieved net product sales of $25.2 million in Q3 2024, up from $20.9 million in Q3 2023. The company reported a net loss of $23.7 million ($0.55 per share) and maintained a strong cash position of $254.2 million. The Phase 3 ENVISION trial for UGN-102 showed a 79.6% complete response rate and 82.3% 12-month duration of response in treating low-grade intermediate-risk non-muscle invasive bladder cancer.

UroGen Pharma (Nasdaq: URGN), a biotech company focused on urothelial and specialty cancer treatments, has announced its participation in the Guggenheim Securities Healthcare Innovation Conference. The company will engage in a fireside chat on November 12, 2024, at 3:00 PM ET in Boston, MA. The event will include one-on-one investor meetings and will be accessible via public webcast through UroGen's Investor Relations website, with replay available for 90 days.

UroGen Pharma (Nasdaq: URGN), a biotech company focused on urothelial and specialty cancer treatments, will release its 2024 third quarter financial results on Wednesday, November 6, 2024, before market open. The company will host a conference call and live audio webcast at 10:00 AM ET on the same day. The webcast will be accessible through UroGen's Investor Relations website, with a replay available for approximately 30 days afterward.

UroGen Pharma announced promising results from the Phase 3 ENVISION study of UGN-102 for treating low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC). The study showed an 82.3% duration of response at 12 months in patients achieving complete response. The trial met its primary endpoint with a 79.6% complete response rate at three months. UroGen completed its NDA submission to the FDA with a PDUFA date of June 13, 2025. The treatment demonstrated mild-to-moderate side effects, consistent with previous trials.

UroGen Pharma (Nasdaq: URGN) announced FDA acceptance of its New Drug Application (NDA) for UGN-102, an investigational drug for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA set a PDUFA goal date of June 13, 2025. If approved, UGN-102 would be the first FDA-approved medicine for LG-IR-NMIBC.

The NDA is supported by data from three clinical trials, including the ENVISION trial, which met its primary endpoint with a 79.6% complete response rate at three months. The trial also showed an 82.3% 12-month duration of response by Kaplan-Meier estimate in patients who achieved a complete response at 3 months. Common adverse events included dysuria, hematuria, and urinary tract infection.

UroGen's CEO, Liz Barrett, emphasized the potential of UGN-102 to expand treatment options for LG-IR-NMIBC patients, addressing unmet needs in this space.