Urogen Pharma - URGN STOCK NEWS

UroGen Pharma (Nasdaq: URGN) announced results from subgroup analyses of the pivotal ENVISION trial evaluating UGN-102 for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The study demonstrated strong complete response (CR) rates across different patient subgroups:

- 82.8% CR for patients with tumor burden ≤3 cm vs 73.2% for >3 cm
- 79.3% CR for patients with multiple tumors vs 82.9% for single tumors

The ENVISION trial included 240 patients, with 95% receiving all six weekly intravesical instillations. The overall CR rate was 79.6% at three months, with 82.3% probability of maintaining response after 12 months. UroGen completed its NDA submission to the FDA with a PDUFA date of June 13, 2025. A separate ATLAS trial analysis showed UGN-102 reduced risk of recurrence, progression or death by 54% compared to TURBT.

UroGen Pharma (NASDAQ: URGN) has published results from a long-term follow-up study of JELMYTO® in The Journal of Urology. The study shows significant durability in treating low-grade upper tract urothelial cancer (LG-UTUC). Among the 41 patients who achieved complete response in the OLYMPUS trial, the median duration of response was 47.8 months (nearly four years), with a median follow-up of 28.1 months.

The study demonstrates JELMYTO's potential for sustained disease control and organ preservation in LG-UTUC patients. Currently, a real-world usage study called the JELMYTO uTRACT Registry is ongoing, with 228 patients enrolled across 21 sites as of January 2025.

UroGen Pharma (Nasdaq: URGN), a biotech company focused on urothelial and specialty cancer treatments, has announced its participation in two major investor conferences in February 2025.

The company will present at the Guggenheim Securities SMID Cap Biotech Conference on February 5, 2025, at 10:30 AM ET in New York, NY, featuring both a presentation and one-on-one investor meetings. Additionally, UroGen will participate in the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 11, 2025, at 1:20 PM ET in a virtual format.

Both conference presentations will be webcast and available on UroGen's Investor Relations website, with replays accessible for approximately 90 days following the events.

UroGen Pharma (Nasdaq: URGN) has released significant findings from the largest post-commercialization study of JELMYTO (mitomycin), showing a 68% recurrence-free survival rate at three years in patients with low-grade upper tract urothelial cancer (LG-UTUC).

The study, involving 56 patients from 15 high-volume centers, demonstrated that recurrence-free survival was not affected by factors such as tumor size, location, number of tumors, or administration route. The median follow-up period was 23.5 months.

Notably, patients receiving maintenance treatment showed better recurrence-free survival, although this finding requires further research as only 15 patients received maintenance therapy. The study's limitations include its retrospective design, lack of a control group, and absence of centralized pathology review.

Dr. Solomon L. Woldu from UT Southwestern Medical Center highlighted the treatment's broad applicability, while Dr. Mark Schoenberg, UroGen's Chief Medical Officer, emphasized the promising long-term potential of JELMYTO in managing this challenging disease.

UroGen Pharma (NASDAQ: URGN) announced the publication of Phase 3 ENVISION trial results for UGN-102 in The Journal of Urology. The study showed an 82.3% duration of response at 12 months and a 79.6% complete response rate at three months in patients with low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC).

The company completed its New Drug Application (NDA) submission to the FDA in August, with a PDUFA date set for June 13, 2025. If approved, UGN-102 would be the first FDA-approved treatment for LG-IR-NMIBC, offering a non-surgical alternative for patients who currently face repeated surgeries under general anesthesia.

The trial reported mild-to-moderate treatment-emergent adverse events, including dysuria, hematuria, and urinary tract infection, which were generally resolving or resolved.

UroGen Pharma (Nasdaq: URGN) announced the granting of inducement restricted stock units (RSUs) to 35 new employees who will support the commercialization of Jelmyto® and pipeline development. The grants allow for the issuance of up to 112,800 ordinary shares, which will vest equally over three years, with one-third vesting annually on the anniversary of the vesting date. The RSUs are subject to continued employment and were granted under UroGen's 2019 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4).

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.