This section highlights FDA-related milestones and regulatory updates for drugs developed by Urogen Pharma (URGN).
Over the past two years, Urogen Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
JELMYTO®, UGN-102, UGN-103, and UGN-301. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
JELMYTO® (mitomycin) - FDA Regulatory Timeline and Events
JELMYTO® (mitomycin) is a drug developed by Urogen Pharma for the following indication: For primary chemoablative treatment of LG-UTUC in adults.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- JELMYTO® (mitomycin)
- Announced Date:
- June 2, 2025
- Indication:
- For primary chemoablative treatment of LG-UTUC in adults.
Announcement
UroGen Pharma Ltd today highlights the presentation of the uTRACT Registry study design at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.
AI Summary
UroGen Pharma Ltd. presented the design of its uTRACT Registry study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. The study is a single-arm, multicenter registry that includes both prospective and retrospective data collection. It will examine the real-world use of JELMYTO, a treatment approved for low-grade upper tract urothelial carcinoma (LG-UTUC) in adults. The registry aims to gather detailed information on how JELMYTO is administered, including dosing, mode of delivery, and patient history, while also tracking key clinical outcomes such as treatment response and recurrence-free survival.
This robust data set is expected to provide valuable insights into treatment patterns, long-term patient outcomes, and safety. Ultimately, the uTRACT Registry could help establish best practices for managing LG-UTUC in real-world clinical settings.
Read Announcement- Drug:
- JELMYTO® (mitomycin)
- Announced Date:
- April 27, 2025
- Indication:
- For primary chemoablative treatment of LG-UTUC in adults.
Announcement
UroGen Pharma Ltd. today highlights a duration of response of nearly four years from a long-term follow-up study with JELMYTO® (mitomycin) for pyelocalyceal solution, which is FDA-approved for the treatment of low-grade upper tract urothelial cancer (LG-UTUC) in adult patients.
AI Summary
UroGen Pharma Ltd. announced long-term follow-up study results with JELMYTO® (mitomycin) for pyelocalyceal solution, which is FDA-approved to treat low-grade upper tract urothelial cancer in adults. The study from the OLYMPUS trial showed that patients who achieved a complete response had a median duration of response of 47.8 months, or nearly four years, regardless of whether the cancer was new or recurring. The treatment uses a reverse thermal gel that remains in the upper urinary tract for several hours, enhancing the drug’s effectiveness.
These findings support the idea that JELMYTO® can offer lasting disease control and reduce the need for repeated interventions. The results strengthen JELMYTO’s promise as a valuable non-surgical treatment option and provide hope for a better quality of life for patients with LG-UTUC. The promising data underscores a robust potential for improved long-term outcomes in treating this challenging cancer.
Read Announcement- Drug:
- JELMYTO® (mitomycin)
- Announced Date:
- February 12, 2025
- Indication:
- For primary chemoablative treatment of LG-UTUC in adults.
Announcement
UroGen Pharma Ltd. today highlights results from a long-term follow-up study with JELMYTO® (mitomycin) for pyelocalyceal solution, which is FDA approved for the treatment of low-grade, upper tract urothelial cancer (LG-UTUC) in adult patients.
AI Summary
UroGen Pharma Ltd. announced promising long-term results from a follow-up study of JELMYTO, an FDA-approved treatment for low-grade upper tract urothelial cancer (LG-UTUC) in adults. The study, drawn from the OLYMPUS trial, focused on patients who achieved a complete response following chemoablation. Among these participants, the median duration of response was 47.8 months, with a median follow-up of 28.1 months. These results, published in The Journal of Urology, provide compelling evidence that JELMYTO offers durable, long-term disease control for LG-UTUC patients. The nearly four-year median response duration highlights JELMYTO’s potential as a primary treatment option, emphasizing sustained effectiveness in managing the condition. This study reinforces the importance of JELMYTO as an option for patients while ongoing initiatives, such as enrollment in the JELMYTO uTRACT Registry, aim to collect more real-world data on its benefit.
Read Announcement- Drug:
- JELMYTO® (mitomycin)
- Announced Date:
- January 22, 2025
- Indication:
- For primary chemoablative treatment of LG-UTUC in adults.
Announcement
UroGen Pharma Ltd. today highlights results from a study on the durability of response from the first and largest post-commercialization study of JELMYTO® (mitomycin) for pyelocalyceal solution.
AI Summary
UroGen Pharma Ltd. released results from the first and largest post-commercialization study on the durability of response for JELMYTO® (mitomycin) used as a pyelocalyceal solution. The study evaluated 56 patients who achieved a complete response and found that 68% remained free of disease recurrence three years after treatment, as confirmed by endoscopy. The results showed that recurrence-free survival was not affected by whether JELMYTO was used as primary chemoablation or as adjuvant therapy after endoscopic ablation. Additionally, factors such as tumor size, location, number of tumors, or how the treatment was administered did not change the outcomes. Notably, patients receiving maintenance treatment experienced significantly better recurrence-free survival. These findings underscore the long-term potential of JELMYTO in managing low-grade upper tract urothelial cancer, offering promise for durable disease control in patients.
Read Announcement- Drug:
- JELMYTO® (mitomycin)
- Announced Date:
- December 5, 2024
- Indication:
- For primary chemoablative treatment of LG-UTUC in adults.
Announcement
UroGen Pharma Ltd today highlights results from a long-term follow-up study with JELMYTO (mitomycin) for pyelocalyceal solution, which is FDA approved for the treatment of adults with low-grade, upper tract urothelial cancer (LG-UTUC).
AI Summary
UroGen Pharma today announced promising long‐term data from its follow‐up study of JELMYTO (mitomycin) for pyelocalyceal solution, which is FDA approved to treat adults with low-grade upper tract urothelial cancer (LG-UTUC). The study, part of the OLYMPUS trial, reported that patients who achieved a complete response maintained a median response of 47.8 months, with a median follow-up period of 28.1 months. These results underscore JELMYTO’s potential to provide durable control of LG-UTUC, offering patients a non‐surgical treatment option that may extend the recurrence-free interval and help preserve kidney function. Researchers and company leaders highlighted that this sustained response could reduce the need for more invasive treatments and improve overall quality of life for patients battling this rare form of cancer.
Read Announcement- Drug:
- JELMYTO® (mitomycin)
- Announced Date:
- November 26, 2024
- Indication:
- For primary chemoablative treatment of LG-UTUC in adults.
Announcement
UroGen Pharma Ltd today highlights results from a long-term follow-up study with JELMYTO (mitomycin) for pyelocalyceal solution, which is FDA approved for the treatment of low-grade, upper tract urothelial cancer (LG-UTUC) in adult patients.
AI Summary
UroGen Pharma Ltd. announced new long-term follow-up study results on JELMYTO (mitomycin) for pyelocalyceal solution. This drug is FDA approved to treat low-grade upper tract urothelial cancer (LG-UTUC) in adults. In the study from the OLYMPUS trial, 41 patients achieved a complete response after receiving JELMYTO, and 20 of those patients joined the long-term follow-up study. The findings revealed a median duration of response of 47.8 months, highlighting the treatment's potential to maintain long-term cancer control.
Medical experts are encouraged by these results, stating that JELMYTO may offer durable, recurrence-free intervals for patients while supporting kidney-sparing management strategies. The study was published in the Journal of Urology, providing robust evidence to further validate the effectiveness of JELMYTO in treating LG-UTUC. These findings support ongoing efforts to improve treatment options for patients with this type of cancer.
Read Announcement- Drug:
- JELMYTO® (mitomycin)
- Announced Date:
- May 4, 2024
- Indication:
- For primary chemoablative treatment of LG-UTUC in adults.
Announcement
UroGen Pharma Ltd. today highlights the results of a sub-analysis from a real-world patient cohort review of JELMYTO (mitomycin) for pyelocalyceal solution presented at the American Urological Association Meeting 2024 in San Antonio, TX.
AI Summary
UroGen Pharma Ltd. shared new results from a sub-analysis of a real-world patient cohort review of JELMYTO (mitomycin) for pyelocalyceal solution. The data was presented at the American Urological Association Meeting 2024 in San Antonio, TX. In this study, 20 patients received JELMYTO via a retrograde approach in the clinic. The findings revealed a 60% complete response rate, meaning that 60% of patients showed no signs of tumor lesions after treatment. Additionally, the study found that 25% of patients required a ureteral stent for stent placement, a rate that is lower than what was observed in the pivotal OLYMPUS study.
The results support the effectiveness and safety of retrograde administration under local anesthesia and suggest that this treatment method may offer durable outcomes. These insights add to the growing evidence for using JELMYTO in the clinical management of low-grade upper tract urothelial cancer.
Read Announcement
UGN-102 - FDA Regulatory Timeline and Events
UGN-102 is a drug developed by Urogen Pharma for the following indication: Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- UGN-102
- Announced Date:
- June 12, 2025
- Indication:
- Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Announcement
UroGen Pharma Ltd announced the U.S. Food and Drug Administration (FDA) approved ZUSDURI, the first and only FDA-approved medication for adults with recurrent LG-IR-NMIBC. ZUSDURI consists of mitomycin and sterile hydrogel, using UroGen's proprietary sustained release RTGel®technology.
AI Summary
UroGen Pharma Ltd announced that the U.S. Food and Drug Administration (FDA) has approved ZUSDURI, marking the first and only medication approved for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ZUSDURI is a localized treatment that combines mitomycin and a sterile hydrogel, delivered using UroGen’s proprietary sustained release RTGel® technology. This innovative formulation is designed for effective tumor ablation without the need for surgical intervention.
The FDA decision was supported by the positive results of the pivotal Phase 3 ENVISION trial, which showed that 78% of patients achieved a complete response at three months, and 79% of these responders maintained the benefit through 12 months. This approval offers a promising alternative to repeated surgeries for approximately 59,000 U.S. patients who experience recurring LG-IR-NMIBC each year.
Read Announcement- Drug:
- UGN-102
- Announced Date:
- June 2, 2025
- Indication:
- Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Announcement
UroGen Pharma Ltd announced results from the ENVISION and ATLAS clinical studies exploring investigational therapy UGN-102 (mitomycin) for intravesical solution for the treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
AI Summary
UroGen Pharma announced promising results from its ENVISION and ATLAS clinical studies for UGN-102 (mitomycin), an investigational intravesical solution aimed at treating recurrent low‐grade intermediate‐risk non‐muscle invasive bladder cancer. The data presented includes an 18‑month duration of response from the ENVISION study, which highlights how long patients maintained a positive response after treatment. In addition, a substudy within ENVISION examined the impact of tumor burden on treatment outcomes, providing further insights into patient responses. Combined results from both the ENVISION and ATLAS studies showed encouraging complete response rates and durability of response, suggesting that UGN-102 could offer a non-surgical treatment alternative. UGN-102 uses UroGen’s unique RTGel technology, designed to extend the contact time between the drug and bladder tissue, potentially improving treatment efficacy and reducing the need for invasive procedures.
Read Announcement- Drug:
- UGN-102
- Announced Date:
- May 22, 2025
- Indication:
- Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Announcement
UroGen Pharma Ltd. nnounced that the FDA's Oncologic Drugs Advisory Committee ("ODAC") voted against the risk/benefit profile of UroGen's UGN-102, a therapy intended to treat patients with low-grade, intermediate-risk non-muscle invasive bladder cancer ("LG-IR-NMIBC") for which no drugs are currently FDA-approved.
AI Summary
UroGen Pharma Ltd. recently announced that the FDA’s Oncologic Drugs Advisory Committee voted against the risk/benefit profile of its investigational treatment, UGN-102. This therapy is being developed for patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), a condition for which no drugs are currently approved by the FDA. The committee’s decision highlights concerns over the balance between the potential benefits and risks of UGN-102.
Despite the setback, UroGen remains committed to advancing innovative treatments for urothelial and specialty cancers. The company continues to develop its proprietary RTGel® reverse-thermal hydrogel platform, which aims to improve the delivery and effectiveness of drugs in the urinary tract. UroGen’s efforts seek to offer better, non-surgical options designed to ablate tumors for patients with limited treatment choices.
Read Announcement- Drug:
- UGN-102
- Announced Date:
- May 21, 2025
- Indication:
- Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Announcement
UroGen Pharma Ltd announced the outcome of today's meeting of the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA), which discussed the new drug application (NDA) for investigational drug UGN-102 (mitomycin) for intravesical solution.
AI Summary
UroGen Pharma Ltd. announced the outcome of today’s FDA Oncologic Drugs Advisory Committee meeting regarding its new drug application for UGN-102 (mitomycin) intravesical solution. During the meeting, the ODAC reviewed clinical data for UGN-102, which is being developed for the treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The committee voted by a narrow margin—4 to 5—on the benefit/risk profile of the therapy. Although the vote indicated that the benefit/risk was viewed as favorable by some members, UroGen’s leadership expressed disappointment with the outcome. The company remains confident in its clinical data and committed to addressing the unmet needs of LG-IR-NMIBC patients, who often face repeated surgeries due to the recurrent nature of their disease. UroGen looks forward to collaborating with the FDA as the review of its NDA continues.
Read Announcement- Drug:
- UGN-102
- Announced Date:
- May 7, 2025
- Indication:
- Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Announcement
UroGen announced that the U.S. Food and Drug Administration (FDA) has scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting on May 21, 2025 to review the new drug application (NDA) for UGN-102 (mitomycin) for intravesical solution, an investigational treatment for recurrent LG-IR-NMIBC.
AI Summary
UroGen announced that the FDA has scheduled an Oncologic Drugs Advisory Committee meeting on May 21, 2025, to review the new drug application for UGN-102 (mitomycin) intravesical solution. This investigational treatment targets recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), a condition currently lacking any FDA-approved therapies.
The advisory meeting will enable independent clinicians and experts to evaluate the UGN-102 data and provide recommendations regarding its approval and potential conditions for use. The FDA aims to finish its review in time to meet the Prescription Drug User Fee Act (PDUFA) target action date of June 13, 2025, although it is not bound by the committee’s recommendation.
This review is seen as an important step toward offering patients a new treatment option that may lessen the need for repeated surgical procedures, underscoring UroGen’s commitment to advancing bladder cancer care.
Read Announcement- Drug:
- UGN-102
- Announced Date:
- April 27, 2025
- Indication:
- Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Announcement
UroGen Pharma Ltd announced new data from the OPTIMA II Phase 2b study of UGN‑102 (mitomycin) for intravesical solution demonstrate clinically meaningful two-year duration of response (24.2 months) by Kaplan-Meier analysis.
AI Summary
UroGen Pharma Ltd. recently shared promising data from the OPTIMA II Phase 2b study for their drug UGN‑102, an intravesical solution using mitomycin in a sustained-release formulation. The study demonstrated a clinically meaningful median duration of response of 24.2 months, as calculated using Kaplan-Meier analysis. This result is noteworthy since many patients in the trial had recurrent disease and had undergone multiple prior procedures, showing the drug’s potential to offer long-lasting benefit even for those with repeated recurrences.
In the trial, 41 patients achieved a complete response at three months, and a significant number maintained this response at longer follow-ups. These findings highlight UGN‑102’s durability and its promise as a treatment option for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
Read Announcement- Drug:
- UGN-102
- Announced Date:
- April 26, 2025
- Indication:
- Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Announcement
UroGen Pharma Ltd announced an updated 18-month DOR of 80.6% (95% CI: 74.0, 85.7), by Kaplan-Meier estimate, from the Phase 3 ENVISION trial of UGN-102 (mitomycin) for intravesical solution, an investigational treatment for recurrent LG-IR-NMIBC.
AI Summary
UroGen Pharma Ltd reported promising updates from its Phase 3 ENVISION trial testing UGN‑102, an investigational intravesical solution for recurrent low-grade, intermediate-risk non–muscle invasive bladder cancer. The trial showed an 18‐month duration of response (DOR) of 80.6% (95% CI: 74.0 to 85.7) by Kaplan-Meier estimate. This means that among patients who achieved a complete response at three months, 80.6% maintained that response for 18 months. These results highlight the potential of UGN‑102 to provide a lasting, non-surgical treatment alternative to the standard transurethral resection of bladder tumors (TURBT), which can be invasive and require repeated surgeries. The update was presented at the AUA 2025 Annual Meeting in Las Vegas, showing promise for a new option that could improve quality of life and ease treatment burden for patients facing recurrent bladder cancer.
Read Announcement- Drug:
- UGN-102
- Announced Date:
- April 14, 2025
- Indication:
- Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Announcement
UroGen Pharma Ltd announced that data on investigational drug UGN-102 (mitomycin) for intravesical solution, JELMYTO (mitomycin) for pyelocalyceal solution and UGN-301 (zalifrelimab) will be presentedat the American Urological Association (AUA) 2025 Annual Meeting being held in Las Vegas, Nevada from April 26-29.
AI Summary
UroGen Pharma Ltd announced that new data for its investigational treatments will be showcased at the American Urological Association (AUA) 2025 Annual Meeting in Las Vegas, Nevada, from April 26-29. The company will present results involving three key therapies: UGN-102 (mitomycin) for intravesical delivery, JELMYTO (mitomycin) for pyelocalyceal delivery, and UGN-301 (zalifrelimab), an anti-CTLA-4 monoclonal antibody being developed for recurrent non-muscle invasive bladder cancer. Among the data highlights, UGN-102’s ongoing Phase 3 trial results, including an 18-month duration of response and patient-reported outcomes, will be discussed. The presentations underscore the potential of these therapies to improve treatment outcomes for urothelial cancers. Detailed findings, including long-term outcomes and dose escalation study results for UGN-301, are scheduled to be shared throughout the meeting.
Read Announcement- Drug:
- UGN-102
- Announced Date:
- March 10, 2025
- Indication:
- Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Announcement
UroGen Pharma Ltd provided an overview of recent developments.
AI Summary
UroGen Pharma recently provided an update on its latest advancements. The company emphasized significant progress with its investigational drug UGN-102, which is being developed to treat low-grade intermediate-risk non-muscle invasive bladder cancer. They highlighted promising Phase 3 ENVISION trial results showing that 80.6% of patients maintained their complete response at 18 months. The company’s new drug application for UGN-102 is under FDA review, with a target action date on June 13, 2025.
In addition to these clinical achievements, UroGen shared details about expanding its pipeline, including acquiring a next-generation investigational oncolytic virus, ICVB-1042. This addition supports their long-term growth strategy and potential expansion into treatments for other cancers. Overall, these developments underline UroGen’s commitment to advancing innovative therapies in the field of urothelial and specialty cancers.
Read Announcement - Drug:
- UGN-102
- Announced Date:
- December 5, 2024
- Indication:
- Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Announcement
UroGen Pharma Ltd announced the presentation of the Phase 3 ENVISION trial's efficacy and safety results at the Society of Urologic Oncology (SUO) annual meeting in Dallas, TX.
AI Summary
UroGen Pharma Ltd recently presented key results from its Phase 3 ENVISION trial at the Society of Urologic Oncology annual meeting in Dallas, TX. The trial evaluated the investigational therapy UGN-102, an intravesical, mitomycin-based solution designed to treat recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer. In the study, 79.6% of patients achieved a complete response at three months, with an 82.3% duration of response maintained at 12 months according to Kaplan-Meier estimates. The efficacy findings, published online in the Journal of Urology, underscore the potential of UGN-102 as a significant treatment option, especially for patients who may otherwise face repeated surgeries. The safety profile noted was consistent with prior clinical trials, reinforcing the promising nature of UGN-102 in addressing a major unmet need in bladder cancer treatment.
Read Announcement- Drug:
- UGN-102
- Announced Date:
- August 14, 2024
- Indication:
- Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Announcement
UroGen anticipates potential FDA approval in early 2025, if the NDA is accepted for filing by the FDA and priority review is granted.
AI Summary
UroGen Pharma has reached an important milestone by completing its New Drug Application (NDA) submission for UGN-102, an investigational formulation of mitomycin designed for patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The company hopes that if the FDA accepts the NDA for filing and grants it priority review, UroGen could receive full FDA approval as early as 2025. This potential approval is significant because UGN-102 may offer patients a promising alternative to repeated surgeries, potentially improving quality of life by providing longer recurrence-free intervals.
The submission builds on supportive clinical data from the Phase 3 ENVISION study, which demonstrated promising efficacy and safety results. UroGen’s progress in this area underscores its commitment to developing innovative treatments that address urgent clinical needs in cancer care.
Read Announcement- Drug:
- UGN-102
- Announced Date:
- August 14, 2024
- Indication:
- Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Announcement
UroGen Pharma Ltd. announced the successful completion of its New Drug Application (NDA) submission for investigational drug UGN-102, (mitomycin) for intravesical solution, a significant step forward in potentially addressing the urgent need for innovative treatments for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
AI Summary
UroGen Pharma Ltd. announced a significant achievement with the successful completion of its New Drug Application (NDA) submission for the investigational drug UGN-102 (mitomycin) for intravesical use. This milestone brings the company one step closer to addressing the urgent need for innovative treatments for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). If the FDA accepts the NDA for filing and grants priority review, UroGen anticipates potential approval of UGN-102 as early as 2025. The investigational drug is developed using UroGen’s proprietary RTGel® technology, which offers a sustained-release formulation designed to extend the exposure of bladder tissue to mitomycin, providing a potential non-surgical alternative for patients. This approach could ultimately improve patients’ quality of life by reducing the need for repeated surgeries and lowering recurrence rates.
Read Announcement- Drug:
- UGN-102
- Announced Date:
- August 13, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 2025
- Indication:
- Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Announcement
UroGen Pharma Ltd. announced that There is potential for an FDA decision as early as the first quarter of 2025, assuming the FDA grants priority review.
AI Summary
UroGen Pharma Ltd. announced that it is moving forward with its submission for a New Drug Application for UGN-102, an innovative treatment targeting low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The company highlighted that if the FDA grants priority review, a decision could be reached as early as the first quarter of 2025. This potential timeline follows impressive clinical outcomes from the Phase 3 ENVISION trial, where patients who achieved a complete response at three months experienced an 82.3% duration of response at 12 months. The promising data supports UGN-102’s role as a potentially practice-changing therapy. UroGen is focused on rapidly advancing its efforts to prepare for potential approval and market launch, aiming to offer a new non-surgical treatment option for patients who suffer from this recurrent form of bladder cancer.
Read Announcement- Drug:
- UGN-102
- Announced Date:
- August 13, 2024
- Indication:
- Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Announcement
UroGen Pharma Ltd announced that The latest DOR data is expected to support a New Drug Application (NDA) for UGN-102 as a treatment for LG-IR-NMIBC, which the Company plans to complete in the very near term.
AI Summary
UroGen Pharma announced positive results from its Phase 3 ENVISION trial, where UGN‐102 showed an 82.3% 12‐month Duration of Response in low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) patients who achieved a complete response at three months. This compelling clinical data supports the company’s plan to submit a New Drug Application (NDA) for UGN-102 in the very near term as a potential treatment for LG-IR-NMIBC.
With the strong performance of UGN-102 in the trial, UroGen is positioning the drug to become a first-in-class therapy for this cancer type. The company is aiming for a potential FDA decision as early as the first quarter of 2025, assuming a priority review, which could bring a transformative therapy to approximately 82,000 patients each year.
Read Announcement- Drug:
- UGN-102
- Announced Date:
- August 13, 2024
- Indication:
- Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Announcement
UroGen Pharma Ltd provided an overview of recent developments.
AI Summary
UroGen Pharma provided an update on its latest developments and financial results. The company remains focused on advancing its innovative treatments for urothelial cancers, especially with UGN-102. UroGen highlighted promising data from the Phase 3 ENVISION trial, where patients with low-grade intermediate-risk non‑muscle invasive bladder cancer achieved an unprecedented 82.3% duration of response at 12 months following an initial complete response. The strong clinical outcomes support the company’s goal to complete a New Drug Application for UGN-102 soon, with a potential FDA decision as early as the first quarter of 2025 under priority review.
Along with these clinical milestones, UroGen reported solid financial indicators for the second quarter of 2024, including JELMYTO net product revenues of $21.8 million and a robust cash position totaling $241.3 million, further backing their strategic initiatives in the urothelial cancer space.
Read Announcement- Drug:
- UGN-102
- Announced Date:
- June 13, 2024
- Indication:
- Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Announcement
UroGen Pharma Ltd announced 82.3% (95% CI, 75.9%, 87.1%) 12-month duration of response (DOR) data by Kaplan-Meier estimate (n=108) from its Phase 3 ENVISION trial in patients who achieved complete response (CR) at three months after the first instillation of investigational drug UGN-102 (mitomycin) for intravesical solution.
AI Summary
UroGen Pharma Ltd announced promising results from its Phase 3 ENVISION trial evaluating UGN-102, an investigational intravesical solution for low-grade intermediate-risk non-muscle invasive bladder cancer. The data revealed an 82.3% duration of response (DOR) at 12 months, based on a Kaplan-Meier estimate with a 95% confidence interval of 75.9% to 87.1%. This result was observed in 108 patients who achieved a complete response at three months after their initial UGN-102 treatment.
The findings reinforce UroGen’s commitment to developing effective, non-surgical treatment options, offering a potential alternative to repetitive surgeries for patients. The consistency in safety and response rates highlights UGN-102’s potential as a transformative therapy in managing this recurring bladder cancer subtype, with further developments anticipated as the trial progresses.
Read Announcement- Drug:
- UGN-102
- Announced Date:
- June 6, 2024
- Indication:
- Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Announcement
UroGen Pharma Ltd. shared additional details about the upcoming ENVISION virtual data event on Thursday, June 13, 2024, at 11:00 a.m. Eastern Time. The event will focus on UGN-102 (mitomycin) for intravesical solution for patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
AI Summary
UroGen Pharma Ltd. has announced an upcoming ENVISION virtual data event on Thursday, June 13, 2024, at 11:00 a.m. Eastern Time. The session will focus on UGN-102, an investigational intravesical solution that uses mitomycin for treating patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). During the event, UroGen will present 12-month durability of response data from patients who achieved a complete response three months after undergoing six weekly treatments with UGN-102. The presentation will include insights from Key Opinion Leaders and a panel discussion, emphasizing the potential benefits of UroGen’s RTGel® technology, which allows longer exposure of bladder tissue to the medication. Those interested in learning more or participating can register on the Company’s Investor Relations website, with a replay of the live webcast available afterward.
Read Announcement- Drug:
- UGN-102
- Announced Date:
- May 4, 2024
- Indication:
- Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Announcement
UroGen Pharma Ltd. announced results from a new analysis of the ATLAS trial, which estimates using Kaplan Meier methods the probabilities of remaining in complete response for both new and recurrent low-grade intermediate-risk non- muscle invasive bladder cancer (LG-IR-NMIBC) patients following treatment with investigational drug UGN-102 as primary therapy, with or without subsequent transurethral resection of the bladder tumor (TURBT) at 3 months.
AI Summary
UroGen Pharma Ltd. announced new findings from a detailed analysis of its ATLAS trial. The study used Kaplan Meier methods to estimate how long patients maintained a complete response after treatment with UGN-102 as a primary therapy, with or without a follow-up TURBT at three months. Results showed that 12-month durability of response (DOR) was 87.5% in new low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) patients and 69.1% in those with recurrent cancer. The analysis highlights that both new and recurrent patients responded similarly to UGN-102, suggesting its potential as a nonsurgical treatment option. These findings could help reduce the need for repetitive surgeries and address the high recurrence rates often seen in LG-IR-NMIBC, providing a promising alternative for patient care.
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UGN-103 - FDA Regulatory Timeline and Events
UGN-103 is a drug developed by Urogen Pharma for the following indication: For Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- UGN-103
- Announced Date:
- July 7, 2025
- Indication:
- For Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
Announcement
UroGen Pharma Ltd. announced that it has completed patient enrollment in its Phase 3 UTOPIA clinical trial of UGN-103 (mitomycin) for intravesical solution, a next-generation formulation in development for the treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
AI Summary
UroGen Pharma Ltd. announced that it has completed patient enrollment in its Phase 3 UTOPIA clinical trial for UGN-103, a next-generation mitomycin formulation for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The trial enrolled 99 patients across multiple centers worldwide. UGN-103 utilizes UroGen’s proprietary sustained release RTGel® technology, which is designed to provide a longer drug presence in the bladder by slowly releasing mitomycin. This new formulation aims to offer significant improvements over existing treatments, including a shorter manufacturing process and a simpler reconstitution procedure, making it more convenient for healthcare providers. This milestone in the UTOPIA trial is a key step in advancing UGN-103 as a promising non-surgical treatment option for patients facing recurrent bladder cancer.
Read Announcement- Drug:
- UGN-103
- Announced Date:
- October 2, 2024
- Indication:
- For Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
Announcement
UroGen Pharma Ltd. announced that the first patient was dosed in the Phase 3 clinical trial of investigational drug UGN-103 (mitomycin) for intravesical solution in development for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
AI Summary
UroGen Pharma Ltd. has reached an important milestone by dosing the first patient in its Phase 3 clinical trial for UGN-103, a next-generation mitomycin formulation designed to treat low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The investigational intravesical solution is developed to offer a shorter manufacturing process and a simpler reconstitution procedure compared to existing options. UGN-103 uses UroGen’s proprietary RTGel® platform, a sustained-release hydrogel that helps to deliver the drug over a prolonged period, potentially improving treatment effectiveness while reducing the need for surgery. The ongoing UTOPIA study will evaluate the safety and efficacy of UGN-103 in patients who receive weekly doses for six weeks, with responses assessed at the three-month point and patients followed up for up to 15 months. This trial represents a significant step forward in the search for improved therapies for bladder cancer.
Read Announcement- Drug:
- UGN-103
- Announced Date:
- April 15, 2024
- Indication:
- For Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
Announcement
UroGen Pharma Ltd announced the U.S. Food and Drug Administration (FDA) accepted the Company's Investigational New Drug (IND) application for UGN-103, a next-generation novel mitomycin-based formulation for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
AI Summary
UroGen Pharma Ltd announced that the U.S. FDA has accepted its Investigational New Drug (IND) application for UGN‑103, marking a significant step forward in the development of a novel treatment for low-grade intermediate-risk non-muscle invasive bladder cancer (LG‑IR‑NMIBC). UGN‑103 is a next-generation mitomycin-based formulation that uses the company’s RTGel® technology, a reverse‑thermal hydrogel designed for sustained drug release and enhanced therapeutic delivery.
This innovative formulation offers an 80 mg mitomycin dosage that may shorten the manufacturing process and simplify the reconstitution procedure, with the potential to secure intellectual property protection until December 2041. UroGen also plans to begin a Phase 3 study in 2024 to evaluate the safety and efficacy of UGN‑103, providing hope for improved treatment options for patients with this recurrent bladder cancer type.
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UGN-301 (zalifrelimab) - FDA Regulatory Timeline and Events
UGN-301 (zalifrelimab) is a drug developed by Urogen Pharma for the following indication: Recurrent Non-Muscle Invasive Bladder Cancer (NMIBC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- UGN-301 (zalifrelimab)
- Announced Date:
- April 26, 2025
- Indication:
- Recurrent Non-Muscle Invasive Bladder Cancer (NMIBC)
Announcement
UroGen Pharma Ltd announced encouraging safety data from the Phase 1 dose-escalation study for UGN-301 (zalifrelimab) intravesical solution, an investigational drug in development for the treatment of recurrent non-muscle invasive bladder cancer (NMIBC).
AI Summary
UroGen Pharma Ltd recently announced encouraging safety data from its Phase 1 dose-escalation study for UGN-301 (zalifrelimab) intravesical solution. This investigational drug is being developed to treat recurrent non-muscle invasive bladder cancer (NMIBC). In the study, UGN-301 was administered directly into the bladder, and early results showed that the treatment was well tolerated with no unexpected safety concerns. The dose-escalation design allowed researchers to carefully evaluate different doses and identify a promising safety profile for further clinical testing. These positive preliminary findings support the continued development of UGN-301 as a potential non-surgical treatment option for NMIBC patients. With this favorable safety data, the drug may progress to later trial phases, offering hope for improved management of recurrent bladder cancer and a better quality of life for patients.
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