Latest news with #URGN
Associated Press
2 days ago
- Business
- Associated Press
INVESTOR DEADLINE APPROACHING: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of UroGen
Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $75,000 In UroGen To Contact Him Directly To Discuss Their Options If you suffered losses exceeding $75,000 in UroGen between July 27, 2023 and May 15, 2025 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] New York, New York--(Newsfile Corp. - June 8, 2025) - Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against UroGen Pharma Ltd. ('UroGen' or the 'Company') (NASDAQ: URGN) and reminds investors of the July 28, 2025 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. [ This image cannot be displayed. Please visit the source: ] Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia. The firm has recovered hundreds of millions of dollars for investors since its founding in 1995. See As detailed below, the complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose that: (1) the ENVISION clinical study was not designed to demonstrate substantial evidence of effectiveness of UGN-102 because it lacked a concurrent control arm; (2) as a result, the Company would have difficulty demonstrating that the duration of response endpoint was attributable to UGN-102; (3) UroGen failed to heed the FDA's warnings about the study design used to support a drug application for UGN-102; (4) as a result of the foregoing, there was a substantial risk that the NDA for UGN-102 would not be approved; and (5) as a result of the foregoing, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis. On May 16, 2025, before the market opened, the U.S. Food and Drug Administration ('FDA') published a briefing document in advance of its Oncologic Drugs Advisory Committee meeting regarding UroGen's new drug application ('NDA') for UGN-102, which stated the agency doubted whether the submitted data was sufficient to conclude that UGN-102 was effective. In the briefing document, the FDA stated: "[g]iven that [the ENVISION trial] lacked a concurrent control arm, the primary endpoints of complete response (CR) and duration of response (DOR) are difficult to interpret.' The FDA also said it had 'recommended a randomized trial design to the Applicant several times during their product's development due to concerns with interpreting efficacy results' but UroGen 'chose not to conduct a randomized trial with a design and endpoints that the FDA considered appropriate.' On this news, UroGen's stock price fell $2.54, or 25.8%, to close at $7.31 per share on May 16, 2025, on unusually heavy trading volume. Then, on May 21, 2025, before the market opened, the Oncologic Drugs Advisory Committee voted against approving the UGN-102 NDA. The committee found that the overall benefit-risk of the investigational therapy UGN-102 (intravesical mitomycin) is not favorable in patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer. On this news, UroGen's stock price fell $3.37, or 44.7%, to close at $4.17 per share on May 21, 2025, on unusually heavy trading volume. The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not. Faruqi & Faruqi, LLP also encourages anyone with information regarding UroGen's conduct to contact the firm, including whistleblowers, former employees, shareholders and others. To learn more about the UroGen Pharma Ltd. class action, go to or call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). Follow us for updates on LinkedIn, on X, or on Facebook. Attorney Advertising. The law firm responsible for this advertisement is Faruqi & Faruqi, LLP ( ). Prior results do not guarantee or predict a similar outcome with respect to any future matter. We welcome the opportunity to discuss your particular case. All communications will be treated in a confidential manner. To view the source version of this press release, please visit
Associated Press
03-06-2025
- Business
- Associated Press
URGN Investors Have the Opportunity to Lead the UroGen Securities Fraud Lawsuit with Faruqi & Faruqi, LLP
Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $75,000 In UroGen To Contact Him Directly To Discuss Their Options If you suffered losses exceeding $75,000 in UroGen between July 27, 2023 and May 15, 2025 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] New York, New York--(Newsfile Corp. - June 3, 2025) - Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against UroGen Pharma Ltd. ('UroGen' or the 'Company') (NASDAQ: URGN) and reminds investors of the July 28, 2025 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. [ This image cannot be displayed. Please visit the source: ] Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia. The firm has recovered hundreds of millions of dollars for investors since its founding in 1995. See As detailed below, the complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose that: (1) the ENVISION clinical study was not designed to demonstrate substantial evidence of effectiveness of UGN-102 because it lacked a concurrent control arm; (2) as a result, the Company would have difficulty demonstrating that the duration of response endpoint was attributable to UGN-102; (3) UroGen failed to heed the FDA's warnings about the study design used to support a drug application for UGN-102; (4) as a result of the foregoing, there was a substantial risk that the NDA for UGN-102 would not be approved; and (5) as a result of the foregoing, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis. On May 16, 2025, before the market opened, the U.S. Food and Drug Administration ('FDA') published a briefing document in advance of its Oncologic Drugs Advisory Committee meeting regarding UroGen's new drug application ('NDA') for UGN-102, which stated the agency doubted whether the submitted data was sufficient to conclude that UGN-102 was effective. In the briefing document, the FDA stated: "[g]iven that [the ENVISION trial] lacked a concurrent control arm, the primary endpoints of complete response (CR) and duration of response (DOR) are difficult to interpret.' The FDA also said it had 'recommended a randomized trial design to the Applicant several times during their product's development due to concerns with interpreting efficacy results' but UroGen 'chose not to conduct a randomized trial with a design and endpoints that the FDA considered appropriate.' On this news, UroGen's stock price fell $2.54, or 25.8%, to close at $7.31 per share on May 16, 2025, on unusually heavy trading volume. Then, on May 21, 2025, before the market opened, the Oncologic Drugs Advisory Committee voted against approving the UGN-102 NDA. The committee found that the overall benefit-risk of the investigational therapy UGN-102 (intravesical mitomycin) is not favorable in patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer. On this news, UroGen's stock price fell $3.37, or 44.7%, to close at $4.17 per share on May 21, 2025, on unusually heavy trading volume. The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not. Faruqi & Faruqi, LLP also encourages anyone with information regarding UroGen's conduct to contact the firm, including whistleblowers, former employees, shareholders and others. To learn more about the UroGen Pharma Ltd. class action, go to or call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). Follow us for updates on LinkedIn, on X, or on Facebook. Attorney Advertising. The law firm responsible for this advertisement is Faruqi & Faruqi, LLP ( ). Prior results do not guarantee or predict a similar outcome with respect to any future matter. We welcome the opportunity to discuss your particular case. All communications will be treated in a confidential manner. To view the source version of this press release, please visit
Associated Press
01-06-2025
- Business
- Associated Press
ONGOING DEADLINE ALERT: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of UroGen
Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses In UroGen To Contact Him Directly To Discuss Their Options If you purchased or acquired securities in UroGen between July 27, 2023 and May 15, 2025 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] New York, New York--(Newsfile Corp. - June 1, 2025) - Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against UroGen Pharma Ltd. ('UroGen' or the 'Company') (NASDAQ: URGN) and reminds investors of the July 28, 2025 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. [ This image cannot be displayed. Please visit the source: ] Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia. The firm has recovered hundreds of millions of dollars for investors since its founding in 1995. See As detailed below, the complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose that: (1) the ENVISION clinical study was not designed to demonstrate substantial evidence of effectiveness of UGN-102 because it lacked a concurrent control arm; (2) as a result, the Company would have difficulty demonstrating that the duration of response endpoint was attributable to UGN-102; (3) UroGen failed to heed the FDA's warnings about the study design used to support a drug application for UGN-102; (4) as a result of the foregoing, there was a substantial risk that the NDA for UGN-102 would not be approved; and (5) as a result of the foregoing, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis. On May 16, 2025, before the market opened, the U.S. Food and Drug Administration ('FDA') published a briefing document in advance of its Oncologic Drugs Advisory Committee meeting regarding UroGen's new drug application ('NDA') for UGN-102, which stated the agency doubted whether the submitted data was sufficient to conclude that UGN-102 was effective. In the briefing document, the FDA stated: "[g]iven that [the ENVISION trial] lacked a concurrent control arm, the primary endpoints of complete response (CR) and duration of response (DOR) are difficult to interpret.' The FDA also said it had 'recommended a randomized trial design to the Applicant several times during their product's development due to concerns with interpreting efficacy results' but UroGen 'chose not to conduct a randomized trial with a design and endpoints that the FDA considered appropriate.' On this news, UroGen's stock price fell $2.54, or 25.8%, to close at $7.31 per share on May 16, 2025, on unusually heavy trading volume. Then, on May 21, 2025, before the market opened, the Oncologic Drugs Advisory Committee voted against approving the UGN-102 NDA. The committee found that the overall benefit-risk of the investigational therapy UGN-102 (intravesical mitomycin) is not favorable in patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer. On this news, UroGen's stock price fell $3.37, or 44.7%, to close at $4.17 per share on May 21, 2025, on unusually heavy trading volume. The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not. Faruqi & Faruqi, LLP also encourages anyone with information regarding UroGen's conduct to contact the firm, including whistleblowers, former employees, shareholders and others. To learn more about the UroGen Pharma Ltd. class action, go to or call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). Follow us for updates on LinkedIn, on X, or on Facebook. Attorney Advertising. The law firm responsible for this advertisement is Faruqi & Faruqi, LLP ( ). Prior results do not guarantee or predict a similar outcome with respect to any future matter. We welcome the opportunity to discuss your particular case. All communications will be treated in a confidential manner. To view the source version of this press release, please visit
Business Insider
28-04-2025
- Business
- Business Insider
UroGen Pharma announces long-term follow up data from OPTIMA II Phase 2b study
UroGen Pharma (URGN) announced new data from the OPTIMA II Phase 2b study of UGN-102 for intravesical solution demonstrate clinically meaningful two-year duration of response by Kaplan-Meier analysis. UGN-102 is UroGen's sustained-release formulation of mitomycin being developed for the treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The majority of patients included in OPTIMA II had recurrent disease at baseline, with multiple prior transurethral resection of bladder tumor procedures. Among the 41 patients achieving a complete response at three months, 25 remained in CR at 12 months, and 17 of these patients entered long-term follow-up. The median Kaplan-Meier estimate of duration of response for the 41 patients that achieved CR was 24.2 months, with a median follow-up time of 33.6 months. Twenty patients experienced recurrence of low-grade disease. One patient progressed to high-grade disease and one patient died due to a cardiac disorder. Five patients remained disease-free at the time of the four-year data analysis. Stay Ahead of the Market:
Business Insider
28-04-2025
- Health
- Business Insider
UroGen Pharma announces patient-reported outcomes on UGN-102
UroGen Pharma (URGN) announced patient-reported outcomes following treatment of patients with low-grade intermediate-risk non-muscle invasive bladder cancer, LG-IR-NMIBC, that showed investigational drug UGN-102 for intravesical solution achieved robust and durable complete response rates without negatively impacting quality of life. The data were presented at the AUA 2025 Annual Meeting in Las Vegas, Nevada. In the OPTIMA II, ATLAS, and ENVISION late-phase studies, most patients completed the questionnaires at baseline, three months, and 12 months or study end. Baseline scores indicated high levels of functioning and low symptom burden prior to treatment. UGN-102 did not cause sustained declines in functioning or symptom burden, and no measured domains or items exceeded the threshold for clinically significant worsening at three or 12 months, suggesting no negative impact on quality of life. Stay Ahead of the Market: Discover outperforming stocks and invest smarter with Top Smart Score Stocks. Filter, analyze, and streamline your search for investment opportunities using Tipranks' Stock Screener.
