NEW YORK, May 30, 2025 (GLOBE NEWSWIRE) -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC, a nationally recognized law firm, notifies investors that a class action lawsuit has been filed against UroGen Pharma Ltd. (“UroGen” or “the Company”) (NASDAQ: URGN) and certain of its officers. Class Definition This lawsuit seeks to recover damages against Defendants for alleged violations of the federal securities laws on behalf of all persons and entities that purchased or otherwise acquired UroGen secu ...

Core Viewpoint - A class action has been filed against UroGen Pharma Ltd. for allegedly failing to conduct a proper trial for its lead drug candidate, UGN-102, which is intended to treat low-grade intermediate risk non-muscle invasive bladder cancer [1][2]. Group 1: Allegations and FDA Concerns - The complaint alleges that UroGen submitted a rolling new drug application (NDA) for UGN-102 on August 14, 2024 [2]. - On May 16, 2025, the FDA expressed doubts about the sufficiency of the submitted data for UGN-102's effectiveness, highlighting the lack of a concurrent control arm in the ENVISION clinical study [3]. - The FDA had previously recommended a randomized trial design to UroGen multiple times, which the company did not follow [3]. Group 2: Stock Price Impact - Following the FDA's briefing document on May 16, 2025, UroGen's stock price fell by $2.54, or 25.8%, closing at $7.31 per share [3]. - After the Oncological Drugs Advisory Committee voted against the approval of UGN-102 on May 21, 2025, UroGen's stock price dropped by $3.37, or 44.7%, closing at $4.17 per share [4]. Group 3: Class Action Details - The plaintiff claims that UroGen failed to disclose critical information regarding the study design and its implications for the NDA approval process [5]. - Shareholders interested in participating in the class action can contact Robbins LLP, which is leading the litigation [6].

Core Viewpoint - A securities class action lawsuit has been filed against UroGen Pharma Ltd. due to significant share price decline following FDA concerns regarding the company's drug application for UGN-102 [1][2]. Group 1: Lawsuit Details - The lawsuit, Cockrell v. UroGen Pharma Ltd., seeks to represent investors who acquired UroGen securities between July 27, 2023, and May 15, 2025 [1]. - The litigation focuses on UroGen's disclosures about its communications with the FDA regarding the UGN-102 NDA, particularly the design of the pivotal trial ENVISION [3][4]. Group 2: FDA Concerns - The FDA's briefing document indicated that UroGen was advised to conduct a randomized trial for UGN-102 due to concerns about efficacy interpretation and safety data [5]. - The FDA noted that the ENVISION trial lacked a concurrent control arm, making it difficult to interpret primary endpoints such as complete response and duration of response [5]. Group 3: Impact on Share Price - Following the FDA's publication of the briefing document, UroGen's share price experienced a sharp decline on May 16, 2025, leading to substantial losses for investors [2][5]. - On May 21, 2025, it was reported that the ODAC voted 5 to 4 against the risk/profile of UGN-102, further impacting investor confidence [5].

Core Viewpoint - A shareholder class action lawsuit has been filed against UroGen Pharma Ltd, alleging that the company made materially false and misleading statements regarding its business and the effectiveness of its drug UGN-102 [1] Group 1: Allegations in the Lawsuit - The lawsuit claims that the ENVISION clinical study was not properly designed to demonstrate substantial evidence of effectiveness for UGN-102 due to the absence of a concurrent control arm [1] - It is alleged that UroGen would face challenges in proving that the duration of response endpoint was attributable to UGN-102 [1] - The company reportedly ignored FDA warnings concerning the study design used to support the drug application for UGN-102 [1] - As a result of these issues, there is a significant risk that the New Drug Application (NDA) for UGN-102 may not receive approval [1] - Consequently, the positive statements made by the defendants regarding UroGen's business and prospects are claimed to be materially misleading and lacking a reasonable basis [1]

Core Viewpoint - UroGen Pharma Ltd. is facing a federal securities class action due to allegations of misleading statements regarding the effectiveness of its drug UGN-102, leading to significant stock price declines following negative FDA feedback and advisory committee decisions [4][5][6]. Group 1: Legal Investigation and Class Action - Faruqi & Faruqi, LLP is investigating potential claims against UroGen and has set a deadline of July 28, 2025, for investors to seek the role of lead plaintiff in the class action [2]. - Investors who suffered losses exceeding $75,000 in UroGen between July 27, 2023, and May 15, 2025, are encouraged to contact the firm to discuss their legal options [1]. Group 2: Allegations Against UroGen - The complaint alleges that UroGen and its executives violated federal securities laws by making false or misleading statements regarding the ENVISION clinical study and its design, which lacked a concurrent control arm [4]. - The FDA expressed doubts about the effectiveness of UGN-102, stating that the trial's design made it difficult to interpret primary endpoints [5]. - UroGen's stock price fell significantly after the FDA's briefing document and the advisory committee's negative vote on the NDA for UGN-102, with a drop of 25.8% to $7.31 per share on May 16, 2025, and a further decline of 44.7% to $4.17 per share on May 21, 2025 [5][6]. Group 3: Class Action Participation - The lead plaintiff in the class action will be the investor with the largest financial interest who is also typical of class members, and any member of the class can move to serve as lead plaintiff [7]. - Participation as a lead plaintiff does not affect the ability of other class members to share in any recovery [7]. Group 4: Additional Information - Faruqi & Faruqi encourages anyone with information regarding UroGen's conduct, including whistleblowers and former employees, to contact the firm [8]. - For more information about the class action, interested parties can visit the firm's website or contact the partner directly [9].

Core Viewpoint - UroGen Pharma Ltd. is facing a class action lawsuit due to alleged violations of the Securities Exchange Act of 1934, with claims centered around misleading statements regarding the effectiveness of its lead product, UGN-102, and its clinical study design [1][3]. Company Overview - UroGen Pharma Ltd. specializes in developing and commercializing solutions for specialty cancers, with its primary product being UGN-102, an intravesical solution aimed at treating low-grade intermediate risk non-muscle invasive bladder cancer [2]. Allegations of the Lawsuit - The lawsuit claims that UroGen made false or misleading statements and failed to disclose critical information, including: - The ENVISION clinical study for UGN-102 was inadequately designed, lacking a concurrent control arm, which undermined its ability to demonstrate substantial evidence of effectiveness [3]. - UroGen did not adequately address FDA warnings regarding the study design for its new drug application (NDA) for UGN-102, leading to a significant risk of NDA rejection [3][4]. Impact of FDA Findings - On May 16, 2025, the FDA released a briefing document indicating concerns about the ENVISION study's design, stating that the primary endpoints were difficult to interpret due to the absence of a concurrent control arm. This led to a nearly 26% drop in UroGen's stock price [4]. - Following the FDA's Oncologic Drugs Advisory Committee vote against the approval of UGN-102 on May 21, 2025, citing unfavorable benefit-risk assessment, UroGen's stock price fell nearly 45% [5]. Legal Process for Lead Plaintiff - The Private Securities Litigation Reform Act of 1995 allows any investor who purchased UroGen securities during the specified class period to seek appointment as lead plaintiff in the class action lawsuit. The lead plaintiff represents the interests of all class members [6]. Law Firm Background - Robbins Geller Rudman & Dowd LLP is a prominent law firm specializing in securities fraud and shareholder litigation, having secured over $2.5 billion for investors in 2024 alone, and is recognized for obtaining significant recoveries in securities class action cases [7].

Core Viewpoint - A class action has been filed against UroGen Pharma Ltd. due to allegations of improper trial conduct for its lead drug candidate UGN-102, which is intended for treating low-grade intermediate risk non-muscle invasive bladder cancer [1][2]. Group 1: Allegations and FDA Concerns - The complaint alleges that UroGen failed to conduct a proper trial for UGN-102, specifically that the ENVISION clinical study lacked a concurrent control arm, making it difficult to demonstrate the drug's effectiveness [5]. - On May 16, 2025, the FDA expressed doubts about the sufficiency of the submitted data for UGN-102, stating that the lack of a concurrent control arm complicated the interpretation of primary endpoints [3]. - The FDA had previously recommended a randomized trial design multiple times during UroGen's product development, which the company did not follow [3]. Group 2: Stock Price Impact - Following the FDA's briefing document release on May 16, 2025, UroGen's stock price fell by $2.54, or 25.8%, closing at $7.31 per share [3]. - After the Oncological Drugs Advisory Committee voted against the approval of UGN-102 on May 21, 2025, UroGen's stock price dropped by $3.37, or 44.7%, closing at $4.17 per share [4]. Group 3: Class Action Participation - Shareholders may be eligible to participate in the class action against UroGen Pharma Ltd., with options to serve as lead plaintiff or remain an absent class member [6].

Investors can contact the law firm at no cost to learn more about recovering their losses LOS ANGELES, May 29, 2025 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises UroGen Pharma Ltd. ("UroGen " or the "Company") (NASDAQ: URGN) investors of a class action representing investors that bought securities between July 27, 2023 and May 15, 2025, inclusive (the "Class Period"). UroGen investors have until July 28, 2025 to file a lead plaintiff motion. Investors are encouraged to contact attorney Lesley F. Portnoy, ...

Core Viewpoint - UroGen Pharma Ltd. is facing a class action lawsuit due to alleged violations of the Securities Exchange Act of 1934, with claims centered around misleading statements regarding its lead product UGN-102 and its clinical study design [1][3]. Company Overview - UroGen Pharma Ltd. specializes in developing and commercializing solutions for specialty cancers, with its primary product being UGN-102, an intravesical solution aimed at treating low-grade intermediate risk non-muscle invasive bladder cancer [2]. Allegations of the Lawsuit - The lawsuit claims that UroGen made false or misleading statements and failed to disclose critical information regarding the ENVISION clinical study for UGN-102, including: - The study was not designed to provide substantial evidence of effectiveness due to the absence of a concurrent control arm [3]. - UroGen's challenges in demonstrating that the duration of response was attributable to UGN-102 [3]. - Ignoring FDA warnings about the study design for the new drug application (NDA) [3]. - The substantial risk that the NDA for UGN-102 would not receive approval [3]. Impact of FDA Findings - On May 16, 2025, the FDA released a briefing document indicating concerns about the ENVISION study's design, stating that the primary endpoints were difficult to interpret due to the lack of a concurrent control arm. This led to a nearly 26% drop in UroGen's stock price [4]. - Following the FDA's Oncologic Drugs Advisory Committee vote against the approval of UGN-102 on May 21, 2025, citing unfavorable benefit-risk assessment, UroGen's stock price fell nearly 45% [5]. Legal Process for Lead Plaintiff - The Private Securities Litigation Reform Act of 1995 allows investors who purchased UroGen securities during the class period to seek appointment as lead plaintiff, representing the interests of the class [6]. Law Firm Background - Robbins Geller Rudman & Dowd LLP is a prominent law firm specializing in securities fraud and shareholder litigation, having secured over $2.5 billion for investors in 2024 alone, and is recognized for its significant recoveries in securities class action cases [7].

URGN Investors with Losses Encouraged to Contact Hagens BermanSAN FRANCISCO, May 29, 2025 /PRNewswire/ -- On May 21, 2025, investors in UroGen Pharma Ltd. (NASDAQ: URGN) saw the price of their shares crash 44% after the company announced 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 ...