Latest news with #UGN-102NDA
Business Wire
6 hours ago
- Business
- Business Wire
Law Offices of Frank R. Cruz Encourages UroGen Pharma Ltd. (URGN) Investors To Inquire About Securities Fraud Class Action
LOS ANGELES--(BUSINESS WIRE)-- The Law Offices of Frank R. Cruz announces that a class action lawsuit has been filed on behalf of investors who purchased UroGen Pharma Ltd. ('UroGen' or the 'Company') (NASDAQ: URGN) securities between , inclusive (the 'Class Period'). UroGen investors have until July 28, 2025 to file a lead plaintiff motion. Law Offices of Frank R. Cruz Encourages UroGen Pharma Ltd. (URGN) Investors To Inquire About Securities Fraud Class Action Share IF YOU SUFFERED A LOSS ON YOUR UROGEN PHARMA LTD. INVESTMENTS, CLICK HERE TO SUBMIT A CLAIM TO POTENTIALLY RECOVER YOUR LOSSES IN THE ONGOING SECURITIES FRAUD LAWSUIT. You can also contact the Law Offices of Frank R. Cruz to discuss your legal rights by email at info@ by telephone at (310) 914-5007, or visit our website at What Happened? 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. What Is The Lawsuit About? The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants failed to disclose to investors 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. Contact Us To Participate or Learn More: If you purchased UroGen securities, wish to learn more about this action, or have any questions concerning this announcement or your rights or interests with respect to these matters, please click HERE or contact us at: This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
Business Wire
3 days ago
- Business
- Business Wire
URGN INVESTOR ALERT: Robbins Geller Rudman & Dowd LLP Announces that UroGen Pharma Ltd. Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit
SAN DIEGO--(BUSINESS WIRE)--The law firm of Robbins Geller Rudman & Dowd LLP UroGen class action lawsuit. Captioned , 25-cv-06088 (D.N.J.), the UroGen class action lawsuit charges UroGen and certain of UroGen's top current and former executives with violations of the Securities Exchange Act of 1934. If you suffered substantial losses and wish to serve as lead plaintiff of the UroGen class action lawsuit, please provide your information here: CASE ALLEGATIONS: UroGen engages in the development and commercialization of solutions for specialty cancers. According to the complaint, UroGen's lead pipeline product is UGN-102 (mitomycin), an intravesical solution intended to treat low-grade intermediate risk non-muscle invasive bladder cancer. The UroGen class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (i) UroGen's ENVISION clinical study for UGN-102 was not designed to demonstrate substantial evidence of effectiveness of UGN-102 because it lacked a concurrent control arm; (ii) as a result, UroGen would have difficulty demonstrating that the duration of response endpoint was attributable to UGN-102; (iii) UroGen failed to heed the U.S. Food and Drug Administration's ('FDA') warnings about the study design used to support a new drug application ('NDA') for UGN-102; and (iv) as a result, there was a substantial risk that the NDA for UGN-102 would not be approved. The UroGen class action lawsuit further alleges that on May 16, 2025, the FDA published a briefing document in advance of its Oncologic Drugs Advisory Committee meeting regarding UroGen's NDA for UGN-102, which stated that '[g]iven that ENVISION lacked a concurrent control arm, the primary endpoints of complete response (CR) and duration of response (DOR) are difficult to interpret,' and that the FDA 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, the price of UroGen stock fell nearly 26%, according to the complaint. Then, on May 21, 2025, the UroGen class action lawsuit further alleges that the Oncologic Drugs Advisory Committee voted against approving the UGN-102 NDA, finding that the overall benefit-risk of the investigation therapy UGN-102 is not favorable in patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer. On this news, the price of UroGen stock fell nearly 45%, according to the complaint. THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired UroGen securities during the Class Period to seek appointment as lead plaintiff in the UroGen class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the UroGen class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the UroGen class action lawsuit. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the UroGen class action lawsuit. ABOUT ROBBINS GELLER: Robbins Geller Rudman & Dowd LLP is one of the world's leading law firms representing investors in securities fraud and shareholder litigation. Our Firm has been ranked #1 in the ISS Securities Class Action Services rankings for four out of the last five years for securing the most monetary relief for investors. In 2024, we recovered over $2.5 billion for investors in securities-related class action cases – more than the next five law firms combined, according to ISS. With 200 lawyers in 10 offices, Robbins Geller is one of the largest plaintiffs' firms in the world, and the Firm's attorneys have obtained many of the largest securities class action recoveries in history, including the largest ever – $7.2 billion – in In re Enron Corp. Sec. Litig. Please visit the following page for more information: Past results do not guarantee future outcomes. Services may be performed by attorneys in any of our offices.
Business Wire
5 days ago
- Business
- Business Wire
Law Offices of Howard G. Smith Encourages UroGen Pharma Ltd. (URGN) Investors To Inquire About Securities Fraud Class Action
BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased UroGen Pharma Ltd. ('UroGen' or the 'Company') (NASDAQ: URGN) securities between , inclusive (the 'Class Period'). UroGen investors have until July 28, 2025 to file a lead plaintiff motion. IF YOU ARE AN INVESTOR WHO SUFFERED A LOSS IN UROGEN PHARMA LTD. (URGN), CONTACT THE LAW OFFICES OF HOWARD G. SMITH TO PARTICIPATE IN THE ONGOING SECURITIES FRAUD LAWSUIT. Contact the Law Offices of Howard G. Smith to discuss your legal rights by email at howardsmith@ by telephone at (215) 638-4847 or visit our website at What Happened? 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. What Is The Lawsuit About? The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants failed to disclose to investors 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. Contact Us To Participate or Learn More: If you purchased UroGen securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact us: Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, Telephone: (215) 638-4847 Email: howardsmith@ Visit our website at: This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
