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Business Wire
17 hours ago
- Business
- Business Wire
Deadline Approaching: UroGen Pharma Ltd. (URGN) Investors Who Lost Money Urged To Contact Law Offices of Howard G. Smith
BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith reminds investors of the upcoming July 28, 2025 deadline to file a lead plaintiff motion in the case filed on behalf of investors who purchased UroGen Pharma Ltd. ('UroGen' or the 'Company') (NASDAQ: URGN) securities between , inclusive (the 'Class Period'). 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. If you purchased or otherwise acquired UroGen securities during the Class Period, you may move the Court no later than July 28, 2025 to ask the Court to appoint you as lead plaintiff if you meet certain legal requirements. Contact Us To Participate or Learn More: If you wish to learn more about this class action, or if you 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: To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
Malaysian Reserve
18 hours ago
- Business
- Malaysian Reserve
URGN Investors Have Opportunity to Lead UroGen Pharma Ltd. Securities Fraud Lawsuit with the Schall Law Firm
LOS ANGELES, June 2, 2025 /PRNewswire/ — The Schall Law Firm, a national shareholder rights litigation firm, reminds investors of a class action lawsuit against UroGen Pharma Ltd. ('UroGen' or 'the Company') (NASDAQ: URGN) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission. Investors who purchased the Company's securities between July 27, 2023 and May 15, 2025, inclusive (the 'Class Period'), are encouraged to contact the firm before July 28, 2025. If you are a shareholder who suffered a loss, click here to participate. We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at or by email at bschall@ The class, in this case, has not yet been certified, and until certification occurs, you are not represented by an attorney. If you choose to take no action, you can remain an absent class member. According to the Complaint, the Company made false and misleading statements to the market. UroGen's ENVISION clinical study for UGN-102 failed to demonstrate evidence of effectiveness due to its design lacking a concurrent control arm. The Company struggled to demonstrate that its duration of response endpoint could be attributed to UGN-102. The Company ignored warnings from the FDA related to its study design. Based on these facts, the Company's public statements were false and materially misleading throughout the class period. When the market learned the truth about UroGen, investors suffered damages. Join the case to recover your losses. The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics. CONTACT: The Schall Law FirmBrian Schall, Esq., 310-301-3335info@
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
3 days ago
- Business
- Business Wire
URGN ALERT: Kirby McInerney LLP Announces the Filing of a Securities Class Action on Behalf of UroGen Pharma Ltd. Investors
NEW YORK--(BUSINESS WIRE)--The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the District of New Jersey on behalf of those who acquired UroGen Pharma Ltd. ('UroGen' or the 'Company') (NASDAQ:URGN) securities during the period from July 27, 2023, through May 15, 2025 ('the Class Period'). Investors have until July 28, 2025 to apply to the Court to be appointed as lead plaintiff in the lawsuit. [LEARN MORE ABOUT THE CLASS ACTION] UroGen is a biopharmaceutical company focused on the development and commercialization of solutions for urothelial and specialty cancers. One of its lead product candidates, UGN-102, is a treatment for low-grade, intermediate-risk invasive bladder cancer. UGN-103 is currently in phase 3 of clinical trials ('ENVISION'). On May 16, 2025, the Federal Drug Administration ('FDA') released a briefing document in advance of an Oncologic Drugs Advisory Committee meeting on May 21 to discuss a New Drug Application ('NDA') for UGN-102. In the briefing, the FDA stated: 'Given that ENVISION lacked a concurrent control arm, the primary endpoints of complete response ('CR') and duration of response ('DOR') are difficult to interpret. While CR indicates drug activity of UGN-102, it is unclear whether the observed DOR can be attributed to the investigational product or instead reflects the natural history of the disease.' Moreover, the FDA questioned the long-term benefits of UGN-102, noting a lack of data on future treatments and its potential to reduce the frequency of transurethral resection of bladder tumor procedures in certain patient populations. 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, the price of UroGen fell $2.54 per share, or approximately 26%, from $9.85 per share on May 15, 2025, to close at $7.31 on May 16, 2025. 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 complaint alleges that defendants, throughout the Class Period, failed 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; and (4) as a result of the foregoing, there was a substantial risk that the NDA for UGN-102 would not be approved. If you purchased or otherwise acquired UroGen securities, have information, or would like to learn more about this investigation, please contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@ or fill out the contact form below, to discuss your rights or interests with respect to these matters without any cost to you. Kirby McInerney LLP is a New York-based plaintiffs' law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm's efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP's website. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
Business Wire
4 days ago
- Business
- Business Wire
URGN Investors Have Opportunity to Lead UroGen Pharma Ltd. Securities Fraud Lawsuit with the Schall Law Firm
LOS ANGELES--(BUSINESS WIRE)-- The Schall Law Firm, a national shareholder rights litigation firm, reminds investors of a class action lawsuit against UroGen Pharma Ltd. ('UroGen' or 'the Company') (NASDAQ: URGN) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission. Investors who purchased the Company's securities between July 27, 2023 and May 15, 2025, inclusive (the 'Class Period'), are encouraged to contact the firm before July 28, 2025. If you are a shareholder who suffered a loss, click here to participate. We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at or by email at bschall@ The class, in this case, has not yet been certified, and until certification occurs, you are not represented by an attorney. If you choose to take no action, you can remain an absent class member. According to the Complaint, the Company made false and misleading statements to the market. UroGen's ENVISION clinical study for UGN-102 failed to demonstrate evidence of effectiveness due to its design lacking a concurrent control arm. The Company struggled to demonstrate that its duration of response endpoint could be attributed to UGN-102. The Company ignored warnings from the FDA related to its study design. Based on these facts, the Company's public statements were false and materially misleading throughout the class period. When the market learned the truth about UroGen, investors suffered damages. Join the case to recover your losses. The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.
