Rosen Law Firm Urges UroGen Pharma Ltd. (NASDAQ: URGN) Stockholders With Large Losses to Contact the Firm for Information About Their Rights
NEW YORK--(BUSINESS WIRE)--Rosen Law Firm, a global investor rights law firm, announces that a shareholder filed a class action lawsuit on behalf of purchasers and acquirers of UroGen Pharms Ltd. (NASDAQ: URGN) securities between July 27, 2023 and May 15, 2025, both dates inclusive (the 'Class Period'). UroGen engages in the development and commercialization of solutions for specialty cancers.
For more information, submit a form, email attorney Phillip Kim, or give us a call at 866-767-3653.
The Allegations: Rosen Law Firm is Investigating the Allegations that UroGen Pharma Ltd. (NASDAQ: URGN) Misled Investors Regarding its Business Operations.
According to the lawsuit, throughout the Class Period, defendants made false and misleading statements and/or failed to disclose that: (1) the ENVISION clinical study was not designed to demonstrate substantial evidence of effectiveness of UGN-102 (UroGen's lead pipeline product, which is an intravesical solution intended to treat low-grade intermediate risk non-muscle invasive bladder cancer) because it lacked a concurrent control arm; (2) as a result, UroGen 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 UroGen's business, operations, and prospects were materially misleading and/or lacked a reasonable basis. When the true details entered the market, the lawsuit claims that investors suffered damages.
What Now: You may be eligible to participate in the class action against UroGen Pharma Ltd. Shareholders who want to serve as lead plaintiff for the class must file their motions with the court by July 28, 2025. A lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation. You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member. For more information, click here.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.
About Rosen Law Firm: Some law firms issuing releases about this matter do not actually litigate securities class actions. Rosen Law Firm does. Rosen Law Firm is a recognized leader in shareholder rights litigation, dedicated to helping shareholders recover losses, improving corporate governance structures, and holding company executives accountable for their wrongdoing. Since its inception, Rosen Law Firm has obtained over $1 billion for shareholders.
Attorney Advertising. Prior results do not guarantee a similar outcome.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
14 hours ago
- Business Wire
Anodyne Nanotech Drives Major Advancement in the Treatment of Sarcopenia with Novel Muscle-Preserving Therapy
BOSTON--(BUSINESS WIRE)--Anodyne Nanotech, a clinical-stage biotech company, today announced new preclinical data demonstrating that administration of ANN-102 - an APJ receptor agonist via its proprietary HeroPatch™ microneedle system - significantly improved muscle strength, with efficacy equivalent to daily injections. These results lay the foundation for a novel, non-invasive, muscle-preserving therapy aimed at addressing sarcopenia, a major health challenge in aging populations. Beginning at age 30, people lose on average 3–8% of their muscle mass per decade, and this accelerates after age 60. By the time individuals reach their 80s or 90s, up to 50% of their muscle mass may be lost, particularly in those who are inactive. This deterioration extends beyond reduced strength; it increases vulnerability to chronic diseases, falls, fractures, hospitalization and loss of independence. Population studies have shown that muscle wasting is associated with up to a 36% increase in all-cause mortality, and it is a critical risk factor in cardiovascular disease, cancer, respiratory illness, and metabolic decline. Beyond its clinical toll, sarcopenia places a substantial economic burden on healthcare systems. In the United States alone, hospitalizations related to sarcopenia in adults over 65 cost an estimated $19.1 billion annually, underscoring the urgent need for scalable, preventive interventions that can help preserve muscle mass and physical function as people age. By targeting the APJ receptor, Anodyne's ANN-102 engages a powerful pathway implicated in several aging-related processes. Activation of this receptor has been shown to stimulate muscle stem cell activity and vascular repair, supporting muscle regeneration and directly addressing sarcopenia. It also improves insulin sensitivity, enhances mitochondrial function, promotes fat oxidation, and helps regulate appetite—offering metabolic benefits particularly relevant in older adults. Additionally, APJ receptor activation has demonstrated cardioprotective effects, including reduced myocardial damage and improved vascular function. Taken together, these effects position the APJ pathway as a promising therapeutic target for extending healthspan and addressing the systemic decline associated with aging. In a 20-day study in an aged mouse model, ANN-102 significantly increased grip strength, a common marker of functional muscle performance and a powerful predictor of overall longevity. The treatment was as effective as daily injections with an endogenous APJ RA, demonstrating the potential for a first non-invasive, sustained delivery. Full data will be presented later this year. 'These preclinical results continue to demonstrate the HeroPatch's ability to deliver complex therapies through the skin in a clinically meaningful way,' said Jake Lombardo, Anodyne's CEO and Co-Founder. 'We have developed an alternative route of administration for molecules that have strong therapeutic potential but have been held back by delivery challenges. This can make life-changing therapies accessible to patients for the first time.' Anodyne's lead asset is a once-weekly transdermal GLP-1 patch for obesity, entering clinical trials in 2026. While GLP-1 receptor agonists like semaglutide (Wegovy®) and tirzepatide (Zepbound®) have demonstrated significant weight loss benefits, emerging research has raised concerns about their impact on muscle mass. Studies indicate that up to 40% of weight lost on GLP-1 therapies may come from lean body mass, including muscle tissue, particularly in older adults or those with low baseline muscle reserves. Given Anodyne's ability to co-formulate multiple therapeutic agents in a single patch, there is substantial potential to combine GLP-1-based therapies with muscle-preserving agents like an APJ-RA in a single, patient-friendly patch—addressing both obesity and sarcopenia in an integrated approach to healthy aging. Based on these encouraging preclinical results, Anodyne will advance the APJ-RA program toward clinical development. The company is open to strategic partnerships and co-development opportunities to accelerate the path toward delivering this promising muscle-preserving therapy to patients worldwide. About Anodyne Nanotech Anodyne Nanotech develops novel therapies by combining proven molecules with its proprietary HeroPatch technology. Designed to simplify chronic disease management, the HeroPatch has the potential to reduce side effects, eliminate refrigeration requirements, and improve clinical outcomes. The company is advancing multiple assets into clinical development for conditions such as diabetes, obesity, autoimmune diseases, and oncology. For more information, visit
Yahoo
14 hours ago
- Yahoo
Anodyne Nanotech Drives Major Advancement in the Treatment of Sarcopenia with Novel Muscle-Preserving Therapy
BOSTON, June 09, 2025--(BUSINESS WIRE)--Anodyne Nanotech, a clinical-stage biotech company, today announced new preclinical data demonstrating that administration of ANN-102 - an APJ receptor agonist via its proprietary HeroPatch™ microneedle system - significantly improved muscle strength, with efficacy equivalent to daily injections. These results lay the foundation for a novel, non-invasive, muscle-preserving therapy aimed at addressing sarcopenia, a major health challenge in aging populations. Beginning at age 30, people lose on average 3–8% of their muscle mass per decade, and this accelerates after age 60. By the time individuals reach their 80s or 90s, up to 50% of their muscle mass may be lost, particularly in those who are inactive. This deterioration extends beyond reduced strength; it increases vulnerability to chronic diseases, falls, fractures, hospitalization and loss of independence. Population studies have shown that muscle wasting is associated with up to a 36% increase in all-cause mortality, and it is a critical risk factor in cardiovascular disease, cancer, respiratory illness, and metabolic decline. Beyond its clinical toll, sarcopenia places a substantial economic burden on healthcare systems. In the United States alone, hospitalizations related to sarcopenia in adults over 65 cost an estimated $19.1 billion annually, underscoring the urgent need for scalable, preventive interventions that can help preserve muscle mass and physical function as people age. By targeting the APJ receptor, Anodyne's ANN-102 engages a powerful pathway implicated in several aging-related processes. Activation of this receptor has been shown to stimulate muscle stem cell activity and vascular repair, supporting muscle regeneration and directly addressing sarcopenia. It also improves insulin sensitivity, enhances mitochondrial function, promotes fat oxidation, and helps regulate appetite—offering metabolic benefits particularly relevant in older adults. Additionally, APJ receptor activation has demonstrated cardioprotective effects, including reduced myocardial damage and improved vascular function. Taken together, these effects position the APJ pathway as a promising therapeutic target for extending healthspan and addressing the systemic decline associated with aging. In a 20-day study in an aged mouse model, ANN-102 significantly increased grip strength, a common marker of functional muscle performance and a powerful predictor of overall longevity. The treatment was as effective as daily injections with an endogenous APJ RA, demonstrating the potential for a first non-invasive, sustained delivery. Full data will be presented later this year. "These preclinical results continue to demonstrate the HeroPatch's ability to deliver complex therapies through the skin in a clinically meaningful way," said Jake Lombardo, Anodyne's CEO and Co-Founder. "We have developed an alternative route of administration for molecules that have strong therapeutic potential but have been held back by delivery challenges. This can make life-changing therapies accessible to patients for the first time." Anodyne's lead asset is a once-weekly transdermal GLP-1 patch for obesity, entering clinical trials in 2026. While GLP-1 receptor agonists like semaglutide (Wegovy®) and tirzepatide (Zepbound®) have demonstrated significant weight loss benefits, emerging research has raised concerns about their impact on muscle mass. Studies indicate that up to 40% of weight lost on GLP-1 therapies may come from lean body mass, including muscle tissue, particularly in older adults or those with low baseline muscle reserves. Given Anodyne's ability to co-formulate multiple therapeutic agents in a single patch, there is substantial potential to combine GLP-1-based therapies with muscle-preserving agents like an APJ-RA in a single, patient-friendly patch—addressing both obesity and sarcopenia in an integrated approach to healthy aging. Based on these encouraging preclinical results, Anodyne will advance the APJ-RA program toward clinical development. The company is open to strategic partnerships and co-development opportunities to accelerate the path toward delivering this promising muscle-preserving therapy to patients worldwide. About Anodyne Nanotech Anodyne Nanotech develops novel therapies by combining proven molecules with its proprietary HeroPatch technology. Designed to simplify chronic disease management, the HeroPatch has the potential to reduce side effects, eliminate refrigeration requirements, and improve clinical outcomes. The company is advancing multiple assets into clinical development for conditions such as diabetes, obesity, autoimmune diseases, and oncology. For more information, visit View source version on Contacts Jake LombardoChief Executive Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
17 hours ago
- Associated Press
INVESTOR NOTICE: Robbins Geller Rudman & Dowd LLP Announces that UroGen Pharma Ltd. (URGN) Investors with Substantial Losses Have Opportunity to Lead Investor Class Action Lawsuit
SAN DIEGO, June 09, 2025 (GLOBE NEWSWIRE) -- Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of UroGen Pharma Ltd. (NASDAQ: URGN) securities between July 27, 2023 and May 15, 2025, all dates inclusive (the 'Class Period'), have until July 28, 2025 to seek appointment as lead plaintiff of the UroGen class action lawsuit. Captioned Cockrell v. UroGen Pharma Ltd., 25-cv-06088 (D.N.J.), the UroGen class action lawsuit charges UroGen as well as 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: You can also contact attorneys J.C. Sanchez or Jennifer N. Caringal of Robbins Geller by calling 800/449-4900 or via e-mail at [email protected]. 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. Contact: Robbins Geller Rudman & Dowd LLP J.C. Sanchez, Jennifer N. Caringal 655 W. Broadway, Suite 1900, San Diego, CA 92101 800-449-4900 [email protected]
