Latest news with #UroGenPharma
Associated Press
3 days ago
- Business
- Associated Press
URGN STOCK: Suffer Losses on UroGen Pharma Ltd.? BFA Law Notifies Investors of Imminent July 28 Securities Class Action Deadline (NASDAQ:URGN)
NEW YORK, June 02, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against UroGen Pharma Ltd. (NASDAQ: URGN) and certain of the Company's senior executives for potential violations of the federal securities laws. If you invested in UroGen you are encouraged to obtain additional information by visiting Investors have until July 28, 2025, to ask the Court to be appointed to lead the case. The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased UroGen securities. The case is pending in the U.S. District Court for the District of New Jersey and is captioned: Cockrell v. UroGen Pharma Ltd., et al., No. 3:25-cv-06088. Why was UroGen Sued for Securities Fraud? UroGen develops treatments for specialty cancers. The Company's lead pipeline product is UGN-102 (mitomycin), an intravesical solution intended to treat low-grade intermediate risk non-muscle invasive bladder cancer. One of the Phase 3 trials for UGN-102 is named ENVISION. As alleged, UroGen stated that the ENVISION trial met its primary endpoint and that UroGen had reached 'agreement with the FDA' that the ENVISION trial would support an NDA submission. In truth, the FDA had previously expressed significant concerns to UroGen regarding the ENVISION trial, which lacked a concurrent control arm. The Stock Declines as the Truth is Revealed On May 16, 2025, the FDA published a briefing document stating that it doubted whether the submitted data was sufficient to conclude that UGN-102 was effective. FDA stated that because 'ENVISION lacked a concurrent control arm,' the primary endpoints were 'difficult to interpret' and that 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 declined $2.54 per share, or nearly 26%, from a closing price of $9.85 per share on May 15, 2025, to $7.31 per share on May 16, 2025. Then, on May 21, 2025, the Oncologic Drugs Advisory Committee voted against approving the UGN-102 NDA, finding that the overall benefit-risk profile of UGN-102 was not favorable in patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer. On this news, the price of UroGen stock declined $3.37 per share, or nearly 45%, from a closing price of $7.54 per share on May 20, 2025, to $4.17 per share on May 21, 2025. Click here if you suffered losses: What Can You Do? If you invested in UroGen you may have legal options and are encouraged to submit your information to the firm. All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses. Submit your information by visiting: Or contact: Ross Shikowitz [email protected] 212-789-3619 Why Bleichmar Fonti & Auld LLP? Bleichmar Fonti & Auld LLP is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It was named among the Top 5 plaintiff law firms by ISS SCAS in 2023 and its attorneys have been named Titans of the Plaintiffs' Bar by Law360 and SuperLawyers by Thompson Reuters. Among its recent notable successes, BFA recovered over $900 million in value from Tesla, Inc.'s Board of Directors, as well as $420 million from Teva Pharmaceutical Ind. Ltd. For more information about BFA and its attorneys, please visit Attorney advertising. Past results do not guarantee future outcomes.
Yahoo
15-05-2025
- Business
- Yahoo
UroGen Pharma Ltd. (NASDAQ:URGN) Just Reported Earnings, And Analysts Cut Their Target Price
The analysts might have been a bit too bullish on UroGen Pharma Ltd. (NASDAQ:URGN), given that the company fell short of expectations when it released its quarterly results last week. Earnings fell badly short of analyst estimates, with US$20m revenue falling -11% short, and statutory losses of US$0.92 per share being -18% greater than forecast. Following the result, the analysts have updated their earnings model, and it would be good to know whether they think there's been a strong change in the company's prospects, or if it's business as usual. We've gathered the most recent statutory forecasts to see whether the analysts have changed their earnings models, following these results. Our free stock report includes 2 warning signs investors should be aware of before investing in UroGen Pharma. Read for free now. Taking into account the latest results, the consensus forecast from UroGen Pharma's eight analysts is for revenues of US$119.7m in 2025. This reflects a major 30% improvement in revenue compared to the last 12 months. The loss per share is expected to ameliorate slightly, reducing to US$2.87. Before this latest report, the consensus had been expecting revenues of US$121.7m and US$2.77 per share in losses. Overall it looks as though the analysts were a bit mixed on the latest consensus updates. Although revenue forecasts held steady, the consensus also made a modest increase to its losses per share forecasts. View our latest analysis for UroGen Pharma With the increase in forecast losses for next year, it's perhaps no surprise to see that the average price target dipped 6.4% to US$32.63, with the analysts signalling that growing losses would be a definite concern. That's not the only conclusion we can draw from this data however, as some investors also like to consider the spread in estimates when evaluating analyst price targets. There are some variant perceptions on UroGen Pharma, with the most bullish analyst valuing it at US$55.00 and the most bearish at US$16.00 per share. So we wouldn't be assigning too much credibility to analyst price targets in this case, because there are clearly some widely different views on what kind of performance this business can generate. As a result it might not be a great idea to make decisions based on the consensus price target, which is after all just an average of this wide range of estimates. Of course, another way to look at these forecasts is to place them into context against the industry itself. We can infer from the latest estimates that forecasts expect a continuation of UroGen Pharma'shistorical trends, as the 42% annualised revenue growth to the end of 2025 is roughly in line with the 37% annual growth over the past five years. Compare this with the broader industry, which analyst estimates (in aggregate) suggest will see revenues grow 17% annually. So it's pretty clear that UroGen Pharma is forecast to grow substantially faster than its industry. The most important thing to note is the forecast of increased losses next year, suggesting all may not be well at UroGen Pharma. Happily, there were no major changes to revenue forecasts, with the business still expected to grow faster than the wider industry. Furthermore, the analysts also cut their price targets, suggesting that the latest news has led to greater pessimism about the intrinsic value of the business. With that said, the long-term trajectory of the company's earnings is a lot more important than next year. We have forecasts for UroGen Pharma going out to 2027, and you can see them free on our platform here. Plus, you should also learn about the 2 warning signs we've spotted with UroGen Pharma (including 1 which is significant) . Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Yahoo
15-05-2025
- Business
- Yahoo
UroGen Pharma Ltd. (NASDAQ:URGN) Just Reported Earnings, And Analysts Cut Their Target Price
The analysts might have been a bit too bullish on UroGen Pharma Ltd. (NASDAQ:URGN), given that the company fell short of expectations when it released its quarterly results last week. Earnings fell badly short of analyst estimates, with US$20m revenue falling -11% short, and statutory losses of US$0.92 per share being -18% greater than forecast. Following the result, the analysts have updated their earnings model, and it would be good to know whether they think there's been a strong change in the company's prospects, or if it's business as usual. We've gathered the most recent statutory forecasts to see whether the analysts have changed their earnings models, following these results. Our free stock report includes 2 warning signs investors should be aware of before investing in UroGen Pharma. Read for free now. Taking into account the latest results, the consensus forecast from UroGen Pharma's eight analysts is for revenues of US$119.7m in 2025. This reflects a major 30% improvement in revenue compared to the last 12 months. The loss per share is expected to ameliorate slightly, reducing to US$2.87. Before this latest report, the consensus had been expecting revenues of US$121.7m and US$2.77 per share in losses. Overall it looks as though the analysts were a bit mixed on the latest consensus updates. Although revenue forecasts held steady, the consensus also made a modest increase to its losses per share forecasts. View our latest analysis for UroGen Pharma With the increase in forecast losses for next year, it's perhaps no surprise to see that the average price target dipped 6.4% to US$32.63, with the analysts signalling that growing losses would be a definite concern. That's not the only conclusion we can draw from this data however, as some investors also like to consider the spread in estimates when evaluating analyst price targets. There are some variant perceptions on UroGen Pharma, with the most bullish analyst valuing it at US$55.00 and the most bearish at US$16.00 per share. So we wouldn't be assigning too much credibility to analyst price targets in this case, because there are clearly some widely different views on what kind of performance this business can generate. As a result it might not be a great idea to make decisions based on the consensus price target, which is after all just an average of this wide range of estimates. Of course, another way to look at these forecasts is to place them into context against the industry itself. We can infer from the latest estimates that forecasts expect a continuation of UroGen Pharma'shistorical trends, as the 42% annualised revenue growth to the end of 2025 is roughly in line with the 37% annual growth over the past five years. Compare this with the broader industry, which analyst estimates (in aggregate) suggest will see revenues grow 17% annually. So it's pretty clear that UroGen Pharma is forecast to grow substantially faster than its industry. The most important thing to note is the forecast of increased losses next year, suggesting all may not be well at UroGen Pharma. Happily, there were no major changes to revenue forecasts, with the business still expected to grow faster than the wider industry. Furthermore, the analysts also cut their price targets, suggesting that the latest news has led to greater pessimism about the intrinsic value of the business. With that said, the long-term trajectory of the company's earnings is a lot more important than next year. We have forecasts for UroGen Pharma going out to 2027, and you can see them free on our platform here. Plus, you should also learn about the 2 warning signs we've spotted with UroGen Pharma (including 1 which is significant) . Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
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.
