Latest news with #UroGen
Associated Press
16-06-2025
- Business
- Associated Press
ROSEN, HIGHLY REGARDED INVESTOR COUNSEL, Encourages UroGen Pharma Ltd. Investors to Secure Counsel Before Important Deadline in Securities Class Action
New York, New York--(Newsfile Corp. - June 15, 2025) - WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of UroGen Pharma Ltd. (NASDAQ: URGN) between July 27, 2023 and May 15, 2025, both dates inclusive (the 'Class Period'), of the important July 28, 2025 lead plaintiff deadline. SO WHAT: If you purchased UroGen securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement. WHAT TO DO NEXT: To join the UroGen class action, go to or call Phillip Kim, Esq. at 866-767-3653 or email [email protected] for more information. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than July 28, 2025. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm achieved the largest ever securities class action settlement against a Chinese Company at the time. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs' Bar. Many of the firm's attorneys have been recognized by Lawdragon and Super Lawyers. DETAILS OF THE CASE: 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. To join the UroGen class action, go to or call Phillip Kim, Esq. at 866-767-3653 or email [email protected] for more information. No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff. Follow us for updates on LinkedIn: on Twitter: or on Facebook: Attorney Advertising. Prior results do not guarantee a similar outcome. ------------------------------- Contact Information: Laurence Rosen, Esq. Phillip Kim, Esq. The Rosen Law Firm, P.A. 275 Madison Avenue, 40th Floor New York, NY 10016 Tel: (212) 686-1060 Toll Free: (866) 767-3653 Fax: (212) 202-3827 [email protected] To view the source version of this press release, please visit
Business Insider
14-06-2025
- Business
- Business Insider
UroGen Pharma price target raised to $31 from $10 at Oppenheimer
Oppenheimer analyst Leland Gershell raised the firm's price target on UroGen Pharma (URGN) to $31 from $10 and keeps an Outperform rating on the shares following yesterday's approval of Zusduri. The firm says key reveal on this morning's conference call was the $21,500 per-dose list price. Oppenheimer awaits clarity on the approval path for UGN-103, which is needed to extend franchise exclusivity beyond early 2031, but notes management does not expect the potential need for a randomized controlled trial in lieu of the recently-initiated single-arm study to materially alter its financial outlook. The analyst sees $1B in sales over time and would would take advantage of any near-term weakness to buy UroGen shares. Confident Investing Starts Here:
Business Wire
12-06-2025
- Business
- Business Wire
U.S. FDA Approves UroGen's ZUSDURI™ (mitomycin) for Intravesical Solution as the First and Only Medication for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)
PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the U.S. Food and Drug Administration (FDA) approved ZUSDURI, the first and only FDA-approved medication for adults with recurrent LG-IR-NMIBC. ZUSDURI consists of mitomycin and sterile hydrogel, using UroGen's proprietary sustained release RTGel ® technology. ZUSDURI has been designed for potent tumor ablation. This landmark approval is based on the positive results from the Phase 3 ENVISION trial that demonstrated ZUSDURI delivers 78% complete response (CR) for patients at 3 months, and of those patients 79% remained event-free 12 months later. 'The approval of ZUSDURI represents a significant step forward for our company and for the treatment of recurrent LG-IR-NMIBC," said Liz Barrett, President and CEO of UroGen. "For the first time, the estimated 59,000 U.S. patients facing recurrent LG-IR-NMIBC each year have access to an FDA-approved medicine. This historic achievement is a bold leap forward in our mission to redefine uro-oncology and bring innovation to patients who need it most. We are deeply grateful to the FDA for their collaboration and to the investigators, patients, and caregivers whose commitment made this milestone possible. Their contributions have been essential in bringing meaningful innovation to the bladder cancer community.' The existing standard of care for LG-IR-NMIBC is a surgical procedure typically performed under general anesthesia called transurethral resection of bladder tumor (TURBT). Due to high recurrence rates of LG-IR-NMIBC, repeat TURBTs may be necessary. "ZUSDURI marks a breakthrough in uro-oncology, offering a new alternative for recurrent LG-IR-NMIBC patients who can live for many years with the disease but often endure multiple resections, under general anesthesia,' said Dr. Sandip Prasad, MD, Director of Genitourinary Surgical Oncology at Morristown Medical Center/Atlantic Health System, NJ, and principal investigator of the ENVISION trial. 'For decades, TURBT has been the standard approach for bladder cancer treatment. That's why innovative treatments like ZUSDURI are essential, especially for those adult patients with recurrent low-grade, intermediate-risk NMIBC.' The most common (≥ 10%) adverse reactions, including laboratory abnormalities, that occurred in patients were increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria. Serious adverse reactions occurred in 12% of patients who received ZUSDURI, including, urinary retention (0.8%) and urethral stenosis (0.4%). Product Availability ZUSDURI is expected to be available in the U.S. on or around July 1, 2025, for the treatment of adults with recurrent LG-IR-NMIBC. In the interim, patients can visit (available soon). UroGen Patient Support UroGen is committed to helping patients access ZUSDURI. UroGen Support may help identify appropriate financial assistance programs for eligible patients with commercial, Medicare or Medicaid coverage, as well as those with no insurance coverage. These programs are for eligible patients who have been prescribed ZUSDURI and who need help managing the cost of treatment. The appropriate program will depend on the patient's insurance coverage. Visit (available soon) or contact UroGen Support at 1-833-UROGEN-1 (1-833-876-4361) for additional information. Post-Marketing Commitment As a post-marketing commitment, UroGen has agreed with the FDA to complete the ongoing ENVISION trial to further characterize the clinical benefit of ZUSDURI for the treatment of patients with recurrent LG-IR-NMIBC. In addition, UroGen committed to provide the FDA annual updates on duration of response (DOR) for all patients with ongoing complete responses. The annual updates will continue until all ongoing patients experience a recurrence of LG-IR-NMIBC; progression; death; loss to follow-up; or reach 63 months after the first instillation as planned in the protocol, whichever occurs first. Conference Call & Webcast Information Members of UroGen's management team will host a live conference call and webcast on June 13, 2025 at 8:30 AM Eastern Time to review ZUSDURI approval details and commercialization plans. The live webcast can be accessed by visiting the Investors section of the Company's website at Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. An archive of the webcast will be available on the Company's website. About ZUSDURI ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen's proprietary RTGel ® technology, a sustained release, hydrogel-based formulation, ZUSDURI is delivered directly into the bladder in an out-patient procedure by a trained healthcare professional using a urinary catheter to enable the treatment of tumors by non-surgical means. About Non-Muscle Invasive Bladder Cancer (NMIBC) LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include TURBT as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at About UroGen Pharma Ltd. UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen's sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product to treat low-grade upper tract urothelial cancer and ZUSDURI (mitomycin) for intravesical solution, UroGen's first product to treat recurrent LG-IR-NMIBC are both designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit to learn more or follow us on X, @UroGenPharma. APPROVED USE FOR ZUSDURI ZUSDURI (mitomycin) for intravesical solution is a prescription medicine used to treat adults with a type of cancer of the lining of the bladder called low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) after previously receiving bladder surgery to remove tumor that did not work or is no longer working. IMPORTANT SAFETY INFORMATION You should not receive ZUSDURI if you have a hole or tear (perforation) of your bladder or if you have had an allergic reaction to mitomycin or to any of the ingredients in ZUSDURI. Before receiving ZUSDURI, tell your healthcare provider about all of your medical conditions, including if you: have kidney problems are pregnant or plan to become pregnant. ZUSDURI can harm your unborn baby. You should not become pregnant during treatment with ZUSDURI. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZUSDURI. Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with ZUSDURI and for 6 months after the last dose. Males being treated with ZUSDURI: You should use effective birth control (contraception) during treatment with ZUSDURI and for 3 months after the last dose. are breastfeeding or plan to breastfeed. It is not known if ZUSDURI passes into your breast milk. Do not breastfeed during treatment with ZUSDURI and for 1 week after the last dose. How will I receive ZUSDURI? You will receive your ZUSDURI dose from your healthcare provider 1 time a week for 6 weeks into your bladder through a tube called a urinary catheter. It is important that you receive all 6 doses of ZUSDURI according to your healthcare provider's instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. During treatment with ZUSDURI, your healthcare provider may tell you to take additional medicines or change how you take your current medicines. After receiving ZUSDURI: ZUSDURI may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 24 hours. To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water. Clothing that comes in contact with urine should be washed right away and washed separately from other clothing. The most common side effects of ZUSDURI include: increased blood creatinine levels, increased blood potassium levels, trouble with urination, decreased red blood cell counts, increase in certain blood liver tests, increased or decreased white blood cell counts, urinary tract infection, and blood in your urine. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436. Please see ZUSDURI Full Prescribing Information, including the Patient Information, for additional information. ZUSDURI ™ is a trademark and UroGen ® is a registered trademark of UroGen Pharma, Ltd. Copyright©2025 UroGen Pharma, Inc. All rights reserved. Forward-Looking Statements This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the estimated annual U.S. patient population and demographics for LG-IR-NMIBC; the potential benefits to patients and opportunities for ZUSDURI; the potential of UroGen's proprietary RTGel technology to improve therapeutic profiles of existing drugs other than mitomycin; and UroGen's sustained release technology making local delivery potentially more effective as compared to other treatment options. Words such as 'can,' 'expect,' 'may,' 'plan,' 'potential,' 'target,' 'will' or other words that convey uncertainty of future events or outcomes are used to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the ability to maintain regulatory approval; complications associated with commercialization activities; labeling limitations; competition in UroGen's industry; the scope, progress and expansion of developing and commercializing UroGen's products and product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies or procedures, such as surgery; UroGen's ability to attract or retain key management, members of the board of directors and other personnel; UroGen's RTGel technology and ZUSDURI may not perform as expected; new data relating to ZUSDURI, including from spontaneous adverse event reports and from the ongoing ENVISION trial, may result in changes to the product label and may adversely affect sales, or result in withdrawal of ZUSDURI from the market; the potential for payors to delay, limit or deny coverage for ZUSDURI; and UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 12, 2025. The events and circumstances discussed in such forward-looking statements may not occur, and UroGen's actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.
Associated Press
09-06-2025
- Business
- 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]
Business Upturn
08-06-2025
- Business
- Business Upturn
URGN INVESTOR NEWS: UroGen Pharma Ltd. has been Sued for Securities Fraud – Contact BFA Law before July 28 Deadline (NASDAQ:URGN)
NEW YORK, June 08, 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
