Latest news with #OncologicDrugsAdvisoryCommittee
Medscape
13-06-2025
- Health
- Medscape
FDA Bucks Advisors to Approve Mitomycin for NMIBC
The FDA has approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The intravesical mitomycin formulation is meant to be an alternative to the current standard of care for recurrent disease: Transurethral resection of bladder tumor (TURBT). The surgical procedure is usually done under general anesthesia, while Zusduri can be instilled by a catheter in a urologist's office. Treatment is once a week for 6 weeks. The approval came shortly after the FDA's Oncologic Drugs Advisory Committee met to consider the agency's concern that UroGen's approval study — ENVISION — was a single-arm trial with no direct comparison to TURBT. The agency had concerns about comparative safety because TURBT's side effects are generally limited to the day of the procedure, while Zusduri's side effects span the full 6 weeks of administration. There were also concerns about comparative efficacy. One panelist commented that without a randomized trial, 'it's very hard to determine the true benefit of this, and there is toxicity.' Plus, 'this is a $140,000 treatment that might not change how many follow-up TURBTs you need after 3 months.' The panel voted 5 to 4 that the risk/benefit of Zusduri wasn't favorable based on the available data, but in the end, the FDA apparently decided it was. The multicenter ENVISION trial included 240 adults who had recurred after TURBT and who had multiple tumors, a solitary tumor > 3 cm, and/or a recurrence within 1 year of TURBT. Patients in the trial were treated with 75 mg once a week for 6 consecutive weeks, the approved mitomycin dosage. Among 223 evaluable patients, 78% had a complete response, meaning no detectable disease; 12 months after a complete response, 79% of patients remained recurrence free. As for adverse events, 10% or more patients had 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 events occurred in 12% of patients and included urinary retention (0.8%) and urethral stenosis (0.4%). One patient died of heart failure.
Malaysian Reserve
07-06-2025
- Business
- Malaysian Reserve
URGN INVESTOR DEADLINE: UroGen Pharma Ltd. Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit
SAN DIEGO, June 6, 2025 /PRNewswire/ — The law firm of 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, 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 info@ 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 info@
Business Wire
05-06-2025
- Business
- Business Wire
URGN INVESTOR DEADLINE: 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 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: 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
31-05-2025
- 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.
Yahoo
25-05-2025
- Business
- Yahoo
US FDA Votes in Favor of Benefit-Risk Profile of Johnson & Johnson's DARZALEX FASPRO
On May 20, Johnson & Johnson (NYSE:JNJ) announced that the FDA Oncologic Drugs Advisory Committee/ODAC voted 6-2 in favor of the benefit-risk profile of single-agent DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for treating adult patients with high-risk smoldering multiple myeloma (HR-SMM). This recommendation is a step towards potentially making DARZALEX FASPRO the first treatment to delay or prevent the progression of this condition to active multiple myeloma. A closeup of pills in a pharmacy, representing the high quality medications of the company. An application for this approval was submitted to the FDA in November 2024. Currently, there are no approved treatments specifically for HR-SMM. The ODAC's decision was based on data from the Phase 3 AQUILA study. This was a randomized and open-label trial that evaluated the efficacy and safety of DARZALEX FASPRO versus active monitoring in HR-SMM patients. Smoldering multiple myeloma is an asymptomatic intermediate stage of multiple myeloma. However, ~50% of patients with HR-SMM are likely to develop active disease within 2 to 3 years. The current standard of care for SMM is active monitoring, which can lead to therapeutic intervention only after the detection of end-organ damage. Multiple myeloma is a blood cancer affecting plasma cells in the bone marrow, and it remains incurable. DARZALEX FASPRO received US FDA approval in May 2020 and is currently approved for 9 indications in multiple myeloma, including 4 for frontline treatment. Johnson & Johnson (NYSE:JNJ) engages in the R&D, manufacture, and sale of various products in the healthcare field worldwide. In August 2012, Janssen Biotech Inc. (a subsidiary of Johnson & Johnson) and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture, and commercialize daratumumab. This is the active ingredient in DARZALEX FASPRO. While we acknowledge the potential of JNJ to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than JNJ and that has 100x upside potential, check out our report about the cheapest AI stock. READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
