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 https://www.bfalaw.com/cases-investigations/urogen-pharma-ltd-class-action-lawsuit.
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: https://www.bfalaw.com/cases-investigations/urogen-pharma-ltd-class-action-lawsuit.
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:
https://www.bfalaw.com/cases-investigations/urogen-pharma-ltd-class-action-lawsuit
Or contact:Ross Shikowitz
[email protected]
212-789-3619
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
2 hours ago
- Yahoo
Sarepta Therapeutics (NasdaqGS:SRPT) Gains 19% Over Past Month Following Japan Approval
Sarepta Therapeutics saw its share price rise by 19% over the past month, a move that notably outpaced the broader market's 1% increase for the week and the 13% gain over the year. This significant increase can be partially attributed to several key announcements, including the FDA's platform technology designation for their rAAVrh74 viral vector, pivotal updates from ongoing studies related to their ELEVIDYS treatment for Duchenne Muscular Dystrophy, and new approval in Japan. These developments highlight the company's continued progress and innovation in gene therapy, reinforcing investor confidence amidst market growth. We've identified 2 weaknesses for Sarepta Therapeutics (1 is a bit concerning) that you should be aware of. Diversify your portfolio with solid dividend payers offering reliable income streams to weather potential market turbulence. Recent developments for Sarepta Therapeutics have sparked a positive response in short-term share price, primarily driven by advancements in their gene therapy programs. These innovations, particularly the FDA's designation and updates on the ELEVIDYS program, are poised to bolster investor confidence. However, despite this optimism, it's essential to acknowledge that Sarepta's shares have experienced a 37.80% decline over the past three years, highlighting challenges the company has faced. Relative to the biotechnology industry, Sarepta has underperformed in the past year compared to the US Biotechs market, which returned -9.3%. The recent announcements could potentially impact Sarepta's revenue and earnings forecasts considerably. Analysts project a significant annual revenue increase over the next three years, with expectations that profit margins will improve. Crucially, these updates could address operational delays and safety concerns surrounding ELEVIDYS, enhancing the therapy's credibility and market uptake. In terms of valuation, Sarepta's recent share price movements are in the context of an analyst price target of US$89.96, indicating further room for growth if the company's strategic objectives translate into financial success. These factors collectively shape a complex but promising outlook for Sarepta as it navigates both opportunities and challenges in its field. The valuation report we've compiled suggests that Sarepta Therapeutics' current price could be quite moderate. This 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. Companies discussed in this article include NasdaqGS:SRPT. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ 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
Yahoo
2 hours ago
- Yahoo
Sarepta Therapeutics (NasdaqGS:SRPT) Gains 19% Over Past Month Following Japan Approval
Sarepta Therapeutics saw its share price rise by 19% over the past month, a move that notably outpaced the broader market's 1% increase for the week and the 13% gain over the year. This significant increase can be partially attributed to several key announcements, including the FDA's platform technology designation for their rAAVrh74 viral vector, pivotal updates from ongoing studies related to their ELEVIDYS treatment for Duchenne Muscular Dystrophy, and new approval in Japan. These developments highlight the company's continued progress and innovation in gene therapy, reinforcing investor confidence amidst market growth. We've identified 2 weaknesses for Sarepta Therapeutics (1 is a bit concerning) that you should be aware of. Diversify your portfolio with solid dividend payers offering reliable income streams to weather potential market turbulence. Recent developments for Sarepta Therapeutics have sparked a positive response in short-term share price, primarily driven by advancements in their gene therapy programs. These innovations, particularly the FDA's designation and updates on the ELEVIDYS program, are poised to bolster investor confidence. However, despite this optimism, it's essential to acknowledge that Sarepta's shares have experienced a 37.80% decline over the past three years, highlighting challenges the company has faced. Relative to the biotechnology industry, Sarepta has underperformed in the past year compared to the US Biotechs market, which returned -9.3%. The recent announcements could potentially impact Sarepta's revenue and earnings forecasts considerably. Analysts project a significant annual revenue increase over the next three years, with expectations that profit margins will improve. Crucially, these updates could address operational delays and safety concerns surrounding ELEVIDYS, enhancing the therapy's credibility and market uptake. In terms of valuation, Sarepta's recent share price movements are in the context of an analyst price target of US$89.96, indicating further room for growth if the company's strategic objectives translate into financial success. These factors collectively shape a complex but promising outlook for Sarepta as it navigates both opportunities and challenges in its field. The valuation report we've compiled suggests that Sarepta Therapeutics' current price could be quite moderate. This 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. Companies discussed in this article include NasdaqGS:SRPT. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
Business Upturn
5 hours ago
- Business Upturn
Bitcoin Solaris Presale Surges Past $3.8M as Final $6 Phase Nears Close
By GlobeNewswire Published on June 8, 2025, 16:11 IST TALLINN, Estonia, June 08, 2025 (GLOBE NEWSWIRE) — The crypto community is buzzing as Bitcoin Solaris (BTC-S) crosses a major milestone, raising $3.8 million in its ongoing presale. With over 11,000 participants already onboard and the token price still at just $6, this marks one of the most rapid early-stage raises of 2025. Built with a clear focus on speed, decentralization, and developer-ready infrastructure, Bitcoin Solaris is more than just another token—it's a full-stack blockchain ecosystem gearing up for mainnet launch. The current phase of the presale is expected to end within days, ahead of the next price jump to $7. Why Bitcoin Solaris Is Outpacing the Crypto Pack Bitcoin Solaris was built to take the best of each and leave the problems behind. Here's how it does that: Combines Proof-of-Work and Delegated Proof-of-Stake for a dual-consensus model. Runs up to 100,000 TPS on the Solaris Layer, with 2-second finality. Secures its Base Layer with SHA-256, keeping it compatible with existing mining rigs. Includes 21 rotating validators, ensuring decentralization with performance. Why Everyone Is Talking About It From top Telegram groups to influencer channels, the buzz around Bitcoin Solaris is only growing. The detailed breakdown by Ben Crypto highlights why this project stands out in a sea of overpromises. With real use cases, deep audits, and a scalable structure, the hype isn't artificial—it's earned. What makes this even more incredible? The presale isn't even over yet. Current phase: 6 (last day) Current price: $6 Next phase: $7 Launch price: $20 Potential return: 1,900% Already raised: $3.8 million This is being hailed as one of the shortest and most explosive presales in recent memory, and the countdown has officially begun. Core Features That Power the Frenzy At the heart of Bitcoin Solaris is one idea: speed without compromise. Let's break down why it's different: Hybrid PoW/DPoS Consensus: Maintains decentralization while enabling speed. Validator Rotation: Every 24 hours, keeping the system agile and secure. Energy Efficiency: Uses 99.95% less power than Bitcoin. Cross-Chain Bridges: Built-in support for interoperability with Solana and others. Rust-Based Smart Contracts: Initially leveraging Solana tools for dApps and DeFi expansion. Audited Infrastructure: Smart contracts have been fully reviewed by Cyberscope and Freshcoins for trust and security. This Is How Bitcoin Solaris Will Make People Rich Wealth isn't made by buying late. It's built by spotting what's early—but solid. Bitcoin Solaris isn't a copycat. It's a new layer of infrastructure designed to generate value for real participants. The reward distribution model ensures that every piece of the network feeds back into the community: 40% of rewards go to miners 25% go to validators 20% go to stakers 10% funds for long-term development 5% support community initiatives Unlike many coins where wealth consolidates at the top, BTC-S is structured to empower long-term holders, contributors, and those who participate early. Real Vision, Real Roadmap Bitcoin Solaris isn't pitching hope—it's executing a plan. Here's the official roadmap: Bitcoin Solaris Roadmap Summary Phase 1 (Q2–Q4 2025): Token generation, whitepaper, core devs, and presale launch Phase 2 (Q1 2026): Testnet, wallet, bridge integration, architecture optimization Phase 3 (Q2 2026): Final mainnet prep, dev tools, exchange listings Phase 4 (Q3 2026): Mainnet launch, AI-powered app release, governance rollout Phase 5 (Q4 2026): DApp accelerator, Mining Power Marketplace, hardware wallet integration Phase 6 (Q1–Q2 2027): Layer-2 upgrades, DEX, and quantum security Phase 7 (Q3–Q4 2027): Fortune 500 partnerships, institutional tools, Innovation Labs Phase 8 (2028+): AI integration, government collaborations, long-term evolution That's not just a vision board—it's an execution framework already in motion. The Final Surge Is On Bitcoin Solaris isn't just another token looking for attention. It's a serious infrastructure play backed by smart tech, audited code, and a growing army of supporters. With $3.8 million raised and momentum accelerating, this is one of the few presales that feels like more than a hype train. And with the price still sitting at just $6 for a very short time—this might be the final opportunity to ride the wave before it takes off. For more information on Bitcoin Solaris: Website: Telegram: X: Media ContactXander Levine [email protected] Press Kit: Available upon request Disclaimer: This is a paid post and is provided by Bitcoin Solaris . The statements, views, and opinions expressed in this content are solely those of the content provider and do not necessarily reflect the views of this media platform or its publisher. We do not endorse, verify, or guarantee the accuracy, completeness, or reliability of any information presented. We do not guarantee any claims, statements, or promises made in this article. This content is for informational purposes only and should not be considered financial, investment, or trading in crypto and mining-related opportunities involves significant risks, including the potential loss of capital. It is possible to lose all your capital. These products may not be suitable for everyone, and you should ensure that you understand the risks involved. Seek independent advice if necessary. Speculate only with funds that you can afford to lose. Readers are strongly encouraged to conduct their own research and consult with a qualified financial advisor before making any investment decisions. However, due to the inherently speculative nature of the blockchain sector—including cryptocurrency, NFTs, and mining—complete accuracy cannot always be the media platform nor the publisher shall be held responsible for any fraudulent activities, misrepresentations, or financial losses arising from the content of this press release. In the event of any legal claims or charges against this article, we accept no liability or responsibility. Globenewswire does not endorse any content on this page. Legal Disclaimer: This media platform provides the content of this article on an 'as-is' basis, without any warranties or representations of any kind, express or implied. We assume no responsibility for any inaccuracies, errors, or omissions. We do not assume any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information presented herein. Any concerns, complaints, or copyright issues related to this article should be directed to the content provider mentioned above. Photos accompanying this announcement are available at: Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
