Court dismisses United Therapeutics' dispute against Liquidia
Liquidia Corporation (LQDA) announced that Judge Kelly of the U.S. District Court for the District of Columbia dismissed, without prejudice, the cross-claim filed by United Therapeutics (UTHR) that sought to challenge Liquidia's amendment to its New Drug Applicationfor YUTREPIA inhalation powder, which added the treatment of pulmonary hypertension associated with interstitial lung disease to the proposed label for YUTREPIA. In its ruling, the District Court determined that UTHR's claim was unripe and that UTHR had failed to plausibly allege that it has standing. Dr. Roger Jeffs, CEO, Liquidia said: 'We are pleased with the court's decision to dismiss this cross-claim, specifically holding that UTHR failed to establish standing. We also continue to believe that the FDA was correct to accept, and subsequently tentatively approve, our amended NDA for YUTREPIA to include the PH-ILD indication. We remain laser focused on the potential final approval of YUTREPIA following the expiration of gating regulatory exclusivity on May 23, 2025, and look forward to delivering what we believe will become the prostacyclin of first choice for patients with PAH and PH-ILD and the physicians who treat them.' UTHR has the right to appeal the Court's ruling. The FDA has set a Prescription Drug User Fee Act goal date for the YUTREPIA NDA of May 24, 2025.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
3 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
3 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
6 hours ago
- 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
