Latest news with #ApellisPharmaceuticals
Yahoo
15 hours ago
- Health
- Yahoo
Sobi and Apellis report new data from Phase III trial for C3G and IC-MPGN
Sobi and Apellis Pharmaceuticals have reported new results from the open-label period of the randomised Phase III VALIANT trial, assessing Aspaveli (pegcetacoplan) in treating C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). The data were showcased during a late-breaking session at the European Renal Association Congress. This multi-centre, double-blinded, placebo-controlled study aims to assess the efficacy and safety of pegcetacoplan in 124 subjects who are aged 12 years and above with these conditions. Its primary endpoint was the log-transformed ratio in the urine protein-to-creatinine ratio (UPCR) at week 26 versus the baseline. Subjects were randomised and given the therapy or placebo two times a week for 26 weeks. After 26 weeks, the subjects were able to proceed to a 26-week open-label phase in which all of them received the therapy. At week 26, the therapy led to a 68% reduction in proteinuria compared to placebo, a benefit that persisted after one year. Those who received Aspaveli's treatment achieved kidney function stabilisation as per estimated glomerular filtration rate (eGFR) measurements. Subjects who transitioned from placebo to the therapy in the open-label phase experienced similar improvements in proteinuria and kidney function stabilisation. The tolerability and safety profile of Aspaveli, also known as Empaveli, remained favourable and aligned with previous findings, without any safety concerns. C3G and primary IC-MPGN are rare kidney conditions that can result in its failure. Sobi medical affairs and clinical development head Nils Kinnman said: 'The results from the Phase III VALIANT study underscore the potential of Aspaveli in addressing the urgent needs of patients living with the kidney diseases C3G and primary IC-MPGN.' Both companies share worldwide joint development rights for systemic pegcetacoplan, with Sobi holding exclusive rights ex-US and Apellis retaining US commercialisation rights and global rights for ophthalmological pegcetacoplan, inclusive of geographic atrophy. Last year, the companies reported positive topline data from the same Phase III VALIANT trial assessing pegcetacoplan in treating C3G and primary IC-MPGN. "Sobi and Apellis report new data from Phase III trial for C3G and IC-MPGN" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. 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 days ago
- Business
- Yahoo
Apellis, Sobi present data from open-label period of Phase 3 VALIANT study
Apellis Pharmaceuticals (APLS) and Sobi (BIOVF) presented new data from the open-label period of the Phase 3 VALIANT study, investigating EMPAVELI for C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis. The data were presented as part of a late-breaking session at the European Renal Association Congress. In the VALIANT study, EMPAVELI demonstrated a statistically significant 68% proteinuria reduction versus placebo at Week 26, which was sustained at one year. Additionally, patients treated with EMPAVELI continued to achieve stabilization of kidney function as measured by estimated glomerular filtration rate. 'The one-year Phase 3 results are very compelling, confirming EMPAVELI's sustained benefits across key markers of disease,' said Fadi Fakhouri, presenting author, co-lead principal investigator for the VALIANT study, and professor of nephrology at CHUV Lausanne. 'Given the high risk of kidney failure, treatment efficacy is incredibly important to C3G and primary IC-MPGN patients, many of whom are in the prime of their lives. These data further underscore the potential of EMPAVELI to make a meaningful difference for patients.' In patients who switched from placebo to EMPAVELI at the start of the open-label period, EMPAVELI demonstrated a similar magnitude of benefit in proteinuria reduction and stabilization of kidney function. EMPAVELI showed favorable safety and tolerability, consistent with its established profile. There were no new safety signals. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on APLS: Disclaimer & DisclosureReport an Issue Apellis Pharmaceuticals Holds Annual Stockholders Meeting Apellis price target raised to $29 from $26 at Wells Fargo Cautious Hold on Apellis Pharmaceuticals Amid Uncertainties with Pegcetacoplan Launch and Financial Stability Apellis price target lowered to $41 from $49 at Citi Apellis price target lowered to $20 from $30 at Mizuho 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
4 days ago
- Business
- Yahoo
High Growth Tech Stocks To Watch In The US June 2025
As the U.S. market experiences a modest rebound with key indices like the S&P 500 and Nasdaq Composite extending their winning streaks, investors are closely monitoring developments in trade talks and upcoming economic reports that could influence market sentiment. In this environment, high growth tech stocks present intriguing opportunities for those looking to capitalize on innovation and resilience amidst fluctuating trade policies and economic conditions. Name Revenue Growth Earnings Growth Growth Rating Super Micro Computer 26.38% 39.09% ★★★★★★ Mereo BioPharma Group 53.63% 66.57% ★★★★★★ Ardelyx 20.78% 59.46% ★★★★★★ Travere Therapeutics 26.41% 64.47% ★★★★★★ TG Therapeutics 26.46% 38.75% ★★★★★★ AVITA Medical 27.28% 60.66% ★★★★★★ Alkami Technology 20.54% 76.67% ★★★★★★ Alnylam Pharmaceuticals 23.64% 61.12% ★★★★★★ Ascendis Pharma 35.15% 60.20% ★★★★★★ Lumentum Holdings 22.24% 111.72% ★★★★★★ Click here to see the full list of 228 stocks from our US High Growth Tech and AI Stocks screener. We're going to check out a few of the best picks from our screener tool. Simply Wall St Growth Rating: ★★★★★☆ Overview: TeraWulf Inc. operates as a digital asset technology company in the United States, with a market cap of $1.62 billion. Operations: The company generates revenue primarily through digital currency mining, amounting to $132.02 million. TeraWulf, navigating the volatile tech landscape, has demonstrated a robust growth trajectory with an annual revenue increase of 38.3%, outpacing the US market average of 8.6%. Despite current unprofitability, projections indicate a potential shift to profitability within three years, supported by an aggressive R&D focus which underscores its commitment to innovation. Recent strategic moves include a significant share repurchase totaling $151.36 million and expansionary activities such as filing for a $22.79 million Shelf Registration, signaling confidence in future growth prospects and operational scalability in high-tech sectors. Get an in-depth perspective on TeraWulf's performance by reading our health report here. Review our historical performance report to gain insights into TeraWulf's's past performance. Simply Wall St Growth Rating: ★★★★★☆ Overview: Apellis Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company dedicated to discovering, developing, and commercializing novel therapeutic compounds for diseases with high unmet needs, with a market cap of $2.37 billion. Operations: Apellis Pharmaceuticals focuses on developing and commercializing novel therapeutic compounds, generating $775.84 million in revenue from this segment. The company operates within the biopharmaceutical sector and targets diseases with significant unmet needs. Apellis Pharmaceuticals, amid a challenging landscape for biotech firms, is poised for significant transitions with expected profitability in three years, supported by a forecasted annual earnings growth of 64.2%. Despite current unprofitability and a recent dip in quarterly revenue to $166.8 million from $172.33 million year-over-year, the firm's commitment to innovation is underscored by substantial R&D investments linked directly to its strategic goals. Notably, Apellis's focus on developing treatments for rare diseases was highlighted at multiple industry conferences and reinforced by the FDA's Priority Review designation for its leading drug candidate, showcasing potential future revenue streams and industry impact. Click here to discover the nuances of Apellis Pharmaceuticals with our detailed analytical health report. Gain insights into Apellis Pharmaceuticals' past trends and performance with our Past report. Simply Wall St Growth Rating: ★★★★★☆ Overview: Commvault Systems, Inc. offers a cyber resilience platform focused on data protection and recovery for cloud-native applications across the Americas and internationally, with a market cap of $8.09 billion. Operations: The company's primary revenue stream is from its Software & Programming segment, generating $995.62 million. Commvault Systems, despite a challenging year with earnings declining by 54.9%, is gearing up for substantial growth with an anticipated annual earnings increase of 26.4%. This optimism is bolstered by strategic advancements like extending Kubernetes protection and forming alliances such as the one with Deloitte, aimed at enhancing cyber resilience. At the forefront of innovation, Commvault's R&D expenses have strategically fueled these developments, ensuring the company remains competitive in a rapidly evolving tech landscape. Furthermore, their recent product enhancements and partnerships underscore a commitment to robust cybersecurity solutions, crucial for maintaining client trust and sector relevance in today's digital economy. Click to explore a detailed breakdown of our findings in Commvault Systems' health report. Understand Commvault Systems' track record by examining our Past report. Reveal the 228 hidden gems among our US High Growth Tech and AI Stocks screener with a single click here. Hold shares in these firms? Setup your portfolio in Simply Wall St to seamlessly track your investments and receive personalized updates on your portfolio's performance. Simply Wall St is your key to unlocking global market trends, a free user-friendly app for forward-thinking investors. Explore high-performing small cap companies that haven't yet garnered significant analyst attention. Fuel your portfolio with companies showing strong growth potential, backed by optimistic outlooks both from analysts and management. Find companies with promising cash flow potential yet trading below their fair value. 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 WULF APLS and CVLT. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
Yahoo
7 days ago
- Business
- Yahoo
Why Apellis Pharmaceuticals, Inc. (APLS) Skyrocketed On Monday
We recently published a list of . In this article, we are going to take a look at where Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) stands against other top-performing stocks on Monday. Apellis Pharmaceuticals surged by 13.05 percent on Monday to finish at $19.14 apiece after earning a higher price target from an investment firm. On Monday, Wells Fargo raised its price target for the company to $29 from $26 previously, while maintaining an 'equal weight' rating for the stock. Wells Fargo said that the adjustment reflected its optimism about Apellis Pharmaceuticals, Inc.'s (NASDAQ:APLS) potential treatment for rare kidney diseases C3G and IC-MPGN, which could bolster opportunities for the company. A biomedical scientist in a lab coat conducting research on biopharmaceutical compounds. Wells Fargo expected the treatment to secure an approval, but underscored the need for a clearer understanding of its potential downside risks before becoming more optimistic on the stock. In the first quarter of the year, Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) widened its net loss by 39 percent to $92 million from $66 million in the same period last year. Revenues inched up by 3 percent to $166.8 million from $172.3 million year-on-year. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. 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
7 days ago
- Business
- Yahoo
Why Apellis Pharmaceuticals, Inc. (APLS) Skyrocketed On Monday
We recently published a list of . In this article, we are going to take a look at where Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) stands against other top-performing stocks on Monday. Apellis Pharmaceuticals surged by 13.05 percent on Monday to finish at $19.14 apiece after earning a higher price target from an investment firm. On Monday, Wells Fargo raised its price target for the company to $29 from $26 previously, while maintaining an 'equal weight' rating for the stock. Wells Fargo said that the adjustment reflected its optimism about Apellis Pharmaceuticals, Inc.'s (NASDAQ:APLS) potential treatment for rare kidney diseases C3G and IC-MPGN, which could bolster opportunities for the company. A biomedical scientist in a lab coat conducting research on biopharmaceutical compounds. Wells Fargo expected the treatment to secure an approval, but underscored the need for a clearer understanding of its potential downside risks before becoming more optimistic on the stock. In the first quarter of the year, Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) widened its net loss by 39 percent to $92 million from $66 million in the same period last year. Revenues inched up by 3 percent to $166.8 million from $172.3 million year-on-year. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey.
