FDA Approves AstraZeneca's Imfinzi As First Perioperative Immunotherapy For Muscle-Invasive Bladder Cancer Patients
The FDA approval was based on results from the NIAGARA Phase 3 trial.
In a planned interim analysis, the Imfinzi-based perioperative regimen demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm.
Also Read:
The estimated median event-free survival (EFS) has not yet been reached for the Imfinzi arm versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the regimen were event-free at two years compared to 59.8% in the comparator arm.
Results from the key secondary endpoint of overall survival (OS) showed that the Imfinzi-based perioperative regimen reduced the risk of death by 25% versus neoadjuvant chemotherapy with radical cystectomy.
Median survival was not yet reached for either arm. An estimated 82.2% of patients treated with the regimen were alive at two years compared to 75.2% in the comparator arm.
Concurrently, AstraZeneca's Calquence (acalabrutinib) in combination with bendamustine and rituximab was recommended for approval in the European Union for adult patients with previously untreated mantle cell lymphoma who are not eligible for autologous hematopoietic stem cell transplantation.
The positive opinion was based on the ECHO Phase 3 trial results.
Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy.
Median PFS was 66.4 months for patients treated with the Calquence combination versus 49.6 with chemoimmunotherapy alone.
Price Action: AZN stock is down 0.86% at $73.16 at the last check Monday.
Read Next:Image by Robert Way via Shutterstock
UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets.
Get the latest stock analysis from Benzinga?
ASTRAZENECA (AZN): Free Stock Analysis Report
This article FDA Approves AstraZeneca's Imfinzi As First Perioperative Immunotherapy For Muscle-Invasive Bladder Cancer Patients originally appeared on Benzinga.com
© 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
13 minutes ago
- Yahoo
Amazon Founder Jeff Bezos Loses $17 Billion Following Company's Mixed Q2 Earnings
Benzinga and Yahoo Finance LLC may earn commission or revenue on some items through the links below. Jeff Bezos, the founder and Executive Chairman of Inc. (NASDAQ:AMZN), saw his net worth take a plunge, alongside the shares of his company, following its second quarter results last week. What Happened: The fourth-richest man in the world, with a net worth of $237 billion, according to the Bloomberg Billionaires Index, lost $17 billion last week on Friday, from $254 billion the prior day, after investors were unimpressed with the company's second-quarter earnings. The stock was down 8.27% on Friday, following the company's results, despite it beating consensus estimates on sales and earnings. Don't Miss: 7,000+ investors have joined Timeplast's mission to eliminate microplastics— This AI-Powered Trading Platform Has 5,000+ Users, 27 Pending Patents, and a $43.97M Valuation — You Can Become an Investor for Just $500.25 This was largely attributed to the slowing momentum in the company's AWS cloud computing segment, which generated $10.2 billion in sales during the quarter, up 17.5% year-over-year, which fell short of consensus estimates at 20%. Amazon shares currently constitute a significant chunk of Bezos' net worth, with 884 million shares, or 8.3% of total shares outstanding, which, at the stock's current market price, is valued at $190 billion. The rest of his fortune comprises Blue Origin, his space exploration company, which, being privately held, is valued at the cost of investment. Why It Matters: According to analyst Eric Allen of Stealth, the market's reaction to the company's earnings was 'totally wrong,' since this was a capacity issue, with Amazon unable to meet the growing demand for its AWS computing resources. Amazon reported $167.7 billion in sales during the quarter, up 13% year-over-year, and ahead of consensus estimates at $161.9 billion. It posted a profit of $1.68 per share, which again beat analyst consensus estimates at $1.30. Bezos has been consistently offloading his stake in the company he founded, having sold 95 million shares in 2024 and 2025 so far, with net proceeds of $18.2 billion. Read More: $100k+ in investable assets? Match with a fiduciary advisor for free to learn how you can maximize your retirement and save on taxes – no cost, no obligation. If there was a new fund backed by Jeff Bezos offering a 7-9% target yield with monthly dividends would you invest in it? Photo courtesy: Shutterstock This article Amazon Founder Jeff Bezos Loses $17 Billion Following Company's Mixed Q2 Earnings originally appeared on Sign in to access your portfolio
Miami Herald
27 minutes ago
- Miami Herald
Palantir's blockbuster results sparks stock surge
Concerns were raging earlier this year that the artificial intelligence revolution was overhyped and AI stocks were due for a reckoning. It certainly felt like that were true this spring, when stocks got battered amid worries over peak AI spending and growing fear that the US economy was destined for recession. The risk-off environment led to a 24% drop in the technology-laden Nasdaq, and even bigger losses for individual stocks like Palantir Technologies, which tumbled 47% from its February peak to April's low. Don't miss the move: Subscribe to TheStreet's free daily newsletter Those concerns, however, have yet to materialize, and stocks, including Palantir, have produced substantial returns since April 8. The Nasdaq has rallied nearly 40% and Palantir, which is increasingly being viewed as an AI lynchpin, has seen its stock price more than double. The reality is that while concerns remain, there's little to suggest that companies are tapping their brakes on AI investments, and Palantir's latest quarterly results and guidance suggest spending strength will continue to prop up its business this year. The first wave of AI development centered on large language models, or chatbots, that could digest huge data sets and parse data based on user questions, including OpenAI's ChatGPT, Anthropic's Claude, Perplexity, and Google's Gemini. The spending on network infrastructure to support creating those chatbots was enormous, with hundreds of billions flowing out of enterprises and cloud service providers, including hyperscalers, to buy semiconductor chips from Nvidia and servers from Super Micro and Dell. Related: Major analyst who forecast stocks' rally sends 3-word message to investors While that spending is likely to continue, R&D is increasingly shifting to the second wave of AI -- solutions like agentic AI that can be used to assist and in some cases replace workers across industries. Developing those AI apps, however, isn't easy, especially since it requires breaking down data silos to find solutions securely. To do that, companies need help, and increasingly, they're turning to Palantir's Artificial Intelligence Platform. Palantir's (PLTR) roots stretch back to the early 2000s, when the Peter-Thiel founded company was tasked with securing data for the Defense Department. It still does a ton of work for the government, but recently, its seen explosive demand for AIP within companies using Palantir's Foundry platform. As a result, Palantir's sales and earnings are surging. The company's second quarter earnings results show solid and growing demand for its service. Palantir's revenue jumped 48% year-over-year to $1 billion, $61 million better than Wall Street was expecting. As a result, earnings per share (EPS) increased to 16 cents per share, 2 cents higher than analysts forecast, and up 78% from one year ago thanks to improving profit margins. Related: Apple CEO drops bombshell about its future Government deals contributed to the revenue beat, but the real shining star during the quarter was demand from corporations. US sales were up 68% from last year, reaching $733 million. US government revenue rose 53% to $426 million, while commercial revenue surged 93% to $306 million. "It's a blowout across the board. I mean, look, that's why they're the Messi of AI, right? I mean, it just speaks to, this is transformational, the type of growth they're seeing," said Wedbush Securities influential technology analyst Dan Ives on Yahoo!Finance. "I've covered tech 25 years. This is unprecedented territory. It speaks to our view. It's a trillion dollar market cap in the next two to three years." The company closed contracts worth a record $2.27 billion, including commercial deals worth $843 million, up 222% from one year ago. Net income of $327 million helped its cash and investment securities stockpile grow to above $6 billion from about 5.2 billion coming into the year. That's a lot of financial flexibility, especially given that the company is debt free. The growth rate of our business has accelerated radically, after years of investment on our part and derision by some," said CEO Alex Karp. "The skeptics are admittedly fewer now, having been defanged and bent into a kind of submission. Yet we see no reason to pause, to relent, here." The company's CEO, Alex Karp, expects the good times to not only continue but accelerate. Palantir raised its full year revenue guidance to between $4.142 billion and $4.15 billion. Consensus analyst forecasts were targeting $3.9 billion. For a startup, even one only a thousandth of our size, this growth rate would be striking," said Karp. "For a business of our scale, however, it is, we continue to believe, nearly without precedent or comparison." Palantir expects commercial deals to continue to be the big driver, guiding for US commercial revenue of $1.3 billion, up at least 85%. Palantir is also targeting adjusted income from operations of $1.912 billion to $1.92 billion and it raised its adjusted free cash flow guidance to between $1.8 billion to $2 billion. Overall, it expects to remain profitable throughout 2025. Currently, Wall Street consensus targets full year EPS of 58 cents, up from 55 cents ninety days ago. It wouldn't be surprising to see those earnings estimates climb more in the coming days following the updated guidance. Following the second-quarter results, Palantir's shares are up 4.6% to $168, a new all-time high. That move isn't going to let those concerned about the company's valuation sleep any better. Palantir was already trading with a forward price to earnings ratio (a key valuation measure) of 276, making it among one of priciest stocks out there. For comparison, the S&P 500's forward P/E is 22.4. Technology stocks often command higher than normal valuations, but even the price to sales ratio is arguably stretched, given shares are trading at about 123 times sales. Given that backdrop, Palantir is arguably priced to perfection, so it will need to continue to put up similarly eye-popping growth from here to keep investors happy. Todd Campbell owns Palantir shares. Related: Nvidia AI outlook resets after Meta Platforms, Microsoft update plans The Arena Media Brands, LLC THESTREET is a registered trademark of TheStreet, Inc.
Yahoo
an hour ago
- Yahoo
Should You Invest in Fractional Real Estate or Just Buy a REIT?
Benzinga and Yahoo Finance LLC may earn commission or revenue on some items through the links below. If you're looking to invest in real estate without the hassle of managing a property yourself, you're probably deciding between two major options: buying into a REIT (real estate investment trust) or using a platform like Arrived, which lets you invest directly in individual rental homes with as little as $100. On the surface, both offer a way to earn passive income and diversify outside of the stock market. But once you dig into the details, these two options are actually very different—and which one is right for you depends on what kind of investor you are. REITs are often pitched as the "set it and forget it" way to invest in real estate. You buy shares like a stock, and the REIT takes care of owning and managing properties. But you don't get to choose what those properties are, and you typically don't get the same tax benefits or direct ownership perks that come with owning physical real estate. That's where Arrived stands out. It gives you the chance to pick the homes you want to invest in, earn quarterly rental income, and get a share of the appreciation if the home goes up in value—all without ever becoming a landlord. So which one's better? Let's break it down. What Is a REIT, and Why Do People Invest in Them? REITs are publicly traded companies that own and operate income-producing real estate—think office buildings, apartment complexes, shopping centers, and warehouses. When you buy a REIT, you're essentially buying stock in a company that makes its money from collecting rent and managing properties. You don't own any specific property yourself, but you do get paid a portion of the income as dividends, typically on a monthly or quarterly basis. The upside? Liquidity. You can buy and sell REIT shares just like you would any stock. That makes them easy to trade, easy to diversify, and easy to access through regular brokerage accounts or retirement plans. For many investors, that simplicity is the main draw. You don't need to do much homework or track individual properties—you're trusting the REIT's management team to handle everything behind the scenes. But here's the tradeoff: when you invest in a REIT, you're buying into a giant pool of assets, and you don't have any say in what those assets are. You're also not treated like a direct owner, which means you miss out on some of the tax benefits—like depreciation and expense write-offs—that come with actual real estate ownership. Don't Miss: 'Scrolling To UBI' — Deloitte's #1 fastest-growing software company allows users to earn money on their phones. You can invest today for just $0.30/share. Warren Buffett once said, "If you don't find a way to make money while you sleep, you will work until you die." Here's how you can earn passive income with just $100. What Arrived Does Differently Arrived takes a very different approach. Instead of pooling your money into a fund, it lets you invest in individual homes—mostly single-family rentals across the U.S. Each property is owned by an LLC, and you buy shares in that LLC. The minimum investment? Just $100. From there, Arrived takes care of everything: they vet and acquire the home, hire a local property manager, find tenants, collect rent, and handle maintenance. You just collect your portion of the rent as passive income every quarter—and when the property is sold after a 5–7 year hold period, you also get your share of any profits from appreciation. This structure means you have more control. You pick which homes to invest in. You see full financial projections, including rent estimates, expense breakdowns, and expected returns. You can diversify across cities, types of homes, and even different property strategies (like vacation rentals). And because you're a direct equity holder, you get access to tax benefits that traditional REIT shareholders don't. The best part? No landlord duties. You don't answer phone calls. You don't fix leaks. You don't even have to think about it. You're earning real estate income from real homes—without the job of owning them. How They CompareFeature REITs Arrived Minimum Investment As low as 1 share ($10–$100) $100 minimum per property Liquidity Highly liquid (traded on stock exchanges) Illiquid (5–7 year hold period) Asset Selection You don't choose the properties You hand-pick each property Ownership Indirect (stockholder in a company) Direct (equity in property-specific LLC) Tax Benefits Limited (no pass-through depreciation) Yes (depreciation, expense allocation) Payouts Dividends (monthly or quarterly) Rent-based dividends (quarterly) Property Type Commercial-focused Single-family and short-term rentals Risk Profile Market-linked volatility Property-based cash flow + appreciation So which one's better? If you want liquidity and don't care about property-level control, a REIT might make more sense. But if you want to build a real estate portfolio one home at a time, earn rental income with more transparency, and enjoy tax advantages, Arrived gives you far more ownership and far less noise. The Tax Angle Most Investors Miss One of the most overlooked differences between REITs and Arrived is how they're treated at tax time. REIT dividends are taxed as ordinary income, and you don't benefit from the property-level deductions or depreciation that traditional landlords enjoy. But with Arrived, because you're technically a member of an LLC that owns a specific property, you can receive a share of the tax benefits. That includes things like depreciation (which lowers your taxable income on paper), maintenance deductions, and write-offs for capital expenses. Over time, this can add up to meaningful savings—especially if you continue reinvesting your income to grow your portfolio. It's the kind of benefit you wouldn't think about at first glance, but it's a real reason why Arrived feels more like property ownership than simply holding a stock. So, Should You Choose Arrived or a REIT? There's no universal answer—it depends on what you're optimizing for. If you want real estate exposure with zero commitment, fast liquidity, and the ability to buy and sell with a few clicks, REITs are the easy answer. But if you want deeper ownership, long-term rental income, and more direct control over what you're investing in, Arrived offers something REITs can't: a true stake in actual homes, with real tenants, managed on your behalf for as little as $100. And while REITs fluctuate with the market just like any stock, Arrived's performance is tied to local rental markets, occupancy rates, and property appreciation—not the S&P 500. That makes it a compelling way to diversify your portfolio and build passive income over time, especially in markets where real estate is holding strong even when stocks don't. See Next: Maximize saving for your retirement and cut down on taxes: Schedule your free call with a financial advisor to start your financial journey – no cost, no obligation. It's no wonder Jeff Bezos holds over $250 million in art — this beloved alternative asset has outpaced the S&P 500 since 1995, delivering an average annual return of 11.4%. This article Should You Invest in Fractional Real Estate or Just Buy a REIT? originally appeared on 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
