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2026-06-12 21:26
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2026-04-28 17:51
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Ventas, Inc. (VTR) Q1 2026 Earnings Call Transcript | FMP Stock News | |
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2026-06-12 21:26
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2026-04-29 14:41
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Welltower's Q1 FFO Beat Estimates on Strong SHO NOI Growth | FMP Stock News | |
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Key Takeaways WELL beat Q1 estimates with $1.47 normalized FFO per share and $3.35 billion in revenues.Welltower's SHO portfolio posted 22.1% SSNOI growth as occupancy climbed to 89.0%.WELL raised 2026 normalized FFO guidance to $6.21-$6.35 and held $11.1 billion in liquidity. Welltower Inc. (WELL - Free Report) reported first-quarter 2026 normalized funds from operations (FFO) of $1.47 per share, topping the Zacks Consensus Estimate of $1.45 by 1.38%. Total revenues of $3.35 billion beat the consensus mark of $3.23 billion by 3.68% and rose 38.3% year over year.Results reflected continued strength in the seniors housing operating (SHO) portfolio, where same-store net operating income (SSNOI) growth remained robust and occupancy gains supported margin recovery. Total portfolio year-over-year SSNOI increased 16.4% in the quarter, led by SHO performance. WELL’s Revenue Mix Tilted Toward Resident FeesWelltower’s top line was driven primarily by resident fees and services, reflecting the scale of its operating exposure. Resident fees and services rose 49.1% year over year to $2.78 billion in the first quarter, forming the bulk of total revenues. Other revenue lines were comparatively smaller and moved in a mixed fashion. Rental income slipped 1.7% year over year to $453.8 million, while interest income increased 13.5% to $70.9 million and other income rose 34% to $46.2 million. WELL’s SHO Portfolio Drove Operating LeverageWelltower’s SHO portfolio delivered another quarter of outsized SSNOI growth. Same-store revenues rose 9.5% year over year to $1.72 billion, supported by a 370-basis-point occupancy gain to 89.0% in the first quarter of 2026. Operating leverage showed up in profitability and margins. Same-store operating expenses increased 4.7% to $1.19 billion, well below the pace of revenue growth, lifting SSNOI 22.1% to $531.8 million. SSNOI margin expanded to 30.9% from 27.7% a year ago, a 320-basis-point improvement. WELL Expanded Capital Deployment While Recycling AssetsCapital allocation remained active. During the first quarter, Welltower completed $3.3 billion of pro rata gross investments and, year to date though April 28, 2026, closed or was under contract to close $10.5 billion of investment activity. The company also continued to recycle capital through dispositions and loan repayments. In the quarter, it completed $2.8 billion of pro rata dispositions and loan repayments, including $1.4 billion of outpatient medical dispositions, $524 million of sales of long-term/post-acute care properties and $873 million of loan repayments. WELL Ended Q1 With Low Leverage and Deep LiquidityWELL’s balance sheet position remained a notable support for its external growth strategy. As of March 31, 2026, the company reported Net Debt to Adjusted EBITDA of 2.73x and approximately $11.1 billion of available liquidity, including $4.8 billion of cash and restricted cash plus full capacity under its $6.25 billion line of credit. The company also highlighted recent financing actions that improved flexibility and reduced refinancing pressure, including the expansion of its senior unsecured revolving credit line and the repayment of $700 million of senior unsecured notes at maturity in April using free cash flow. With leverage low and liquidity substantial, Welltower appears positioned to pursue announced investment pipelines while maintaining balance sheet capacity for additional opportunities. WELL Raised 2026 Outlook on NOI MomentumManagement lifted 2026 guidance following the first-quarter performance. The company raised its full-year normalized FFO outlook to a range of $6.21-$6.35 per share from its prior range of $6.09-$6.25. The Zacks Consensus Estimate for the same is pegged at $6.22, which stands within the guided range. WELL’s guidance assumes the average blended SSNOI growth of 12.25-16.00%, comprising 16.5-21.5% growth in Seniors Housing Operating, 3.0-4.0% in Seniors Housing Triple-net, 2.0-3.0% in Outpatient Medical and 2.0-3.0% in Long-Term/Post-Acute Care. Currently, the company carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Performance of Other REITsVentas, Inc. (VTR - Free Report) delivered first-quarter 2026 normalized FFO per share of 94 cents, beating the Zacks Consensus Estimate of 91 cents by 3.3%. The metric increased 9.3% from 86 cents in the prior-year quarter. VTR’s revenues came in at $1.66 billion, up 22% year over year and above the Zacks Consensus Estimate of $1.54 billion by 4.58%. Results were powered by the SHOP, while the company ended the quarter with $5.5 billion of liquidity. Prologis, Inc. (PLD - Free Report) posted first-quarter 2026 core FFO per share of $1.50, up 5.6% from $1.42 a year ago. The figure beat the Zacks Consensus Estimate of $1.48 by 1.49%. Rental revenues came in at $2.13 billion, increasing 6.9% year over year. The top line also topped the Zacks Consensus Estimate of $2.10 billion, with a 1.12% surprise. PLD’s results were supported by robust leasing activity. Note: Anything related to earnings presented in this write-up represents FFO, a widely used metric to gauge the performance of REITs. |
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2026-06-12 21:26
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2026-05-11 12:47
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Ventas (VTR) Could Be a Great Choice | FMP Stock News | |
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All investors love getting big returns from their portfolio, whether it's through stocks, bonds, ETFs, or other types of securities. However, when you're an income investor, your primary focus is generating consistent cash flow from each of your liquid investments.Cash flow can come from bond interest, interest from other types of investments, and, of course, dividends. A dividend is the distribution of a company's earnings paid out to shareholders; it's often viewed by its dividend yield, a metric that measures a dividend as a percent of the current stock price. Many academic studies show that dividends make up large portions of long-term returns, and in many cases, dividend contributions surpass one-third of total returns. Based in Chicago, Ventas (VTR - Free Report) is in the Finance sector, and so far this year, shares have seen a price change of 12.77%. The seniors housing real estate investment trust is paying out a dividend of $0.52 per share at the moment, with a dividend yield of 2.38% compared to the REIT and Equity Trust - Other industry's yield of 4.56% and the S&P 500's yield of 1.41%. Looking at dividend growth, the company's current annualized dividend of $2.08 is up 8.3% from last year. Over the last 5 years, Ventas has increased its dividend 1 times on a year-over-year basis for an average annual increase of 0.70%. Looking ahead, future dividend growth will be dependent on earnings growth and payout ratio, which is the proportion of a company's annual earnings per share that it pays out as a dividend. Ventas's current payout ratio is 58%, meaning it paid out 58% of its trailing 12-month EPS as dividend. Looking at this fiscal year, VTR expects solid earnings growth. The Zacks Consensus Estimate for 2026 is $3.85 per share, with earnings expected to increase 10.63% from the year ago period. From greatly improving stock investing profits and reducing overall portfolio risk to providing tax advantages, investors like dividends for a variety of different reasons. It's important to keep in mind that not all companies provide a quarterly payout. High-growth firms or tech start-ups, for example, rarely provide their shareholders a dividend, while larger, more established companies that have more secure profits are often seen as the best dividend options. Income investors have to be mindful of the fact that high-yielding stocks tend to struggle during periods of rising interest rates. With that in mind, VTR is a compelling investment opportunity. Not only is it a strong dividend play, but the stock currently sits at a Zacks Rank of #3 (Hold). |
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2026-06-12 21:26
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2026-05-13 16:30
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Ventas Declares Quarterly Dividend of $0.52 Per Common Share | FMP Stock News | |
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-CHICAGO--(BUSINESS WIRE)--Ventas, Inc. (NYSE: VTR) today announced that its Board of Directors has declared a quarterly dividend of $0.52 per common share. The dividend will be payable in cash on July 16, 2026, to stockholders of record as of the close of business on June 30, 2026. About Ventas Ventas, Inc. (NYSE: VTR) is an S&P 500 company enabling exceptional environments that benefit a large and growing aging population. With more than 1,400 properties in North America and the United Kingdom, Ventas occupies an essential role in the longevity economy. The Company’s growth is fueled by its approximately 900 senior housing communities, which provide valuable services to residents and enable them to thrive in supported environments. Ventas aims to deliver outsized performance by leveraging its operational expertise, data-driven insights from its Ventas OITM platform, extensive relationships and strong financial position. The Ventas portfolio also includes outpatient medical buildings, research centers and healthcare facilities. Ventas’s seasoned team of talented professionals shares a commitment to excellence, integrity and a common purpose of helping people live longer, healthier, happier lives. More News From Ventas, Inc. Back to Newsroom |
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2026-06-12 21:26
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2026-05-27 12:45
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Why Ventas (VTR) is a Top Dividend Stock for Your Portfolio | FMP Stock News | |
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Original source text
All investors love getting big returns from their portfolio, whether it's through stocks, bonds, ETFs, or other types of securities. However, when you're an income investor, your primary focus is generating consistent cash flow from each of your liquid investments.While cash flow can come from bond interest or interest from other types of investments, income investors hone in on dividends. A dividend is the distribution of a company's earnings paid out to shareholders; it's often viewed by its dividend yield, a metric that measures a dividend as a percent of the current stock price. Many academic studies show that dividends account for significant portions of long-term returns, with dividend contributions exceeding one-third of total returns in many cases. Headquartered in Chicago, Ventas (VTR - Free Report) is a Finance stock that has seen a price change of 14.2% so far this year. The seniors housing real estate investment trust is paying out a dividend of $0.52 per share at the moment, with a dividend yield of 2.35% compared to the REIT and Equity Trust - Other industry's yield of 4.18% and the S&P 500's yield of 1.42%. Looking at dividend growth, the company's current annualized dividend of $2.08 is up 8.3% from last year. Over the last 5 years, Ventas has increased its dividend 1 times on a year-over-year basis for an average annual increase of 0.70%. Looking ahead, future dividend growth will be dependent on earnings growth and payout ratio, which is the proportion of a company's annual earnings per share that it pays out as a dividend. Ventas's current payout ratio is 58%, meaning it paid out 58% of its trailing 12-month EPS as dividend. Looking at this fiscal year, VTR expects solid earnings growth. The Zacks Consensus Estimate for 2026 is $3.87 per share, representing a year-over-year earnings growth rate of 11.21%. Investors like dividends for a variety of different reasons, from tax advantages and decreasing overall portfolio risk to considerably improving stock investing profits. But, not every company offers a quarterly payout. High-growth firms or tech start-ups, for example, rarely provide their shareholders a dividend, while larger, more established companies that have more secure profits are often seen as the best dividend options. Income investors have to be mindful of the fact that high-yielding stocks tend to struggle during periods of rising interest rates. With that in mind, VTR is a compelling investment opportunity. Not only is it a strong dividend play, but the stock currently sits at a Zacks Rank of #3 (Hold). |
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2026-06-12 21:26
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2026-05-28 08:03
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Ford, Ventas, QXO And More On CNBC's 'Final Trades' | FMP Stock News | |
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Ford shares gained on Wednesday as traders continue to lean into optimism about the company’s European product roadmap and its new energy storage push.Don't forget to check out our premarket coverage here Jenny Van Leeuwen Harrington, CEO of Gilman Hill Asset Management, LLC, named Ventas, Inc. (NYSE:VTR) as her final trade. Lending support to her choice, Scotiabank analyst Nicholas Yulico maintained Ventas at Sector Perform on May 21 and raised the price target from $93 to $95. SoFi’s Liz Young Thomas picked Pacer US Cash Cows 100 ETF (NASDAQ:COWZ). Joshua Brown, co-founder and CEO of Ritholtz Wealth Management, named QXO, Inc. (NASDAQ:QXO) as his final trade. On the earnings front, QXO reported first-quarter losses of 12 cents per share on May 12, missing the analyst consensus estimate of 9 cents per share. The company reported quarterly sales of $1.730 billion which missed the analyst consensus estimate of $1.735 billion. Price Action Ventas shares fell 0.4% to close at $88.05 on Wednesday. Pacer US Cash Cows 100 ETF slipped 0.02% during the session. Ford shares gained 3.7% to close at $15.88 on Wednesday. QXO shares rose 1.4% to settle at $17.40 on Wednesday. Photo via Shutterstock Market News and Data brought to you by Benzinga APIs © 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved. To add Benzinga News as your preferred source on Google, click here. |
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2026-06-12 21:25
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2026-06-01 16:15
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Ventas Issues Business Update and Will Participate in Investor Meetings at Nareit's REITweek 2026 Investor Conference | FMP Stock News | |
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CHICAGO--(BUSINESS WIRE)--Ventas, Inc. (NYSE: VTR) (“Ventas” or the “Company”) today announced that it has issued an investor presentation, which is available on the Company's website at ir.ventasreit.com/events-and-presentations. Company management will participate in investor meetings at Nareit's REITweek 2026 Investor Conference. About Ventas Ventas, Inc. (NYSE: VTR) is an S&P 500 company enabling exceptional environments that benefit a large and growing aging population. With more than. |
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2026-06-12 21:25
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2026-06-03 16:21
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Ventas Chairman and CEO Debra A. Cafaro to Receive Cyrus McCormick Making History Award for Historic Corporate Achievement | FMP Stock News | |
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CHICAGO--(BUSINESS WIRE)--Ventas, Inc. (NYSE: VTR) today announced that Chairman and Chief Executive Officer Debra A. Cafaro will receive the Cyrus McCormick Making History Award for Historic Corporate Achievement at the Chicago History Museum’s 32nd Annual Making History Awards this evening.The Cyrus McCormick Making History Award for Historic Corporate Achievement recognizes business leaders and organizations whose work has made enduring contributions to Chicago’s economic and civic life. Under Cafaro’s leadership, Ventas has grown into one of the world’s leading enterprises at the center of the longevity economy, with ownership of over 1,400 properties and a mission focused on serving a large and growing aging population. The Company is headquartered in Chicago. “Debra Cafaro exemplifies the leadership and vision that have long defined Chicago’s business community,” said Michael Anderson, Interim President and Chief Executive Officer of the Chicago History Museum. “Through hard work, enduring determination and exceptional strategic leadership, she has built Ventas into one of Chicago’s leading public companies, delivering tremendous value along the way. We are proud to celebrate Debra’s contributions to Chicago and beyond.” Since 1999, Cafaro has led Ventas through a multi-decade period of strategic growth and value creation – expanding the Company’s market capitalization from $200 million to more than $40 billion. Ventas has grown to a nearly $57 billion enterprise and is the second-largest owner of senior housing in the world, with approximately 900 communities that are home to nearly 100,000 residents and employ over 60,000 workers. Across its properties, the Company is positioned to meet the increasing demand for its high-quality environments that support health, longevity and well-being. A prominent civic leader in Chicago and beyond, Cafaro is a past Chair of the Economic Club of Chicago and serves on the boards of The PNC Financial Services Group, Inc. (NYSE: PNC), The University of Chicago and the Civic Committee and the Commercial Club of Chicago, in addition to her leadership work for several national organizations. She is also an owner of the NWSL Chicago Stars FC, as well as the MLB Baltimore Orioles and the NHL Pittsburgh Penguins. Cafaro’s biography is available here. “Chicago has provided a vibrant backdrop for us to grow Ventas over the past three decades,” said Cafaro. “I’m honored to accept this award with deep gratitude to my outstanding colleagues, past and present, whose work is dedicated to supporting people as they age and to strengthening the communities and stakeholders we serve. I’m proud to join fellow honorees whose contributions have left an important mark on Chicago’s history and continue to shape its future.” The Making History Awards support the Chicago History Museum’s mission to connect people to the city’s history and each other through learning, inspiration and civic engagement. About Ventas Ventas, Inc. (NYSE: VTR) is an S&P 500 company enabling exceptional environments that benefit a large and growing aging population. With more than 1,400 properties in North America and the United Kingdom, Ventas occupies an essential role in the longevity economy. The Company’s growth is fueled by its approximately 900 senior housing communities, which provide valuable services to residents and enable them to thrive in supported environments. Ventas aims to deliver outsized performance by leveraging its operational expertise, data-driven insights from its Ventas OITM platform, extensive relationships and strong financial position. The Ventas portfolio also includes outpatient medical buildings, research centers and healthcare facilities. Ventas’s seasoned team of talented professionals shares a commitment to excellence, integrity and a common purpose of helping people live longer, healthier, happier lives. More News From Ventas, Inc. |
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2026-06-12 21:25
1mo ago
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2026-06-12 12:46
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Why Ventas (VTR) is a Great Dividend Stock Right Now | FMP Stock News | |
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Original source text
Whether it's through stocks, bonds, ETFs, or other types of securities, all investors love seeing their portfolios score big returns. However, when you're an income investor, your primary focus is generating consistent cash flow from each of your liquid investments.While cash flow can come from bond interest or interest from other types of investments, income investors hone in on dividends. A dividend is the distribution of a company's earnings paid out to shareholders; it's often viewed by its dividend yield, a metric that measures a dividend as a percent of the current stock price. Many academic studies show that dividends make up large portions of long-term returns, and in many cases, dividend contributions surpass one-third of total returns. Ventas (VTR - Free Report) is headquartered in Chicago, and is in the Finance sector. The stock has seen a price change of 8.41% since the start of the year. Currently paying a dividend of $0.52 per share, the company has a dividend yield of 2.48%. In comparison, the REIT and Equity Trust - Other industry's yield is 4.23%, while the S&P 500's yield is 1.44%. Looking at dividend growth, the company's current annualized dividend of $2.08 is up 8.3% from last year. Over the last 5 years, Ventas has increased its dividend 1 times on a year-over-year basis for an average annual increase of 0.70%. Looking ahead, future dividend growth will be dependent on earnings growth and payout ratio, which is the proportion of a company's annual earnings per share that it pays out as a dividend. Ventas's current payout ratio is 58%, meaning it paid out 58% of its trailing 12-month EPS as dividend. Looking at this fiscal year, VTR expects solid earnings growth. The Zacks Consensus Estimate for 2026 is $3.87 per share, with earnings expected to increase 11.21% from the year ago period. Investors like dividends for many reasons; they greatly improve stock investing profits, decrease overall portfolio risk, and carry tax advantages, among others. But, not every company offers a quarterly payout. High-growth firms or tech start-ups, for example, rarely provide their shareholders a dividend, while larger, more established companies that have more secure profits are often seen as the best dividend options. During periods of rising interest rates, income investors must be mindful that high-yielding stocks tend to struggle. With that in mind, VTR is a compelling investment opportunity. Not only is it a strong dividend play, but the stock currently sits at a Zacks Rank of #3 (Hold). |
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2026-06-12 21:25
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2026-05-29 09:00
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Biogen Inc. (BIIB) Investors with Losses are Urged to Contact The Gross Law Firm to Discuss Their Rights | FMP Stock News | |
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NEW YORK, May 29, 2026 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Biogen Inc.:Due to the forgoing, The Gross Law Firm is investigating potential securities fraud claims on behalf of certain Biogen Inc. investors. If you incurred a loss on your BIIB investment, please contact us using the link below to discuss your rights. https://securitiesclasslaw.com/securities/biogen-inc-loss-submission-form-3/?id=187164&from=3 WHY GROSS LAW FIRM? The Gross Law Firm is a nationally recognized class action law firm, and our mission is to protect the rights of all investors who have suffered as a result of deceit, fraud, and illegal business practices. The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship. The firm seeks recovery on behalf of investors who incurred losses when false and/or misleading statements or the omission of material information by a company lead to artificial inflation of the company's stock. Attorney advertising. Prior results do not guarantee similar outcomes. CONTACT: The Gross Law Firm 15 West 38th Street, 12th floor New York, NY, 10018 Email: [email protected] Phone: (646) 453-8903 |
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2026-06-12 21:25
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2026-05-29 10:55
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Should You Buy, Sell or Hold BIIB Stock After it Rises Almost 12% YTD? | FMP Stock News | |
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Biogen climbs 11.5% YTD as new drugs, pipeline progress and M&A activity fuel confidence in Biogen???s multiyear turnaround. |
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2026-06-12 21:25
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2026-05-29 12:32
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Why Is Biogen (BIIB) Up 3.8% Since Last Earnings Report? | FMP Stock News | |
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It has been about a month since the last earnings report for Biogen Inc. (BIIB - Free Report) . Shares have added about 3.8% in that time frame, underperforming the S&P 500.Will the recent positive trend continue leading up to its next earnings release, or is Biogen due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the latest earnings report in order to get a better handle on the important catalysts. Q1 Earnings & Sales BeatBiogen reported first-quarter 2026 adjusted earnings per share (EPS) of $3.57, which significantly beat the Zacks Consensus Estimate of $2.95. Earnings rose 18% year over year. The adjusted EPS reflected approximately 20 cents per share impact of IPR&D charges, related primarily to Alteogen and Alloy transactions. Total revenues during the quarter came in at $2.48 billion, up 2% year over year on a reported basis. However, revenues declined 2% on a constant-currency basis. Revenues beat the Zacks Consensus Estimate of $2.25 billion. Lower sales of key Tecfidera and Spinraza were partially offset by higher revenues from new drugs, Skyclarys, Qalsody and Zurzuvae. Improved inventory dynamics also benefited sales of MS drugs like Tysabri and Vumerity in the quarter. Biogen’s growth products (Skyclarys, Qalsody, Zurzuvae, Vumerity and Spinraza Alzheimer’s revenues form Leqembi collaboration) generated sales of $851 million in the first quarter, rising 12% year over year. Product sales in the quarter were $1.75 billion, down 3% year over year on a constant currency basis. Revenues from anti-CD20 therapeutic programs rose 11% to $419 million. Contract manufacturing and royalty revenues declined 20% year over year to $247.0 million. Alzheimer’s collaboration revenues were $60 million, up 80% year over year. Alzheimer’s collaboration revenues include Biogen’s 50% share of net product revenues and cost of sales (including royalties) from Leqembi. Eisai recorded nearly $168 million in global revenues from Leqembi sales in the first quarter, up 74% year over year and 25% sequentially, driven by demand growth globally. The drug’s U.S. sales rose 10.3% quarter over quarter to $86 million. Multiple Sclerosis RevenuesMS revenues totaled $958 million, down 3% on a constant-currency basis, due to generic competition for Tecfidera globally and Tysabri in Europe and rising competitive pressure in the MS market. Tecfidera sales declined 47% to around $109.5 million due to generic erosion globally, particularly in Europe. The drug’s sales also missed the Zacks Consensus Estimate of $111 million. Vumerity recorded $179 million in sales, up around 29% year over year, driven by strong demand and improved inventory dynamics in the United States. This metric beat the Zacks Consensus Estimate of $164 million. Tysabri sales rose 15.7% year over year to $441.5 million as the impact of biosimilar competition in Europe and a decrease in U.S. demand were offset by favorable adjustments to discounts and allowances and the favorable impact of inventory timing. The drug’s sales beat the Zacks Consensus Estimate of $359 million. Combined interferon revenues (Avonex and Plegridy) were almost flat year over year at about $227.5 million. In 2026, Biogen expects revenues for MS products, excluding Vumerity, to decline by a mid-teen percentage versus 2025. Rare Disease DrugsSales of Spinraza declined around 12% to $374 million. The figure missed the Zacks Consensus Estimate of $379 million Spinraza’s U.S. sales declined 8% year over year to $142.2 million due to lower demand and unfavorable inventory dynamics. In the rest of the world, Spinraza sales declined 14% to $231.8 million due to unfavorable timing of shipments. Skyclarys generated sales of $150.7 million, up 21.6% year over year, driven by continued demand growth. In the United States, revenues of $71.8 million rose 4% year over year. However, on a sequential basis, Skyclarys’ U.S. sales declined 19.2% due to unfavorable inventory dynamics, which offset the positive impact of moderate demand growth. In ex-U.S. markets, sales rose 44% to $78.9 million, driven by strong adoption trends. Qalsody added sales of $32.5 million, up more than 100% year over year, driven by demand growth. In 2026, Biogen expects Rare Disease revenues to grow due to the continued launch of Skyclarys in the EU and other ex-U.S. markets and the continued launch of Qalsody in Europe. Biogen expects global Spinraza revenues to be relatively flat in 2026. Other ProductsNew drug Zurzuvae (for postpartum depression) recorded sales of nearly $55.4 million in the quarter, down 16% on a sequential basis as demand growth was partially offset by inventory dynamics. Biosimilar revenues declined 7% year over year to $182 million during the quarter. Costs DeclineAdjusted research and development (R&D) expenses rose 13% year over year to $480 million due to increased costs behind the company’s late-stage candidates like litifilimab and felzartamab. Adjusted selling, general and administrative (SG&A) expenses rose 5% to $600 million due to higher costs to support the new product launches. In the quarter, the collaboration profit-sharing was a net expense of around $74 million, which included nearly $57 million of net profit-sharing expenses related to Biogen’s biosimilar collaboration with Samsung Bioepis and around $17 million of net profit-sharing expenses linked to Biogen’s collaboration with Supernus Pharmaceuticals for marketing Zurzuvae in the United States. Maintains 2026 GuidanceBiogen maintained its revenue guidance for the year while lowering its earnings guidance to include IPR&D charges related to M&A activities. Total revenues are expected to decline by a mid-single-digit percentage in constant currency terms in 2026 from the 2025 level. A decline in MS revenues (excluding Vumerity) is expected to be partially offset by higher revenues from growth products. Adjusted EPS guidance was lowered from a range of $15.25 to $16.25 to $14.25 to $15.25 to include an IPR&D charge of $1.00 per share. The charge comprised approximately 20 cents recorded in the first quarter and approximately 80 cents expected to be recorded in the second quarter (mainly for the TJ Bio transaction for felzartamab rights in China) but does not include any costs related to the Apellis transaction. Biogen expects Apellis to be accretive to earnings in 2027 and the acquisition to boost Biogen’s adjusted EPS growth rate over the remainder of the decade. The gross margin in 2026 is expected to be similar to the 2025 levels. Combined adjusted R&D and SG&A costs are also expected to be similar to 2025 levels. In the second quarter, Biogen expects core operating expenses to be roughly consistent with the first quarter. How Have Estimates Been Moving Since Then?Since the earnings release, investors have witnessed a downward trend in estimates revision. The consensus estimate has shifted -20.37% due to these changes. VGM ScoresAt this time, Biogen has a nice Growth Score of B, though it is lagging a lot on the Momentum Score front with an F. However, the stock has a grade of B on the value side, putting it in the second quintile for this investment strategy. Overall, the stock has an aggregate VGM Score of B. If you aren't focused on one strategy, this score is the one you should be interested in. OutlookEstimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Interestingly, Biogen has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. |
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2026-06-12 21:25
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2026-06-01 01:30
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UCB and Biogen Announce Publication in The Lancet of Positive Dapirolizumab Pegol (DZP) Phase 3 Study Results in Systemic Lupus Erythematosus | FMP Stock News | |
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Publication adds to previously reported findings from Phase 3 PHOENYCS GO study, demonstrating statistically significant improvement in disease activity at Week 48 with dapirolizumab pegol plus standard of care versus placebo plus standard of careFindings showed results in favor of dapirolizumab pegol plus standard of care versus placebo plus standard of care across endpoints, including multiple disease activity measures, severe flares, patient-reported outcomes, including fatigue, and glucocorticoid taperingResults support the continued development of dapirolizumab pegol; the ongoing confirmatory Phase 3 PHOENYCS FLY clinical trial is currently recruiting BRUSSELS, Belgium and CAMBRIDGE, Mass., June 01, 2026 (GLOBE NEWSWIRE) -- UCB (Euronext Brussels: UCB) and Biogen Inc. (Nasdaq: BIIB) today announced that The Lancet, a world-leading medical journal, has published the full results from the Phase 3 PHOENYCS GO clinical trial evaluating dapirolizumab pegol (DZP), an investigational, novel Fc-free CD40L inhibitor, in patients living with moderate-to-severe active systemic lupus erythematosus (SLE). The results showed statistically significant improvement in disease activity with DZP added to standard of care (SOC) versus placebo plus standard of care.1“The publication of the PHOENYCS GO results in The Lancet reflects the importance of these data to the rheumatology community, providing evidence of dapirolizumab pegol as a potential treatment option for people living with systemic lupus erythematosus,” said Megan E. B. Clowse, M.D., MPH, Chief of the Division of Rheumatology and Immunology, Duke University, and primary author of the publication. “Given the acute need for additional treatment options for SLE, these findings are encouraging for both clinicians and patients and clearly warrant further evaluation in the confirmatory Phase 3 PHOENYCS FLY study.” In the Phase 3 study, DZP successfully met the primary endpoint: a significantly greater proportion of patients receiving DZP plus standard of care (SOC) achieved British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at Week 48 (50%; 103/208) compared to placebo plus SOC (35%; 37/107; p=0.011).1 BICLA is a composite endpoint measuring clinically relevant improvement of disease activity across all affected organ systems with no worsening in other lupus domains; a higher BICLA response rate reflects a treatment response and is associated with clinical benefit.1 Because the first key secondary endpoint was not met (BICLA response at week 24), subsequent outcomes were not controlled for multiplicity. Results in favor of DZP plus SOC were observed across multiple outcomes, including severe BILAG flares, SRI-4, SLEDAI-2K, skin- and joint-related outcomes, and the serological markers anti-dsDNA antibodies and complement C3 and C4.¹ Additionally, at week 48 the data showed clinically meaningful improvements in patient-reported FACIT-Fatigue, which is often cited by patients as one of the most debilitating symptoms of SLE.1,2 Importantly, these results were achieved within the context of glucocorticoid tapering in line with treatment guidelines.1,3 At week 48, a greater proportion of patients in the DZP plus SOC group versus PBO plus SOC were able to reduce their glucocorticoid dose from >7.5 mg/day to ≤7.5 mg/day, suggesting a glucocorticoid-sparing effect of DZP.1 In the PHOENYCS GO study, DZP demonstrated a generally favorable safety profile, with safety findings consistent with previous DZP studies.1,4 Treatment-emergent adverse events (TEAEs) were more common with DZP plus SOC versus PBO plus SOC (82.6% [176/213] vs. 75.0% [81/108], respectively), while serious TEAEs were less frequent in the DZP plus SOC arm (10.0% [21/213] vs. 14.8% [16/108]) respectively.1 Discontinuations due to TEAEs were low in both groups (4.7% vs. 3.7%) respectively.1 These positive Phase 3 results support the continued development of DZP. UCB and Biogen are actively progressing the confirmatory Phase 3 PHOENYCS FLY clinical trial (NCT06617325), which is currently recruiting patients and is intended to support future regulatory filings.5 Further data from the PHOENYCS GO study will be presented this week at the Annual European Congress of Rheumatology (EULAR). About Dapirolizumab Pegol Dapirolizumab pegol is a novel investigational humanized Fc-free polyethylene glycol (PEG)-conjugated antigen-binding (Fab’) fragment.4 Dapirolizumab pegol inhibits CD40L signaling which has been shown to reduce B-cell activation and autoantibody production, mitigate type 1 interferon (IFN) secretion and attenuate T-cell and antigen-presenting cell (APC) activation.4 Dapirolizumab pegol is presently in Phase 3 clinical development for the treatment of systemic lupus erythematosus (SLE) under a collaboration between UCB and Biogen.5,6 Dapirolizumab pegol is an investigational biologic currently in clinical development. The safety and efficacy have not been established, and it is not approved by any health authority worldwide. About UCB UCB, Brussels, Belgium (www.ucb.com), is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 11,000 people in approximately 40 countries, the company generated revenue of €7.7 billion in 2025. UCB is listed on Euronext Brussels (symbol: UCB). About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - Facebook, LinkedIn, X, YouTube. Forward-looking Statements - UCB This document contains forward-looking statements, including, without limitation, statements containing the words “potential”, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “continue” and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guaranteeing future performance and are subject to known and unknown risks, uncertainties, and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this document. Important factors that could result in such differences include but are not limited to: global spread and impacts of wars, pandemics and terrorism, the general geopolitical environment, climate change, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues, supply chain disruption and business continuity risks; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars or disruptive technologies/business models, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring, retention and compliance of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB’s efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB’s products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB’s data and systems. Given these uncertainties, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are made only as of the date of this document, and do not reflect any potential impacts from the evolving event or risk as mentioned above as well as any other adversity, unless indicated otherwise. The company continues to follow the development diligently to assess the financial significance of these events, as the case may be, to UCB. UCB expressly disclaims any obligation to update any forward-looking statements in this document, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. Biogen Safe Harbor This news release contains forward-looking statements, including, among others, relating to: the potential benefits, safety and efficacy of dapirolizumab pegol (DZP); the potential of dapirolizumab pegol to be an important option in addressing the effects of systemic lupus erythematosus; the anticipated benefits, risks and potential of Biogen's collaboration arrangements with UCB; the potential of Biogen's commercial business and pipeline programs, including dapirolizumab pegol; potential regulatory discussions, submissions and approvals and the timing thereof; and the risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would,” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, factors relating to: uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov. These statements speak only as of the date of this presentation and the discussions during this conference call and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. Biogen Digital Media Disclosure From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors. References: Clowse MEB, Isenberg DA, Merrill JT, et al. Efficacy and safety of the CD40 ligand inhibitor dapirolizumab pegol in systemic lupus erythematosus (PHOENYCS GO): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. Published online May 29, 2026. doi:10.1016/S0140-6736(26)00691-4.Cornet A, Andersen J, Myllys K, et al. Living with systemic lupus erythematosus in 2020: a European patient survey. Lupus Sci Med. 2021;8:e000469.Fanouriakis A, Kostopoulou M, Alunno A, et al. 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus. Ann Rheum Dis 2019; 78(6): 736–45.Furie RA, Bruce IN, Dörner T, et al. Phase 2 randomized, placebo-controlled trial of dapirolizumab pegol in patients with moderate to severe active systemic lupus erythematosus. Rheumatology (Oxford). 2021;60(11):5397–407.ClinicalTrials.gov (NCT06617325). A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (PHOENYCS FLY) 2024. Available at: https://clinicaltrials.gov/study/NCT06617325. Retrieved May 18, 2026.ClinicalTrials.gov (NCT04294667). A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (PHOENYCS GO) 2023. Available at: https://clinicaltrials.gov/ct2/show/NCT04294667. Retrieved May 18, 2026. |
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2026-06-12 21:25
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2026-06-02 16:54
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Biogen Inc. - BIIB | FMP Stock News | |
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NEW YORK, June 02, 2026 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Biogen Inc. (“Biogen” or the “Company”) (NASDAQ: BIIB). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.The investigation concerns whether Biogen and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On May 14, 2026, Biogen issued a press release announcing “topline results from the Phase 2 CELIA study evaluating diranersen (BIIB080), an investigational antisense oligonucleotide (ASO) therapy targeting tau, in individuals with early Alzheimer’s disease.” Although Biogen described the results as “compelling,” the study missed its primary dose-response endpoint. On this news, Biogen’s stock price fell $13.16 per share, or 6.43%, to close at $191.37 per share on May 14, 2026. Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com. Attorney advertising. Prior results do not guarantee similar outcomes. CONTACT: Danielle Peyton Pomerantz LLP [email protected] 646-581-9980 ext. 7980 |
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2026-06-12 21:25
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Biogen Announces Upcoming Kidney Presentations at European Renal Association and American Transplant Congresses | FMP Stock News | |
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Data presentations across multiple kidney diseases illustrate the breadth of Biogen’s nephrology portfolio with EMPAVELI® (pegcetacoplan) and felzartamab, an investigational anti-CD38 monoclonal antibody. CAMBRIDGE, Mass., June 03, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that fourteen abstracts highlighting data from its nephrology portfolio, including EMPAVELI® (pegcetacoplan) and investigational felzartamab, have been accepted for presentation at the 63rd European Renal Association Congress (ERA) and the 2026 American Transplant Congress (ATC).“Our presence across two key medical congresses highlights the momentum of our newly broadened nephrology portfolio, which now includes EMPAVELI® (pegcetacoplan) in addition to the multiple Phase 3 studies of felzartamab,” said Daniel Quirk, MD, Chief Medical Officer at Biogen. “We look forward to continuing to advance the science and development across a spectrum of kidney diseases, with the goal of helping to bring meaningful progress to patients.” At ERA, taking place June 3-6 in Glasgow, Scotland, presentations include new post-hoc analyses from the pivotal Phase 3 VALIANT study for EMPAVELI and its long-term extension VALE study showing the sustained efficacy and safety profile of EMPAVELI over one year in patients with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN). Presentations of EMPAVELI will be made in collaboration with Sobi, which retains commercial rights to EMPAVELI® (Aspaveli® in the EU) outside the U.S. At ATC, taking place June 20-24 in Boston, Massachusetts, additional analyses of the Phase 2 felzartamab trial in antibody-mediated rejection (AMR) assess the impact of the investigational treatment on patients with long-standing rejection history and different forms of previous rejection treatment. A sponsored Symposium will educate on emerging biomarkers for early identification and monitoring of transplant rejection and illustrate the role of CD38+ cells in AMR and microvascular inflammation (MVI). Additionally, a presentation on EMPAVELI will share pooled data from two studies assessing treatment in post transplant patients with recurrent C3G or primary IC-MPGN. European Renal Association Congress presentations include: Oral Presentation: “Pegcetacoplan treatment response in VALIANT/VALE: Impact of disease chronicity in C3G and primary IC-MPGN,” on Thursday, June 4th at 9:21 a.m. BSTOral Presentation: “Pegcetacoplan sustained clinical benefit in C3G and primary IC-MPGN through 1 year of therapy: Data from VALIANT/VALE,” on Thursday, June 4th at 11:27 a.m. BSTOral Presentation: “Pegcetacoplan treatment response in VALIANT/VALE: Impact of genetic and acquired complement dysregulation and disease type in C3G and primary IC-MPGN,” on Thursday, June 4th at 12:09 p.m. BSTOral Presentation: “Real-world clinical profile, treatment patterns and outcomes associated with C3G and primary IC-MPGN: insights from the UK RaDaR registry,” on Thursday, June 4th at 12:21 p.m. BSTOral Presentation: “Investigating the Effects of Felzartamab Treatment on Peripheral Blood Transcriptomes in Patients with Chronic Antibody-mediated Rejection,” on Thursday, June 4th at 12:33 p.m. BSTOral Presentation: “Safety and low incidence of meningococcal infections with pegcetacoplan in C3G / primary IC-MPGN and PNH,” on Thursday, June 4th at 3:27 p.m. BSTOral Presentation: “Evaluation of pegcetacoplan in adults and adolescents with focal segmental glomerulosclerosis: Rationale and design of a sequential phase 2/3 study,” on Thursday, June 4th at 4:24 p.m. BSTOral Presentation: “Decreasing rates of injection site reactions over time: Long-term outcomes across multiple indications support pegcetacoplan for C3G/primary IC-MPGN,” on Friday, June 5th at 9:03 a.m. BSTOral Presentation: “Prolonged CD38 Targeting with Felzartamab Achieves Sustained Suppression of Antibody-mediated Rejection: Biomarker-guided Open-label Phase 2 Extension,” on Friday, June 5th at 9:27 a.m. BSTOral Presentation: “Soluble BCMA as a Biomarker of CD38+ Plasma Cell Depletion in Felzartamab-Treated Patients With IgA Nephropathy From the Phase 2 IGNAZ Study,” on Friday, June 5th at 4:24 p.m. BSTPoster Presentations: Pegcetacoplan population pharmacokinetics and exposure-response analysis in adolescent and adult patients with C3G or primary IC-MPGN on Friday, June 5th at 6:15 p.m. BSTEpidemiology of C3G and primary IC-MPGN: a systematic literature review and meta-analysis on Friday, June 5th at 6:15 p.m. BST American Transplant Congress presentations include: Symposium: “Advancements in Antibody-Mediated Rejection and Microvascular Inflammation of Kidney Allograft: Biology, Biomarkers, and Beyond,” on Tuesday, June 23rd from 12:15 p.m. – 1:15 p.m. EDTOral Presentation: “Felzartamab, an anti-CD38 antibody, in late AMR: efficacy independent of prior rejection history or therapy “on Monday, June 22nd at 11:15 a.m. EDTOral Presentation: “Effects of felzartamab on Digital Cytometry Leukocyte Estimates in Biopsies with ABMR,” on Sunday, June 21st at 3:45 p.m. EDTOral Presentation: “Pegcetacoplan for Posttransplant Patients with Complement 3 Glomerulopathy or Primary (Idiopathic) Immune-Complex membranoproliferative Glomerulonephritis,” on Sunday, June 21st at 3:45 p.m. EDTPoster Presentations: Late breaking poster: “Felzartamab for antibody mediated rejection: a phase 2 open label extension study,” on Saturday, June 20th at 5:45 p.m. EDT“Establishing a central pathology review process and adjudication framework to standardize biopsy-based endpoints in transplant clinical trials” on Saturday, June 20th at 5:45 p.m. EDT“TRANSCEND and TRANSPIRE: phase 3 and 2 trials of the anti-CD38 antibody felzartamab in kidney transplant recipients with antibody medical rejection or isolated microvascular inflammation,” on Monday, June 22nd at 2:45 p.m. EDT“Monitoring anti-CD38 treatment with felzartamab in antibody mediated kidney allograft rejection,” on Monday, June 22nd at 2:45 p.m. EDT“Effect of the anti-CD38 antibody felzartamab on Natural Killer cells” on Monday, June 22nd at 2:45 p.m. EDT About Felzartamab Felzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on plasma cells, plasmablasts, and natural killer, or NK, cells. Felzartamab is a potential first-in-class therapeutic candidate with promise as a pipeline-in-a-product across a range of immune-mediated diseases. Felzartamab has been shown in clinical studies to selectively deplete CD38+ plasma cells, which may allow applications that ultimately improve clinical outcomes in a broad range of diseases driven by pathogenic antibodies. Felzartamab was originally developed by MorphoSys AG (now MorphoSys GmbH, a Novartis company). Biogen owns exclusive worldwide rights to felzartamab. Felzartamab is an investigational therapeutic candidate that has not yet been approved by any regulatory authority and its safety and effectiveness have not been established. About Antibody-Mediated Rejection (AMR) in Kidney Transplant Recipients Antibody-mediated rejection (AMR) is a major cause of kidney transplant failure. AMR in kidney transplant is caused by the immune system recognizing the donor kidney as foreign. This can result in antibodies being generated against the donor kidney and potentially leading to its destruction and eventual rejection. AMR demonstrates different properties depending on whether it occurs early (<6 months) or late (>6 months) post-transplantation. Late AMR is associated with a greater risk of graft loss versus early.1 Effective treatment options for late AMR are currently limited.2 About C3 Glomerulopathy (C3G) and Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) C3G and primary IC-MPGN are rare and debilitating kidney diseases that can lead to kidney failure. Excessive C3 deposits are a key marker of disease activity, which can lead to kidney inflammation, damage, and failure. Approximately 50% of people living with C3G and primary IC-MPGN suffer from kidney failure within five to 10 years of diagnosis, requiring a burdensome kidney transplant or lifelong dialysis therapy.3-5 Additionally, approximately 90% of patients who previously received a kidney transplant will experience disease recurrence.6 About the VALIANT Study The VALIANT Phase 3 study (NCT05067127) was a randomized, placebo-controlled, double-blinded, multi-center study that evaluated EMPAVELI® (pegcetacoplan) efficacy and safety in 124 patients who were 12 years of age and older with C3G or primary IC-MPGN. It is the largest single trial conducted in these populations and the only study to include pediatric and adult patients, with native and post-transplant kidneys. Study participants were randomized to receive EMPAVELI or placebo twice weekly for 26 weeks. Following this 26-week randomized controlled period, patients were able to proceed to a 26-week open-label phase in which all patients received EMPAVELI. The primary endpoint of the study was the log transformed ratio of urine protein-to-creatinine ratio (UPCR) at Week 26 compared to baseline. About Empaveli (pegcetacoplan) Empaveli (pegcetacoplan) is a targeted C3 and C3b therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. It is the first treatment approved in the United States for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older, to reduce proteinuria. Empaveli is also approved for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) in the United States, European Union, and other countries globally, and is under investigation for other rare diseases. U.S. Important Safety Information for EMPAVELI BOXED WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA EMPAVELI, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, unless the risks of delaying therapy with EMPAVELI outweigh the risks of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor. Patients receiving EMPAVELI are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected. Because of the risk of serious infections caused by encapsulated bacteria, EMPAVELI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the EMPAVELI REMS. CONTRAINDICATIONS Hypersensitivity to pegcetacoplan or to any of the excipients For initiation in patients with unresolved serious infection caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B WARNINGS AND PRECAUTIONS Serious Infections Caused by Encapsulated Bacteria EMPAVELI, a complement inhibitor, increases a patient’s susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis (caused by any serogroup, including non-groupable strains), and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initiation of EMPAVELI treatment is contraindicated in patients with unresolved serious infection caused by encapsulated bacteria. Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of EMPAVELI, according to the most current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with EMPAVELI. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent EMPAVELI therapy is indicated in a patient who is not up to date with vaccines against encapsulated bacteria according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible. The benefits and risks of treatment with EMPAVELI, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by encapsulated bacteria. Vaccination does not eliminate the risk of serious encapsulated bacterial infections, despite development of antibodies following vaccination. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Serious infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of EMPAVELI in patients who are undergoing treatment for serious infections. EMPAVELI is available only through a restricted program under a REMS. EMPAVELI REMS EMPAVELI is available only through a restricted program under a REMS called EMPAVELI REMS, because of the risk of serious infections caused by encapsulated bacteria. Notable requirements of the EMPAVELI REMS include the following: Under the EMPAVELI REMS, prescribers must enroll in the program. Prescribers must counsel patients about the risks, signs, and symptoms of serious infections caused by encapsulated bacteria, provide patients with the REMS educational materials, ensure patients are vaccinated against encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, prescribe antibacterial drug prophylaxis if patients’ vaccine status is not up to date and treatment must be started urgently, and provide instructions to always carry the Patient Safety Card both during treatment, as well as for 2 months following last dose of EMPAVELI. Pharmacies that dispense EMPAVELI must be certified in the EMPAVELI REMS and must verify prescribers are certified. Further information is available at www.empavelirems.com or 1-888-343-7073. Infusion-Related Reactions Systemic hypersensitivity reactions (eg, facial swelling, rash, urticaria, pyrexia) have occurred in patients treated with EMPAVELI, which may resolve after treatment with antihistamines. Cases of anaphylaxis leading to treatment discontinuation have been reported. If a severe hypersensitivity reaction (including anaphylaxis) occurs, discontinue EMPAVELI infusion immediately, institute appropriate treatment, per standard of care, and monitor until signs and symptoms are resolved. Interference with Laboratory Tests There may be interference between silica reagents in coagulation panels and EMPAVELI that results in artificially prolonged activated partial thromboplastin time (aPTT); therefore, avoid the use of silica reagents in coagulation panels. ADVERSE REACTIONS Most common adverse reactions in adult and pediatric patients 12 years of age and older with C3G or primary IC-MPGN (incidence ≥10%) were infusion-site reactions, pyrexia, nasopharyngitis, influenza, cough, and nausea. USE IN SPECIFIC POPULATIONS Females of Reproductive Potential EMPAVELI may cause embryo-fetal harm when administered to pregnant women. Pregnancy testing is recommended for females of reproductive potential prior to treatment with EMPAVELI. Advise female patients of reproductive potential to use effective contraception during treatment with EMPAVELI and for 40 days after the last dose. Please see full Prescribing Information, including Boxed WARNING regarding serious infections caused by encapsulated bacteria, and Medication Guide. About the Sobi® and Apellis (now part of Biogen) Collaboration Apellis and Sobi have global co-development rights for systemic pegcetacoplan. Sobi has exclusive ex-U.S. commercialization rights for systemic pegcetacoplan. Apellis has exclusive U.S. commercialization rights for systemic pegcetacoplan and worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy. About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - Facebook, LinkedIn, X, YouTube. Biogen Safe Harbor This news release contains forward-looking statements, relating to, among others: the potential benefits, safety and efficacy of EMPAVELI and felzartamab; the potential of felzartamab to be an important option in addressing the effects of AMR and MVI; the potential of Biogen's commercial business and pipeline programs, including EMPAVELI and felzartamab; potential regulatory discussions, submissions and approvals and the timing thereof; and the risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would” or the negative of these words or other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to differ materially from those stated or implied in this document, including, among others, uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov. These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. Digital Media Disclosure From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors. References: Fernando et al. (2023) Early Versus Late Acute AMR in Kidney Transplant Recipients – A Comparison of Treatment Approaches and Outcomes From the ANZDATA Registry. Available at: https://pubmed.ncbi.nlm.nih.gov/37322595/Schinstock et al. (2018) Kidney Transplant with Low Levels of DSA or Low Positive B-Flow Crossmatch: An Underappreciated Option for Highly-Sensitized Transplant Candidates (Page 8). Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5481511/pdf/nihms837168.pdf#page=8; Ciancio et al. 2018 Antibody-Mediated Rejection Implies a Poor Prognosis in Kidney Transplantation: Results From a Single Center. Available at: https://onlinelibrary.wiley.com/doi/10.1111/ctr.13392 Smith RJH, et al. Nat Rev Nephrol. 2019;15(3):129-143.Servais A, et al. Kidney Int. 2012;82(4):454-464.Zand L, et al. J Am Soc Nephrol. 2014;25(5):1110-1117.Tarragón, B, et al. C3 Glomerulopathy Recurs Early after Kidney Transplantation in Serial Biopsies Performed within the First 2 Years after Transplantation. Clinical Journal of the American Society of Nephrology. August 2024; 19(8)1005-1015. |
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EULAR 2026: Dapirolizumab Pegol Shows Potential to Reduce Flare Rates and Maintain Disease Control in Systemic Lupus Erythematosus | FMP Stock News | |
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Original source text
Steroid use reduction and disease control: In additional results from the Phase 3 PHOENYCS GO study, dapirolizumab pegol (DZP) plus standard of care was associated with sustained disease control at lower glucocorticoid doses through Week 48 compared with placebo plus standard of care, supporting reduced long-term steroid exposureReduced flare rates and immune marker improvements: In other findings presented at EULAR 2026, improvements in immunological markers and reduced flare rates were observed, supporting the potential of dapirolizumab pegol to address the complex burden of SLE BRUSSELS, Belgium and CAMBRIDGE, Mass., June 04, 2026 (GLOBE NEWSWIRE) -- UCB (Euronext Brussels: UCB) and Biogen Inc. (Nasdaq: BIIB) today announced data, comprising two posters and three abstracts, at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, demonstrating the clinical profile of dapirolizumab pegol (DZP), an investigational biologic in patients with systemic lupus erythematosus (SLE).Systemic lupus erythematosus (SLE) is a chronic autoimmune disease affecting multiple organs, including skin, joints and kidneys, often requiring long-term treatment to control disease activity.1 Patients with SLE frequently experience flares, transient worsening of disease activity that can lead to permanent organ damage, increased morbidity, and even early mortality.2 Many patients rely on steroid-based therapy to manage flares; however, prolonged steroid use is associated with significant cumulative toxicity, making steroid tapering while maintaining disease control a key goal in SLE management.3,4 “Achieving and maintaining durable disease control while reducing glucocorticoid exposure is one of the central challenges in managing SLE,” said Megan E. B. Clowse, M.D., MPH, Chief of the Division of Rheumatology and Immunology, Duke University, and primary author of the PHOENYCS GO primary results. “The Phase 3 PHOENYCS GO data showed patients receiving dapirolizumab pegol were more likely to maintain disease control while tapering steroids – an important finding given strong evidence that cumulative steroid exposure and uncontrolled disease activity are major drivers of organ damage accrual, morbidity and mortality in SLE.” Post hoc analyses displayed in one of the posters from the PHOENYCS GO program showed that, in patients with baseline glucocorticoid dose >7.5 mg/day prednisone equivalent, treatment with DZP plus standard of care was associated with a higher proportion of patients achieving control of disease activity while enabling glucocorticoid tapering to ≤7.5 mg/day through Week 48, compared with placebo plus standard of care.5 Importantly, these findings suggest that higher proportions of patients receiving DZP plus standard of care versus placebo plus standard of care achieved sustained glucocorticoid tapering while also achieving BICLA response, achieving SRI-4 response, or remaining free from moderate or severe BILAG-2004 flares through Week 48.5 “At UCB, our mission is to help improve the lives of people living with serious inflammatory diseases by advancing therapies that address unmet needs,” said Donatello Crocetta, Chief Medical Officer and Head of Global Medical Affairs at UCB. “These data showed the potential of dapirolizumab pegol to reduce long-term glucocorticoid use while maintaining disease control, an important goal for people living with SLE and the clinicians who care for them.” Additional EULAR 2026 presentations highlighted the breadth of data from the PHOENYCS GO program, including: Improvements in key immunological markers, including reduced anti-dsDNA antibodies and increased complement proteins C3 and C4 in patients with abnormal levels at baseline (Poster POS1364).6Lower rates of moderate or moderate/severe BILAG-2004 flares with DZP plus standard of care versus placebo plus standard of care through Week 48, using alternative definitions of flares to increase measurement sensitivity (Abstract AB1163).7Insights into how symptoms and flares are assessed in SLE, including fatigue as a burdensome patient-reported symptom that can be difficult to capture in clinical trials (Abstracts AB1184 and AB1125).8,9 Together, these findings support the importance of tools that can measure patient experience and help inform more meaningful assessment of disease impact in both clinical practice and research.8,9 “Systemic lupus erythematosus is a biologically complex disease, and these EULAR data further characterize dapirolizumab pegol’s impact across clinical, biological and patient-reported outcomes,” said Diana Gallagher, MD, Head of Immunology, MS and Alzheimer’s Development Units at Biogen. “Delivering this data reflects the strength of the UCB and Biogen collaboration and our shared commitment to advancing evidence that may help address the complex and multifaceted needs of people living with SLE.” The EULAR data follow the recent publication of the Phase 3 PHOENYCS GO study in The Lancet, reporting clinically meaningful improvements in disease activity with dapirolizumab pegol at Week 48.10 In the Phase 3 PHOENYCS GO study, DZP demonstrated a generally favorable safety profile, with safety findings consistent with previous DZP studies.10,11 Treatment-emergent adverse events were more common with DZP plus standard of care versus placebo plus standard of care, while serious treatment-emergent adverse events were less frequent in the DZP plus standard of care arm, and discontinuations due to treatment-emergent adverse events were low in both groups.10 About Dapirolizumab Pegol Dapirolizumab pegol is a novel investigational humanized Fc-free polyethylene glycol (PEG)-conjugated antigen-binding (Fab’) fragment.11 Dapirolizumab pegol inhibits CD40L signaling, which has been shown to reduce B-cell activation and autoantibody production, mitigate type 1 interferon (IFN) secretion and attenuate T-cell and antigen-presenting cell (APC) activation.11 Dapirolizumab pegol is presently in Phase 3 clinical development for the treatment of systemic lupus erythematosus (SLE) under a collaboration between UCB and Biogen.12,13 Dapirolizumab pegol is an investigational biologic currently in clinical development. The safety and efficacy have not been established, and it is not approved by any health authority worldwide. About UCB UCB, Brussels, Belgium (www.ucb.com), is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €7.7 billion in 2025. UCB is listed on Euronext Brussels (symbol: UCB). About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - Facebook, LinkedIn, X, YouTube. Forward-looking Statements - UCB This document contains forward-looking statements, including, without limitation, statements containing the words “potential”, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “continue” and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guaranteeing future performance and are subject to known and unknown risks, uncertainties, and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this document. Important factors that could result in such differences include but are not limited to: global spread and impacts of wars, pandemics and terrorism, the general geopolitical environment, climate change, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues, supply chain disruption and business continuity risks; potential or actual data security and data privacy breaches, or disruptions of UCB’s information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars or disruptive technologies/business models, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in laws and/or rules pertaining to tax and duties or the administration of such laws and/or rules, and hiring, retention and compliance of employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB’s efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB’s products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB’s data and systems. Given these uncertainties, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are made only as of the date of this document, and do not reflect any potential impacts from the evolving event or risk as mentioned above as well as any other adversity, unless indicated otherwise. The company continues to follow the development diligently to assess the financial significance of these events, as the case may be, to UCB. UCB expressly disclaims any obligation to update any forward-looking statements in this document, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. Biogen Safe Harbor This news release contains forward-looking statements, including, among others, relating to: the potential benefits, safety and efficacy of dapirolizumab pegol (DZP); the potential of dapirolizumab pegol to address the needs of people living with systemic lupus erythematosus (SLE), including the potential to help patients maintain disease control while tapering steroids; the anticipated benefits, risks and potential of Biogen's collaboration arrangements with UCB; the potential of Biogen's commercial business and pipeline programs, including dapirolizumab pegol; potential regulatory discussions, submissions and approvals and the timing thereof; and the risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would,” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, factors relating to: uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov. These statements speak only as of the date of this presentation and the discussions during this conference call and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. Biogen Digital Media Disclosure From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors. References: Pons-Estel GJ, Alarcón GS, Scofield L, et al. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthritis Rheum. 2010;39(4):257-68.Thanou A, Jupe E, Purushothaman M, et al. Clinical disease activity and flare in SLE: current concepts and novel biomarkers. J Autoimmun. 2021;119:102615. doi:10.1016/j.jaut.2021.102615.Palmowski A, Pankow A, Terziyska K, et al. Continuing versus tapering low-dose glucocorticoids in patients with rheumatoid arthritis and systemic lupus erythematosus in states of low disease activity or remission: a systematic review and meta-analysis of randomised trials. Semin Arthritis Rheum. 2024;64:152349. doi:10.1016/j.semarthrit.2023.152349.Fanouriakis A, Kostopoulou M, Alunno A, et al. 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus. Ann Rheum Dis. 2019;78(6):736–45. doi:10.1136/annrheumdis-2019-215089.Morand EF, Bertsias G, Carter LM, et al. Glucocorticoid-sparing maintenance of disease control in patients with systemic lupus erythematosus: 48-week results from a phase 3 trial of dapirolizumab pegol. Ann Rheum Dis. 2026;85(Suppl 1):POS0730.Dörner T, Pisetsky DS, Fava A, et al. Dapirolizumab pegol treatment and improvement in laboratory markers of disease activity in patients with systemic lupus erythematosus: 48-week results from a phase 3 trial. Ann Rheum Dis. 2026;85(Suppl 1):POS1364.Furie RA, Bertsias G, Carter LM, et al. Dapirolizumab pegol and flare reduction in patients with systemic lupus erythematosus in a 48-week phase 3 trial: an updated post hoc analysis of alternative definitions of flares that reflect clinical practice. Ann Rheum Dis. 2026;85(Suppl 1):AB1163.de la Loge C, Touma Z, Gordon C, et al. Measuring fatigue in systemic lupus erythematosus: measurement properties of the FATIGUE-PRO total score using data from a phase 3 trial of dapirolizumab pegol. Ann Rheum Dis. 2026;85(Suppl 1):AB1184.Mosca M, Anjohrin S, Rawlings A, et al. Physicians’ perspectives on recognition of flares in patients with systemic lupus erythematosus in the clinic: real world insights from the United States and Europe. Ann Rheum Dis. 2026;85(Suppl 1):AB1125.Clowse MEB, Isenberg DA, Merrill JT, et al. Efficacy and safety of the CD40 ligand inhibitor dapirolizumab pegol in systemic lupus erythematosus (PHOENYCS GO): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. Published online May 29, 2026. doi:10.1016/S0140-6736(26)00691-4.Furie RA, Bruce IN, Dörner T, et al. Phase 2 randomized, placebo-controlled trial of dapirolizumab pegol in patients with moderate to severe active systemic lupus erythematosus (SLE). Rheumatology (Oxford). 2021;60(11): 5397-407.ClinicalTrials.gov. NCT04294667. https://clinicaltrials.gov/study/NCT04294667. Accessed May 29, 2026.ClinicalTrials.gov. NCT06617325. https://clinicaltrials.gov/study/NCT06617325. Accessed May 29, 2026. |
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2026-06-12 21:25
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2026-06-04 07:30
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Biogen's Salanersen Receives FDA Breakthrough Therapy Designation for Spinal Muscular Atrophy | FMP Stock News | |
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Designation is supported by an exploratory analysis from the Phase 1b study showing that some children with SMA previously treated with gene therapy who had suboptimal clinical status experienced slowing of neurodegeneration and clinically meaningful improvements in motor function following initiation of salanersenSalanersen is an investigational antisense oligonucleotide dosed once-yearly with the potential to be a meaningful therapy in the future SMA treatment landscape CAMBRIDGE, Mass., June 04, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has granted salanersen Breakthrough Therapy Designation for the treatment of spinal muscular atrophy (SMA). Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). Salanersen is an investigational novel antisense oligonucleotide (ASO) and has the potential to offer high efficacy in SMA with once-yearly dosing.“The FDA’s designation of salanersen as a breakthrough therapy recognizes that there is continued unmet need in spinal muscular atrophy, and there is more that can be done for people impacted by the disease,” said Diana Castro, M.D., of the Neurology Rare Disease Center in Flower Mound, Texas. “In the Phase 1b study of salanersen, we saw unexpected improvements on exploratory endpoints in children previously dosed with gene therapy who gained critical functions, such as sitting and walking, after receiving salanersen. We are excited about the potential of salanersen and eager to help advance the Phase 3 program.” The FDA’s decision is based on data from the Phase 1b study of salanersen, which were recently presented at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference and the 5th International Scientific Congress on SMA (SMA Europe 2026). After initiation of once-yearly salanersen in children with SMA who had a suboptimal response to prior gene therapy, clinically meaningful improvements in motor function were observed as well as slowing of neurodegeneration, as measured by reduced neurofilament levels. Salanersen was generally well-tolerated in the study. “This designation reflects the FDA's continued commitment to SMA and its recognition of the potential meaningful impact salanersen may offer,” said Kenneth Hobby, President of Cure SMA. “It affirms what our SMA community has recently communicated to the agency: urgent, unmet needs remain, and promising therapies deserve a rapid path forward.” “This designation reflects the FDA’s determination that salanersen has the potential to demonstrate substantial improvement over available therapies,” said Stephanie Fradette, Pharm.D., Head of the Rare Neurology Development Unit at Biogen. “This is a significant milestone for our SMA portfolio as we advance the Phase 3 studies designed to establish the role of salanersen in the future SMA treatment landscape.” The salanersen Phase 3 program consists of three global studies: STELLAR-1 (recruiting), an open-label study, will evaluate the effects of salanersen in young (under 6 weeks old), treatment-naïve and clinically presymptomatic infants with a genetic diagnosis of SMASOLAR (recruiting), an open-label study, will evaluate the effects of salanersen in teens and adults (aged 15–60 years) with SMA who are either treatment-naïve or previously treated with risdiplamSTELLAR-2 (recruitment expected to begin in June 2026), a randomized, double-blind, sham-controlled study, will evaluate the effects of salanersen when initiated ~6 months after onasemnogene abeparvovec-xioi in infants with SMA who received presymptomatic treatment with gene therapy at 6 weeks of age or younger More information on the STELLAR-1 study (NCT07221669), STELLAR-2 (NCT07444450) and SOLAR (NCT07444476) are available at clinicaltrials.gov. About Salanersen Salanersen (BIIB115) is a novel, intrathecally administered antisense oligonucleotide (ASO) in development for SMA. Salanersen is designed to correct splicing of SMN2 pre-mRNA to increase production of SMN protein. It has a new chemistry that leads to high potency, enabling the potential for high efficacy with once-yearly dosing. Salanersen is being evaluated in three global Phase 3 studies designed to evaluate safety and efficacy of 80 mg administered once-yearly in a broad spectrum of individuals living with SMA. Biogen licensed the global development, manufacturing and commercialization rights for salanersen from Ionis Pharmaceuticals, Inc. Salanersen was discovered by Ionis. Salanersen Phase 1b Study Results The Phase 1b study included participants (n=24, aged 0.5-12 years), who received at least 2 doses of salanersen (40 mg or 80 mg). The 80 mg dose will be further evaluated in the Phase 3 studies. In participants who received salanersen 40 mg and 80 mg and had elevated baseline concentrations of neurofilament light chain (NfL), a potential marker of ongoing neurodegeneration, meaningful reductions (75%) in NfL levels were observed at six months; these reductions were sustained throughout the follow-up period. All 24 participants treated with salanersen experienced increases from baseline on one or more endpoints. Notably, 12 of the 24 achieved at least one new WHO motor milestone, and all participants maintained the motor milestones documented at their baseline. Salanersen has been generally well-tolerated at both 40 and 80 mg doses in the ongoing Phase 1 study, and most adverse events (AEs) have been mild to moderate in severity. As of the analysis, the most common AEs in the 40 mg group were upper respiratory tract infection and vomiting, and the most common AEs in the 80 mg group were pyrexia and upper respiratory tract infection. About Spinal Muscular Atrophy (SMA) SMA is a rare, genetic, neuromuscular disease that affects individuals of all ages. It is characterized by a loss of motor neurons in the spinal cord and lower brain stem, resulting in progressive muscle atrophy and weakness.1 SMA is caused by a deficiency in the production of survival motor neuron (SMN) protein due to a damaged or missing SMN1 gene, with a spectrum of disease severity.1 Some individuals with SMA may never sit; some sit but never walk; and some walk but may lose that ability over time.2 In the absence of treatment, children with the most severe form of SMA would usually not be expected to reach their second birthday.1 SMA impacts approximately 1 in 10,000 live births,3-6 is a leading cause of genetic death among infants7 and causes a range of disability in teenagers and adults.2 About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - Facebook, Instagram, LinkedIn, X, YouTube. Biogen Safe Harbor This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential clinical effects of salanersen; the potential benefits, safety and efficacy of salanersen, including the potential to slow neurodegeneration and improve motor function; the clinical development program for salanersen; the identification and treatment of SMA; our research and development program for the treatment of SMA; the potential of our commercial business and pipeline programs, including salanersen; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “will,” “would,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would” or the negative of these words or other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to differ materially from those stated or implied in this document, including, among others, uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov. These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. Digital Media Disclosure From time to time we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and this social media channel in addition to our press releases, SEC filings, public conference calls and webcasts, as the information posted on them could be material to investors. References: National Institute of Neurological Disorders and Stroke, NIH. Spinal Muscular Atrophy Fact Sheet. Available at https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Spinal-Muscular-Atrophy-Fact-Sheet. Accessed: March 2026.Wadman RI, Wijngaarde CA, Stam M, et al. Muscle strength and motor function throughout life in a cross-sectional cohort of 180 patients with spinal muscular atrophy types 1c–4. Eur J Neurol. 2018;25(3):512-518.Arkblad E, Tulinius M, Kroksmark AK, Henricsson M, Darin N. A population-based study of genotypic and phenotypic variability in children with spinal muscular atrophy. Acta Paediatr. 2009 May;98(5):865-72. doi: 10.1111/j.1651-2227.2008.01201.x. Epub 2009 Jan 20. Jedrzejowska M, Milewski M, Zimowski J, Zagozdzon P, Kostera-Pruszczyk A, Borkowska J, Sielska D, Jurek M, Hausmanowa-Petrusewicz I. Incidence of spinal muscular atrophy in Poland--more frequent than predicted? Neuroepidemiology. 2010;34(3):152-7. doi: 10.1159/000275492. Epub 2010 Jan 15.Prior TW, Snyder PJ, Rink BD, Pearl DK, Pyatt RE, Mihal DC, Conlan T, Schmalz B, Montgomery L, Ziegler K, Noonan C, Hashimoto S, Garner S. Newborn and carrier screening for spinal muscular atrophy. Am J Med Genet A. 2010 Jul;152A(7):1608-16. doi: 10.1002/ajmg.a.33474.Sugarman EA, Nagan N, Zhu H, Akmaev VR, Zhou Z, Rohlfs EM, Flynn K, Hendrickson BC, Scholl T, Sirko-Osadsa DA, Allitto BA. Pan-ethnic carrier screening and prenatal diagnosis for spinal muscular atrophy: clinical laboratory analysis of >72,400 specimens. Eur J Hum Genet. 2012 Jan;20(1):27-32. doi: 10.1038/ejhg.2011.134. Epub 2011 Aug 3.Kolb SJ, Coffey CS, Yankey JW, et al. Natural history of infantile-onset spinal muscular atrophy. Ann Neurol. 2017;82(6):883-891. doi:10.1002/ana.25101. |
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Biogen Inc. - BIIB | FMP Stock News | |
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, /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Biogen Inc. ("Biogen" or the "Company") (NASDAQ: BIIB). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.The investigation concerns whether Biogen and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On May 14, 2026, Biogen issued a press release announcing "topline results from the Phase 2 CELIA study evaluating diranersen (BIIB080), an investigational antisense oligonucleotide (ASO) therapy targeting tau, in individuals with early Alzheimer's disease." Although Biogen described the results as "compelling," the study missed its primary dose-response endpoint. On this news, Biogen's stock price fell $13.16 per share, or 6.43%, to close at $191.37 per share on May 14, 2026. Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com. Attorney advertising. Prior results do not guarantee similar outcomes. CONTACT: Danielle Peyton Pomerantz LLP [email protected] 646-581-9980 ext. 7980 SOURCE Pomerantz LLP |
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BIIB Investors Have Opportunity to Join Biogen Inc. Fraud Investigation with the Schall Law Firm | FMP Stock News | |
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LOS ANGELES--(BUSINESS WIRE)--The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Biogen Inc. (“Biogen” or “the Company”) (NASDAQ: BIIB) for violations of the securities laws.The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Biogen revealed on May 14, 2026, that the topline data from its Phase 2 CELIA study for diranersen failed to meet its primary endpoints. Based on these facts, the Company’s shares fell about 6.4% on the same day. If you are a shareholder who suffered a loss, click here to participate. We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at www.schallfirm.com, or by email at [email protected]. The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics. |
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BIIB Investors Have Opportunity to Join Biogen Inc. Fraud Investigation with the Schall Law Firm | FMP Stock News | |
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The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Biogen Inc. (“Biogen” or “the Company”) (NASDAQ: BIIB) for violations of the securities laws.The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Biogen revealed on May 14, 2026, that the topline data from its Phase 2 CELIA study for diranersen failed to meet its primary endpoints. Based on these facts, the Company’s shares fell about 6.4% on the same day. If you are a shareholder who suffered a loss, click here to participate. We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at www.schallfirm.com, or by email at [email protected]. The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics. View source version on businesswire.com: https://www.businesswire.com/news/home/20260604049144/en/ |
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BIIB's Next-Gen SMA Therapy Salanersen Wins FDA's Breakthrough Tag | FMP Stock News | |
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Key Takeaways BIIB's salanersen received FDA Breakthrough Therapy designation for spinal muscular atrophy.Phase Ib data showed motor function gains, lower neurofilament levels and a favorable safety profile.Salanersen may allow once-yearly dosing and is being tested in three global phase III studies. Biogen (BIIB - Free Report) recently announced that the FDA has granted Breakthrough Therapy designation to Salanersen, an investigational next-generation antisense oligonucleotide (ASO) for the treatment of patients with spinal muscular atrophy (SMA).The FDA’s Breakthrough Therapy designation is intended to facilitate drug development and expedite the review of therapies for serious diseases with unmet medical needs. Breakthrough Therapy Tag Based on BIIB’s Phase Ib DataThe FDA's Breakthrough Therapy Designation for salanersen was supported by data from the phase Ib study in children with SMA who had an inadequate response to prior gene therapy. The study demonstrated that treatment with once-yearly dosing of salanersen led to meaningful improvements in motor function, reduced neurodegeneration as measured by lower neurofilament levels and a favorable safety profile. SMA is a rare genetic neuromuscular disorder caused by insufficient production of the survival motor neuron (SMN) protein, leading to the progressive loss of motor neurons in the spinal cord. It represents one of the leading genetic causes of infant mortality and can result in varying degrees of disability in adolescents and adults. Biogen currently markets Spinraza, the first FDA-approved treatment for SMA. Salanersen and Spinraza are ASOs designed to increase SMN protein production by modifying SMN2 gene splicing. However, Salanersen has several potential advantages. The biggest differentiator is dosing frequency. Spinraza requires four loading doses followed by maintenance doses every four months, while Salanersen has been engineered for enhanced potency, which may allow once-yearly administration, significantly reducing the treatment burden for patients. The FDA approved a higher dose of Spinraza in March, which offers two initial doses spaced 14 days apart, followed by a maintenance dose every four months. However, the dosing regimen has not yet been launched. Year to date, shares of Biogen have risen 11.7% against the industry’s 3.4% decline. Image Source: Zacks Investment Research More on Biogen’s SalanersenBiogen acquired worldwide rights to develop, manufacture and commercialize Salanersen from Ionis Pharmaceuticals (IONS - Free Report) in January 2022. The candidate was originally discovered by IONS. Salanersen is being studied in a broad global phase III program comprising three studies: STELLAR-1, SOLAR and STELLAR-2. STELLAR-1 is assessing salanersen in treatment-naïve, presymptomatic infants younger than six weeks with a genetic diagnosis of SMA. SOLAR is evaluating the therapy in adolescents and adults aged 15 to 60 years with SMA, including both treatment-naïve patients and those previously treated with Evrysdi (risdiplam), Roche's (RHHBY - Free Report) approved SMA therapy. Meanwhile, STELLAR-2 will study salanersen in presymptomatic infants who received Zolgensma (onasemnogene abeparvovec-xioi) gene therapy at six weeks of age or younger, with Salanersen treatment initiated approximately six months later. The study is expected to begin this month. Zolgensma is a one-time gene replacement therapy developed by Novartis (NVS - Free Report) . BIIB’s Zacks RankBiogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. |
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BIIB Investors Have Opportunity to Join Biogen Inc. Fraud Investigation with the Schall Law Firm | FMP Stock News | |
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, /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Biogen Inc. ("Biogen" or "the Company") (NASDAQ: BIIB) for violations of the securities laws.The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Biogen revealed on May 14, 2026, that the topline data from its Phase 2 CELIA study for diranersen failed to meet its primary endpoints. Based on these facts, the Company's shares fell about 6.4% on the same day. If you are a shareholder who suffered a loss, click here to participate. We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at www.schallfirm.com, or by email at [email protected]. The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics. CONTACT: The Schall Law Firm Brian Schall, Esq. 310-301-3335 [email protected] www.schallfirm.com SOURCE The Schall Law Firm |
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This Biogen Analyst Turns Bullish; Here Are Top 3 Upgrades For Monday | FMP Stock News | |
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Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades, downgrades and initiations, please see our analyst ratings page.Considering buying BIIB stock? Here’s what analysts think: Photo via Shutterstock Market News and Data brought to you by Benzinga APIs © 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved. To add Benzinga News as your preferred source on Google, click here. |
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2026-06-09 13:42
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Biogen Inc. - BIIB | FMP Stock News | |
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Original source text
NEW YORK, June 09, 2026 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Biogen Inc. (“Biogen” or the “Company”) (NASDAQ: BIIB). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.The investigation concerns whether Biogen and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On May 14, 2026, Biogen issued a press release announcing “topline results from the Phase 2 CELIA study evaluating diranersen (BIIB080), an investigational antisense oligonucleotide (ASO) therapy targeting tau, in individuals with early Alzheimer’s disease.” Although Biogen described the results as “compelling,” the study missed its primary dose-response endpoint. On this news, Biogen’s stock price fell $13.16 per share, or 6.43%, to close at $191.37 per share on May 14, 2026. Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com. Attorney advertising. Prior results do not guarantee similar outcomes. CONTACT: Danielle Peyton Pomerantz LLP [email protected] 646-581-9980 ext. 7980 |
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2026-06-10 10:29
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BIIB Investors Have Opportunity to Join Biogen Inc. Fraud Investigation with the Schall Law Firm | FMP Stock News | |
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Original source text
LOS ANGELES, June 10, 2026 (GLOBE NEWSWIRE) -- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Biogen Inc. (“Biogen” or “the Company”) (NASDAQ: BIIB) for violations of the securities laws.The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Biogen revealed on May 14, 2026, that the topline data from its Phase 2 CELIA study for diranersen failed to meet its primary endpoints. Based on these facts, the Company’s shares fell about 6.4% on the same day. If you are a shareholder who suffered a loss, click here to participate. We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at www.schallfirm.com, or by email at [email protected]. The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics. CONTACT: The Schall Law Firm Brian Schall, Esq. 310-301-3335 [email protected] www.schallfirm.com |
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Biogen Inc. - BIIB | FMP Stock News | |
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Original source text
, /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Biogen Inc. ("Biogen" or the "Company") (NASDAQ: BIIB). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.The investigation concerns whether Biogen and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On May 14, 2026, Biogen issued a press release announcing "topline results from the Phase 2 CELIA study evaluating diranersen (BIIB080), an investigational antisense oligonucleotide (ASO) therapy targeting tau, in individuals with early Alzheimer's disease." Although Biogen described the results as "compelling," the study missed its primary dose-response endpoint. On this news, Biogen's stock price fell $13.16 per share, or 6.43%, to close at $191.37 per share on May 14, 2026. Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com. Attorney advertising. Prior results do not guarantee similar outcomes. CONTACT: Danielle Peyton Pomerantz LLP [email protected] 646-581-9980 ext. 7980 SOURCE Pomerantz LLP |
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BIIB Investors Have Opportunity to Join Biogen Inc. Fraud Investigation with the Schall Law Firm | FMP Stock News | |
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Original source text
, /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Biogen Inc. ("Biogen" or "the Company") (NASDAQ: BIIB) for violations of the securities laws.The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Biogen revealed on May 14, 2026, that the topline data from its Phase 2 CELIA study for diranersen failed to meet its primary endpoints. Based on these facts, the Company's shares fell about 6.4% on the same day. If you are a shareholder who suffered a loss, click here to participate. We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at www.schallfirm.com, or by email at [email protected]. The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics. CONTACT: The Schall Law Firm Brian Schall, Esq. 310-301-3335 [email protected] www.schallfirm.com SOURCE The Schall Law Firm |
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2026-04-19 10:52
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3 S&P 500 Dividend Stocks Marked Down as Much as 37% | FMP Stock News | |
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Dividend stocks started the new year on a bullish foot. With growth stocks surging again, however, dividend payers have fallen a bit back out of favor.If you're an income-minded investor though, nothing's really changed... except for the price of the tickers you may be interested in owning. A bunch of them now cost much less than they did just a few weeks ago, while a small handful of them are now dirt cheap. Here's a look at three of the S&P 500's (^GSPC +0.50%) top dividend names that are now down 34%, 29%, and a hefty 37% from recent highs that you may want to scoop up at a discount while you can. Progressive It's been a tough 12-month stretch for Progressive's (PGR +0.32%) shareholders. The insurer's stock is down 29% from last May's peak, largely on (legitimate) concerns that a fantastic 2024 would be a tough act to follow. Not only has its competition stepped up, but the rising cost of reimbursements poses a clear threat to its profitability. The company's also posted some disappointing quarterly numbers in the meantime. Today's Change ( 0.32 %) $ 0.65 Current Price $ 202.91 For all the naysaying, though, it's worth highlighting that last year's net income grew more than 30% on revenue growth of 16%, which widened its underwriting profit margin from 11.2% to 12.6%. The company's off to a pretty good start this year as well, with net income up 10% through the first three months of 2026 on premium growth of 6% and a 9% increase in the total number of active policies. Investors are waiting for problems that just aren't materializing. They'll figure it out sooner or later, and likely sooner. Between now and then, however, this stock's steep sell-off has inflated its trailing dividend yield up to 6.8%. Just bear in mind that the vast majority of its underlying payout is a once-per-year payment of its profits achieved during the year. It's not exactly consistent, even if it is usually sizable. You won't want to make PGR your first or only dividend holding, particularly if you use these dividend payments to pay your bills. Gen Digital Gen Digital (GEN +1.59%) may be one of the stock market's best-kept secrets. In fact, there's a good chance you've never even heard of it -- its $12 billion market just doesn't turn many heads. Nevertheless, with a forward-looking dividend yield of 2.5% and a well-established history of paying something every quarter to shareholders, this stock's 37% pullback from August's high makes for a compelling bullish argument. Gen Digital is a digital security service provider. It does a lot, but you may know it best by its brands LifeLock and Norton. It also owns Avast and financial websites Moneylion and GoBankingRates, which it also operates. Roughly 500 million people use at least one of its products, most of which generate recurring revenue. It was on pace to turn nearly $5 billion worth of revenue into a per-share profit of $2.55 for the fiscal year that ended in March, up 26% and 15%, respectively. Image source: Getty Images. As for why shares have performed so poorly of late despite this pullback, dialing back their forward-looking price-to-earnings ratio to less than 7, it was largely caught up in the same sell-off that upended plenty of artificial intelligence (AI) and cybersecurity stocks; broad economic weakness isn't helping either. Indeed, some investors -- professional and amateur alike -- fear that the rise of AI-powered alternatives will reduce the need for custom-coded security solutions like the ones this company offers. In reality, though, the rise of AI-powered hacking and digital security threats is increasing the need for proven cybersecurity solutions like LifeLock and Norton. As is the case with Progressive, the market should see this soon enough. The one arguable downside to Gen Digital is that it hasn't raised its dividend since 2020. The company's not necessarily unwilling to do so; it's just waiting for the right time. Ares Management Last but not least, add Ares Management (ARES +1.57%) to your list of S&P 500 dividend stocks to buy while it's still down 34% from its early January high. Newcomers will be plugging into a forward-looking yield of 4.6%; its dividend has now been raised for eight years in a row. That's nowhere near the sort of dividend growth track record held by the market's official Dividend Kings, which have upped their annual payouts for a minimum of 50 years. But it's a solid start for this company that's been committed to a more predictable quarterly payout since 2018. And it's improved by more than a little. Its quarterly per-share payment of $0.28 back in 2018 has since grown to this year's payment of $1.35 per share. Today's Change ( 1.57 %) $ 2.08 Current Price $ 134.90 It's a business built for this sort of consistency, of course. Just as the name suggests, Ares Management is an investment manager, collecting a quarterly fee for the capital it provides to companies, and then oversees. It turned $5.6 billion worth of revenue into nearly $1.1 billion in net income last year, most of which was passed along to shareholders in the form of dividends. That's down slightly from 2024's comparisons, although the market didn't really start to worry about the matter until this year, when broad economic weakness became a much more serious threat to the private credit industry. Investment bank JPMorgan Chase even went as far as to write down the values of some of its private-credit loans last quarter, while -- as part of an effort to curb the liquidity headache that such heavy redemptions cause -- Ares itself recently imposed a limit on the amount of money its investors could withdraw from their stake in the company; it looks problematic. The headwind isn't anything the asset manager has faced and survived before, however. And buying on these dips has typically paid off in the long run. |
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Gen Brings Trusted Financial Intelligence to Microsoft's Copilot Discover Feeds | FMP Stock News | |
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Engine by Gen to power real-time compliant financial insights and recommendations in Copilot-powered Discover feeds, /PRNewswire/ -- Gen (NASDAQ: GEN), a global company dedicated to powering Digital Freedom, announced today it is integrating Engine by Gen directly into Microsoft products like Copilot, MSN and Bing, bringing trusted, compliant financial information and relevant offers into AI-powered experiences across Microsoft. The integration helps provide easier access to trusted, personalized information that empowers users to make more confident financial decisions. "AI is quickly becoming a common place people turn for financial decisions, from choosing a credit card to evaluating savings options," said Travis Witteveen, Head of Products and Portfolios at Gen. "By bringing Engine into Microsoft Discover feeds, we're ensuring people get accurate, personalized financial guidance directly within the digital experiences they already use." As part of this collaboration, Engine by Gen will: Add to Copilot's intelligence layer, ingesting key compliant product terms and offer details from Engine. Be a grounding source to host a comprehensive, regulatory refreshed financial product catalog, starting with credit cards, deposits, loans, insurance and more. Deliver a seamless path to financial product recommendation, with no data leakage and no added compliance burden on Microsoft or the financial institutions. "As AI supports people in more complex, real-world decisions, the guidance it provides must be grounded in accuracy and compliance," said Ganga Venkatasubramanian, Partner Product Group Manager, Microsoft. "This marks an important step toward a future where AI can responsibly guide consumers through important financial choices with confidence." Engine by Gen is starting to roll out across Microsoft surfaces with additional Engine-powered Copilot experiences expected in the future. About Gen Gen (NASDAQ: GEN) is a global company dedicated to powering Digital Freedom through its trusted consumer brands including Norton, Avast, LifeLock, MoneyLion and more. The Gen family of consumer brands is rooted in providing financial empowerment and cyber safety for the first digital generations. Today, Gen empowers people to live their digital lives safely, privately and confidently for generations to come. Gen brings award-winning products and services in cybersecurity, online privacy, identity protection and financial wellness to nearly 500 million users in more than 150 countries. Learn more at GenDigital.com. Media Contacts: Audra Proctor Gen [email protected] SOURCE Gen Digital Inc. |
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Gen and xAI Partner to Build Trusted AI Assistants for Millions of Consumers | FMP Stock News | |
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xAI's frontier models will supercharge Gen's AI-native products, Norton Neo and AI Assistants, bringing safe and simple autonomous AI to everyone., /PRNewswire/ -- Gen (NASDAQ: GEN), the company behind Norton, Avast, LifeLock and MoneyLion, and xAI today announced a partnership to bring xAI's frontier Grok models into Gen's consumer platforms. xAI and Gen will collaborate to rapidly advance their technologies for the next wave of AI-powered consumer products. Gen and xAI Partner to Build Trusted AI Assistants for Millions of Consumers Through this collaboration, Gen's AI Foundry will use xAI's unique access to coherent compute, data, and technology to bring Grok frontier intelligence to the next generation of secure and trusted consumer AI products, beginning with Norton Neo AI Browser and Assistant powered by Grok. "As agentic AI systems grow increasingly capable, safely and effectively delivering intelligence to everyday consumers requires robust trust and security infrastructure," said Howie Xu, Chief AI & Innovation Officer. "Through our co-architect partnership, our xAI-powered consumer products will utilize Grok's frontier models to not only answer questions but also take real-world action in a secure and trusted environment." From Model Intelligence to Trusted Action Scaling powerful AI responsibly for widespread consumer use benefits from strong safety infrastructure. As part of this collaboration: xAI will provide advanced models optimized for reasoning and real-world tasks. xAI frontier intelligence will power agentic systems operating in Gen's secure environment. Gen's Agent Trust Hub will verify, monitor, and enforce safe agent behavior across the full lifecycle of interaction, governing which tools agents use and how they act at runtime. xAI's models will be integrated across Gen's AI-first experiences, starting with the Norton Neo Browser and Assistant, enabling users to interact with AI agents in a secure, trusted environment. All processing is designed by Gen and Norton with privacy and security by default, supported by enterprise-grade protections, including end-to-end encryption and globally recognized security certifications – putting the consumers in control of its privacy. About Gen Gen (NASDAQ: GEN) is a global company dedicated to powering Digital Freedom through its trusted consumer brands including Norton, Avast, LifeLock, MoneyLion and more. The Gen family of consumer brands is rooted in providing financial empowerment and cyber safety for the first digital generations. Today, Gen empowers people to live their digital lives safely, privately and confidently for generations to come. Gen brings award-winning products and services in cybersecurity, online privacy, identity protection and financial wellness to nearly 500 million users in more than 150 countries. Learn more at GenDigital.com. About Gen AI Foundry Rooted in Gen's commitment to safety and transparency, the Gen AI Foundry is the engine behind its most recent AI innovations, from AI-powered security experiences to autonomous financial helpers and identity agents. It also serves as the place where core trust infrastructure is developed and operationalized, including the Agent Trust Hub, extending protection across the agent lifecycle from verification to execution. Here, Gen's AI strategy becomes real through visible ventures, prototypes, working products, partnerships and an open ecosystem designed to shape and secure the AI era with and for both people and agents. About xAI xAI is building artificial intelligence to accelerate our understanding of the universe. Our mission is to advance human scientific discovery by creating AI that is all-encompassing and as far-reaching as possible. Guided by first-principles reasoning, we tackle ambitious challenges with rapid iteration and a focus on solving real problems. We are a focused team driven by curiosity and the pursuit of unprecedented progress. Follow us on x.ai or @xai. Media Contacts: Brittany Posey Gen [email protected] SOURCE Gen Digital Inc. |
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Gen Accelerates Agentic Security and Privacy for the AI Era | FMP Stock News | |
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Gen Agent Trust Hub Now Includes VPN for Agents, Norton 360 Enhances Agent Protection, /PRNewswire/ -- Gen (NASDAQ: GEN), a global leader powering Digital Freedom with a family of trusted brands including Norton, Avast, LifeLock and MoneyLion, today announced two advancements in its mission to build the trust layer for the AI agent era: the launch of VPN for Agents, the first consumer AI-native VPN built for autonomous AI agents and available through the Gen Agent Trust Hub, and the expansion of Norton AI Agent Protection within Norton 360. With these advancements, Gen is building the go-to consumer Cyber Safety platform that delivers both the trust layer and real-time oversight for AI agents. Gen accelerates agentic security and privacy for the AI era with VPN for Agents, advancements to Norton AI Agent Protection (PRNewsfoto/Gen Digital Inc.) AI agents are no longer experimental. They read emails, manage financial workflows, execute code, and operate across sensitive accounts on behalf of millions of people every day. While traditional VPNs protect the device and network these agents operate through, they fall short of what AI agents need today. They don't separate your traffic from an agent's or allow control over where agents connect and what they access. As agents take on more complex tasks, dedicated, agent-aware protection is becoming essential. Today's announcement addresses these growing needs, extending Gen's Agent Trust Hub from verification and detection into real-time communication security and consumer-grade enforcement. "As people embrace AI agents and use them to manage more of their digital lives, they deserve security and privacy that keeps pace," said Howie Xu, Chief AI Innovation Officer at Gen. "Our VPN for Agents protects that activity in real time, and with Agent Protection embedded into Norton 360, we are giving millions of people the confidence to let AI work on their behalf, knowing every connection and action is secured. And we're excited to integrate this technology into more of our products." The first truly AI-native, multi-tunnel VPN for AI agents Traditional VPNs were designed for human-driven web browsing. VPN for Agents reimagines secure connectivity for the agentic era, creating an encrypted trust corridor engineered for the high-frequency, multi-service, multi-channel communication patterns of autonomous AI agents. Powered by Norton VPN's secure infrastructure, it delivers private, consistent, and installation-optional connectivity for AI agents. VPN for Agents introduces three critical advancements: Agent-native design with no downloads or client set-up required. Multiple tunnel technology enabling agents to run simultaneously across different countries – a first of its kind. Protected identity and location to reduce tracking and profiling while delivering more complete, consistent results across regions. Norton AI Agent Protection: Safe AI execution within Norton 360 Norton AI Agent Protection brings AI agent security directly into Norton 360, the trusted Cyber Safety platform used by tens of millions of customers worldwide. As people begin to embrace AI agents to automate tasks, handle files, and manage sensitive data, those agents can face both familiar threats like malware and new risks, where hidden or malicious prompts try to steer them toward risky sites, dangerous commands, or data misuse. To help people use AI agents safely and confidently, Norton AI Agent Protection monitors what supported AI agents do and where they connect, adding smart security layers between decision and execution. It provides action-level monitoring, intelligent blocking, and clear, user-friendly prompts – all seamlessly integrated into Norton 360. Building on its initial launch, Norton AI Agent Protection is expanding with new defenses across the AI agent workflow, including: Pre-use for AI plugins, skills, and tools to help block malicious or over-privileged integrations. Prompt injection defense that detects and neutralizes attacks attempting to manipulate agent behavior. Advanced code and file scanning of content that AI agents access or generate, detecting malware and unsafe scripts before they can execute. Powered by Norton Security, Built on Gen's Trust Layer The Agent Trust Hub, VPN for Agents and Norton AI Agent Protection are all developed in collaboration between Gen Threat Labs and Gen AI Foundry, the company's engine for rapidly prototyping and scaling AI innovations. As AI moves from simple chat to taking real-world actions on a person's behalf, people need real-time protection across every step of that journey. Gen, with its portfolio of consumer Cyber Safety brands, is uniquely positioned to be the trust layer for people to benefit from AI-native product and agentic innovation, without compromising security or privacy. Availability VPN for Agents is available now. To sign up, get your access token and receive setup instructions, visit ai.gendigital.com/agentvpn. For a limited number of customers. Norton AI Agent Protection is available to Norton 360 customers on Windows using Claude Code, Cursor, and OpenClaw. Mac support to also launch soon. About Gen Gen (NASDAQ: GEN) is a global company dedicated to powering Digital Freedom through its trusted consumer brands including Norton, Avast, LifeLock, MoneyLion and more. The Gen family of consumer brands is rooted in providing cyber safety and financial empowerment for the first digital generations. Today, Gen empowers people to live their digital lives safely, privately and confidently for generations to come. Gen brings award-winning products and services in cybersecurity, online privacy, identity protection and financial wellness to nearly 500 million users in more than 150 countries. Learn more at GenDigital.com. About Gen AI Foundry Rooted in Gen's commitment to safety and transparency, the Gen AI Foundry is the engine behind its most recent AI innovations, from AI-powered security experiences to autonomous financial helpers and identity agents. It also serves as the place where core trust infrastructure is developed and operationalized, including the Agent Trust Hub, extending protection across the agent lifecycle from verification to execution. Here, Gen's AI strategy becomes real through visible ventures, prototypes, working products, partnerships and an open ecosystem designed to shape and secure the AI era with and for both people and agents. About Gen Threat Labs Gen Threat Labs is the Cyber Safety research & technology team within Gen, focused on uncovering and analyzing the latest digital threats and scams worldwide. Their insights, and innovative defense measures, power the security technologies that protect people across Gen's portfolio of trusted brands. Media Contacts: Brittany Posey Gen [email protected] SOURCE Gen Digital Inc. |
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2026-06-12 21:25
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2026-05-04 12:45
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Gen Digital to Report Q4 Earnings: What's in Store for the Stock? | FMP Stock News | |
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Key Takeaways GEN expects Q4 revenues of $1.24B-$1.26B, implying 22.7% year-over-year growth.AI-driven platform, Norton 360 and MoneyLion momentum support monetization growth.Weak consumer sentiment and rising AI and R&D spending may pressure margins. Gen Digital (GEN - Free Report) is scheduled to report fourth-quarter fiscal 2026 results on May 7, after market close.GEN expects non-GAAP revenues in the band of $1.24-$1.26 billion for the quarter. The Zacks Consensus Estimate for revenues is pegged at $1.24 billion, indicating 22.7% year-over-year growth. For the fiscal fourth quarter, Gen Digital expects non-GAAP earnings in the range of 64-66 cents per share. The consensus mark for the same is pegged at 65 cents per share, suggesting a year-over-year rise of 10.2%. The estimate has remained unchanged over the past 60 days. GEN’s earnings beat the Zacks Consensus Estimate in each of the trailing four quarters, the average surprise being 2.9%. Factors to NoteGen Digital is expected to gain from sustained demand for cybersecurity, identity protection and financial safety solutions due to the rapid rise in cyber threats, particularly AI-enabled scams. The emergence of cyber safety and financial wellness is also a tailwind for Gen Digital in the to-be-reported quarter. Traction in Gen Digital’s unified AI-driven platform, combining data from security, identity and financial behavior and innovation in higher-tier subscriptions like Norton 360 and strong momentum in MoneyLion, will further reinforce monetization tailwinds in the fourth quarter of fiscal 2026. Momentum in the quarter is likely to have been supported by the AI-powered Genie Scam Protection feature, Norton Deepfake Detection and Norton Neo. An increase in client bookings, supported by strong retention, international expansion and strategic partnerships, is likely to have aided top-line growth in the fiscal third quarter. Robust demand for identity theft protection solutions, dark web monitoring, social media monitoring, stolen wallet assistant and ID restoration is expected to have been positive for the quarter under review. However, Gen Digital is also facing some near-term headwinds. Weak consumer sentiment could impact discretionary spending on subscriptions. GEN’s continuous investment in AI, R&D and infrastructure to stay ahead, pressuring margins. The integration of new businesses like MoneyLion introduces execution risks, especially in aligning customer experience and realizing cross-selling synergies. However, GEN’s efforts to innovate make it a strong long-term investment choice. Earnings Whispers for GEN StockOur proven model predicts an earnings beat for GEN this earnings season. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the chances of an earnings beat, which is the case here. Earnings ESP: Earnings ESP, which represents the difference between the Most Accurate Estimate (65 cents per share) and the Zacks Consensus Estimate 65 cents per share), is +0.52%. You can uncover the best stocks to buy or sell before they are reported with our Earnings ESP Filter. Zacks Rank: GEN carries a Zacks Rank #3 at present. You can see the complete list of today’s Zacks #1 Rank stocks here. Stocks to ConsiderHere are some stocks you may want to consider in the broader Zacks Computer and Technology sector, as our model shows that these have the right combination of elements to post an earnings beat: NVIDIA (NVDA - Free Report) has an Earnings ESP of +0.24% and carries a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank stocks here. NVIDIA is slated to report first-quarter 2026 results on May 20. The Zacks Consensus Estimate for NVIDIA’s first-quarter earnings is pegged at $1.77 per share, up by a penny over the past 30 days, indicating a rise of 118.5% from the year-ago quarter’s reported figure. Cisco Systems (CSCO - Free Report) has an Earnings ESP of +1.92% and carries a Zacks Rank #2 at present. Cisco Systems is set to report third-quarter fiscal 2026 results on May 13. The Zacks Consensus Estimate for Cisco Systems’ third-quarter 2026 earnings is pegged at $1.04 per share, unchanged over the past 60 days, indicating a rise of 8.33% from the year-ago quarter’s reported figure. Audioeye (AEYE - Free Report) has an Earnings ESP of +9.62% and carries a Zacks Rank #2 at present. It is set to report first-quarter fiscal 2026 results on May 12. The Zacks Consensus Estimate for Audioeye’s first-quarter earnings is pegged at 17 cents per share, up by 2 cents over the past 60 days, indicating a rise of 13.3% from the year-ago quarter’s reported figure. |
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2026-06-12 21:25
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2026-05-04 13:10
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Why Gen Digital (GEN) is Poised to Beat Earnings Estimates Again | FMP Stock News | |
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Looking for a stock that has been consistently beating earnings estimates and might be well positioned to keep the streak alive in its next quarterly report? Gen Digital (GEN - Free Report) , which belongs to the Zacks Technology Services industry, could be a great candidate to consider.This security software maker has an established record of topping earnings estimates, especially when looking at the previous two reports. The company boasts an average surprise for the past two quarters of 1.61%. For the last reported quarter, Gen Digital came out with earnings of $0.64 per share versus the Zacks Consensus Estimate of $0.63 per share, representing a surprise of 1.59%. For the previous quarter, the company was expected to post earnings of $0.61 per share and it actually produced earnings of $0.62 per share, delivering a surprise of 1.64%. Price and EPS Surprise For Gen Digital, estimates have been trending higher, thanks in part to this earnings surprise history. And when you look at the stock's positive Zacks Earnings ESP (Expected Surprise Prediction), it's a great indicator of a future earnings beat, especially when combined with its solid Zacks Rank. Our research shows that stocks with the combination of a positive Earnings ESP and a Zacks Rank #3 (Hold) or better produce a positive surprise nearly 70% of the time. In other words, if you have 10 stocks with this combination, the number of stocks that beat the consensus estimate could be as high as seven. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a version of the Zacks Consensus whose definition is related to change. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Gen Digital currently has an Earnings ESP of +0.52%, which suggests that analysts have recently become bullish on the company's earnings prospects. This positive Earnings ESP when combined with the stock's Zacks Rank #3 (Hold) indicates that another beat is possibly around the corner. We expect the company's next earnings report to be released on May 7, 2026. Investors should note, however, that a negative Earnings ESP reading is not indicative of an earnings miss, but a negative value does reduce the predictive power of this metric. Many companies end up beating the consensus EPS estimate, but that may not be the sole basis for their stocks moving higher. On the other hand, some stocks may hold their ground even if they end up missing the consensus estimate. Because of this, it's really important to check a company's Earnings ESP ahead of its quarterly release to increase the odds of success. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. |
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2026-06-12 21:25
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2026-05-04 16:17
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Norton Neo Raises the Bar on Security and Privacy for the AI-Native Browser | FMP Stock News | |
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With a built-in VPN that adapts automatically, alongside anti-phishing, anti-fingerprinting and smarter ad-block controls, users get the full power of AI browsing without compromise., /PRNewswire/ -- Norton, a global leader in consumer Cyber Safety and part of Gen (NASDAQ: GEN), today released a major update to Norton Neo, its AI-native browser. The upgrade embeds integrated VPN, anti-phishing, and anti-fingerprinting protection into the browsing experience. No extensions, no separate tools, no manual set-ups. Norton Neo ensures that AI is not only embedded into a streamlined browsing experience that unifies search and chat, but that protection is built-in by default. Norton Neo AI-native browser expands built-in privacy and security. According to the Gen Threat Labs, roughly 83% of attacks blocked in early 2026 were web-based, including phishing and spam ads. Gen is also tackling a newer category: indirect prompt injections that hijack AI features through malicious page content. Norton Neo handles these at the browser layer rather than asking users to bolt on protection. "People can get a lot done on a browser, but digital threats, including spam and phishing, are rampant. Every AI feature added to a browser is another attack surface, and people shouldn't need to be security experts to feel safe online" said Howie Xu, Chief AI and Innovation Officer at Gen. "With Norton Neo, protection isn't a setting you turn on, it's the foundation. The VPN adapts on its own, phishing is caught before you click, and your AI queries can't be turned against you." Protection That Adapts as You Browse Adaptive VPN. Norton Neo's built-in VPN encrypts traffic and lets users control their location without a separate install. This built-in VPN intelligently adapts to sensitive sites, like banking or healthcare, and steps back during everyday browsing. By leveraging VPN for Agents, the industry's first consumer multi-channel agent-native VPN service released by Gen on April 30, Norton Neo is able to intelligently apply protection when it's needed without requiring users to turn it on or off. Advanced anti-fingerprinting. To further strengthen privacy, Norton Neo now helps prevent websites and trackers from uniquely identifying people through their device and browser characteristics. This reduces persistent tracking and enhances anonymity online. Incognito mode now delivers true anonymity, not just the perception of it. Safe browsing and phishing defense. The browser proactively detects and blocks phishing and malicious websites before people land on them, helping safeguard against credential theft and deceptive online content. Norton Neo extends the same protection to webmail through Norton's Scam Analyzer engine. In addition, the browser defends against indirect prompt injection attacks, so AI features cannot be manipulated by instructions hidden in web content. Together, these defense layers formed a built-in intelligent protection, backed by the expertise of the Gen Threat Labs and powered by Norton and its decades of security expertise. More Control, Less Friction In addition to core protections, Norton Neo has expanded its ad blocking capabilities to offer more granular control over what is blocked and when, allowing customization based on browsing preferences and regional requirements. Cookie consent has also been streamlined to cut down on banner fatigue without giving up control. These updates are designed to simplify privacy management while maintaining strong protection in the background. To make the browsing experience seamless, Norton Neo extends across platforms, including Windows, Mac, iOS, and Android, ensuring consistent privacy and protection wherever and however people browse. Norton Neo protects people's data and stores all chats locally by default. Queries within the browser are processed under strict, binding contractual safeguards that prevent any AI providers from retaining data or using it for model training. AI providers do not have access to sensitive identification such as IP address or location. AI That Does More, on a Foundation You Can Trust Alongside its privacy and security enhancements, Norton Neo continues to expand its AI-native capabilities to help people get more done, more efficiently. Norton Neo's chat experience now supports deeper reasoning and more complex tasks. With fewer limitations and a more responsive experience, users can explore ideas, refine outputs, and take action without interruption. Unified search lets users find anything they've browsed or discussed in chat using plain language, instead of exact keywords. Features like vertical tabs, better tab management, and a customizable newsfeed round out the experience. As part of this update, Norton Neo also gives its users early access to a new agentic AI assistant; a private, always-on helper for managing online activities, and a step toward Norton's vision of secure AI assistance for everyone. Learn more and try Norton Neo at neobrowser.ai About Norton Norton is a leader in Cyber Safety, and part of Gen (NASDAQ: GEN), a global company dedicated to powering Digital Freedom with a family of trusted consumer brands. Norton empowers millions of individuals and families with award-winning protection for their devices, online privacy, and identity. Norton products and services are certified by independent testing organizations including AV-TEST, AV Comparatives, and SE Labs. Norton is a founding member of the Coalition Against Stalkerware. Learn more at https://us.norton.com. Media Contact: Brittany Posey Gen [email protected] SOURCE Norton |
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2026-05-05 09:00
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Gen Cyber Safety Brands Sweep 28 Honors from the World's Top Independent Testing Labs, Nearly Doubling Last Year's Recognition | FMP Stock News | |
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Norton, Avast, AVG and Avira earn top marks from AV-Comparatives, AV-Test, SE Labs and AVLab, reinforcing Gen's position as the global leader in consumer Cyber Safety, /PRNewswire/ -- Gen (NASDAQ: GEN), a global leader dedicated to powering Digital Freedom, today celebrates that its consumer Cyber Safety brands Norton, Avast, AVG and Avira earned 28 annual award recognitions – up from 16 the year before – from the world's most respected independent testing organizations: AV-Comparatives, AV-Test, SE Labs and AVLab. Gen brands earn 28 awards across leading independent testing labs. "Independent labs put security technology through the most rigorous tests in the industry, and earning 28 honors across our brands is a clear signal that Gen is setting the standard for consumer Cyber Safety," said Vita Santrucek, Chief Technology & Development Officer at Gen. "As threats grow more sophisticated and AI-driven, our customers need protection that not only keeps pace but stays ahead. These results validate the depth of our technology and the talent behind it, and they reflect what nearly 500 million people around the world already trust us to deliver every day." The awards span categories, including the full range of malware protection, advanced threat defense, system performance, usability and cross-platform coverage. Only a small handful of vendors are recognized across this full range, and even fewer sustain that breadth of awards across multiple brands and operating systems in the same year. Powered by advanced AI and machine learning and backed by one of the world's largest threat-intelligence networks, Gen's technology blocks billions of cyberattacks every quarter on behalf of its customers, turning consistent independent validation into constant peace of mind. Recognition Across Key Protection Categories AV-Comparatives, widely regarded as the gold standard in independent security testing, awarded Gen's brands 16 honors, marking the broadest recognition in the company's history of working with the institute. Norton, Avast and AVG were each named "Top-Rated Product 2025," AV-Comparatives' most prestigious annual distinction, while all four brands achieved the institute's "Approved Security Product" certification. Gen brands took home Gold recognitions in the categories that matter most to its customers: Norton earned Gold for Real-World Protection, while Avast and AVG took Gold for delivering protection with the lowest impact on system performance. Norton added Silver in the same category. In Advanced Threat Protection testing, Norton, Avast and AVG each earned Silver, with Avira contributing additional Bronze recognition for both Real-World Protection and Advanced Threat Protection. AV-Test, one of the industry's most rigorous independent evaluators, conferred "Best Usability" and "Best MacOS Security" honors on seven Gen products, recognizing strong protection that doesn't compromise the user experience. Norton 360, Avast Free Security, AVG Internet Security, and Avira Security each received "Best Usability" awards. Norton 360, Avast Security, and AVG Antivirus were also recognized for "Best MacOS Security" for home users. SE Labs named Norton its "Consumer Security Innovator" for 2025, a distinction reserved for the brand judged to be advancing the state of consumer protection. SE Labs additionally awarded both Norton and Avast top honors for consumer endpoint security. In addition to these awards, AVLab awarded its top honor, "Product of the Year" to both Avast Free Antivirus and Norton Antivirus Plus for their performance in advanced, in-the-wild malware protection testing. For more information on the latest in Gen's threat research, visit https://www.gendigital.com/blog/insights. About Gen Gen (NASDAQ: GEN) is a global company dedicated to powering Digital Freedom through its trusted consumer brands including Norton, Avast, LifeLock, MoneyLion and more. The Gen family of consumer brands is rooted in providing financial empowerment and cyber safety for the first digital generations. Today, Gen empowers people to live their digital lives safely, privately and confidently for generations to come. Gen brings award-winning products and services in cybersecurity, online privacy, identity protection and financial wellness to nearly 500 million users in more than 150 countries. Learn more at GenDigital.com. MEDIA CONTACT Brittany Posey Gen [email protected] SOURCE Gen Digital Inc. |
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2026-06-12 21:25
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2026-05-07 16:05
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Gen Crosses $5B in FY26 Revenue with Growth Accelerating to Double-Digits | FMP Stock News | |
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Company Raises FY27 Guidance for Revenue and EPS, /PRNewswire/ -- Gen Digital Inc. (NASDAQ: GEN), a global leader dedicated to powering Digital Freedom, released its results for fiscal year 2026 fourth quarter and full year, which ended April 3, 2026. Gen Crosses $5B in FY26 Revenue with Growth Accelerating to Double-Digits "FY26 was a defining year for Gen, our strongest results in a decade, with revenue crossing $5 billion for the first time," said Vincent Pilette, CEO of Gen. "Our guidance proves that we are even more confident today that cyber safety and financial wellness belong together as we continue to expand and connect the Gen platform. And as the world enters the agentic AI era, Gen's platform is uniquely positioned to be the trust layer for everyone. The momentum is ours, and the road ahead has never looked clearer." Fiscal Year 2026 Financial Highlights Fiscal Year 2026 GAAP Results Revenue of $5,000 million, up 27% Operating income of $2,120 million, up 32% Diluted EPS of $1.57, up 53% Operating cash flow of $1,545 million Fiscal Year 2026 Non-GAAP Results Bookings of $5,107 million, up 28% Revenue of $5,000 million, up 27% Operating income of $2,543 million, up 11% Diluted EPS of $2.56, up 15% Free cash flow of $1,523 million Q4 Fiscal Year 2026 Financial Highlights Q4 GAAP Results Revenue of $1,283 million, up 27% Operating income of $803 million, up 93% Diluted EPS of $0.84, up 269% Operating cash flow of $452 million Q4 Non-GAAP Results Bookings of $1,364 million, up 27% Revenue of $1,283 million, up 27% Operating income of $641 million, up 9% Diluted EPS of $0.67, up 14% Free cash flow of $449 million "Our fourth quarter capped a record year for Gen, with results exceeding guidance, driven by healthy demand for our Cyber Safety Platform, double-digit revenue growth in Trust-Based Solutions and strong execution across the board," said Natalie Derse, CFO of Gen. "This growth momentum, combined with our extraordinary free cash flow generation, gives us the confidence to raise the bar for FY27. We will continue to execute with discipline and allocate capital prioritizing high-return investments to extend our growth and deliver strong returns for our shareholders." Non-GAAP Q1 Fiscal Year 2027 Guidance Q1 FY27 Revenue expected to be in the range of $1,300 million to $1,325 million Q1 FY27 EPS expected to be in the range of $0.68 to $0.70 Non-GAAP Fiscal Year 2027 Guidance FY27 Revenue expected to be in the range of $5,325 million to $5,425 million FY27 EPS expected to be in the range of $2.85 to $2.95 Quarterly Cash Dividend Gen's Board of Directors has approved a regular quarterly cash dividend of $0.125 per common share to be paid on June 10, 2026, to all shareholders of record as of the close of business on May 18, 2026. Q4 Fiscal Year 2026 Earnings Call May 7, 2026 2 p.m. PT / 5 p.m. ET Webcast & Dial-in instructions at Investor.GenDigital.com. A replay will be posted following the call. For additional details regarding Gen's results and outlook, please see the Financials section of the Investor Relations website at Investor.GenDigital.com. About Gen Gen (NASDAQ: GEN) is a global company dedicated to powering Digital Freedom through its trusted consumer brands including Norton, Avast, LifeLock, MoneyLion and more. The Gen family of consumer brands is rooted in providing financial empowerment and cyber safety for the first digital generations. Today, Gen empowers people to live their digital lives safely, privately and confidently for generations to come. Gen brings award-winning products and services in cybersecurity, online privacy, identity protection and financial wellness to nearly 500 million users in more than 150 countries. Learn more at GenDigital.com. Forward-Looking Statements This press release contains statements which may be considered forward-looking within the meaning of the U.S. federal securities laws. In some cases, you can identify these forward-looking statements by the use of terms such as "expect," "will," "continue," or similar expressions, and variations or negatives of these words, but the absence of these words does not mean that a statement is not forward-looking. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, but not limited to, the quotes under "Fiscal Year 2026 Financial Highlights" and "Q4 Fiscal Year 2026 Financial Highlights" including expectations relating to achievement of long-term objectives, and the statements under "Non-GAAP Q1 Fiscal Year 2027 Guidance" and "Non-GAAP Fiscal Year 2027 Guidance" including expectations relating to Q1 Fiscal Year 2027 and Fiscal Year 2027 non-GAAP revenue and non-GAAP EPS, and any statements of assumptions underlying any of the foregoing. These statements are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from results expressed or implied in this press release. Such risk factors include, but are not limited to, those related to: the consummation of or anticipated impacts of acquisitions (including our ability to achieve synergies and associated cost savings from any such acquisitions); divestitures, restructurings, stock repurchases, financings, debt repayments and investment activities; the outcome or impact of pending litigation, claims or disputes; difficulties in executing the operating model for the consumer Cyber Safety business; lower than anticipated returns from our investments in direct customer acquisition; difficulties in retaining our existing customers and converting existing non-paying customers to paying customers; difficulties and delays in reducing run rate expenses and monetizing underutilized assets; the successful development of new products and upgrades and the degree to which these new products and upgrades gain market acceptance; our ability to maintain our customer and partner relationships; the anticipated growth of certain market segments; fluctuations and volatility in our stock price; our ability to successfully execute strategic plans; the vulnerability of our solutions, systems, websites and data to intentional disruption by third parties; changes to existing accounting pronouncements or taxation rules or practices; and general business and macroeconomic changes in the U.S. and worldwide, including economic recessions, the impact of inflation, fluctuations in foreign currency exchange rates, changes in interest rates or tax rates, and ongoing and new geopolitical conflicts, and other global macroeconomic factors on our operations and financial performance. Additional information concerning these and other risk factors is contained in the Risk Factors sections of our most recent reports on Form 10-K and Form 10-Q. We encourage you to read those sections carefully. There may also be other factors that have not been anticipated or are not described in our periodic filings, generally because we did not believe them to be significant at the time, which could cause actual results to differ materially from our projections and expectations. All forward-looking statements should be evaluated with the understanding of their inherent uncertainty. We assume no obligation, and do not intend, to update these forward-looking statements as a result of future events or developments. Use of Non-GAAP Financial Information We use non-GAAP measures of operating margin, operating income, net income and earnings per share, which are adjusted from results based on GAAP and exclude certain expenses, gains and losses. We also provide the non-GAAP metrics of revenues, and constant currency revenues. These non-GAAP financial measures are provided to enhance the user's understanding of our past financial performance and our prospects for the future. Our management team uses these non-GAAP financial measures in assessing Gen's performance, as well as in planning and forecasting future periods. These non-GAAP financial measures are not computed according to GAAP and the methods we use to compute them may differ from the methods used by other companies. Non-GAAP financial measures are supplemental, should not be considered a substitute for financial information presented in accordance with GAAP and should be read only in conjunction with our condensed consolidated financial statements prepared in accordance with GAAP. Readers are encouraged to review the reconciliation of our non-GAAP financial measures to the comparable GAAP results, which is attached to our quarterly earnings release, and which can be found, along with other financial information including the Earnings Presentation, on the investor relations page of our website at Investor.GenDigital.com. No reconciliation of the forecasted range for non-GAAP revenues and EPS guidance is included in this release because most non-GAAP adjustments pertain to events that have not yet occurred. It would be unreasonably burdensome to forecast, therefore we are unable to provide an accurate estimate. GEN DIGITAL INC. Condensed Consolidated Balance Sheets (Unaudited, in millions) April 3, 2026 March 28, 2025 ASSETS Current assets: Cash, cash equivalents and restricted cash $ 411 $ 1,006 Accounts receivable, net 361 171 Other current assets 295 245 Assets held for sale 14 22 Total current assets 1,081 1,444 Property and equipment, net 71 60 Intangible assets, net 2,096 2,267 Goodwill 10,996 10,237 Deferred income tax assets 1,153 1,218 Other long-term assets 192 269 Total assets $ 15,589 $ 15,495 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 96 $ 94 Accrued compensation and benefits 115 105 Current portion of long-term debt 181 291 Contract liabilities 1,904 1,846 Other current liabilities 414 515 Total current liabilities 2,710 2,851 Long-term debt 8,015 7,968 Long-term contract liabilities 73 77 Deferred income tax liabilities 198 222 Long-term income taxes payable 1,588 1,420 Other long-term liabilities 394 688 Total liabilities 12,978 13,226 Total stockholders' equity (deficit) 2,611 2,269 Total liabilities and stockholders' equity $ 15,589 $ 15,495 GEN DIGITAL INC. Condensed Consolidated Statements of Operations (Unaudited, in millions, except per share amounts) Three Months Ended Year Ended April 3, 2026 March 28, 2025 April 3, 2026 March 28, 2025 Net revenues $ 1,283 $ 1,010 $ 5,000 $ 3,935 Cost of revenues 276 199 1,077 776 Gross profit 1,007 811 3,923 3,159 Operating expenses: Sales and marketing 327 196 1,228 745 Research and development 104 81 409 329 General and administrative (291) 67 (87) 291 Amortization of intangible assets 54 44 218 174 Restructuring and other costs 10 3 35 7 Impairment of intangible assets — 3 — 3 Total operating expenses 204 394 1,803 1,549 Operating income (loss) 803 417 2,120 1,610 Interest expense (130) (135) (569) (578) Other income (expense), net (4) 5 (40) (3) Income (loss) before income taxes 669 287 1,511 1,029 Income tax expense (benefit) 157 145 538 386 Net income (loss) $ 512 $ 142 $ 973 $ 643 Net income (loss) per share - basic $ 0.85 $ 0.23 $ 1.59 $ 1.04 Net income (loss) per share - diluted $ 0.84 $ 0.23 $ 1.57 $ 1.03 Weighted-average shares outstanding: Basic 602 616 612 617 Diluted 609 624 619 624 GEN DIGITAL INC. Condensed Consolidated Statements of Cash Flows (Unaudited, in millions) Three Months Ended Year Ended April 3, 2026 March 28, 2025 April 3, 2026 March 28, 2025 OPERATING ACTIVITIES: Net income (loss) $ 512 $ 142 $ 973 $ 643 Adjustments: Amortization and depreciation 119 104 493 419 Impairments and write-offs of current and long-lived assets — 5 — 7 Stock-based compensation expense 62 36 237 133 Loss on sale of Instacash Advances 59 — 205 — Deferred income taxes 92 18 92 (32) Loss on extinguishment of debt 9 — 9 — Gain on sale of nonfinancial assets — — (15) — Non-cash operating lease expense 5 5 18 16 Change in fair value and impairment of non-marketable equity investments — — 79 30 Foreign currency remeasurement loss (gain) (32) 12 54 (2) Legal contract dispute cost (1) — 24 — 66 Other 12 3 47 13 Changes in operating assets and liabilities, net of acquisitions: Accounts receivable, net 7 (19) (32) (53) Accounts payable 4 (9) (48) 26 Accrued compensation and benefits (3) 11 8 27 Contract liabilities 75 63 74 36 Income taxes payable 17 56 (96) (80) Instacash Advances held for sale, net (57) — (205) — Other assets (56) 11 16 86 Other liabilities (373) 11 (364) (114) Net cash provided by (used in) operating activities 452 473 1,545 1,221 INVESTING ACTIVITIES: Purchases of property and equipment (3) (3) (22) (15) Purchase of non-marketable equity investments — — — (4) Payments for acquisitions, net of cash acquired (156) (84) (1,032) (84) Payments for originations of notes receivable (83) — (283) — Proceeds from principal repayments of notes receivable 80 — 253 — Proceeds from the maturities and sales of short-term investments — — 13 — Proceeds from the sale of properties — — 21 — Proceeds from sale of nonfinancial assets — — 40 — Other — 4 (1) 3 Net cash provided by (used in) investing activities (162) (83) (1,011) (100) FINANCING ACTIVITIES: Repayments of debt (2,960) (1,164) (3,620) (1,311) Proceeds from issuance of debt, net of issuance costs (2) 2,734 941 3,475 941 Net proceeds from sales of common stock under employee stock incentive plans 6 5 13 11 Tax payments related to vesting of stock units (3) (1) (55) (26) Dividends and dividend equivalents paid (76) (77) (312) (313) Repurchases of common stock (200) — (634) (272) Net cash provided by (used in) financing activities (499) (296) (1,133) (970) Effect of exchange rate fluctuations on cash, cash equivalents and restricted cash 1 29 4 9 Change in cash, cash equivalents and restricted cash (208) 123 (595) 160 Beginning cash, cash equivalents and restricted cash 619 883 1,006 846 Ending cash, cash equivalents and restricted cash $ 411 $ 1,006 $ 411 $ 1,006 ______________________ (1) During fiscal 2025, in connection with a legal settlement terminating our agreement with an Avast e-commerce partner that acted as payment processor and merchant of record for a subset of customers, we released our claims to $66 million of outstanding accounts receivable (net of fees payable) in exchange for the transfer of the related customer information to us. The $66 million was charged off as general and administrative expense and is reflected as a non-cash item within the change in accounts receivable in operating activities for fiscal 2025. No comparable activity occurred in fiscal 2026 or fiscal 2024. (2) Issuance costs paid for issuance of debt for the three months ended April 3, 2026 and March 28, 2025 was $7 million and $9 million, respectively, and for the fiscal year ended 2026 and 2025 was $16 million and $9 million, respectively. GEN DIGITAL INC. Reconciliation of Selected GAAP Measures to Non-GAAP Measures (1) (2) (Unaudited, in millions, except per share amounts) Three Months Ended Year Ended April 3, 2026 March 28, 2025 April 3, 2026 March 28, 2025 Operating income (loss) $ 803 $ 417 $ 2,120 $ 1,610 Stock-based compensation 62 37 235 134 Amortization of intangible assets 115 100 477 401 Impairment of intangible assets — 3 — 3 Restructuring and other costs 10 3 35 7 Acquisition and integration costs 3 1 12 11 Litigation costs (353) 4 (336) 65 Legal contract dispute cost — 24 — 66 Other 1 1 — 1 Operating income (loss) (Non-GAAP) $ 641 $ 590 $ 2,543 $ 2,298 Operating margin 62.6 % 41.3 % 42.4 % 40.9 % Operating margin (Non-GAAP) 50.0 % 58.4 % 50.9 % 58.4 % Net income (loss) $ 512 $ 142 $ 973 $ 643 Adjustments to net income (loss): Stock-based compensation 62 37 235 134 Amortization of intangible assets 115 100 477 401 Impairment of intangible assets — 3 — 3 Restructuring and other costs 10 3 35 7 Acquisition and integration costs 3 1 12 11 Litigation costs (353) 4 (336) 65 Legal contract dispute cost — 24 — 66 Other — 4 — 6 Non-cash interest expense 8 6 28 26 Loss (gain) on extinguishment of debt 9 — 9 — Loss (gain) on equity investments — — 79 30 Loss (gain) on sale of properties — — (15) — Total adjustments to GAAP income (loss) before income taxes (146) 182 524 749 Adjustment to GAAP provision for income taxes 42 42 90 (5) Total adjustment to income (loss), net of taxes (104) 224 614 744 Net income (loss) (Non-GAAP) $ 408 $ 366 $ 1,587 $ 1,387 Diluted net income (loss) per share $ 0.84 $ 0.23 $ 1.57 $ 1.03 Adjustments to diluted net income (loss) per share: Stock-based compensation 0.10 0.06 0.38 0.21 Amortization of intangible assets 0.19 0.16 0.77 0.64 Impairment of intangible assets — 0.00 — 0.00 Restructuring and other costs 0.02 0.00 0.06 0.01 Acquisition and integration costs 0.00 0.00 0.02 0.02 Litigation costs (0.58) 0.01 (0.54) 0.10 Legal contract dispute cost — 0.04 — 0.11 Other — 0.01 — 0.01 Non-cash interest expense 0.01 0.01 0.05 0.04 Loss (gain) on extinguishment of debt 0.01 — 0.01 — Loss (gain) on equity investments — — 0.13 0.05 Loss (gain) on sale of properties — — (0.02) — Total adjustments to GAAP income (loss) before income taxes (0.24) 0.29 0.85 1.20 Adjustment to GAAP provision for income taxes 0.07 0.07 0.15 (0.01) Total adjustment to income (loss), net of taxes (0.17) 0.36 0.99 1.19 Diluted net income (loss) per share (Non-GAAP) $ 0.67 $ 0.59 $ 2.56 $ 2.22 Diluted weighted-average shares outstanding 609 624 619 624 Diluted weighted-average shares outstanding (Non-GAAP) 609 624 619 624 GEN DIGITAL INC. Reconciliation of Selected GAAP Measures to Non-GAAP Measures (1) (2) (Unaudited, in millions, except per share amounts) Three Months Ended Year Ended April 3, 2026 March 28, 2025 April 3, 2026 March 28, 2025 Net cash provided by (used in) operating activities $ 452 $ 473 $ 1,545 $ 1,221 Adjustments to net cash provided by (used in) operating activities: Purchases of property and equipment (3) (3) (22) (15) Free cash flow (Non-GAAP) $ 449 $ 470 $ 1,523 $ 1,206 ______________________ (1) This presentation includes non-GAAP measures. Non-GAAP financial measures are supplemental and should not be considered a substitute for financial information presented in accordance with GAAP. For a detailed explanation of these non-GAAP measures, see Appendix A. (2) Amounts may not add due to rounding. GEN DIGITAL INC. Performance Metrics (Unaudited, in millions) Performance Metrics Three Months Ended Year Ended April 3, 2026 January 2, 2026 March 28, 2025 April 3, 2026 March 28, 2025 Cyber Safety Platform $ 837 $ 819 $ 808 $ 3,339 $ 3,176 Trust-Based Solutions 446 421 202 1,661 759 Total net revenues $ 1,283 $ 1,240 $ 1,010 $ 5,000 $ 3,935 Direct revenues $ 1,048 $ 1,025 $ 878 $ 4,137 $ 3,463 Partner revenues 235 215 132 863 472 Total net revenues $ 1,283 $ 1,240 $ 1,010 $ 5,000 $ 3,935 Total bookings $ 1,364 $ 1,319 $ 1,076 $ 5,107 $ 3,988 As of April 3, 2026 March 28, 2025 Total paid customers 79 68 GEN DIGITAL INC. Appendix A Explanation of Non-GAAP Measures and Other Items Objective of non-GAAP measures: We believe our presentation of non-GAAP financial measures, when taken together with corresponding GAAP financial measures, provides meaningful supplemental information regarding the Company's operating performance for the reasons discussed below. Our management team uses these non-GAAP financial measures in assessing our performance, as well as in planning and forecasting future periods. Due to the importance of these measures in managing the business, we use non-GAAP measures in the evaluation of management's compensation. These non-GAAP financial measures are not computed according to GAAP and the methods we use to compute them may differ from the methods used by other companies. Non-GAAP financial measures are supplemental and should not be considered a substitute for financial information presented in accordance with GAAP and should be read only in conjunction with our consolidated financial statements prepared in accordance with GAAP. Stock-based compensation: This consists of expenses for employee restricted stock units, performance-based awards, stock options and our employee stock purchase plan, determined in accordance with GAAP. We evaluate our performance both with and without these measures because stock-based compensation is a non-cash expense and can vary significantly over time based on the timing, size, nature and design of the awards granted, and is influenced in part by certain factors that are generally beyond our control, such as the volatility of the market value of our common stock. In addition, for comparability purposes, we believe it is useful to provide a non-GAAP financial measure that excludes stock-based compensation to facilitate the comparison of our results to those of other companies in our industry. Amortization of intangible assets: Amortization of intangible assets consists of amortization of acquisition-related intangibles assets such as developed technology, customer relationships and trade names acquired in connection with business combinations. We record charges relating to the amortization of these intangibles within both cost of revenues and operating expenses in our GAAP financial statements. Under purchase accounting, we are required to allocate a portion of the purchase price to intangible assets acquired and amortize this amount over the estimated useful lives of the acquired intangible assets. However, the purchase price allocated to these assets is not necessarily reflective of the cost we would incur to internally develop the intangible asset. Further, amortization charges for our acquired intangible assets are inconsistent in size and are significantly impacted by the timing and valuation of our acquisitions. We eliminate these charges from our non-GAAP operating results to facilitate an evaluation of our current operating performance and provide better comparability to our past operating performance. Restructuring and other costs: Restructuring charges are costs associated with a formal restructuring plan and are primarily related to employee severance and benefit arrangements, contract termination costs, and assets write-offs, as well as other exit and disposal costs. Included in other exit and disposal costs are costs to exit and consolidate facilities in connection with restructuring events. We exclude restructuring and other costs from our non-GAAP results as we believe that these costs are incremental to core activities that arise in the ordinary course of our business and do not reflect our current operating performance, and that excluding these charges facilitates a more meaningful evaluation of our current operating performance and comparisons to our past operating performance. Acquisition-related and integration costs: These represent the transaction and business integration costs related to significant acquisitions that are charged to operating expense in our GAAP financial statements. These costs include incremental expenses incurred to affect these business combinations such as advisory, legal, accounting, valuation, and other professional or consulting fees. We exclude these costs from our non-GAAP results as they have no direct correlation to the operation of our business, and because we believe that the non-GAAP financial measures excluding these costs provide meaningful supplemental information regarding the spending trends of our business. In addition, these costs vary, depending on the size and complexity of the acquisitions, and are not indicative of costs of future acquisitions. Litigation costs: We may periodically incur charges or benefits related to litigation settlements, legal contingency accruals and third-party legal costs related to certain legal matters. We exclude these charges and benefits when associated with a significant matter because we do not believe they are reflective of ongoing business and operating results. Legal contract dispute cost: During fiscal 2025, we incurred charges in connection with an e-commerce partner settlement. In order to resolve all open disputes with the partner, we entered into a legal settlement agreement which included our release of claims to valid outstanding accounts receivable totaling $66 million, which were charged off as G&A expense in fiscal 2025. We exclude these charges and benefits when associated with a significant matter because we do not believe they are normal, recurring, or reflective of ongoing business and operating results. Non-cash interest expense and amortization of debt issuance costs: In accordance with GAAP, we separately account for the value of the conversion feature on our convertible notes as a debt discount that reflects our assumed non-convertible debt borrowing rates. We amortize the discount and debt issuance costs over the term of the related debt. We exclude the difference between the imputed interest expense, which includes the amortization of the conversion feature and of the issuance costs, and the coupon interest payments. We extinguished our remaining convertible debt on August 15, 2022. During fiscal 2023, we also started amortizing the debt issuance costs associated with our senior credit facilities, which were secured upon close of the acquisition of Avast. We believe that excluding these costs provides meaningful supplemental information regarding the cash cost of our debt instruments and enhance investors' ability to view the Company's results from management's perspective. Gain (loss) on extinguishment of debt: We record gains or losses on extinguishment of debt. Gains or losses represent the difference between the fair value of the exchange consideration and the carrying value of the liability component of the debt at the date of extinguishment. We exclude the gain or loss on debt extinguishment in our non-GAAP results because they are not reflective of our ongoing business. Change in fair value and impairment of non-marketable equity investments: We record gains or losses, unrealized and realized, on equity investments in privately-held companies. We exclude the net gains or losses because we do not believe they are reflective of our ongoing business. Gain (loss) on sale of properties and nonfinancial assets: We periodically recognize gains or losses from the disposition of land, buildings and nonfinancial assets. We exclude such gains or losses because they are not reflective of our ongoing business and operating results. Income tax effects and adjustments: We use a non-GAAP tax rate that excludes (1) the discrete impacts of changes in tax legislation, (2) most other significant discrete items, (3) unrealized gains or losses from remeasurement of foreign currency denominated deferred tax items and uncertain tax benefits, and (4) the income tax effects of the non-GAAP adjustment to our operating results described above. We believe making these adjustments facilitates a better evaluation of our current operating performance and comparisons to past operating results. Our tax rate is subject to change for a variety of reasons, such as significant changes in the geographic earnings mix due to acquisition and divestiture activities or fundamental tax law changes in major jurisdictions where we operate. Diluted GAAP and non-GAAP weighted-average shares outstanding: Diluted GAAP and non-GAAP weighted-average shares outstanding are generally the same, except in periods when there is a GAAP loss from continuing operations. In accordance with GAAP, we do not present dilution for GAAP in periods in which there is a loss from continuing operations. However, if there is non-GAAP net income, we present dilution for non-GAAP weighted-average shares outstanding in an amount equal to the dilution that would have been presented had there been GAAP income from continuing operations for the period. Bookings: Bookings are defined as customer orders received that are expected to generate net revenues in the future. We present the operational metric of bookings because it reflects customers' demand for our products and services and to assist readers in analyzing our performance in future periods. Free cash flow: Free cash flow is defined as cash flows from operating activities less purchases of property and equipment. Free cash flow is not a measure of financial condition under GAAP and does not reflect our future contractual commitments and the total increase or decrease of our cash balance for a given period, and thus should not be considered as an alternative to cash flows from operating activities or as a measure of liquidity. (Unlevered) Free cash flow: Free cash flow is defined as cash flows from operating activities less purchases of property and equipment. Unlevered free cash flow excludes cash interest expense payments, net of payments received through interest rate swap hedges. Free cash flow is not a measure of financial condition under GAAP and does not reflect our future contractual commitments and the total increase or decrease of our cash balance for a given period, and thus should not be considered as an alternative to cash flows from operating activities or as a measure of liquidity. Cyber Safety Platform: Includes our security and privacy products, as well as our cyber safety comprehensive suites which deliver technology solutions and superior threat protection to help people navigate the digital world, securely, privately and confidently. Trust-Based Solutions: Trust-Based Solutions includes our identity, reputation, and financial wellness products, which provide innovative solutions and insights that empower consumers to grow and manage their identity, reputation and finances confidently. Direct revenue: Direct revenue reflects subscriptions sold directly through e-commerce or mobile channels, and revenue generated from financial transactions directly made through Gen properties or marketplaces. Partner revenue: Partner revenue reflects partner-sourced and channel revenue via retailers, employee benefits, telcos, publishers, and strategic partnerships, including revenue generated from product usage or products sold through our financial marketplace. Paid customers: We define paid customers as active users of our products and solutions, including subscribers with an active paid subscription to our products at the end of the reported period. Paid customers also includes product users with a unique account and at least one revenue-generating transaction in the relevant active period of each respective product category, whether through our first-party personal finance products, transacting through our financial marketplaces, or generating revenue through product usage. We exclude users on free trials and those who have not actively transacted in the relevant period of each respective product category. In order to properly reflect Gen's customer cohorts that contribute to revenue given the dynamic nature of consumers and our product portfolio, our methodology is subject to change from time to time. The methodologies used to measure these metrics require judgment and we regularly review our metrics to improve their accuracy. However, our ability to recalculate our historical metrics may be impacted by data limitations or other factors that require us to apply different methodologies for such adjustments. We generally do not intend to update previously disclosed metrics for any such inaccuracies or adjustments that are deemed not material. CONTACTS Investor Contact Ben Lu Media Contact Audra Proctor Gen Gen [email protected] [email protected] SOURCE Gen Digital Inc. |
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2026-06-12 21:25
1mo ago
Published
2026-05-07 18:26
2mo ago
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Gen Digital (GEN) Q4 Earnings and Revenues Beat Estimates | FMP Stock News | |
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Gen Digital (GEN - Free Report) came out with quarterly earnings of $0.67 per share, beating the Zacks Consensus Estimate of $0.65 per share. This compares to earnings of $0.59 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +3.60%. A quarter ago, it was expected that this security software maker would post earnings of $0.63 per share when it actually produced earnings of $0.64, delivering a surprise of +1.59%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Gen Digital, which belongs to the Zacks Technology Services industry, posted revenues of $1.28 billion for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 3.57%. This compares to year-ago revenues of $1.01 billion. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Gen Digital shares have lost about 28.1% since the beginning of the year versus the S&P 500's gain of 7.6%. What's Next for Gen Digital?While Gen Digital has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Gen Digital was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.68 on $1.28 billion in revenues for the coming quarter and $2.90 on $5.22 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Technology Services is currently in the bottom 27% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, Full Truck Alliance Co. Ltd. Sponsored ADR (YMM - Free Report) , has yet to report results for the quarter ended March 2026. The results are expected to be released on May 21. This company is expected to post quarterly earnings of $0.13 per share in its upcoming report, which represents a year-over-year change of -27.8%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Full Truck Alliance Co. Ltd. Sponsored ADR's revenues are expected to be $403.53 million, up 8.5% from the year-ago quarter. |
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Gen Digital Inc. (GEN) Q4 2026 Earnings Call Transcript | FMP Stock News | |
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Gen Digital Inc. (GEN) Q4 2026 Earnings Call Transcript |
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Gen Digital Q4 Earnings Surpass Expectations, Revenues Rise Y/Y | FMP Stock News | |
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Key Takeaways GEN beat Q4 estimates as revenues climbed 26.7% and paid customers rose to 79 million.GEN's Trust-Based Solutions revenues jumped 121% year over year to $446 million.GEN raised fiscal 2027 revenue and earnings guidance amid strong bookings growth. Gen Digital Inc. (GEN - Free Report) reported fourth-quarter fiscal 2026 non-GAAP earnings of 67 cents per share, topping the Zacks Consensus Estimate by 3.6%. GEN’s fourth-quarter fiscal 2026 earnings grew 13.6% year over year.Quarterly revenues of $1.28 billion also beat the consensus mark by 3.57% and rose 26.7% year over year. The quarter reflected healthy demand for GEN’s Cyber Safety Platform and strong execution in Trust-Based Solutions. Paid customers ended the period at 79 million, up from 68 million a year ago. GEN Stays on a Double-Digit Growth TrackGen Digital’s fourth-quarter revenue increase was supported by sustained momentum across the portfolio, as management pointed to strong demand and accelerating growth. The company highlighted a fourth straight quarter of double-digit bookings growth, underscoring ongoing product traction and customer activity. Bookings rose 27% year over year to $1.36 billion in the quarter. The company also emphasized that pro-forma results, which include MoneyLion in the prior-year baseline, showed a 9% revenue increase, pointing to a steadier underlying growth profile after normalizing for the acquisition baseline. Trust-Based Solutions Drive Gen DigitalGEN’s mix segment continued to evolve, with Trust-Based Solutions providing the primary growth engine. In the fiscal fourth quarter, Trust-Based Solutions revenues jumped to $446 million from $202 million in the year-ago period, reflecting 121% year-over-year growth and a much larger contribution from the financial wellness and marketplace assets. Gen Digital described the Trust-Based Solutions performance as supported by strong personal financial management results and expanded “Engine” verticals, while also noting continued investment to drive innovation and market share gains. This faster-growing segment has become a meaningful component of quarterly revenues alongside the more mature Cyber Safety Platform. GEN Keeps Cyber Safety Profitable and DurableGen Digital’s Cyber Safety Platform remained a stable earnings anchor. Segment revenues increased to $837 million in the quarter from $808 million a year earlier, reflecting 4% year-over-year growth and continued demand for cybersecurity and privacy offerings even as growth rates are more modest than in Trust-Based Solutions. Profitability in the core franchise stayed robust. The company reported a 61% operating margin in the Cyber Safety Platform in the fourth quarter, aided by scale and efficiencies. Management also called out Norton 360 memberships enhanced with scam protection and multi-layered security as a support for performance, reinforcing the platform’s role as the company’s durable cash generator. GEN Navigates Margin Dynamics as Costs ShiftGEN’s non-GAAP operating income for the quarter was $641 million, up from $590 million a year ago, showing a 9% year over year growth. This translated to a 50% operating margin. Gen Digital’s Balance Sheet and Cash FlowAs of April 3, 2026, GEN had cash, cash equivalents and restricted cash of $411 million, down from $619 million in the previous quarter. The long-term debt was $8.02 billion. GEN’s cash generation remained a key feature of the quarter. Operating cash flow was $452 million, and free cash flow was $449 million, supporting continued balance sheet actions and shareholder returns. Capital allocation stayed active. The company paid $76 million in dividends during the quarter, repaid $219 million of debt, and repurchased $200 million of shares. The board also approved a regular quarterly cash dividend of 13 cents per common share, payable June 10, 2026, to shareholders of record as of May 18, 2026. GEN Lifts the Bar With Higher FY27 OutlookGEN’s updated outlook leaned constructive, supported by what management described as strong execution and momentum. For first-quarter fiscal 2027, the company expects non-GAAP revenues between $1.30 billion and $1.325 billion. The Zacks Consensus Estimate for GEN’s first-quarter fiscal 2027 revenues is pegged at $1.28 billion, indicating year-over-year growth of 1.8%. For first-quarter fiscal 2027, the company expects non-GAAP earnings to be in the range of 68-70 cents. The Zacks Consensus Estimate for GEN’s first-quarter fiscal 2027 earnings is pegged at 68 cents, indicating year-over-year growth of 6.3%. For fiscal 2027, Gen Digital raised its guidance and now projects revenues between $5.325 billion and $5.425 billion. The Zacks Consensus Estimate for GEN’s fiscal 2027 revenues is pegged at $5.22 billion, indicating year-over-year growth of 5.4%. For fiscal 2027, GEN now projects non-GAAP earnings in the band of $2.85-$2.95. The Zacks Consensus Estimate for Gen Digital’s fiscal 2027 revenues is pegged at $2.54, indicating year-over-year growth of 14.4%. The company’s guidance framework assumes a non-GAAP effective tax rate of about 22% and reflects continued investment in platform and AI capabilities, while targeting stable segment margins of more than 60% in Cyber Safety and about 30% in Trust-Based Solutions. Zacks Rank and Stocks to ConsiderCurrently, Gen Digital carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the broader Zacks Computer and Technology sector are Broadcom (AVGO - Free Report) , Celestica (CLS - Free Report) and Samsara (IOT - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here. Shares of Broadcom have gained 21.7% year to date. The Zacks Consensus Estimate for Broadcom’s 2026 earnings is pegged at $11.45 per share, up by a penny over the past 30 days, indicating an increase of 68% year over year. Shares of Celestica have rallied 41.7% year to date. The Zacks Consensus Estimate for Celestica’s 2026 earnings is pegged at $9.85 per share, up $1.01 over the past seven days, indicating an increase of 62.8% year over year. Samsara shares have lost 14% year to date. The Zacks Consensus Estimate for IOT’s fiscal 2027 earnings is pegged at 68 cents per share, up 11 cents over the past 60 days, indicating an increase of 21.4% year over year. |
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Avast One: Free to Start. Yours to Build. | FMP Stock News | |
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The most comprehensive free consumer cybersecurity solution available — then add only what you need and skip what you don't., /PRNewswire/ -- You already know what you need for your digital life. You've done the research, read the threads, tuned the settings. The last thing you want is a security suite that assumes you haven't. Avast One Avast One product experience Today, Avast, a leader in digital security and privacy and part of Gen (NASDAQ: GEN), is launching a reimagined Avast One that puts you in the driver's seat. Avast One comes with powerful free protection right from the start. Then, if your situation changes, add only the protections you want, directly inside the same app. Your choices. Your tools. Nothing else. The free tier of Avast One provides comprehensive protection, not a stripped-down teaser designed to pressure an upgrade. You get free antivirus and real-time threat protection, AI-powered scam detection, a no-log VPN, data breach monitoring, AI Agent Protection, and device cleanup – all fully functional. "People know what they value and how they want to protect their digital lives," said Travis Witteveen, Head of Products and Portfolios at Gen. "Avast One has been designed to give you greater choice and control making it easy to personalize protection, manage features, and only pay for what you truly need." What the free tier covers: Scam Protection: Built-in AI-powered scam protection that blocks phishing links, fraudulent shopping sites, and banking scams in real-time — while you're browsing, not after credentials are stolen. Includes the Avast AI Assistant for scam and product guidance. Antivirus and Real-Time Threat Protection: Detects and blocks malware, viruses, and malicious downloads before they execute. Intercepts dangerous sites before pages load. Stops ransomware before files are encrypted. You know the drill — this one just does it properly. AI Agent Protection: AI tools acting on your behalf can be hijacked. Avast One vets plugins before they run, blocks malicious instructions injected into AI workflows, and checks AI-generated files before they reach your system. No-Log VPN*: Enhanced, no-log VPN experience with improved privacy protections, protocol options, and a wider selection of server locations. Data Breach Monitoring**: Scans breach databases for your personal information, shows exactly where it was exposed, and walks you through containing the damage. Device Cleanup: Removes junk files, duplicate photos, redundant browser data, and old contacts to restore device performance. Add more when you want it: Avast One is built to flex with how you actually live online. When something changes — a new threat you care about, a device running slower than it should, scam calls that keep getting through — you can unlock more protection without switching apps, re-entering payment details, or rebuilding your setup from scratch. Want more muscle against scam calls and phishing emails? Unlock Avast Premium Security with Scam Protection Pro. Want automated, intelligent cleanup that keeps your laptop running like it should? Unlock Avast Cleanup Premium. When you need it, add it. You choose the pieces. You decide when. The specifics: The new Avast One is available now on Windows, macOS, Android, and iOS. All paid plans cover desktop and mobile under a single subscription. Running the previous Avast One? The new experience is ready when you are. Install it and everything ports overs. No rush – your existing product remains fully supported. Download the free version at avast.com/avast-one. No credit card required. *Avast SecureLine VPN is a 60-day trial requiring a payment method at sign-up. Billed at the end of the trial period unless cancelled first. **BreachGuard is currently only available on desktop. About Avast Avast is a leader in digital security and privacy, and part of Gen (NASDAQ: GEN), a global company dedicated to powering Digital Freedom with a family of trusted consumer brands. Avast protects hundreds of millions of users from online threats, for Mobile, PC or Mac, and is top-ranked and certified by VB100, AV-Comparatives, AV-Test, SE Labs and others. Avast is a member of the Coalition Against Stalkerware, No More Ransom and Internet Watch Foundation. Learn more at Avast.com. SOURCE Gen Digital Inc. |
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Gen to Participate in Upcoming Investor Conferences | FMP Stock News | |
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Resources Investor Relations Journalists Agencies Client Login Send a Release News Products Contact , /PRNewswire/ -- Gen Digital Inc. (NASDAQ: GEN), a global leader dedicated to powering Digital Freedom, today announced that Vincent Pilette, Chief Executive Officer of Gen, and Natalie Derse, Chief Financial Officer of Gen, will participate in the following investor conferences:Jefferies Software, Internet, & AI Conference in Newport, California on May 27, 2026 Evercore TMT Global Conference in San Francisco, California on June 2, 2026 Bank of America Global Technology Conference in San Francisco, California on June 3, 2026 For more information on Gen, visit Investor.GenDigital.com. About Gen Gen (NASDAQ: GEN) is a global company dedicated to powering Digital Freedom through its trusted consumer brands including Norton, Avast, LifeLock, MoneyLion and more. The Gen family of consumer brands is rooted in providing financial empowerment and cyber safety for the first digital generations. Today, Gen empowers people to live their digital lives safely, privately and confidently for generations to come. Gen brings award-winning products and services in cybersecurity, online privacy, identity protection and financial wellness to nearly 500 million users in more than 150 countries. Learn more at GenDigital.com. SOURCE Gen Digital Inc. Also from this source |
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MoneyLion Launches Summer Break Giveaway to Give Consumers a Much-Needed Financial Breather | FMP Stock News | |
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MoneyLion will give away $500 to two winners every day from May 26 through July 4th, totaling $40,000 in summer financial relief, /PRNewswire/ -- According to a new MoneyLion in-app survey, summer spending has a way of getting ahead of even the best-laid plans. Nearly half of consumers (47%) say family activities and BBQs are the summer moments they're most likely to overspend on even when budgets are tight, and more than a third (35%) expect weekend trips to cost more than they budgeted. To help ease the financial pressure that comes with the season, MoneyLion is launching its Summer Break Giveaway, awarding $500 to two winners every day from May 26 through July 4 — $40,000 in total. MoneyLion Launches Summer Break Giveaway to Give Consumers a Much-Needed Financial Breather The Summer Break Giveaway is inspired by the reality that summer is full of moments people don't want to miss, and that the costs add up fast. From mini vacations (the most common splurge at 35%) to last-minute dinner plans (50% of those surveyed always say yes to last-minute invites), the season brings a steady stream of financial decisions. The giveaway offers timely relief, giving people the breathing room to enjoy summer without the financial stress that often follows. "At a time of year when spending can increase quickly, even for well-intentioned consumers, summer also creates meaningful opportunities for connection and celebration," said Ferha Mirdawi, Head of Marketing for MoneyLion. "The Summer Break Giveaway reflects MoneyLion's commitment to helping consumers navigate seasonal expenses with greater confidence and financial flexibility, so they can enjoy the moments that matter most." Enter now at moneylion.com/summerbreak and follow MoneyLion on TikTok, X, and Instagram for updates and winner announcements. The giveaway runs May 26, 2026 at approximately 9:00 AM ET through July 4, 2026 at 11:59:59 PM ET. Two winners will be selected daily, each receiving $500. No purchase is required. Open to residents of all 50 United States and the District of Columbia. Message and data rates may apply. Subject to complete Official Rules including entry method, prize descriptions and odds of winning at https://www.moneylion.com/learn/personal-finance/basics/moneylion-2026-summer-break-giveaway-official-rules . Void where prohibited. Sponsor: MoneyLion Technologies Inc. Survey Methodology MoneyLion surveyed more than 1,000 adults ages 18 and over via the MoneyLion app. About MoneyLion MoneyLion is a leading financial technology platform and part of Gen (NASDAQ: GEN), a global company dedicated to powering Digital Freedom with a family of trusted consumer brands. MoneyLion powers the next generation of personalized products, content, and marketplace technology through its top-rated consumer finance super app, premier embedded finance platform for enterprise businesses, and world-class media arm. Consumers gain control of their finances with an innovative suite of products to save, borrow, spend, and invest, seamlessly integrating the best offers and content from MoneyLion and its 1,300+ enterprise partners into one unified experience. Its mission is to give everyone the power to make their best financial decisions. Learn more at www.moneylion.com. Media contact: Malea Lamb-Hall Gen [email protected] SOURCE Gen Digital Inc. |
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A Look at Gen Digital Inc (GEN) After 7.6% Gain -- GF Value $32.26 vs Price $27.76 | FMP Stock News | |
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On June 01, 2026, Gen Digital Inc GEN shares rose 7.6% to a current price of $27.76, showing strong momentum in recent trading sessions. Over the past week, shares have increased by 11.8%, and in the last month, they have surged by 44.1%. Despite this upward trend, the stock has seen a slight decline of 0.6% over the past year, trading within a 52-week range of $17.78 to $32.22.GF Value™ verdict: Currently priced at $27.76, GEN is estimated to be 13.9% undervalued compared to a GF Value™ of $32.26.GF Score™ of 82/100 indicates a strong overall evaluation based on multiple fundamental factors.Notable signal: No insider transactions have occurred in the last three months, suggesting a stable insider sentiment. Is GEN Overvalued or Undervalued? With a current price of $27.76 and a GF Value™ estimate of $32.26, Gen Digital Inc appears to be undervalued by approximately 13.9%. This margin of safety presents a potential investment opportunity for those looking to capitalize on the disparity between market price and intrinsic value. The GF Valuation label categorizes GEN as "Modestly Undervalued," suggesting that the stock is not only trading below its fair value but also might have room for growth in the future. GF Value™ is GuruFocus' proprietary measure of intrinsic value, calculated from historical trading multiples, past business growth, and future performance estimates. This valuation signals that while there is potential for upward movement, investors should conduct thorough due diligence to assess the company's fundamentals and market conditions before making any investment decisions. How Does GEN's Valuation Compare to Its History? Metric Current Historical P/E (TTM) 17.6x 22.0x Forward P/E 9.6x N/A Currently, GEN is trading at a P/E (TTM) of 17.6x, which is 20% below its 5-year median P/E of 22.0x. The forward P/E of 9.6x further emphasizes the stock's undervaluation in comparison to its historical performance. This P/E analysis aligns with the GF Value™ verdict, reinforcing the notion that GEN is undervalued at its current trading level. What Does GEN's GF Score™ Tell Us? Metric Rating GF Score™ 82 Financial Strength 4/10 Profitability 8/10 Growth 8/10 Valuation 8/10 Momentum 4/10 The GF Score™ of 82/100 reflects a strong overall rating for Gen Digital Inc, indicating that the company has solid potential for long-term returns. The strongest areas are Profitability, Growth, and Valuation, each scoring 8/10, showcasing the company's ability to generate profits and grow effectively. However, Financial Strength and Momentum are relatively weaker, with ratings of 4/10, suggesting that investors should be cautious about the company's financial robustness and market momentum. What Are Insiders Doing with GEN Stock? In the past three months, there have been no insider transactions involving Gen Digital Inc, indicating a stable sentiment among executives and board members regarding the company's prospects. The lack of insider buying or selling suggests that insiders may not currently view the stock as a strong buying opportunity or an immediate concern for selling. What This Means for Investors Based on the GF Value™ assessment, Gen Digital Inc GEN is currently undervalued with a fair value estimate that exceeds its market price by 13.9%. This presents a potential opportunity for investors looking for stocks with intrinsic value discrepancies. However, it is essential to consider the company's financial strength and market momentum before making any investment decisions. For the complete analysis, visit the Gen Digital Inc GEN stock page. You can also explore the GF Value™ page for detailed valuation methodology, or use the GuruFocus Stock Screener to find similar opportunities. Frequently Asked Questions What is GEN's GF Score™? GEN's GF Score™ is 82/100, indicating a strong overall evaluation based on key financial metrics that suggest solid potential for long-term returns. Is GEN overvalued or undervalued? GEN is currently undervalued, with a GF Value™ estimate of $32.26 compared to its market price of $27.76, representing a 13.9% upside. What is GEN's P/E ratio? GEN's P/E (TTM) is 17.6x, which is 20% below its 5-year median P/E of 22.0x, indicating that the stock is trading at a lower valuation compared to its historical averages. This stock alert was generated using automated technology and GuruFocus financial data to provide readers with timely and accurate market reporting. This content was reviewed by GuruFocus editorial team prior to publication. Please send any questions or comments about this story to [email protected]. |
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Gen Digital Earns Best in Class in Javelin Strategy & Research's 2026 Direct-to-Consumer Identity Protection Services Vendor Scorecard | FMP Stock News | |
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SAN FRANCISCO, June 02, 2026 (GLOBE NEWSWIRE) -- Javelin Strategy & Research today released its 2026 Direct-to-Consumer Identity Protection Services Vendor Scorecard, evaluating 14 identity protection service providers. This year’s findings reveal that the market continues to evolve beyond traditional identity theft protection toward scam prevention, cybersecurity integration, and family-focused protections. However, major gaps remain. No providers offer advanced predictive modeling for socially engineered attack mitigation, and just 21% monitor children’s online gaming risks. Few vendors provide robust social media or dark web cleanup services—services which Javelin deems critical for the future of digital risk resiliency.The IDPS market has become increasingly complex for consumers to navigate as offerings expand into broader digital protection and cybersecurity services. Consumer investment in IDPS subscriptions has softened, creating new pressure for providers to communicate the value of their protections better. “The strongest providers are moving beyond reactive alerts to deliver more proactive scam prevention, analytical intelligence, and cyber risk protection,” said Tracy Goldberg, Director of Javelin’s Cybersecurity practice and author of the scorecard report. Gen Digital, provider of Norton 360 with LifeLock Ultimate Plus, was named Best in Class for its leadership in comprehensive monitoring, scam protection, authentication, and customer support. The company also ranked highest in four of the scorecard’s five categories, with standout capabilities addressing social media and online gaming risks. Equifax, provider of ID Watchdog Premium Family, was named an overall Leader for its strengths in child identity theft protection and cybersecurity risk mitigation. Allstate Identity Protection, provider of Blue Family, was also named an overall Leader, recognized for its strong customer support experience and dedicated onboarding assistance for families implementing child protections. “Identity theft recovery has become too difficult for consumers to navigate alone,” Goldberg added. “As scams and identity threats become more sophisticated, consumers increasingly need real-time human support from identity protection providers to help them navigate today’s emerging cybersecurity risks.” Javelin’s biannual 2026 Direct-to-Consumer Identity Protection Services Vendor Scorecard is designed to help financial institutions, financial services providers, and IDPS vendors better understand the rapidly evolving identity protection landscape. This year’s scorecard assessment evaluates 14 direct-to-consumer identity protection providers across 185 criteria and five categories: Detection & Monitoring, User Experience, Prevention, Resolution, and Onboarding & Authentication. About Javelin Strategy & Research Javelin Strategy & Research, part of Escalent Group, helps its clients make informed decisions in a digital financial world. It provides strategic insights to financial institutions including banks, credit unions, brokerages and insurers, as well as payments companies, technology providers, fintechs and government agencies. Javelin’s independent insights result from a rigorous research process that assesses consumers, businesses, providers, and the transactions ecosystem. It conducts in-depth primary research studies to pinpoint dynamic risks and opportunities in digital banking, payments, and fraud & security. Learn more at javelinstrategy.com. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ef8410e9-4811-42a4-81e3-8610cff53953 Javelin's 2026 Direct-to-Consumer Identity Protection Services Vendor Scorecard Results Gen Digital earns Best in Class; Equifax and Allstate Identity Protection named overall Leaders |
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Norton Introduces Family Assistant, the Secure AI Agent Built to Help Families Manage the Chaos of Modern Parenting in the Digital Age | FMP Stock News | |
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New secure AI agent organizes school communications, reminders, schedules, and family logistics, powered by Gen Agent Trust Hub, the trust and safety platform built for autonomous AI, /PRNewswire/ -- Parenting today increasingly feels like managing a second full-time job. School emails, appointment reminders, sports schedules, parent group chats, and last-minute updates now arrive across countless apps, inboxes, and portals, creating a constant stream of fragmented information for families to manage. The challenge is widespread, and the US Surgeon General has identified parental stress as a significant public health concern – nearly half (48%) of parents say that on most days their stress is completely overwhelming. New Norton Family Assistant Helps Families Manage the Chaos of Modern Parenting To help address the problem, Norton, part of Gen (NASDAQ: GEN), has announced the external beta launch of Norton Family Assistanti, a secure 24/7 AI agent developed to help parents stay on top of family life by bringing critical information together into one intelligent experience. Norton Family Assistant securely connects to the tools families already rely on every day, including email inboxes like Gmail, Google Calendar and other calendars, messaging apps, school platforms, and extracurricular apps. It then uses AI to help parents quickly understand what needs attention, what can wait, and what may have been missed. By linking family information from multiple sources, it helps parents and caregivers cut through chaos and stay on top of everyday life. Beyond organizing information, Norton Family Assistant is designed to take action on behalf of parents, helping reduce administrative burden. Its action-focused AI agents are built to help complete tasks while maintaining safety and control, from preparing weekly grocery lists based on family schedules and meal plans to coordinating school pickups with partners, completing permission forms, and helping families avoid scheduling conflicts. By handling routine logistics, Norton Family Assistant helps families spend less time managing administrative tasks and more time together. "At the core of AI, we believe the most important innovations won't just entertain people, they'll solve real-world problems," said Shubh Jagani, Innovation Lead at Gen AI Foundry. "Parents today are overwhelmed by fragmented information spread across countless apps and systems, a lack of time and administrative burden. Norton Family Assistant helps families reclaim quality time, reduce stress, and stay organized in a way that feels intuitive, secure, and worthy of the trust families place in their assistant." For decades, Norton has helped protect families online. As family life becomes increasingly digital, Norton Family Assistant extends that mission by helping families stay organized, reduce stress, and spend more time focused on what matters most. Building on the Gen Agent Trust Hub Developed by the Gen AI Foundry, Norton Family Assistant was designed around a fundamentally different trust and privacy model for AI agents. At the center of that model is the Gen Agent Trust Hub (ATH), a secure platform designed to help AI agents operate privately, safely, and with accountability on behalf of users. As AI systems evolve from passive assistants into autonomous agents capable of taking real-world actions on behalf of users, Gen believes trust becomes foundational infrastructure for the agentic AI era. ATH was designed to support this next generation of AI experiences by helping ensure agents can securely operate while keeping users in control of their information and decisions. Powered by the ATH, Norton Family Assistant is designed to keep family information private and secure. Each family's information remains separate, is accessible only to authorized family members, and is not used to train AI models. Norton Family Assistant represents an early example of how AI agents can move beyond simple assistants to securely help manage real-world responsibilities on behalf of users. Norton Family Assistant is now available on Windows, macOS, iOS and Android. Join the external beta with a free trial by visiting https://us.norton.com/products/family-assistant. About Norton Norton is a leader in Cyber Safety, and part of Gen (NASDAQ: GEN), a global company dedicated to powering Digital Freedom with a family of trusted consumer brands. Norton empowers millions of individuals and families with award-winning protection for their devices, online privacy, and identity. Norton products and services are certified by independent testing organizations including AV-TEST, AV Comparatives, and SE Labs. Norton is a founding member of the Coalition Against Stalkerware. Learn more at https://us.norton.com. About Gen AI Foundry Rooted in Gen's commitment to safety and transparency, the Gen AI Foundry is responsible for rapidly delivering trusted AI-native solutions. From AI-powered security experiences to identity and financial agents, Gen AI Foundry innovations are all rooted in its mission to bring peace of mind to consumers in the AI era. Learn more at https://ai.gendigital.com. Media Contact: Brittany Posey [email protected] i Family Assistant is a beta AI tool and can make mistakes; users are encouraged to verify important information and actions. SOURCE Gen Digital Inc. |
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Norton Reveals the Top 10 Scams Standing Between You and a Scam Free Summer | FMP Stock News | |
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From AI-powered imposter fraud to reservation hijacking, Norton pinpoints the attacks surging most between now and Labor Day, /PRNewswire/ -- SPF isn't the only protection you need this summer. Norton, a global leader in consumer Cyber Safety and part of Gen (NASDAQ: GEN), today launched Scam Free Summer to help people spot and stop the scams that spike in in the summer months. The forecast shines light on the moments scammers tend to show up most. Watch out for these top 10 threats identified by Norton for a Scam Free Summer Norton's 2026 Summer Scam Forecast shares the 10 scam types projected to be most active this summer, grounded in a Norton analysis of millions of scam attacks blocked by Norton in 2024 and 2025 and cross-referenced against emerging threat patterns from spring 2026. Why is Summer So Hot For Some Scams? "Scammers follow the calendar," said Leyla Bilge, Global Head of Scam Research for Norton. "People are understandably distracted, spending more on travel and tickets, tapping confirmation links without a second look. Scam Free Summer gives you the playbook to enjoy the season without lining a scammer's pockets." Gen's threat data shares the top trends: Imposter scams are when fraudsters pose as family members, government agencies, or known contacts. These jumped 144% last summer compared to the rest of the year. Financial scam attacks in the U.S. were up 55% versus the annual average. Package delivery scams rose 89%. Gambling fraud climbed 88%, driven by summer sports events. What's new in 2026: AI is doing even more heavy lifting for scammers. Voice cloning has made phone-based imposter scams harder to detect, and deepfake technology has made romance fraud and investment schemes more convincing. Data breaches are contributing to the rise in Reservation Hijacking Scams, while lookalike sites built to mimic real booking platforms, sportsbooks, and ticket sellers are surfacing through paid search ads, often indistinguishable from the real thing. The Scam-Free Summer Forecast Norton's threat intelligence team is tracking the scams hitting right now. Trending scams include: Reservation hijack attacks that use your real hotel name, real dates, and real confirmation number to redirect your payment to a fake page. Fake ticket sites for sold-out concerts, festivals, or sports events like the World Cup that surface above the legitimate sellers in search results. AI-powered romance scams where the video chats look real (because they are, just not the person on the other end). Gambling sites built specifically for major sporting events, designed to disappear by September before anyone catches up. The forecast details 10 scams in total, each with the threat data behind the seasonal spike and the specific steps to avoid it. The full 2026 Summer Scam Forecast is available now at https://us.norton.com/blog/research/summer-scams. How to Stay Safe For consumers who want real-time protection against these threats, Norton Genie has them covered. Built directly into Norton Cyber Safety products, Genie analyzes texts,, emails, and websites for hidden scam patterns and detects sophisticated schemes even the most careful person can miss. Key features like Safe SMS, Safe Web, and Safe Email proactively flag suspicious content before it can do damage, while Safe Call automatically blocks scam calls. For those who do fall victim, Norton 360 with LifeLock Ultimate Plus also includes Scam Support and Reimbursement to help recover lost funds. You can also use Genie with the Norton App in ChatGPT. Norton wishes everyone a Scam Free Summer and will be sharing additional threat intelligence, expert commentary, and consumer guidance throughout the season. About Norton Norton is a leader in Cyber Safety, and part of Gen (NASDAQ: GEN), a global company dedicated to powering Digital Freedom with a family of trusted consumer brands. Norton empowers millions of individuals and families with award-winning protection for their devices, online privacy, and identity. Norton products and services are certified by independent testing organizations including AV-TEST, AV Comparatives, and SE Labs. Norton is a founding member of the Coalition Against Stalkerware. Learn more at https://us.norton.com. Media Contact: Brittany Posey Gen [email protected] SOURCE Gen Digital Inc. |
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2026-06-12 21:25
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2026-06-07 21:33
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Gen Digital: Stable 10% Cash Flow Yield Is Hard To Ignore (Rating Upgrade) | FMP Stock News | |
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Gen Digital Inc. continues to report stable free cash flow through a slowly growing subscription base. MoneyLion has improved growth. GEN's stability is attractive in current market conditions, where a shaky consumer environment and AI uncertainty drive market volatility. GEN stock currently generates around a 10% cash flow yield, which is very attractive. I estimate GEN to have 56% upside to $41.0. |
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2026-06-12 21:25
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2026-04-06 13:21
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Surging Earnings Estimates Signal Upside for Staar Surgical (STAA) Stock | FMP Stock News | |
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Staar Surgical (STAA - Free Report) could be a solid choice for investors given the company's remarkably improving earnings outlook. While the stock has been a strong performer lately, this trend might continue since analysts are still raising their earnings estimates for the company.The upward trend in estimate revisions for this maker of implantable lenses reflects growing optimism of analysts on its earnings prospects, which should get reflected in its stock price. After all, empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements. Our stock rating tool -- the Zacks Rank -- is principally built on this insight. The five-grade Zacks Rank system, which ranges from a Zacks Rank #1 (Strong Buy) to a Zacks Rank #5 (Strong Sell), has an impressive externally-audited track record of outperformance, with Zacks #1 Ranked stocks generating an average annual return of +25% since 2008. For Staar Surgical, strong agreement among the covering analysts in revising earnings estimates upward has resulted in meaningful improvement in consensus estimates for the next quarter and full year. The chart below shows the evolution of forward 12-month Zacks Consensus EPS estimate: 12 Month EPS Current-Quarter Estimate RevisionsThe company is expected to earn $0.12 per share for the current quarter, which represents a year-over-year change of +123.1%. Over the last 30 days, the Zacks Consensus Estimate for Staar Surgical has increased 57.14% because one estimate has moved higher compared to no negative revisions. Current-Year Estimate RevisionsFor the full year, the company is expected to earn $0.59 per share, representing a year-over-year change of +837.5%. There has been an encouraging trend in estimate revisions for the current year as well. Over the past month, one estimate has moved up for Staar Surgical versus no negative revisions. This has pushed the consensus estimate 28.57% higher. Favorable Zacks RankThanks to promising estimate revisions, Staar Surgical currently carries a Zacks Rank #2 (Buy). The Zacks Rank is a tried-and-tested rating tool that helps investors effectively harness the power of earnings estimate revisions and make the right investment decision. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Our research shows that stocks with Zacks Rank #1 (Strong Buy) and 2 (Buy) significantly outperform the S&P 500. Bottom LineStaar Surgical shares have added 9.5% over the past four weeks, suggesting that investors are betting on its impressive estimate revisions. So, you may consider adding it to your portfolio right away to benefit from its earnings growth prospects. |
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2026-06-12 21:25
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2026-04-08 16:01
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STAAR Surgical Announces Preliminary Net Sales for First Quarter 2026 | FMP Stock News | |
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Original source text
LAKE FOREST, Calif.--(BUSINESS WIRE)--STAAR Surgical Company (NASDAQ: STAA), the global leader in phakic IOLs with the EVO family of Implantable Collamer® Lenses (EVO ICL™) for vision correction, today announced preliminary net sales for the first quarter ended April 3, 2026. STAAR is announcing its preliminary net sales in advance of its quarterly earnings announcement because it expects to be interacting with members of the investment community, as well as with surgeons and other members of the ophthalmology community, at the ASCRS Annual Meeting in Washington, D.C.Net sales for the first quarter of 2026 are expected to be in excess of $90 million, compared to net sales of $42.6 million for the first quarter of 2025. “We are very pleased with our strong first quarter net sales in our largest market, China, which accounted for the majority of the increase in net sales, along with continued double-digit growth in the Americas. Our higher net sales, combined with our significantly improved cost structure, are expected to drive a meaningful improvement in adjusted EBITDA for the first quarter. These results deliver on two of the three core objectives outlined in our Shareholder Letter earlier this year—Revenue Growth and Profit Expansion—and though early in the year, are indicators of the overall good health of our business,” said Deborah Andrews, Interim Co-CEO and CFO. “Current global business conditions are volatile and some portions of our business remain unpredictable. We continue to provide no forward revenue or earnings guidance and look forward to reporting our full first quarter financial results and filing our 10-Q in early May.” In the Middle East and some other parts of the EMEA and APAC regions, net sales were negatively affected by significant geopolitical and macroeconomic challenges, resulting in a decline in sales in parts of those regions. The Company is monitoring the situation and cautions that sales growth could continue to be adversely affected if these conditions persist, and that macroeconomic challenges could spread to other regions. As previously disclosed, net sales during the first quarter of 2025 were impacted as the Company shipped minimal quantities of EVO ICLs to China while distributors worked through excess inventory. As of the end of the first quarter of 2026, distributor inventory appears to be within the Company’s targeted range to appropriately service the refractive market. The financial information in this release is unaudited and subject to adjustment and confirmation as the Company completes its quarterly review and finalizes its financial statements to be filed with the Company’s Quarterly Report on Form 10-Q for the quarter ended April 3, 2026, and the review of the Company’s independent registered public accounting firm's consolidated financial statements for the quarterly period. About STAAR Surgical STAAR Surgical (NASDAQ: STAA) is the global leader in implantable phakic intraocular lenses, a vision correction solution that reduces or eliminates the need for glasses or contact lenses. Since 1982, STAAR has been dedicated solely to ophthalmic surgery, and for 30 years, STAAR has been designing, developing, manufacturing, and marketing advanced Implantable Collamer® Lenses (ICLs), using its proprietary biocompatible Collamer material. STAAR ICL’s are clinically-proven to deliver safe long-term vision correction without removing corneal tissue or the eye’s natural crystalline lens. Its EVO ICL™ product line provides visual freedom through a quick, minimally invasive procedure. STAAR has sold more than 4 million ICLs in over 85 countries. Headquartered in Lake Forest, California, the company operates research, development, manufacturing, and packaging facilities in California and Switzerland. For more information about ICL, visit www.EVOICL.com. To learn more about STAAR, visit http://www.staar.com. We intend to use our website as a means of disclosing material non-public information about the Company and complying with Regulation FD. Such disclosures will be included on our website in the ‘Investor Relations’ sections at investors.staar.com. Accordingly, investors should monitor such portion of our website, in addition to following our press releases, SEC filings and public conference calls and webcasts. In addition, you may automatically receive email alerts and other information about the Company when you enroll your email address by visiting the Email Alerts section at investors.staar.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements often contain words such as “anticipate,” “believe,” “expect,” “plan,” “estimate,” “project,” “continue,” “will,” “should,” “may,” and similar terms. All statements in this press release that are not statements of historical fact are forward-looking statements. These forward-looking statements are neither promises nor guarantees and involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from what is expressed or implied by the forward-looking statements, including, but not limited to: our ability to grow and generate profit; our reliance on independent distributors in international markets; a slowdown or disruption to the Chinese economy; global economic and geopolitical conditions; disruptions in our supply chain; fluctuations in foreign currency exchange rates; international trade disputes (including involving tariffs) and substantial dependence on demand from Asia; changes in effective tax rate or tax laws; any loss of use of our principal manufacturing facility; competition; potential losses due to product liability claims; our exposure to environmental liability; data corruption, cyber-based attacks or network security breaches and/or noncompliance with data protection and privacy regulations; acquisitions of new technologies; climate changes; the willingness of surgeons and patients to adopt a new or improved product and procedure; extensive clinical trials and resources devoted to research and development; compliance with government regulations; the discretion of regulatory agencies to approve or reject existing, new or improved products, or to require additional actions before or after approval, or to take enforcement action; laws pertaining to healthcare fraud and abuse; changes in FDA or international regulations related to product approval; product recalls or failures; and other important factors set forth in the Company’s Annual Report on Form 10-K for the year ended January 2, 2026 under the caption “Risk Factors,” which is filed with the Securities and Exchange Commission (the “SEC”) and available in the “Investor Information” section of the Company’s website under the heading “SEC Filings,” as any such factors may be updated from time to time in the Company’s other filings with the SEC. Forward-looking statements speak only as of the date they are made and, except as may be required under applicable law, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. |
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2026-06-12 21:25
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Published
2026-04-09 07:09
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Wall Street Breakfast Podcast: STAAR Prelims Signal Upside | FMP Stock News | |
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Original source text
STAAR Surgical (STAA) expects Q1 net sales to exceed $90M, more than doubling year-over-year, driven primarily by China and double-digit growth in the Americas. Disney plans 1,000 job cuts in marketing overhaul under new CEO. |
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