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Longeveron Announces FDA Grants Type C Meeting Ahead of Data Readout for Pivotal Phase 2 Clinical Trial (ELPIS II) Evaluating Treatment for Hypoplastic Left Heart Syndrome (HLHS)
Globenewswire· 2026-01-26 14:15
Core Viewpoint - Longeveron Inc. has received a Type C meeting from the FDA to discuss the clinical efficacy data endpoints and statistical analysis plan for its stem cell therapy laromestrocel, aimed at treating Hypoplastic Left Heart Syndrome (HLHS) in pediatric patients, with top-line trial results expected in Q3 2026 [1][6]. Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs, with its lead product being laromestrocel (LOMECEL-B®), an allogeneic mesenchymal stem cell therapy derived from young, healthy adult donors [4]. - The company is pursuing three pipeline indications: HLHS, Alzheimer's disease, and Pediatric Dilated Cardiomyopathy (DCM) [4]. - Laromestrocel has received multiple FDA designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease designations for the HLHS program, and Regenerative Medicine Advanced Therapy (RMAT) designation for the Alzheimer's program [4]. Clinical Trial Details - The ELPIS II trial is a Phase 2b clinical study evaluating laromestrocel as an adjunct therapy for HLHS, enrolling 40 pediatric patients across twelve leading treatment institutions [2]. - The trial is conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) through NIH grants [2]. - The anticipated top-line results from the ELPIS II trial are expected in the third quarter of 2026, with a potential Biological License Application (BLA) submission if results are positive [6]. Medical Context - Hypoplastic Left Heart Syndrome (HLHS) is a congenital heart defect characterized by the underdevelopment or absence of the left ventricle, leading to significantly reduced systemic blood flow and requiring complex surgical interventions [3]. - Despite surgical advancements, early mortality remains high in HLHS patients, primarily due to right ventricular failure, indicating a critical unmet medical need for improved treatment options [3][6].
U.S. Stock Market Navigates Geopolitical Tensions and Key Earnings Week on January 26, 2026
Stock Market News· 2026-01-26 14:07
Market Overview - U.S. stock markets are entering a pivotal week with cautious premarket trading, significant corporate earnings reports, and an anticipated Federal Reserve meeting [1] - Investors are weighing geopolitical developments against robust technological advancements and ongoing economic data releases [1] Premarket Activity and Futures Movements - U.S. stock futures indicate a slightly lower open, with Dow Jones Industrial Average (DJIA) futures fractionally lower, S&P 500 (SPX) futures down by approximately 0.2%, and Nasdaq 100 (NDX) futures down around 0.4% [2] - This subdued sentiment follows a mixed performance last week for major indices [2] Safe-Haven Assets Performance - Gold futures have surpassed $5,000 per ounce for the first time, trading up more than 2% at about $5,080 an ounce [3] - Silver futures have hit a new record high above $110 an ounce, marking an almost 9% increase [3] - The yield on the 10-year Treasury note has slipped to 4.21% from over 4.23% [3] - Bitcoin (BTC) is trading around $87,700, showing a slight uptick from overnight lows [3] - West Texas Intermediate (WTI) crude futures are settling around $60.90 a barrel [3] Current Performance of Major Market Indexes - The S&P 500 (SPX) experienced a slight decline of 0.3%, marking its second consecutive weekly loss [4] - The Nasdaq 100 (NDX) generated a return of 0.3%, while the DJIA finished the week down by 0.5% [4] - On January 26, the DJIA fell 0.6% to 49,098.71 points, the SPX edged up 0.03% to close at 6,915.61, and the Nasdaq Composite (IXIC) advanced 0.3% to 23,501.24 [4] Upcoming Market Events - A significant week for market participants with a heavy slate of corporate earnings and a crucial Federal Reserve meeting [5] - The Federal Reserve's two-day policy meeting concludes on Wednesday, with expectations to keep interest rates unchanged at 3.5%-3.75% [6] - Investors will focus on Fed Chair Jerome Powell's post-meeting press conference for guidance on potential rate cuts and the Fed's stance on inflation and economic growth [6] Economic Data Releases - Investors are closely watching the release of U.S. durable goods orders, expected to have risen by 0.5% in November, and the Producer Price Index (PPI), forecasted to increase by 0.2% in December with core PPI expected to rise by 0.3% [7] Major Earnings Reports - A critical wave of earnings reports from major technology companies, including Microsoft (MSFT), Meta Platforms (META), and Tesla (TSLA), is scheduled for this week [8] - Other notable companies reporting include IBM (IBM), Boeing (BA), General Motors (GM), UnitedHealth Group (UNH), Chevron (CVX), and Exxon Mobil (XOM) [8] Individual Stock Developments - USA Rare Earth (USAR) shares soared over 20% after announcing a non-binding letter of intent with the U.S. Department of Commerce for $1.6 billion in federal funding [10] - CoreWeave (CRWV) stock surged 10% due to an expanded partnership with Nvidia (NVDA), which invested $2 billion in CoreWeave [11] - Intel (INTC) shares were down approximately 2% after a soft outlook and concerns over potential supply issues [12] - Revolution Medicines (RVMD) stock dropped roughly 20% after reports that Merck (MRK) is no longer in acquisition discussions [12] Industry Sentiment - Bill Gates warned about the hype surrounding AI investments, suggesting that not all AI stocks may justify their elevated valuations in a hypercompetitive market [13] - Airline stocks, including Delta Air Lines (DAL), United Airlines (UAL), American Airlines (AAL), and Southwest Airlines (LUV), are pointing modestly lower due to over 20,000 flight cancellations caused by a winter storm [14] Future Expectations - Analysts are keenly watching Tesla (TSLA) for updates on full self-driving (FSD) approval and robotaxi deployment [15] - Apple (AAPL) is anticipated to report a record sales quarter driven by strong iPhone sales and growth in services revenue [15] - Microsoft (MSFT) earnings will be closely monitored for updates on AI developments, while Meta Platforms (META) will provide insights into capital expenditures related to its metaverse ambitions [15]
Avant Technologies Evaluating Advanced Cells for Diabetes Therapy at 15th Annual EPITA Symposium
Prnewswire· 2026-01-26 13:30
LAS VEGAS, Jan. 26, 2026 /PRNewswire/ -- Avant Technologies, Inc. (OTCQB: AVAI) ("Avant" or the "Company"), an emerging biotechnology company focused on developing cell-based therapies for diabetes and age-related disorders, today announced its participation in the 15th European Pancreas and Islet Transplantation Association (EPITA) Symposium, held January 25-27, 2026, in Igls, Austria. As a leader in immunosuppression-free cell therapy solutions, Avant is actively evaluating advanced cells for potential ap ...
BioMarin Announces Proposed Private Offering of Senior Notes and Syndication of New Senior Secured Term Loan Facility
Prnewswire· 2026-01-26 12:45
Core Viewpoint - BioMarin Pharmaceutical Inc. is planning to raise $850 million through the issuance of senior unsecured notes due in 2034 to finance its acquisition of Amicus Therapeutics, Inc. and related expenses [1][3]. Financing Details - The company is launching a $2 billion senior secured term loan "B" facility in addition to an existing $800 million senior secured term loan "A" facility and a $600 million senior secured revolving credit facility to support the acquisition [2]. - The net proceeds from the notes offering, along with borrowings from the term facilities and cash on hand, will be used to fund the acquisition and associated fees [3]. Redemption Conditions - Gross proceeds from the notes will be held in an escrow account until the acquisition is completed, with a mandatory redemption clause if the acquisition is not finalized by December 19, 2026 [4]. Guarantees and Covenants - The notes will be guaranteed by certain subsidiaries of BioMarin, including Amicus post-acquisition, and will include customary covenants that restrict additional debt incurrence and other financial activities [5][6]. Regulatory Information - The notes will not be registered under the Securities Act and will be offered only to qualified institutional buyers or non-U.S. persons, subject to transfer restrictions [7]. Company Overview - BioMarin is a global biotechnology company focused on rare diseases, with a strong portfolio of commercial therapies and a robust pipeline for drug development [9][10].
IBB: Biotech's Hot Streak May Cool
Seeking Alpha· 2026-01-26 11:22
Group 1 - Biotech stocks have shown significant recovery and are now among the top performers in the market over the past few quarters [1] - The iShares Biotechnology ETF (IBB) experienced a substantial decline from Q4 2024 to April 2025, underperforming compared to the S&P [1]
Stock Market Today: Dow Jones, S&P 500 Futures Slip As Investors Brace For Mega-Cap Earnings—Brand Engagement, Nucor In Focus
Benzinga· 2026-01-26 10:36
Market Overview - U.S. stock futures declined on Monday following a mixed close on Friday, with major benchmark indices showing lower futures [1] - Investors are focused on upcoming earnings reports from companies such as UnitedHealth Group, General Motors, Microsoft, Meta Platforms, Tesla, and Starbucks [1] - The Federal Open Market Committee's interest rate decision is anticipated on Wednesday [1] Treasury Yields - The yield on the 10-year Treasury bond is at 4.21%, while the two-year bond yield stands at 3.59% [2] - Market projections indicate a 97.2% likelihood that the Federal Reserve will keep interest rates unchanged in January [2] Index Performance - Dow Jones decreased by 0.12%, S&P 500 fell by 0.24%, Nasdaq 100 dropped by 0.44%, and Russell 2000 declined by 0.29% [3] - SPDR S&P 500 ETF Trust (SPY) was down 0.22% at $687.69, and Invesco QQQ Trust ETF (QQQ) declined 0.43% to $620.04 in premarket trading [3] Stocks in Focus - Baker Hughes Co. reported a 3.74% increase in premarket trading after posting adjusted earnings of 78 cents per share, exceeding estimates of 67 cents [7] - Sarepta Therapeutics Inc. saw a 6.72% rise after completing a trial commitment for its PMO therapies and releasing third-quarter results [7] - Nucor Corp. is projected to report quarterly earnings of $1.91 per share on revenue of $7.87 billion [7] - WR Berkley Corp. is expected to report earnings of $1.13 per share on revenue of $3.66 billion, with a weaker price trend according to Benzinga's Edge Stock Rankings [15] Analyst Insights - Mohamed El-Erian notes a "2025 Paradox" where financial markets remain resilient despite geopolitical tensions, with U.S. economic activity appearing robust [11] - El-Erian anticipates the Federal Reserve will maintain interest rates, with a focus on corporate earnings from tech giants and political issues affecting market stability [12][13] Upcoming Economic Data - Key economic reports to watch include durable-goods orders, consumer confidence data, and the Federal Reserve's interest rate decision [17]
Greenwich: GP2 Vaccine Milestone - What FDA Manufacturing Approval Means For Investors
Seeking Alpha· 2026-01-26 10:08
Core Insights - The recent update from Greenwich LifeSciences, Inc. (GLSI) focuses on manufacturing validation and regulatory progress rather than solely on clinical results [1] Company Overview - Greenwich LifeSciences has received FDA approval, indicating progress in its regulatory journey [1] Analyst Background - The analyst has a Master's degree in Cell Biology and extensive experience in drug discovery, which informs their investment analysis in the biotech sector [1] - The analyst has been active in the investment space for five years, with a focus on identifying promising biotechnology companies [1] Investment Focus - The analyst emphasizes evaluating the science behind drug candidates, competitive landscape, clinical trial design, and market opportunities while balancing financial fundamentals [1] - The goal is to provide insights that help investors understand both opportunities and risks in the biotech sector [1]
Biotech investor Cormorant secures $150M for another SPAC deal
Yahoo Finance· 2026-01-26 09:43
Group 1 - The article discusses the resurgence of SPACs (Special Purpose Acquisition Companies) in 2025 after a decline in popularity due to disappointing returns and increased federal oversight [4][5] - New SPAC issuances more than doubled from 2024 to 2025, indicating a positive trend in the market, driven by experienced SPAC sponsors returning [5] - Cormorant Asset Management has launched Helix Acquisition Corp. III, raising $150 million through an IPO, with plans to focus on healthcare or healthcare-related industries [8] Group 2 - Helix Acquisition Corp. III sold 15 million shares at $10 each, exceeding its initial projection by 2.5 million shares, and began trading on Nasdaq under the ticker "HLXC" [8] - Cormorant Asset Management manages over $2.4 billion and has previously taken three SPACs public since 2022, successfully finding merger partners for its earlier SPACs [8] - The current market environment presents unique opportunities for SPACs, as many drug startups have remained private longer, creating a backlog of mature companies ready for public markets [7][8]
Legend Biotech (LEGN) Advances Cell Therapy Innovation and Expands Oncology Pipeline
Yahoo Finance· 2026-01-26 08:14
Core Viewpoint - Legend Biotech Corporation (NASDAQ:LEGN) is viewed positively by analysts, with Deutsche Bank and Cantor Fitzgerald both maintaining bullish ratings and setting price targets of $60 and $74 respectively, driven by expectations of strong clinical trial results and significant sales growth in its oncology pipeline [1][4]. Group 1: Analyst Ratings and Price Targets - Deutsche Bank reiterated a Buy rating on Legend Biotech and set a price target of $60, anticipating topline results from its first in-vivo CAR T program by year-end [1]. - Cantor Fitzgerald reaffirmed an Overweight rating with a price target of $74, highlighting the expected 100% year-over-year sales increase of Carvykti to $2 billion [4]. Group 2: Clinical Development and Pipeline - Initial preclinical data indicate robust dose-dependent CAR-T expansion in non-human primates, with sustained peripheral B-cell elimination observed from day 8 to day 36, suggesting in vivo CAR-T cells have properties akin to traditional CAR-T treatments [2]. - Legend Biotech aims to achieve profitability by 2026 while continuing to develop its pipeline, focusing on in vivo and allogeneic CAR-T therapies [3]. Group 3: Company Overview - Legend Biotech is a global clinical-stage biotechnology company dedicated to discovering, developing, and commercializing novel cell therapies, primarily targeting cancer and severe diseases, leveraging technologies like CAR-T cell therapy [5].
15 Best S&P 500 Dividend Stocks to Buy in 2026
Insider Monkey· 2026-01-26 01:16
Core Insights - The article discusses the 15 best S&P 500 dividend stocks to consider for investment in 2026, emphasizing the stability that dividend stocks can provide during market downturns [1] Dividend and Buyback Strategy - Dan Lefkovitz from Morningstar Indexes suggests that combining dividend-paying stocks with companies that actively buy back shares can yield better returns compared to a high-dividend-only strategy [2] - An index that includes both dividends and buybacks has outperformed a high-dividend-only index over the past three years, although it still lags behind the overall US market [2] Cash Return to Shareholders - The article highlights the difference in how companies return cash to shareholders, noting that dividends are a long-term commitment while buybacks are more flexible and often increase when management perceives the stock as undervalued [3] - Large technology companies have been leading in buyback activities, while dividend payments are primarily concentrated in sectors like financials, utilities, energy, and consumer staples [3] International Dividend Yields - Income-focused investors are encouraged to look beyond the US, as domestic dividend yields have decreased to approximately 1.1%, while some European regions offer yields above 3% [4] - Caution is advised against chasing high yields, as unusually high payouts may indicate underlying business stress and potential future dividend cuts [4] Methodology for Stock Selection - The selection process for the 15 best dividend stocks involved screening S&P 500 companies with a market cap of at least $10 billion, focusing on those with stable dividends and yields around 2% as of January 21 [6] - The final list was based on popularity among hedge funds, utilizing data from Insider Monkey's Q3 2025 database [6][7] Company-Specific Insights - **Verizon Communications Inc. (NYSE:VZ)**: - Holds a dividend yield of 7.06% as of January 21, with 60 hedge fund holders [8] - Bernstein has cut its price target for Verizon to $44, citing increased competition in the telecom industry [8] - Verizon's $20 billion acquisition of Frontier Communications was approved, with commitments to expand fiber internet and wireless coverage in California [9] - **Amgen Inc. (NASDAQ:AMGN)**: - Has a dividend yield of 3.05% as of January 21, with 62 hedge fund holders [11] - Bernstein downgraded Amgen to Market Perform, indicating 2026 may be a waiting year for its product MariTide [11] - Amgen announced the acquisition of Dark Blue Therapeutics for up to $840 million, enhancing its oncology pipeline [12][13]