Latest news with #VeraTherapeutics
Yahoo
02-07-2025
- Business
- Yahoo
Millions in Insider Buying Point to These 2 Stocks — Here's What It Could Signal
There's a current of optimism in the air as Wall Street's stock markets climb back to record levels, with the S&P 500 hitting an all-time high yesterday. Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. In this environment, it's tempting to just start buying, but a smart investor will still take a moment to pause, check the signals, and find the right stock. Few market signals come in clearer than insider buys, and for good reason. These corporate officers, residents of C-suites and Boards of Directors, know the inside workings of their companies – and when that knowledge informs their stock purchases, investors should all take note. The insiders might sell for a multitude of reasons, but they only buy for one: they believe the shares are going to jump. And when insiders start buying millions worth of their own stock, investors should definitely pay closer attention. We've used the Insiders' Hot Stocks tool from TipRanks to do just that. We've found two stocks that are showing millions of dollars' worth of insider buying. Let's give these names a closer look and find out just why the insiders are scooping them up. Vera Therapeutics (VERA) We'll start with Vera Therapeutics, one of the many clinical-stage biopharmaceutical companies working on the new drugs and therapeutic agents that have so revolutionized modern medicine in recent decades. Vera's focus is on new treatments for dangerous immunological conditions, particularly those that have both high unmet medical needs and a lack of effective treatments currently on the market. The company is developing novel biologic molecules as treatment agents in this field. Currently, Vera has one leading late-stage drug candidate in the clinical pipeline. This drug, atacicept, is under investigation as a treatment for IgA nephropathy (called IgAN, or Berger's disease), as well as for lupus nephritis. The IgAN track is the company's most advanced program, and has recently achieved several milestones. During Q1 of this year, Vera completed enrollment of the pivotal Phase 3 ORIGIN trial of atacicept in the treatment of IgAN, and began enrolling patients in the ORIGIN EXTEND study, which continued dosing and monitoring of atacicept in patients from the Phase 2b and Phase 3 ORIGIN trials. ORIGIN EXTEND will also capture longer-term data on safety and efficacy. Earlier this month, the company announced that atacicept had met the primary endpoint of the ORIGIN Phase 3 trial at week 36. Following up on the successes of the atacicept clinical trial program, Vera has plans to submit a Biologics License Application, or BLA, to the FDA during 4Q25. The company hopes to have an accelerated approval process and to potentially see a PDUFA date and the launch of commercialization activities sometime next year. Despite these developments, VERA shares have shed 44% year-to-date and evidently one insider thinks it is time to pounce. Recently, Patrick Enright, of Vera's Board of Directors, purchased 250,000 shares of VERA, in two purchases that are worth a combined $5.89 million at current valuations. Mr. Enright's stake in Vera currently totals some $148 million. This stock has caught the attention of Goldman Sachs analyst Paul Choi, who is impressed by the company's advances on the IgAN track and sees Vera as a solid choice as a potential merger target going forward. Choi writes, 'While the landscape in IgAN remains competitive, we continue to view VERA's atacicept as a clinically differentiated asset with a largely derisked profile… We have evaluated VERA shares from an M&A perspective given what we think there could be potential interest from a strategic acquirer due to the attractiveness of its end markets and pipeline assets. We assign an M&A rank of 1 (representing high (30%-50%) probability of the company becoming an acquisition candidate), and apply an 11.0x multiple on the second full year of sales (2028 given our modeled launch in 3Q26), in line with similar biotech of this stage, and arrive at a theoretical M&A valuation of $65 per share.' Choi follows this stance by setting a Buy rating on VERA, and although his $55 price target is not as high as that 'theoretical M&A valuation,' the figure still points toward a robust one-year upside potential of 133.5%. (To watch Choi's track record, click here) This stock has 12 recent analyst reviews, breaking down 11 to 1 in favor of Buy over Hold, giving it a Strong Buy consensus rating. The share price of $23.56 and average target of $66.58 together imply an upside of a hefty 182.5% in the next 12 months. (See VERA stock forecast) Marriott Vacations Worldwide (VAC) Will pivot now to an entirely different industry. The second stock we'll look at, Marriott Vacations Worldwide, is the timeshare entity built on the foundation of the hotel industry's famous Marriott name. The company was formed in 2011, when it spun off from its Marriott parent and took that company's vacation ownership and timeshare business public as an independent vacation company. Currently, Marriott Vacations Worldwide operates several brands in its vacation ownership portfolio, including (but not limited to) Marriott Vacation Club, Sheraton Vacation Club, Westin Vacation Club, and the Grand Residences by Marriott. The businesses in this portfolio offer members the ability to choose from a variety of flexible vacation programs, of differing styles, to meet their evolving needs and desires year after year. Marriott Vacations Worldwide has over 120 resorts in its portfolio, with more than 18,000 vacation villas. Vacation destinations include the US, the Caribbean, and Central America, as well as Europe, Asia, and Australia. The company's exchange and third-party management segment includes the Interval International and Aqua-Aston Hospitality brands. These subsidiaries operate vacationer membership programs, giving members access to full-service resorts around the world. Marriott Vacations Worldwide can give its members ownership rights in more than 3,200 resorts located in 80 countries. Looking at some of the company's numbers, we find that Marriott Vacations Worldwide can boast more than 700,000 member-owners on its vacation ownership side, and more than 1.5 million members on the exchange and third-party management side. The company's operations generated $1.2 billion in revenue during 1Q25, the last period reported, a figure that was flat year-over-year and missed the forecast by a mere $7.15 million. The company's earnings in the quarter came to $1.66 per share by non-GAAP measures, beating the forecast by 23 cents per share. This stock has also underperformed so far this year, shedding 17.5% of its value, but one insider must be feeling very confident in VAC's trajectory. On June 17 and 18, Christian Asmar, one of the company's Directors, bought 750,000 shares of VAC in two tranches. His combined purchase is now worth ~$54.2 million. The company has a supporter in Barclays analyst Brandt Montour, who explains why VAC currently has a favorable risk-reward profile. He writes, 'Coming off a long string of tougher quarters, management credibility around execution remains relatively low; however, in the current situation, a de-risked top-line outlook, favorable delinquency trends (corresponding to a higher-income average customer), and washed out sentiment isn't a terrible relative set-up vs. peers. For longer-term shareholders, we believe VAC's valuation remains too cheap to ignore, at <5x our 2026 EBITDA figures.' The analyst goes on to rate these shares as Overweight (i.e., Buy), and he complements that rating with an $88 price target that suggests an upside potential of 22% in the year ahead. (To watch Montour's track record, click here) The 7 recent analyst reviews on this stock include 4 Buys, 2 Holds, and 1 Sell for a Moderate Buy consensus rating. The shares have a current trading price of $72.31 and an average target price of $81.67; together, these imply that the stock will gain 13% by this time next year. (See VAC stock forecast) To find good ideas for stocks trading at attractive valuations, visit TipRanks' Best Stocks to Buy, a tool that unites all of TipRanks' equity insights. Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment. Disclaimer & DisclosureReport an Issue
Yahoo
24-06-2025
- Business
- Yahoo
BAFF- and APRIL-targeted Therapies Market Sees Surge in Activity Amid Rising Autoimmune Disease Burden
The BAFF- and APRIL-targeted therapies market is experiencing steady growth driven by the rising prevalence of autoimmune diseases such as systemic lupus erythematosus (SLE), IgA nephropathy, and Sjögren's syndrome. Advancements in biologics and the entry of pipeline agents with improved efficacy profiles are further fueling market expansion. LAS VEGAS, June 24, 2025 /PRNewswire/ -- DelveInsight's BAFF- and APRIL-targeted Therapies Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as IgA nephropathy (IgAN), lupus nephritis, myasthenia gravis, systemic lupus erythematosus (SLE), Sjögren's syndrome, and other B-cell-mediated autoimmune conditions. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging BAFF- and APRIL-targeted therapies, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM. Key Takeaways from the BAFF- and APRIL-targeted Therapies Market Report As per DelveInsight's analysis, the total market size of BAFF- and APRIL-targeted therapies in the 7MM is expected to surge significantly by 2034. BAFF and APRIL-targeted therapies are actively being developed to address a broad spectrum of autoimmune diseases, including IgA nephropathy (IgAN), lupus nephritis, myasthenia gravis, systemic lupus erythematosus (SLE), Sjögren's syndrome, and other B-cell-mediated autoimmune conditions, offering promising new options to modulate pathogenic B-cell activity and improve patient outcomes. Leading BAFF- and APRIL-targeted therapies companies, such as Vera Therapeutics, RemeGen, Aurinia Pharmaceuticals, and others, are developing novel BAFF- and APRIL-targeted therapies that can be available in the BAFF- and APRIL-targeted therapies market in the coming years. Some of the key BAFF- and APRIL-targeted therapies in the pipeline include Atacicept, Telitacicept, AUR200, and others. In May 2025, Vera Therapeutics announced that primary endpoint results from the pivotal Phase III ORIGIN 3 trial of atacicept in Immunoglobulin A Nephropathy (IgAN) are expected in Q2 2025, with plans to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) in Q4 2025 for accelerated approval, targeting a potential PDUFA date and commercial launch in 2026. In November 2024, the European Medicines Agency (EMA) granted orphan medicine designation to Atacicept for the treatment of IgAN. In May 2024, Vera Therapeutics announced that the US FDA had granted Breakthrough Therapy Designation (BTD) to atacicept for the treatment of IgAN. The designation reflects the FDA's determination that, based on an assessment of data from the Phase IIb ORIGIN clinical trial of atacicept for IgAN, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Discover which indication is expected to grab the major BAFF- and APRIL-targeted therapies market share @ BAFF- and APRIL-targeted Therapies Market Report BAFF- and APRIL-targeted Therapies Market Dynamics The BAFF- and APRIL-targeted therapies market is evolving rapidly, driven by a growing understanding of B-cell biology and its role in autoimmune diseases. BAFF and APRIL are crucial for B-cell survival, maturation, and function. Overexpression of these cytokines has been implicated in diseases such as IgA nephropathy (IgAN), lupus nephritis, myasthenia gravis, systemic lupus erythematosus (SLE), Sjögren's syndrome, and other B-cell-mediated autoimmune conditions. Therapies targeting these pathways aim to modulate abnormal B-cell activity, offering more precise immunomodulatory approaches compared to broad immunosuppressants. Market interest in this space has intensified with the development of biologics like atacicept and, more recently, telitacicept. These agents work by neutralizing excess BAFF and/or APRIL, reducing pathogenic autoantibody production. The differentiated mechanism of dual targeting is believed to offer superior efficacy in certain patient subtypes, fueling competitive development programs. The market dynamics are shaped by both unmet clinical needs and strategic commercial considerations. Autoimmune diseases, particularly lupus and IgAN, have long suffered from limited treatment options with poor tolerability or efficacy. As a result, payers and clinicians are keen on alternatives that offer disease modification and long-term remission. However, safety remains a concern, especially the risk of hypogammaglobulinemia and infections due to B-cell suppression. This risk-benefit balance is a key differentiator in positioning products within the competitive landscape. Overall, the BAFF/APRIL-targeted therapy market is transitioning from experimental to established, with first-in-class and best-in-class competition intensifying. Pipeline diversity, biomarker-driven patient selection, and combinatorial strategies with other immunotherapies will be central to shaping the future landscape. As real-world evidence accumulates and regulatory agencies refine guidance, these therapies may move from niche indications to broader frontline use in autoimmune care. BAFF- and APRIL-targeted Therapies Treatment Market The landscape for BAFF- and APRIL-targeted therapies is undergoing rapid transformation, fueled by the pressing need for more precise B cell modulation in autoimmune disorders. As of 2025, no fusion proteins targeting these pathways have received FDA approval, but several promising candidates are advancing through late-stage clinical trials. This progress reflects a positive shift in the field, pointing toward more effective dual-pathway immunotherapies that could address the shortcomings of existing treatments and provide renewed hope for patients with challenging autoimmune conditions. Learn more about the BAFF- and APRIL-targeted therapies @ BAFF- and APRIL-targeted Therapies Analysis Key Emerging BAFF- and APRIL-targeted Therapies and Companies Some of the BAFF- and APRIL-targeted therapies in the pipeline include Atacicept (Vera Therapeutics), Telitacicept (RemeGen), AUR200 (Aurinia Pharmaceuticals), and others. Atacicept is an investigational fusion protein composed of the soluble form of the TACI receptor, which binds to the cytokines BAFF and APRIL—members of the TNF family involved in supporting B-cell survival and promoting the production of autoantibodies linked to autoimmune conditions such as IgAN and lupus nephritis. Vera Therapeutics views atacicept as a strong contender for best-in-class status due to its dual targeting of B cells and plasma cells to lower autoantibody levels. The drug has already been tested in over 1,500 patients across multiple indications in clinical trials. Atacicept is currently undergoing Phase III trials for the treatment of IgAN. Telitacicept, developed by RemeGen, is another fusion protein that also targets BAFF and APRIL, aiming to treat autoimmune diseases driven by B cells. It is being studied globally, including in the U.S., for conditions such as myasthenia gravis, systemic lupus erythematosus (SLE), and Sjögren's syndrome. The U.S. FDA has granted Orphan Drug Designation (ODD) and Fast Track Designation (FTD) for telitacicept in myasthenia gravis. A notable advancement in its development came in August 2024, when the first U.S. patient was enrolled in a global Phase III trial for generalized myasthenia gravis. The anticipated launch of these emerging therapies are poised to transform the BAFF- and APRIL-targeted therapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the BAFF- and APRIL-targeted therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about BAFF- and APRIL-targeted therapies clinical trials, visit @ BAFF- and APRIL-targeted Therapies Treatment BAFF- and APRIL-targeted Therapies Overview BAFF and APRIL, both part of the TNF family, are key regulators of B cell survival, development, and antibody class switching through their interactions with the receptors BAFF-R, TACI, and BCMA. When the BAFF/APRIL pathway becomes dysregulated, often due to ligand overexpression, it can trigger abnormal B cell activation and drive the development of autoimmune diseases. BAFF mainly signals through BAFF-R, activating both the classical and alternative NF-κB pathways, while APRIL binds to TACI and BCMA and also interacts with heparan sulfate proteoglycans to amplify B cell responses. Given their pivotal role in immune system regulation, BAFF and APRIL have emerged as promising therapeutic targets. Clinical studies have shown that inhibiting BAFF can significantly reduce disease activity in various autoimmune conditions by curbing harmful B-cell activity and helping to restore immune homeostasis. BAFF- and APRIL-targeted Therapies Epidemiology Segmentation The BAFF- and APRIL-targeted therapies market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases in Selected Indications for BAFF- and APRIL-targeted Therapies Total Eligible Patient Pool in Selected Indications for BAFF- and APRIL-targeted Therapies Total Treated Cases in Selected Indications for BAFF- and APRIL-targeted Therapies BAFF- and APRIL-targeted Therapies Report Metrics Details Study Period 2020–2034 BAFF- and APRIL-targeted Therapies Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Indications Covered in the Report IgA nephropathy (IgAN), lupus nephritis, myasthenia gravis, systemic lupus erythematosus (SLE), Sjögren's syndrome, and other B-cell-mediated autoimmune conditions Key BAFF- and APRIL-targeted Therapies Companies Vera Therapeutics, RemeGen, Aurinia Pharmaceuticals, and others Key BAFF- and APRIL-targeted Therapies Atacicept, Telitacicept, AUR200, and others Scope of the BAFF- and APRIL-targeted Therapies Market Report BAFF- and APRIL-targeted Therapies Therapeutic Assessment: BAFF- and APRIL-targeted Therapies current marketed and emerging therapies BAFF- and APRIL-targeted Therapies Market Dynamics: Conjoint Analysis of Emerging BAFF- and APRIL-targeted Therapies Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, BAFF- and APRIL-targeted Therapies Market Access and Reimbursement Discover more about BAFF- and APRIL-targeted therapies in development @ BAFF- and APRIL-targeted Therapies Clinical Trials Table of Contents 1. Key Insights 2. Report Introduction 3. Executive Summary 4. Key Events 5. Epidemiology and Market Forecast Methodology 6. BAFF- and APRIL-targeted Therapies Market Overview at a Glance in the 7MM 6.1. Market Share (%) Distribution by Therapies in 2025 6.2. Market Share (%) Distribution by Therapies in 2034 6.3. Market Share (%) Distribution by Indications in 2025 6.4. Market Share (%) Distribution by Indications in 2034 7. BAFF- and APRIL-targeted Therapies: Background and Overview 7.1. Introduction 7.2. Potential of BAFF- and APRIL-targeted Therapies in Different Indications 7.3. Clinical Applications of BAFF- and APRIL-targeted Therapies 8. Target Patient Pool of BAFF- and APRIL-targeted Therapies 8.1. Assumptions and Rationale 8.2. Key Findings 8.3. Total Cases of Selected Indication for BAFF- and APRIL-targeted Therapies in the 7MM 8.4. Total Eligible Patient Pool of Selected Indication for BAFF- and APRIL-targeted Therapies in the 7MM 8.5. Total Treatable Cases in Selected Indication for BAFF- and APRIL-targeted Therapies in the 7MM 9. Emerging Therapies 9.1. Key Competitors 9.2. Atacicept: Vera Therapeutics 9.2.1. Product Description 9.2.2. Other developmental activities 9.2.3. Clinical development 9.2.4. Safety and efficacy 9.3. Telitacicept: RemeGen 9.3.1. Product Description 9.3.2. Other developmental activities 9.3.3. Clinical development 9.3.4. Safety and efficacy List to be continued in the report 10. BAFF- and APRIL-targeted Therapies: Seven Major Market Analysis 10.1. Key Findings 10.2. Market Outlook 10.3. Conjoint Analysis 10.4. Key Market Forecast Assumptions 10.4.1. Cost Assumptions and Rebates 10.4.2. Pricing Trends 10.4.3. Analogue Assessment 10.4.4. Launch Year and Therapy Uptakes 10.5. Total Market Sizes of BAFF- and APRIL-targeted Therapies by Indications in the 7MM 10.6. The United States Market Size 10.6.1. Total Market Size of BAFF- and APRIL-targeted Therapies in the United States 10.6.2. Market Size of BAFF- and APRIL-targeted Therapies by Indication in the United States 10.6.3. Market Size of BAFF- and APRIL-targeted Therapies by Therapies in the United States 10.7. EU4 and the UK 10.7.1. Total Market Size of BAFF- and APRIL-targeted Therapies in EU4 and the UK 10.7.2. Market Size of BAFF- and APRIL-targeted Therapies by Indications in EU4 and the UK 10.7.3. Market Size of BAFF- and APRIL-targeted Therapies by Therapies in EU4 and the UK 10.8. Japan 10.8.1. Total Market Size of BAFF- and APRIL-targeted Therapies Inhibitors in Japan 10.8.2. Market Size of BAFF- and APRIL-targeted Therapies by Indications in Japan 10.8.3. Market Size of BAFF- and APRIL-targeted Therapies by Therapies in Japan 11. SWOT Analysis 12. KOL Views 13. Unmet Needs 14. Market Access and Reimbursement 15. Appendix 15.1. Bibliography 15.2. Report Methodology 16. DelveInsight Capabilities 17. Disclaimer 18. 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Contact UsShruti Thakur info@ +14699457679 Logo: View original content: SOURCE DelveInsight Business Research, LLP Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data


Reuters
08-06-2025
- Business
- Reuters
Otsuka's kidney disease therapy trial results heat up battle with rival Vera
June 6 (Reuters) - Otsuka's (4578.T), opens new tab experimental therapy for a potentially life-threatening kidney disease more than halved severe levels of protein in the urine of patients, intensifying the battle for an effective new treatment with rival Vera Therapeutics (VERA.O), opens new tab. The Japan-based company said on Friday its therapy, sibeprenlimab, cut proteinuria levels by 51.2% in patients with Immunoglobulin A Nephropathy, also known as Berger's disease, at nine months in a late-stage trial. The data comes just days after Vera said its drug, atacicept, reduced protein levels in patients' urine by 46%, compared with a 7% reduction with a placebo, meeting the main goal of a 428-patient late-stage study. Shares of the U.S.-based drug developer slid 31% to $20.89. Analysts, however, said that though data from Otsuka's sibeprenlimab might look superior, it was unlikely that doctors would interpret it that way. The difference between the two datasets is not too clinically diverse to affect demand for Vera's drug, said Jefferies analyst Farzin Haque. Berger's disease causes abnormal protein buildup in the kidneys and could eventually lead to the organ's failure. Analysts have estimated the U.S. market for its treatments could be worth as much as $10 billion. Otsuka has already applied for the FDA's accelerated approval for its therapy to treat the disease. However, its sales would largely depend on whether the treatment can improve kidney function, analysts said. Even if the drug gains accelerated approval, Otsuka said it plans to study whether it can preserve the organ's ability to filter toxins from blood, measured as the glomerular filtration rate (eGFR). "The magnitude of the protein reduction should translate into eGFR preservation down the line, because ultimately that's what patients are going to be asking for," Dana Rizk, the trial's investigator and a professor of medicine at the University of Alabama in Birmingham, told Reuters. The study is expected to be completed in early 2026.


Business Insider
07-06-2025
- Business
- Business Insider
Vera Therapeutics (VERA) Gets a Buy from Evercore ISI
In a report released today, Liisa Bayko from Evercore ISI reiterated a Buy rating on Vera Therapeutics (VERA – Research Report), with a price target of $75.00. The company's shares opened today at $21.27. Confident Investing Starts Here: Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter According to TipRanks, Bayko is a 4-star analyst with an average return of 7.6% and a 44.00% success rate. Bayko covers the Healthcare sector, focusing on stocks such as Altimmune, Vertex Pharmaceuticals, and Intellia Therapeutics. Currently, the analyst consensus on Vera Therapeutics is a Strong Buy with an average price target of $67.36, implying a 216.76% upside from current levels. In a report released today, TD Cowen also reiterated a Buy rating on the stock with a $60.00 price target.


Business Insider
07-06-2025
- Business
- Business Insider
Vera Therapeutics (VERA) Receives a Buy from Raymond James
Raymond James analyst Ryan Deschner reiterated a Buy rating on Vera Therapeutics (VERA – Research Report) today and set a price target of $73.00. The company's shares opened today at $21.27. Confident Investing Starts Here: Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Deschner covers the Healthcare sector, focusing on stocks such as Liquidia Technologies, ARS Pharmaceuticals, and Trevi Therapeutics. According to TipRanks, Deschner has an average return of 18.4% and a 59.26% success rate on recommended stocks. Currently, the analyst consensus on Vera Therapeutics is a Strong Buy with an average price target of $67.36, a 216.76% upside from current levels. In a report released today, TD Cowen also reiterated a Buy rating on the stock with a $60.00 price target.