Latest news with #Kress
Business Upturn
25-06-2025
- Business
- Business Upturn
Vor Bio Enters into Exclusive Global License Agreement with RemeGen for Late-Stage Autoimmune Asset
– Vor Bio receives ex-Greater China rights to develop and commercialize telitacicept, a novel, dual-target recombinant fusion protein in global Phase 3 development for generalized myasthenia gravis -RemeGen receives initial payment of $125 million consisting of an upfront payment of $45 million plus $80 million of warrants, potential regulatory and commercial milestones exceeding $4 billion, as well as tiered royalties -Seasoned biopharma leader, Jean-Paul Kress, MD, appointed as Chief Executive Officer and Chairman of the Board, bringing proven track record in clinical development, commercialization, and strategic growth CAMBRIDGE, Mass., June 25, 2025 (GLOBE NEWSWIRE) — Vor Bio, Inc. (Nasdaq: VOR) and RemeGen Co., Ltd. (HKEX: 9995, SHA: 688331) today announced entry into an exclusive license agreement granting Vor Bio global rights (excluding China, Hong Kong, Macau and Taiwan) to develop and commercialize telitacicept, a novel dual-target fusion protein approved in China for generalized myasthenia gravis (gMG), systemic lupus erythematosus (SLE), and rheumatoid arthritis (RA). Under the terms of the agreement, Vor Bio will pay RemeGen an initial payment of $125 million consisting of an upfront payment of $45 million as well as $80 million of warrants to purchase common stock with an exercise price of $0.0001 per share. The agreement also provides for potential regulatory and commercial milestones exceeding $4 billion, in addition to tiered royalties. Telitacicept is a novel, investigational fusion protein that targets key immune pathways involved in autoimmune disease. By selectively inhibiting BlyS (also known as BAFF) and APRIL – cytokines critical to B cell survival – telitacicept reduces autoreactive B cells and autoantibody production. RemeGen is conducting a global Phase 3 clinical trial which is now enrolling in the United States, Europe, and South America, with initial results expected in the first half of 2027. Vor Bio also announced that its Board of Directors (the 'Board') has appointed Jean-Paul Kress, M.D., as Chief Executive Officer and Chairman of the Board, effective today. This follows Dr. Robert Ang's resignation from the positions of Chief Executive Officer and director earlier today. Dr. Ang will continue with Vor Bio as a strategic advisor to assist in the transition through October 2025. Dr. Kress's strategic vision and track record of transformative leadership position him to guide the company into its next phase of growth. 'I am absolutely thrilled to be leading Vor Bio as we transform the company to become a major player in autoimmune disease treatment,' said Dr. Kress, Chairman and Chief Executive Officer, Vor Bio. 'Targeting BAFF/APRIL signaling with telitacicept represents a significant advancement in addressing autoantibody driven diseases, which is highly differentiated from other modalities in this space. With a clinically advanced asset, we are uniquely positioned to develop this innovative therapy, with the goal of making a meaningful impact for patients living with autoimmune diseases around the world.' Dr. Kress brings decades of executive leadership experience in the pharmaceutical and biotech industries. He most recently served as Chief Executive Officer of MorphoSys, where he led the development, approval and commercialization of Monjuvi®️ (tafasitamab), and advanced the company's pipeline through the landmark acquisition of Constellation Pharmaceuticals in 2021, strengthening MorphoSys' position in oncology innovation and ultimately leading to its subsequent acquisition by Novartis in 2024. Prior to that, he was CEO of Syntimmune, guiding its lead immunology program through to acquisition by Alexion Pharmaceuticals. He currently serves on the Board of Sanofi S.A. and has held senior roles across leading biopharma companies. 'Today marks a transformative milestone for RemeGen and the global development of telitacicept,' said Dr. Jianmin Fang, CEO of RemeGen. 'The strategic out-licensing of telitacicept's ex-China rights accelerates our mission to deliver this innovative therapy to patients worldwide and will help maximize telitacicept's clinical and commercial potential on the global scale.' About Telitacicept Telitacicept is a novel, investigational recombinant fusion protein designed to treat autoimmune diseases by selectively inhibiting BLyS (BAFF) and APRIL – two cytokines essential to B cell and plasma cell survival. This dual-target mechanism reduces autoreactive B cells and autoantibody production, key drivers of autoimmune pathology. In a Phase 3 clinical trial in generalized myasthenia gravis in China, telitacicept demonstrated a 4.8-point improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living scale) vs. placebo at 24 weeks, the primary endpoint of the trial. Telitacicept is approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG). A global Phase 3 clinical trial in gMG is currently underway across the United States, Europe, and South America to support potential approval in the United States and Europe. About Vor Bio Vor Bio is a clinical-stage biotechnology company transforming the treatment of autoimmune diseases. The company is focused on rapidly advancing telitacicept, a novel dual-target fusion protein, through Phase 3 clinical development and commercialization to address serious autoantibody-driven conditions worldwide. For more information visit About RemeGen Co. Ltd. Founded in 2008, RemeGen is a leading biopharmaceutical company in China committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices in China and the United States. The company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words 'aim,' 'anticipate,' 'can,' 'continue,' 'could,' 'design,' 'enable,' 'expect,' 'initiate,' 'intend,' 'may,' 'on-track,' 'ongoing,' 'plan,' 'potential,' 'should,' 'target,' 'update,' 'will,' 'would,' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include Vor Bio's statements regarding its plans for development and commercialization of telitacicept, the potential of telitacicept in various indications, the timing and pace of patient enrollment and dosing in clinical trials and the availability of data therefrom, the expected safety profile of telitacicept, the market opportunities for telitacicept and the ability of telitacicept to transform patient lives. Vor Bio may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of Vor Bio's product candidates; availability and timing of results from preclinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; uncertainties regarding regulatory approvals to conduct trials or to market products; and availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements and Vor Bio's ability to continue as a going concern. These and other risks are described in greater detail under the caption 'Risk Factors' included in Vor Bio's most recent annual or quarterly report and in other reports it has filed or may file with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Vor Bio expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law. Contact:Investors & MediaSarah Spencer +1 857-242-6076 [email protected]
Yahoo
25-06-2025
- Business
- Yahoo
Vor Bio Enters into Exclusive Global License Agreement with RemeGen for Late-Stage Autoimmune Asset
-Vor Bio receives ex-Greater China rights to develop and commercialize telitacicept, a novel, dual-target recombinant fusion protein in global Phase 3 development for generalized myasthenia gravis -RemeGen receives initial payment of $125 million consisting of an upfront payment of $45 million plus $80 million of warrants, potential regulatory and commercial milestones exceeding $4 billion, as well as tiered royalties -Seasoned biopharma leader, Jean-Paul Kress, MD, appointed as Chief Executive Officer and Chairman of the Board, bringing proven track record in clinical development, commercialization, and strategic growth CAMBRIDGE, Mass., June 25, 2025 (GLOBE NEWSWIRE) -- Vor Bio, Inc. (Nasdaq: VOR) and RemeGen Co., Ltd. (HKEX: 9995, SHA: 688331) today announced entry into an exclusive license agreement granting Vor Bio global rights (excluding China, Hong Kong, Macau and Taiwan) to develop and commercialize telitacicept, a novel dual-target fusion protein approved in China for generalized myasthenia gravis (gMG), systemic lupus erythematosus (SLE), and rheumatoid arthritis (RA). Under the terms of the agreement, Vor Bio will pay RemeGen an initial payment of $125 million consisting of an upfront payment of $45 million as well as $80 million of warrants to purchase common stock with an exercise price of $0.0001 per share. The agreement also provides for potential regulatory and commercial milestones exceeding $4 billion, in addition to tiered royalties. Telitacicept is a novel, investigational fusion protein that targets key immune pathways involved in autoimmune disease. By selectively inhibiting BlyS (also known as BAFF) and APRIL - cytokines critical to B cell survival - telitacicept reduces autoreactive B cells and autoantibody production. RemeGen is conducting a global Phase 3 clinical trial which is now enrolling in the United States, Europe, and South America, with initial results expected in the first half of 2027. Vor Bio also announced that its Board of Directors (the 'Board') has appointed Jean-Paul Kress, M.D., as Chief Executive Officer and Chairman of the Board, effective today. This follows Dr. Robert Ang's resignation from the positions of Chief Executive Officer and director earlier today. Dr. Ang will continue with Vor Bio as a strategic advisor to assist in the transition through October 2025. Dr. Kress's strategic vision and track record of transformative leadership position him to guide the company into its next phase of growth. "I am absolutely thrilled to be leading Vor Bio as we transform the company to become a major player in autoimmune disease treatment," said Dr. Kress, Chairman and Chief Executive Officer, Vor Bio. "Targeting BAFF/APRIL signaling with telitacicept represents a significant advancement in addressing autoantibody driven diseases, which is highly differentiated from other modalities in this space. With a clinically advanced asset, we are uniquely positioned to develop this innovative therapy, with the goal of making a meaningful impact for patients living with autoimmune diseases around the world." Dr. Kress brings decades of executive leadership experience in the pharmaceutical and biotech industries. He most recently served as Chief Executive Officer of MorphoSys, where he led the development, approval and commercialization of Monjuvi®️ (tafasitamab), and advanced the company's pipeline through the landmark acquisition of Constellation Pharmaceuticals in 2021, strengthening MorphoSys' position in oncology innovation and ultimately leading to its subsequent acquisition by Novartis in 2024. Prior to that, he was CEO of Syntimmune, guiding its lead immunology program through to acquisition by Alexion Pharmaceuticals. He currently serves on the Board of Sanofi S.A. and has held senior roles across leading biopharma companies. 'Today marks a transformative milestone for RemeGen and the global development of telitacicept,' said Dr. Jianmin Fang, CEO of RemeGen. 'The strategic out-licensing of telitacicept's ex-China rights accelerates our mission to deliver this innovative therapy to patients worldwide and will help maximize telitacicept's clinical and commercial potential on the global scale.' About TelitaciceptTelitacicept is a novel, investigational recombinant fusion protein designed to treat autoimmune diseases by selectively inhibiting BLyS (BAFF) and APRIL - two cytokines essential to B cell and plasma cell survival. This dual-target mechanism reduces autoreactive B cells and autoantibody production, key drivers of autoimmune pathology. In a Phase 3 clinical trial in generalized myasthenia gravis in China, telitacicept demonstrated a 4.8-point improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living scale) vs. placebo at 24 weeks, the primary endpoint of the trial. Telitacicept is approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG). A global Phase 3 clinical trial in gMG is currently underway across the United States, Europe, and South America to support potential approval in the United States and Europe. About Vor BioVor Bio is a clinical-stage biotechnology company transforming the treatment of autoimmune diseases. The company is focused on rapidly advancing telitacicept, a novel dual-target fusion protein, through Phase 3 clinical development and commercialization to address serious autoantibody-driven conditions worldwide. For more information visit About RemeGen Co. Ltd. Founded in 2008, RemeGen is a leading biopharmaceutical company in China committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices in China and the United States. The company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words 'aim,' 'anticipate,' 'can,' 'continue,' 'could,' 'design,' 'enable,' 'expect,' 'initiate,' 'intend,' 'may,' 'on-track,' 'ongoing,' 'plan,' 'potential,' 'should,' 'target,' 'update,' 'will,' 'would,' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include Vor Bio's statements regarding its plans for development and commercialization of telitacicept, the potential of telitacicept in various indications, the timing and pace of patient enrollment and dosing in clinical trials and the availability of data therefrom, the expected safety profile of telitacicept, the market opportunities for telitacicept and the ability of telitacicept to transform patient lives. Vor Bio may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of Vor Bio's product candidates; availability and timing of results from preclinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; uncertainties regarding regulatory approvals to conduct trials or to market products; and availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements and Vor Bio's ability to continue as a going concern. These and other risks are described in greater detail under the caption 'Risk Factors' included in Vor Bio's most recent annual or quarterly report and in other reports it has filed or may file with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Vor Bio expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law. Contact:Investors & MediaSarah Spencer +1 857-242-6076sspencer@
Yahoo
05-06-2025
- Business
- Yahoo
Nvidia remains best-positioned to benefit from AI boom, BofA says
- Nvidia is still the best-positioned chipmaker to benefit from ongoing enthusiasm around artificial intelligence, even as the firm grapples with recent concerns around its Chinese business, analysts at Bank of America said in a note to clients on Thursday. Last week, the world's most valuable semiconductor firm unveiled quarterly sales that topped expectations thanks to customers stocking up on its AI chips prior to the implementation of new U.S. restrictions on exports of cutting-edge processors to China. The U.S. has placed strict rules around the export of these chips to China, as Washington hopes to limit Beijing's access to -- and harnessing of -- AI technology. For Nvidia (NASDAQ:NVDA), this has particularly meant restrictions on the sale of its H20 chips to China, previously the only AI processor it was legally allowed to export to the country. Some $2.5 billion in H20 sales were lost in the first quarter, Nvidia flagged, while CFO Collette Kress said data center revenue in China slipped. Meanwhile, the California-based business noted that the curbs would lop some $8 million off sales in the current quarter, leading it to announce weaker-than-anticipated financial guidance. Still, the analysts at BofA said that, following an investor dinner with Kress and other Nvidia executives, China is now "fully de-risked" for the company, "with no China-related sales in their current data center forecasts". "While there may be reports of follow-on products for the $50 billion AI total addressable China market, any sales from here are incremental," the brokerage added. According to Reuters, Nvidia has been preparing a variant of its Blackwell chips for China. U.S. President Donald Trump's decision to lift a so-called AI diffusion rule that would have limited the global flows of American AI chips also opens access to opportunities in other countries for Nvidia, the analysts argued. Last month, Nvidia inked a series of deals in the Middle East, including one pertaining to a 10-square mile data center in the United Arab Emirates. Other agreements have also been signed in Saudi Arabia. The BofA analysts maintained their "buy" rating of Nvidia's stock, which has risen by 2.6% so far this year despite deep equity market ructions. The strategists also named the firm as a "top pick" in the semiconductor sector, giving it a price target of $180. On Wednesday, Nvidia shares closed at $141.92. Related articles Nvidia remains best-positioned to benefit from AI boom, BofA says Robinhood stock edges higher on strong May 2025 operating data Morgan Stanley downgrades Coursera, raises Udemy Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
30-05-2025
- Business
- Yahoo
Nvidia's next AI move? Bringing GPUs into the enterprise
This story was originally published on CIO Dive. To receive daily news and insights, subscribe to our free daily CIO Dive newsletter. Nvidia is gearing up to supply enterprise customers with AI processing power amid a rush to deploy agentic tools, the company's CEO Jensen Huang said Wednesday, during a Q1 2026 earnings call for the three-month period ending April 27. 'It's really hard to move every company's data into the cloud, so we're going to move AI into the enterprise,' Huang said. 'We're going to see AI go into enterprise, which is on-prem, because so much of the data is still on-prem.' The GPU giant saw quarterly revenue increase 69% year over year to $44.1 billion as AI usage levels spiked. 'AI workloads have transitioned strongly to inference, and AI factory buildouts are driving significant revenue,' Nvidia EVP and CFO Colette Kress said during the earnings call. Nvidia's fortunes soared in the last two-and-a-half years, driven by massive tech sector investments in AI-optimized data center infrastructure to train and deploy large language models. While hyperscaler hunger for GPUs remains robust, the company is betting on the enterprise market to pick up momentum. Large cloud providers installed an average of roughly 72,000 Nvidia Blackwell GPUs per week during the quarter and are on track to increase consumption, according to Kress. 'Microsoft, for example, has already deployed tens of thousands of Blackwell GPUs and is expected to ramp up to hundreds of thousands of GB200s with OpenAI as one of its key customers,' Kress said. Revenue by quarter, in billions This embedded content is not available in your region. The GB200 Grace Blackwell Superchip, released a year ago, is a high-capacity processor that powers a larger rack designed to handle the most compute-intensive AI workloads, such as model training. In March, Nvidia unveiled its successor, the more powerful GB300 NVL72 rack system. Cloud providers began sampling the new processors earlier this month and Nvidia expects shipments to commence later this quarter, Kress said. As its footprint among hyperscalers continued to expand, Nvidia added to its enterprise product portfolio and forged deeper enterprise partnerships. The company rolled out a line of GPU-powered laptops and workstations in May, turning to its PC manufacturing partners to deliver enterprise customers. 'Enterprise AI is just taking off,' Huang said Wednesday, pointing to the new line of on-premises AI hardware. Kress touted an AI development partnership the company inked with Yum Brands in March. Nvidia will help the corporate parent of KFC, Pizza Hut and Taco Bell deploy AI in 500 restaurants this year and 61,000 locations over time to 'streamline order-taking, optimize operations and enhance service,' Kress said. The initiative represents a step up into the AI big leagues for Yum Brands. The company worked with an unnamed AI startup to create a Taco Bell drive-thru chatbot last year. It also marked Nvidia's first foray into the restaurant business, according to the announcement. Yum used Nvidia technology to power its proprietary Byte by Yum platform and enable AI voice agents, computer vision tools and performance analytics capabilities. 'Enterprise AI must be deployable on-prem and integrated with existing IT,' Huang said. 'It's compute, storage and networking. We've put all three of them together finally, and we're going to market with that.' Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
29-05-2025
- Business
- Yahoo
Nvidia Faces $8B Hit as U.S. Halts H20 AI Chip Exports to China
May 29 - Nvidia has issued a revenue forecast of approximately $45 billion for its fiscal second quarter, acknowledging an anticipated $8 billion impact due to U.S. export restrictions on its H20 AI chips to China. Despite this significant challenge, the company's outlook remains robust, reflecting strong global demand for its AI technologies. Warning! GuruFocus has detected 4 Warning Signs with NVDA. For the fiscal first quarter, Nvidia posted $44 billion in revenue, up 69% year-on-year, and adjusted earnings of $0.81 per share. Data center sales led the way at $39 billion, a 73% increase, driven by rapid adoption of Blackwell GPUs and growing AI inference workloads. CFO Colette Kress said the Blackwell NVL72 ramp was the fastest in company history and that networking revenue climbed 64% sequentially to $5 billion. Spectrum-X now annualizes over $8 billion in sales, with major cloud customers on board. Gaming revenue hit $3.8 billion, up 48% from the prior quarter, while automotive and robotics reached $567 million, up 72% year-on-year. Kress warned that losing access to China's AI accelerator market, expected to approach $50 billion, could benefit non-U.S. rivals. CEO Jensen Huang noted that sovereign investments in AI infrastructure continue to accelerate worldwide. Looking ahead, Nvidia expects modest sequential growth across all platforms and gross margins to improve toward the mid-70 percent range later this year. Based on the one year price targets offered by 51 analysts, the average target price for NVIDIA Corp is $163.77 with a high estimate of $235.92 and a low estimate of $100.00. The average target implies a upside of +21.48% from the current price of $134.81. Based on GuruFocus estimates, the estimated GF Value for NVIDIA Corp in one year is $265.22, suggesting a upside of +96.74% from the current price of $134.81. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data
