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Globe and Mail
3 days ago
- Health
- Globe and Mail
Neuromyelitis Optica Spectrum Disorder Market Poised for Transformation with New Disease-Modifying Therapies and Regulatory Approvals
DelveInsight projects strong NMOSD market growth in the 7MM through 2032, fueled by disease-modifying therapies and key approvals. Leading NMOSD companies include RemeGen, Alexion, Reistone Biopharma, Nihon Pharmaceutical, Harbour BioMed, Bio-Thera Solutions, Abide Therapeutics, Bionure, TG Therapeutics, ENDECE, Boston Pharmaceuticals, and NovelMed, advancing novel mechanisms such as complement inhibition and B-cell depletion. DelveInsight's ' Neuromyelitis Optica Spectrum Disorder Market Insight, Epidemiology And Market Forecast - 2032 ' report delivers a comprehensive analysis of the GnRH Receptor Antagonist market, covering historical and forecasted patient pools, current treatment practices, emerging drugs, and market size trends across the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Key Takeaways Market size projection: As per DelveInsight's analysis, the total market size of Neuromyelitis Optica Spectrum Disorder in the 7MM is expected to surge significantly by 2032, with comprehensive coverage across the United States, EU4 countries (Germany, Spain, Italy, and France), the United Kingdom, and Japan during the forecast period from 2024-2032. Patient population data: The report provides the total Neuromyelitis Optica Spectrum Disorder potential patient pool with detailed epidemiology segmentation across all seven major markets, including historical patient data from 2019 and forecasted trends through 2032, encompassing diagnosed patient pools and treatment-eligible populations. Key companies: Leading Neuromyelitis Optica Spectrum Disorder companies such as RemeGen, Alexion Pharmaceuticals, Reistone Biopharma, Nihon Pharmaceutical, Harbour BioMed, Bio-Thera Solutions, Abide Therapeutics, Bionure, TG Therapeutics, ENDECE, Boston Pharmaceuticals, NovelMed, and others are actively developing innovative therapeutic solutions. Pipeline assets: The comprehensive pipeline analysis covers emerging therapies across Phase II and Phase III development stages, with detailed therapeutic candidate profiles representing diverse mechanisms of action and novel approaches to address current treatment limitations. In April 2025, UPLIZNA® (inebilizumab-cdon) received FDA approval for Immunoglobulin G4-related disease. It represents the continued expansion of this therapy that was originally approved for AQP4-IgG+ NMOSD patients. Discover recent advancements in the Neuromyelitis Optica Spectrum Disorder treatment landscape @ Neuromyelitis Optica Spectrum Disorder Recent Developments. Neuromyelitis Optica Spectrum Disorder Market Dynamics The Neuromyelitis Optica Spectrum Disorder market represents an evolving therapeutic landscape characterized by significant unmet medical needs and emerging treatment paradigms. The current market reflects a critical juncture where traditional treatment approaches are being supplemented by innovative therapeutic strategies targeting specific disease mechanisms. The Neuromyelitis Optica Spectrum Disorder market drivers include increased disease awareness, improved diagnostic capabilities, and growing recognition of NMOSD as a distinct clinical entity requiring specialized treatment approaches. The market's evolution is fundamentally supported by advancing scientific understanding of NMOSD pathophysiology, particularly the role of aquaporin-4 antibodies and complement-mediated inflammatory processes. This enhanced mechanistic insight has enabled the development of targeted therapeutic interventions that address underlying disease mechanisms rather than merely managing symptoms. The therapeutic rationale for emerging treatments centers on complement inhibition, B-cell depletion, and immunomodulatory approaches designed to prevent relapse occurrence and minimize neurological disability progression. The neuromyelitis optica spectrum disorder market clinical development activity demonstrates robust industry engagement, with multiple therapeutic candidates progressing through Phase II and Phase III trials. The pipeline reflects diverse therapeutic approaches, including monoclonal antibodies, small molecules, and biologics targeting different aspects of NMOSD pathogenesis. This diversified development strategy indicates industry confidence in market potential and commitment to addressing varied patient needs across different disease stages and phenotypes. The neuromyelitis optica spectrum disorder competitive landscape reveals significant pharmaceutical industry participation, with established biotechnology companies and emerging biotech firms pursuing complementary development strategies. Strategic collaborations between industry partners and academic institutions are accelerating research progress and enabling risk-sharing arrangements that support continued investment in this rare disease area. Market positioning strategies emphasize differentiation through mechanism of action, safety profiles, and administration convenience. Current Neuromyelitis Optica Spectrum Disorder market barriers include the rarity of NMOSD, which complicates clinical trial design and patient recruitment, while regulatory pathways for rare diseases present both opportunities through expedited review processes and challenges related to evidence generation requirements. Market opportunities are substantial, given the high unmet medical need, potential for premium pricing in rare disease segments, and expanding global awareness leading to improved diagnosis rates. The future neuromyelitis optica spectrum disorder market outlook indicates sustained growth driven by pipeline maturation, regulatory approvals, and expanding treatment accessibility. Market expectations center on the introduction of disease-modifying therapies that can fundamentally alter NMOSD disease trajectory, representing a paradigm shift from current symptomatic management approaches toward comprehensive disease control. Download the Neuromyelitis Optica Spectrum Disorder Market report to understand which factors are driving the therapeutic market @ Neuromyelitis Optica Spectrum Disorder Market Trends. Neuromyelitis Optica Spectrum Disorder Epidemiology The Neuromyelitis Optica Spectrum Disorder epidemiology across the seven major markets reveals significant geographic and demographic variations that influence market dynamics and therapeutic development strategies. The comprehensive epidemiological analysis encompasses the United States, EU5 countries, including Germany, France, Italy, Spain, and the United Kingdom, plus Japan, representing the most significant commercial markets for NMOSD therapeutics. Historical epidemiology data spanning from 2019 provides a baseline understanding of neuromyelitis optica spectrum disorder prevalence patterns, while forecasted trends through 2032 illuminate evolving patient population dynamics driven by improved diagnostic awareness and refined clinical criteria. The neuromyelitis optica spectrum disorder epidemiology segmentation within the report addresses multiple patient population categories, including total diagnosed cases, treatment-eligible patients, and those receiving current therapeutic interventions. This segmentation approach enables precise market sizing and facilitates targeted therapeutic development strategies. The analysis reveals geographic variations in NMOSD prevalence, with certain regions demonstrating higher disease burden potentially related to genetic predisposition, environmental factors, or diagnostic accessibility differences. Total treated cases encompass patients currently receiving therapeutic interventions, ranging from immunosuppressive therapies to symptomatic management approaches. This metric provides insight into current treatment penetration and identifies opportunities for therapeutic improvement and market expansion. Geographic segmentation across the 7MM breakdown reveals market-specific opportunities and challenges, with developed markets typically demonstrating higher diagnostic rates and treatment accessibility compared to emerging regions. The forecast period through 2032 anticipates continued growth in diagnosed patient populations, driven by enhanced physician awareness, improved diagnostic technologies, and expanding healthcare infrastructure accessibility. Discover evolving trends in the Neuromyelitis Optica Spectrum Disorder patient pool forecasts @ Neuromyelitis Optica Spectrum Disorder Epidemiology Analysis. Key Neuromyelitis Optica Spectrum Disorder Companies and Treatment Market The clinical and regulatory landscape for Neuromyelitis Optica Spectrum Disorder reflects a dynamic environment where traditional treatment approaches are being transformed by innovative therapeutic strategies. Current treatment options primarily consist of immunosuppressive therapies and corticosteroids for acute management, along with off-label use of various immunomodulatory agents for relapse prevention. However, these conventional approaches often provide inadequate disease control and carry significant long-term safety concerns, creating substantial opportunities for targeted therapeutic interventions. Key neuromyelitis optica spectrum disorder companies include RemeGen with their complement inhibition platform, Alexion Pharmaceuticals leveraging their expertise in complement-mediated disorders, Reistone Biopharma developing innovative immunomodulatory approaches, and Nihon Pharmaceutical pursuing region-specific therapeutic strategies. Additional significant contributors include Harbour BioMed with their biologics platform, Bio-Thera Solutions focusing on biosimilar and novel therapeutic development, and Abide Therapeutics targeting specific enzymatic pathways. The landscape also features Bionure's neuroprotective approaches, TG Therapeutics' immunomodulatory strategies, ENDECE's innovative therapeutic platforms, Boston Pharmaceuticals' targeted interventions, and NovelMed's comprehensive development programs. Neuromyelitis Optica Spectrum Disorder market positioning strategies reflect the critical importance of demonstrating superior efficacy compared to current standard-of-care approaches while maintaining acceptable safety profiles. Companies are emphasizing mechanism-of-action differentiation, with some focusing on preventing relapse occurrence, others targeting neurological recovery, and several pursuing comprehensive approaches addressing both inflammatory control and neuroprotection. Neuromyelitis Optica Spectrum Disorder drug profiles within the pipeline demonstrate diverse therapeutic rationales, ranging from complement cascade inhibition to selective immune cell targeting. Development status varies across the portfolio, with some candidates approaching regulatory submission while others are in early clinical evaluation phases. Clinical applications span acute treatment settings, maintenance therapy for relapse prevention, and combination approaches designed to optimize long-term outcomes. Recent Neuromyelitis Optica Spectrum Disorder development milestones include advancing clinical trials, regulatory designations such as orphan drug status and fast-track designations, and strategic partnerships enabling accelerated development timelines. Commercial arrangements reflect the collaborative nature of rare disease development, with licensing deals and strategic collaborations enabling resource sharing and risk distribution across multiple development programs. Discover which companies are innovating in the Neuromyelitis Optica Spectrum Disorder treatment landscape @ Neuromyelitis Optica Spectrum Disorder Competitive Landscape. Conclusion The Neuromyelitis Optica Spectrum Disorder market represents a compelling therapeutic opportunity characterized by significant unmet medical needs, robust pipeline development, and expanding patient identification. DelveInsight's comprehensive analysis reveals a market poised for substantial transformation through 2032, driven by innovative therapeutic approaches, enhanced disease understanding, and growing clinical awareness. The convergence of scientific advancement, industry investment, and regulatory support creates an environment conducive to therapeutic breakthroughs that could fundamentally alter NMOSD treatment paradigms and significantly improve patient outcomes across the seven major global markets. Table of Contents 1. Key Insights 2. Executive Summary of Neuromyelitis Optica Spectrum Disorder 3. Competitive Intelligence Analysis for Neuromyelitis Optica Spectrum Disorder 4. Neuromyelitis Optica Spectrum Disorder Market Overview at a Glance 5. Neuromyelitis Optica Spectrum Disorder: Disease Background and Overview 6. Neuromyelitis Optica Spectrum Disorder Patient Journey 7. Neuromyelitis Optica Spectrum Disorder Epidemiology and Patient Population 8. Treatment Algorithm, Current Treatment, and Medical Practices 9. Neuromyelitis Optica Spectrum Disorder Unmet Needs 10. Key Endpoints of Neuromyelitis Optica Spectrum Disorder Treatment 11. Neuromyelitis Optica Spectrum Disorder Marketed Products 12. Neuromyelitis Optica Spectrum Disorder Emerging Therapies 13. Neuromyelitis Optica Spectrum Disorder: Seven Major Market Analysis 14. Attribute analysis 15. 7MM: Market Outlook 16. Access and Reimbursement Overview of Neuromyelitis Optica Spectrum Disorder 17. KOL Views 18. Neuromyelitis Optica Spectrum Disorder Market Drivers 19. Neuromyelitis Optica Spectrum Disorder Market Barriers 20. Appendix 21. DelveInsight Capabilities 22. Disclaimer 23. About DelveInsight About DelveInsight DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Arpit Anand Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: Nevada Country: United States Website:
Yahoo
17-07-2025
- Business
- Yahoo
Vor Bio Appoints Qing Zuraw, M.D. as Chief Development Officer
Dr. Zuraw led clinical development of telitacicept across MG, Sjögren's, SLE, and RA at RemeGen, resulting in multiple regulatory approvals in China; brings deep U.S. and global development experience to support Vor Bio's new development focus and execution of late-stage programs CAMBRIDGE, Mass., July 17, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced the appointment of Qing Zuraw, M.D., M.P.H., M.B.A., as Chief Development Officer, effective immediately. Dr. Zuraw joins Vor Bio with over 25 years of experience leading complex global and U.S. clinical development programs across autoimmune, inflammatory, and immunologic diseases. Most recently, she served as Chief Development Officer and Head of Global Clinical Development for Autoimmune Diseases at RemeGen Co., Ltd., where she was one of the key leaders of successful development and execution of clinical trials for telitacicept across four key indications—systemic lupus erythematosus (SLE), Sjögren's syndrome, myasthenia gravis (MG), and rheumatoid arthritis (RA)—culminating in regulatory approvals in China for the treatment of SLE, generalized MG and RA. At RemeGen, Dr. Zuraw built and led a cross-functional global team that managed all aspects of telitacicept development, including clinical trial design, regulatory strategy, site engagement, and execution. She played a central role in regulatory interactions with the U.S. Food & Drug Administration, European Medicines Agency, and China's Center for Drug Evaluation, achieving Fast Track, Breakthrough Therapy, and Orphan Drug designations for telitacicept across multiple indications. 'We are delighted to welcome Qing to Vor Bio at a critical time for the company,' said Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of the Board. 'Her deep and diverse clinical development expertise across autoimmune and immunological diseases and with telitacicept will be invaluable as we execute on our late-stage programs. Qing's ability to lead high-performing clinical organizations will be instrumental as we drive forward our global development programs, particularly in the U.S.' Dr. Zuraw has also previously held senior leadership roles at Janssen Research & Development, Teva Pharmaceutical Industries Ltd., Akebia Therapeutics, Inc., Biogen Inc., and Covance, Inc., where she led global clinical development programs across rheumatology, nephrology, respiratory, and immunology. She played a key role in the U.S. FDA approval of Guselkumab for psoriatic arthritis and contributed to multiple NDA and BLA submissions across therapeutic areas. Throughout her career, she has built and led high-performing teams to execute complex trials from early development through post-marketing. 'Vor Bio is uniquely positioned to become a leader in autoimmune therapeutics,' said Dr. Zuraw. 'Having been intimately involved in the development of telitacicept in China from early clinical stages through to multiple approvals, I'm thrilled to join the talented team at Vor Bio to bring telitacicept to patients globally.' 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 Forward-Looking StatementsThis 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 Vor Bio's development plans for telitacicept, its ability to change the treatment landscape for patients with autoimmune conditions and other statements that are not historical fact. 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. 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. Media & Investor Contacts:Sarah Spencer+1 857-242-6076investors@ Carl Mauchinvestors@ in to access your portfolio
Yahoo
27-06-2025
- Business
- Yahoo
Vor, with new CEO, changes course to target autoimmune disease
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Vor Biopharma is licensing rights to an immune disease drug from Chinese biotechnology company RemeGen, it said Wednesday, a little over one month after announcing plans to review strategic alternatives. As part of its shift in focus, Vor also announced it appointed former MorphoSys leader Jean-Paul Kress as CEO. Vor's previous chief executive Robert Ang will stay on as an adviser through October. Vor also raised $175 million in a PIPE, or private investment in public equity, that involved half a dozen investors including RA Capital Management, Forbion and Venrock Healthcare Capital Partners. PureTech Health and the oncologist and author Siddhartha Mukherjee founded Vor nearly a decade ago. Progress developing a treatment for leukemia led the company in 2021 to price a $177 million initial public offering. But a rocky few years forced Vor to change direction. The Cambridge, Massachusetts-based biotech had been advancing cell therapies called trem-cel and VCAR33, but in May revealed plans to wind down clinical operations and lay off 95% of its employees. Now, Vor is reestablishing itself as an autoimmune disease company. The deal with RemeGen gives its rights to develop and commercialize in most parts of the world a drug for generalized myasthenia gravis, systemic lupus erythematosus and rheumatoid arthritis that's already approved in China. Vor is paying RemeGene $45 million upfront along with $80 million in warrants to purchase common stock in exchange for the drug, called telitacicept. Telitacicept is in Phase 3 testing for generalized myasthenia gravis in the U.S., Europe and South America, according to the companies. Data from that trial is expected in 2027. 'I am absolutely thrilled to be leading Vor Bio as we transform the company to become a major player in autoimmune disease treatment,' Kress said in a statement. Telitacicept's targets are cytokines known as BAFF and APRIL, which have also been the focus of other dealmaking. Recently, China-based biotechs like RemeGen are providing more and more of the drug candidates licensed by U.S. and European drugmakers. 'Global biopharma companies can increasingly look to China as a cost-effective source of innovation, particularly for validated targets and rapid generation of proof-of-concept data,' Leerink Partners analyst David Risinger wrote in a Thursday note to clients. Vor's decision to start anew with a Phase 3-ready drug candidate contrasts with the route preferred by some activist investors and analysts, who have pushed struggling biotechs to wind down and return cash to shareholders rather than try to reinvent themselves. Some, like Third Harmonic Bio and iTeos Therapeutics, have taken this course, while others have resisted the pressure 'I couldn't be more thrilled with this exciting new direction for Vor, and new leadership with the background and skills appropriate for this asset,' Ang, Vor's former CEO, wrote in a LinkedIn post. Shares in Vor nearly doubled on the news to trade around $1 apiece by Thursday afternoon. Recommended Reading Biopharma sector still growing despite layoff wave, Stifel report finds
Yahoo
26-06-2025
- Business
- Yahoo
Vor Bio back from brink with autoimmune drug deal rising to $4bn
A month and a half after winding operations and laying off almost all its staff, Vor Bio has emerged from the brink with a licensing deal potentially rising to $4bn for an autoimmune drug developed by Chinese biotech RemeGen. According to the deal, Vor Bio – previously a cell and gene therapy specialist – will gain global rights to develop and commercialise telitacicept, a drug already approved in China for a range of autoimmune conditions. Vor Bio is immediately paying $125m via an upfront payment and common stock purchases. Further regulatory and commercial milestones mean the deal could surpass $4bn in total. Shares in Vor Bio opened 45% higher on 26 June following the announcement the day prior. The biotech has a market cap of $144m. RemeGen will keep rights to the dual-target fusion protein in China, Hong Kong, Macau and Taiwan. In China, telitacicept is already approved for generalised myasthenia gravis, systemic lupus erythematosus, and rheumatoid arthritis. Telitacicept reduces B-cell activity by inhibiting two types of cytokines and is tipped to challenge existing autoimmune drugs. RemeGen is conducting a global Phase III clinical trial with telitacicept for the treatment of generalised myasthenia gravis. The study, which is expected to produce initial results in the first half of 2027, will support potential approval in the US and Europe. The deal signals an abrupt turnaround for Vor Bio. Once an incumbent in the cell and gene therapy space, the company became a casualty of the sector's poor performance. The biotech wound down clinical and manufacturing operations in May, along with firing 95% of its staff. The eight that were left were tasked with strategic alternatives. A Vor Bio spokesperson told Pharmaceutical Technology: 'At the time, the company announced it would be initiating a process to pursue strategic alternatives, and this transaction is part of that process.' The company's high-value licensing deal reflects the company's transition away from advanced therapies and into autoimmune indications. Sanofi's blockbuster autoimmune drug Dupixent (dupilumab) is one of the best-selling drugs in the world, representing the lucrative nature of the sector. For example, the rheumatoid arthritis drug market across the eight major global markets is forecast to reach $29.1bn by 2029, according to analysis by GlobalData. GlobalData is the parent company of Pharmaceutical Technology. While announcing the RemeGen deal, Vor Bio revealed that a new CEO will lead the company going forward. Dr Jean-Paul Kress will be at the helm following Dr Robert Ang's resignation on 26 June. Kress most recently served as CEO of MorphoSys, helping roll out Monjuvi (tafasitamab) – a drug acquired for $25m by Incyte. In his first statement as CEO, Kress said he was 'thrilled' to help transform the company into a 'major player in autoimmune disease treatment'. He added: '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.' "Vor Bio back from brink with autoimmune drug deal rising to $4bn" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Business Wire
26-06-2025
- Business
- Business Wire
PureTech Founded Entity Vor Bio Announces Exclusive Global License Agreement with RemeGen for Late-Stage Autoimmune Asset and $175 Million Private Placement
BOSTON--(BUSINESS WIRE)-- PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, noted that its Founded Entity, Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, and RemeGen Co., Ltd. (HKEX: 9995, SHA: 688331) 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. Vor Bio separately announced that it has entered into a securities purchase agreement for a private placement in public equity financing (the 'PIPE') that is expected to result in gross proceeds of approximately $175 million, before deducting expenses. Pursuant to the terms of the securities purchase agreement, at the closing of the PIPE, Vor Bio will issue prefunded warrants (the 'Warrants') to purchase an aggregate of 700,000,000 shares of common stock at a purchase price of $0.25 per Warrant. Vor Bio intends to use the net proceeds from the PIPE to advance development of its clinical pipeline and for general corporate purposes. The PIPE is expected to close on June 27, 2025, subject to the satisfaction of customary closing conditions. The Warrants have an exercise price of $0.0001 per share and will become exercisable upon approval by Vor Bio stockholders of the issuance of the shares underlying the Warrants. Vor Bio intends to hold a special stockholder meeting to approve, among other things, the issuance of the underlying shares. As of May 8, 2025, PureTech's percentage ownership in Vor Bio was approximately 2.1%, calculated on a beneficial ownership basis in accordance with SEC rules. The full text of the announcements from Vor Bio are as follows: 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, MA, June 25, 2025 -- 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. Vor Bio Announces $175 Million Private Placement CAMBRIDGE, MA, June 25, 2025 -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that it has entered into a securities purchase agreement for a private placement in public equity financing (the 'PIPE') that is expected to result in gross proceeds of approximately $175 million, before deducting expenses. Private Placement Pursuant to the terms of the securities purchase agreement, at the closing of the PIPE, Vor Bio will issue prefunded warrants (the 'Warrants') to purchase an aggregate of 700,000,000 shares of common stock at a purchase price of $0.25 per Warrant. The PIPE included a syndicate of world-class investors including Vor Bio's existing stockholder RA Capital Management, as well as Mingxin Capital, Forbion, Venrock Healthcare Capital Partners, Caligan Partners and NEXTBio. Vor Bio intends to use the net proceeds from the PIPE to advance development of its clinical pipeline and for general corporate purposes. The PIPE is expected to close on June 27, 2025, subject to the satisfaction of customary closing conditions. The Warrants have an exercise price of $0.0001 per share and will become exercisable upon approval by Vor Bio stockholders of the issuance of the shares underlying the Warrants. Vor Bio intends to hold a special stockholder meeting to approve, among other things, the issuance of the underlying shares. The securities being issued and sold in the PIPE have not been registered under the Securities Act of 1933, as amended (the 'Securities Act'). Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Concurrently with the execution of the securities purchase agreement, Vor Bio and the investors named therein entered into a registration rights agreement pursuant to which Vor Bio has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issuable upon the exercise of the Warrants. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. 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 PureTech Health PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company has created a broad and deep portfolio through its experienced research and development team and its extensive network of scientists, clinicians, and industry leaders that is being advanced both internally and through its Founded Entities. PureTech's R&D engine has resulted in the development of 29 therapeutics and therapeutic candidates, including three that have been approved by the U.S. Food and Drug Administration. A number of these programs are being advanced by PureTech or its Founded Entities in various indications and stages of clinical development, including registration-enabling studies. All of the underlying programs and platforms that resulted in this portfolio of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points. For more information, visit or connect with us on X (formerly Twitter) @puretechh. Cautionary Note Regarding Forward-Looking Statements This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those related to Vor Bio's 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, the ability of telitacicept to transform patient lives, Vor Bio's statements regarding the PIPE, including expected proceeds, expected use of proceeds and expected closing, expectations and timing with respect to a special stockholder meeting, and Vor Bio's and our future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2023, filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.
