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Demyelinating Diseases Therapeutics Market to Reach USD 45 Billion by 2034, Growing at 6.3% CAGR
Demyelinating Diseases Therapeutics Market Outlook 2025-2034 Luton, Bedfordshire, United Kingdom, June 06, 2025 (GLOBE NEWSWIRE) -- The global market for demyelinating diseases therapeutics is witnessing notable growth and transformation, fueled by the increasing prevalence of neurological disorders and the introduction of innovative treatment solutions. Valued at approximately USD 25 billion in 2024, the market is projected to reach an estimated USD 45 billion by 2034, progressing at a steady Compound Annual Growth Rate (CAGR) of 6.3% during the forecast period from 2025 to 2034. Download PDF Brochure: A major contributor to this expansion is the rising incidence of multiple sclerosis (MS), along with other related disorders such as neuromyelitis optica (NMO), acute disseminated encephalomyelitis (ADEM), and chronic inflammatory demyelinating polyneuropathy (CIDP). The market is undergoing significant advancements through personalized medicine, biologics, and digital health integrations, shaping the way therapies are developed and delivered. Market Segmentation: A Detailed Breakdown The demyelinating diseases therapeutics market is categorized across several parameters including product type, therapeutic application, disease type, route of administration, distribution channels, therapeutic class, and patient demographics. Among product types, monoclonal antibodies, corticosteroids, and immunomodulators dominate due to their high efficacy and role in managing autoimmune responses central to these diseases. Multiple Sclerosis (MS) remains the largest disease segment due to its global prevalence, impacting nearly 2.8 million individuals worldwide. This segment benefits from a strong drug pipeline and sustained investment in research and development. In contrast, diseases like NMO and CIDP, though less prevalent, are becoming more prominent due to improved diagnostic capabilities and novel drug approvals. When it comes to therapeutic applications, Disease-Modifying Therapies (DMTs) are pivotal. These therapies reduce relapse rates and slow disease progression, particularly in MS, capturing the lion's share of the market. Symptomatic treatments, though secondary in market size, are essential for improving patients' quality of life and remain indispensable in overall disease management strategies. Route of Administration and Distribution Channels The preferred routes of administration in this market include injectable, oral, and infusion-based methods. Injectables lead due to their rapid efficacy and widespread use in administering monoclonal antibodies. However, oral therapies are quickly gaining popularity for their convenience and higher patient adherence, which could shift the administration landscape in coming years. From a distribution perspective, hospital pharmacies remain the dominant channel, especially for therapies requiring medical supervision or administration. Meanwhile, online pharmacies are emerging as strong contenders due to their convenience and role in chronic disease management. This growth is driven by increased internet penetration, telehealth services, and changing consumer behavior. Therapeutic Class and Demographic Insights In terms of therapeutic classification, biologics are leading the charge. These include monoclonal antibodies and recombinant proteins that target specific immune pathways. Biologics offer superior efficacy and fewer side effects, making them the preferred option in many treatment regimens. However, small molecules continue to hold value due to their affordability, oral availability, and ease of production, especially in cost-sensitive markets. Demographically, adult patients comprise the majority due to the typical onset age of MS and related disorders. However, pediatric treatments are on the rise as early diagnosis improves. The geriatric population is another growing segment, supported by the aging global population and increasing incidence of neurological conditions in older adults. These patients often require specialized care due to comorbidities and age-related drug interactions. Browse full Report - Market SegmentationType of Demyelinating Disease - Multiple Sclerosis (MS) - Neuromyelitis Optica (NMO) - Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - Acute Disseminated Encephalomyelitis (ADEM) Therapeutic Application - Disease-Modifying Therapies (DMTs) - Symptomatic Treatments - Corticosteroids - Monoclonal Antibodies - Other Immunotherapies & Supportive Care Route of Administration - Oral - Injectable (Subcutaneous, Intravenous) - Infusion Distribution Channel - Hospital Pharmacy - Retail Pharmacy - Online Pharmacy Therapeutic Class - Biologics - Small Molecules - Non-Biologics Patient Demographics - Adults - Pediatric - Geriatric Regional Insights and Global Landscape North America currently commands the largest market share, accounting for around 45% of global revenue in 2024. This dominance is underpinned by advanced healthcare systems, widespread access to therapies, and high levels of R&D investment. The U.S., in particular, plays a significant role with supportive regulatory policies and well-established pharmaceutical players. Europe follows closely, contributing approximately 30% to the market. Growth in this region is propelled by increasing awareness, government-supported healthcare systems, and a favorable environment for clinical research. Countries like Germany, France, and the UK are key hubs for drug development and patient care. The Asia-Pacific region is the fastest-growing market with a projected CAGR of 8% through 2034. Factors such as economic development, expanding healthcare infrastructure, and rising disease prevalence contribute to this rapid growth. Nations like China, India, and Japan are investing heavily in healthcare, which supports both access and innovation in therapeutic offerings. Latin America and the Middle East & Africa are also emerging as regions with untapped market potential. While they currently hold smaller shares, their projected CAGRs of 7% and 6% respectively reflect strong future growth, particularly in urban centers with improving access to care. Key Market Drivers The momentum in this market is largely attributed to scientific and technological advancements, including the development of next-generation therapies like monoclonal antibodies and targeted biologics. The rise of personalized medicine, where treatments are tailored based on patient-specific genetic and biomarker profiles, is reshaping therapeutic strategies. Regulatory developments are also influential. Accelerated approval pathways, especially for orphan and breakthrough therapies, have reduced time-to-market for promising treatments. In tandem, increased global healthcare spending, particularly in neurological and autoimmune sectors, is bolstering the adoption of advanced therapies. Challenges and Restraints Despite promising growth, the market faces a number of hurdles. One major challenge is the high cost of therapies, especially biologics, which limits access for patients in low- and middle-income regions. Prolonged regulatory approval timelines and complex compliance requirements can also delay product launches and increase costs for manufacturers. Supply chain disruptions, particularly in biopharmaceutical manufacturing, further complicate delivery and availability. The sector is also vulnerable to clinical trial failures, which can derail product pipelines and investor confidence. Additionally, generic and biosimilar competition can undercut revenues once patents expire, necessitating continuous innovation. Buy Now : Opportunities and Emerging Trends The market is rich with opportunities for expansion and innovation. Digital health technologies, such as telemedicine platforms and remote monitoring tools, are increasingly integrated into care pathways, enhancing both outcomes and convenience. These technologies also support real-time data collection and predictive analytics, aiding personalized care. Additionally, emerging markets offer considerable potential for growth. As awareness rises and infrastructure improves, pharmaceutical companies are investing in these regions to tap into large, underserved patient populations. The trend toward strategic partnerships, mergers, and acquisitions is another significant development. Collaborations between pharmaceutical firms and tech companies, particularly in AI-driven drug discovery and patient management, are redefining the way therapies are developed and delivered. Key Competitors Biogen Inc. Novartis International AG Roche Holding AG Sanofi S.A. Celgene Corporation (a Bristol-Myers Squibb Company) Merck KGaA Teva Pharmaceutical Industries Ltd. Genzyme Corporation (a Sanofi Company) EMD Serono, Inc. AbbVie Inc. GSK (GlaxoSmithKline) Vertex Pharmaceuticals Incorporated Pfizer Inc. Janssen Pharmaceuticals (a Johnson & Johnson Company) Horizon Therapeutics plc Recent Strategic Developments Company Name: Biogen Inc. Month & Year: August 2023 Type of Development: Product Launch Detailed Analysis: Biogen launched its latest multiple sclerosis (MS) therapy, an oral medication named Alectinib, in August 2023. This drug represents a significant advancement in the treatment landscape for MS, targeting a previously underserved patient demographic. The launch is crucial as the MS market increasingly shifts toward oral therapies that offer improved safety and convenience over traditional injections. Biogen's investment in clinical studies demonstrates their commitment to addressing unmet clinical needs. The release not only strengthens Biogen's portfolio but also rekindles competitive dynamics in the MS therapeutics market. Other companies may need to accelerate their research and focus on innovative delivery mechanisms to retain market share, indicating a potential uptick in R&D spending across the industry. Company Name: Novartis International AG Month & Year: July 2023 Type of Development: Regulatory Approval Detailed Analysis: In July 2023, Novartis received expedited approval from the FDA for its drug ofatumumab aimed at treating neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, debilitating condition, and this regulatory advancement opens new pathways for patients who have historically faced limited treatment options. This approval underlines a broader trend in the industry towards personalized medicine and targeted therapies. The positive regulatory news also strengthens Novartis's position in the demyelinating diseases market, compelling competitors to prioritize novel therapeutic approaches. As regulatory environments evolve, this approval may set a precedent that encourages pharmaceutical companies to innovate and invest heavily in rare disease therapies. Company Name: AbbVie Inc. Month & Year: September 2023 Type of Development: Merger Detailed Analysis: AbbVie entered a strategic merger with a biotech firm specializing in CNS (central nervous system) diseases in September 2023. This merger is pivotal not only for AbbVie's growth but also signifies a consolidation trend within the CNS therapeutics sector. By integrating innovative technologies and pipeline assets, AbbVie aims to bolster its competitive edge significantly in the demyelinating diseases market. This merger highlights the increasing interconnectedness of the pharmaceutical ecosystem, pivoting around collaboration to enhance therapeutic effectiveness and patient outcomes. Industry observers anticipate that this will prompt increased mergers and acquisitions in the sector as firms seek similar synergies to expedite drug development processes. Company Name: Sanofi S.A. Month & Year: October 2023 Type of Development: Product Launch Detailed Analysis: Sanofi unveiled a new monoclonal antibody therapy for treating relapsing forms of MS in October 2023, expanding its treatment arsenal significantly in this field. The introduction of this therapy reflects a commitment to advancing treatment modalities through innovative science. Furthermore, the development showcases a broader industry trend toward biologics and targeted therapies for demyelinating diseases. Market responses indicate that healthcare professionals and payers are eager for alternatives that provide safety and efficacy. This influx of new treatment options may fuel competitive pressure on existing therapies, leading to potential price adjustments and altering market dynamics. Company Name: Teva Pharmaceutical Industries Ltd. Month & Year: November 2023 Type of Development: Partnership Detailed Analysis: Teva announced a strategic partnership with a technology firm to collaborate on AI-driven approaches to MS treatment and patient management in November 2023. This partnership underscores a growing trend of incorporating technology into healthcare to enhance drug discovery and patient outcomes. By utilizing AI, Teva aims to streamline clinical research and tailor therapies to individual patient needs, thereby enhancing therapeutic efficacy. The collaboration could reshape how the pharmaceutical industry conducts research and develops therapies for demyelinating diseases, prompting competitors to explore similar integrations of advanced technologies, ultimately driving innovation in the market. This report is also available in the following languages : Japanese (脱髄疾患治療薬市場), Korean (탈수초성 질환 치료제 시장), Chinese (脱髓鞘疾病治疗市场), French (Marché des thérapies contre les maladies démyélinisantes), German (Markt für Therapeutika gegen demyelinisierende Erkrankungen), and Italian (Mercato terapeutico delle malattie demielinizzanti), etc. Request Sample Pages: More Research Finding – Human Granulocytic Ehrlichiosis Drug Market The market for drugs targeting Human Granulocytic Ehrlichiosis (HGE) is valued at approximately $320 million. Given the rising incidence of tick-borne diseases and increased awareness among healthcare professionals, the market is projected to grow significantly, reaching an estimated value of $580 million by 2034. This indicates a compound annual growth rate (CAGR) of 6.1% during the forecast period from 2025 to 2034. Lymphopenia Therapeutics Market The global lymphopenia therapeutics market is valued at approximately $3.2 billion, driven by increasing awareness of immune disorders and advancements in biologics and immunotherapies. The market is projected to grow significantly, reaching an estimated $6.8 billion by 2034, reflecting a robust Compound Annual Growth Rate (CAGR) of around 8.1% during the forecast period of 2025 to 2034. Cytochrome C Antibody Market The global Cytochrome C Antibody market is valued at approximately $210 million in 2024, driven by increasing research activities in cell apoptosis and related diseases. The market is projected to reach around $350 million by 2034, reflecting a robust growth trajectory fueled by advancements in biotechnology and rising prevalence of cancer and neurodegenerative disorders. AMPK Antibody Market The AMPK antibody market is valued at approximately $1.2 billion, fueled by the growing demand for research products in metabolic diseases and cancer therapy. The market is projected to reach about $2.5 billion by 2034, reflecting accelerating advancements in biotechnology and personalized medicine. Threonine Protein Kinase Chk1 Antibody Insights 2024 The market for Threonine Protein Kinase Chk1 Antibodies is poised for significant growth, with a projected market value of approximately $250 million by 2024. Over the forecast period from 2025 to 2034, the market is expected to expand, reaching an estimated value of $500 million. This growth represents a compound annual growth rate (CAGR) of around 8.5%. TrkC Antibody Market The TrkC antibody market was valued at approximately $1.5 billion in 2024, driven by increasing research funding and rising demand for targeted cancer therapies. This niche market is expected to reach around $3.2 billion by 2034, reflecting a robust growth trajectory. The projected Compound Annual Growth Rate (CAGR) for the period from 2025 to 2034 is estimated at 8.2%. Androgen Antibody Market The androgen antibody market is poised for significant growth, with an estimated market value of approximately $1.2 billion in 2024. Projections indicate that this market could expand to around $2.8 billion by 2034, reflecting increasing demand for advanced diagnostic and therapeutic options in conditions related to androgen imbalance. This growth represents a Compound Annual Growth Rate (CAGR) of about 9.0% during the forecast period from 2025 to 2034. Herpesvirus Entry Mediator HVEM Protein Market The global market for the Herpesvirus Entry Mediator (HVEM) protein is valued at approximately $150 million, primarily driven by its applications in immunotherapy and viral research. The market is poised for significant growth, with a projected value of $300 million by 2034, representing a robust Compound Annual Growth Rate (CAGR) of 7.3% during the forecast period from 2025 to 2034. Histone Deacetylase 1 HDAC1 Antibody Market The market for Histone Deacetylase 1 (HDAC1) antibodies is poised for significant growth, valued at approximately $250 million in 2024. This sector is expected to reach an estimated $750 million by 2034, driven by the rising prevalence of cancer and neurodegenerative diseases, which HDAC1 inhibitors target. The compound annual growth rate (CAGR) is projected at approximately 12% during the forecast period from 2025 to 2034. Prostaglandin-endoperoxide Synthase 2 COX-2 Antibody Market The global market for Prostaglandin-endoperoxide Synthase 2 (COX-2) antibodies is valued at approximately $1.6 billion in 2024, with a projected market value of around $3.2 billion by 2034. This growth corresponds to a robust Compound Annual Growth Rate (CAGR) of about 7.5% during the forecast period from 2025 to 2034. Fecal Incontinence Therapeutics Market The fecal incontinence therapeutics market is poised for significant growth, valued at approximately $1.2 billion in 2024. By 2034, this market is projected to reach around $3 billion, reflecting a robust Compound Annual Growth Rate (CAGR) of 9.2% during the forecast period of 2025–2034. POEMS Syndrome Treatment Market The global market for POEMS Syndrome diagnostic and therapeutic solutions is valued at approximately $700 million. The market is poised for significant growth, with projections estimating a market value of around $1.3 billion by 2034, reflecting a Compound Annual Growth Rate (CAGR) of approximately 6.5% during the forecast period from 2025 to 2034. Non-Alcoholic Steatohepatitis Therapeutics and Diagnostics Market The Non-Alcoholic Steatohepatitis (NASH) therapeutics and diagnostics market was valued at approximately $4.2 billion in 2024 and is projected to reach $12 billion by 2034. This represents a Compound Annual Growth Rate (CAGR) of around 12% during the forecast period of 2025-2034. mRNA Vaccine and Therapeutics Raw Material Market The global market for mRNA vaccine and therapeutics raw materials is valued at approximately $4.5 billion, driven by the accelerating demand for innovative vaccine solutions and therapeutic modalities. The market is projected to reach around $9.2 billion by 2034, reflecting a robust Compound Annual Growth Rate (CAGR) of approximately 8.2% from 2025 to 2034. Gene Editing Kit Market The gene editing kit market is projected to reach a value of approximately $5.4 billion in 2024, driven by advancements in CRISPR technology and increased applications in synthetic biology and personalized medicine. The market is expected to grow significantly, with a forecasted value of $13.2 billion by 2034, representing a Compound Annual Growth Rate (CAGR) of 9.2% during the forecast period from 2025 to 2034. Nanoparticles Market The global nanoparticles market is projected to reach a value of approximately $60 billion in 2024, driven by advancements in nanotechnology across various sectors, including healthcare, electronics, and energy. The market is expected to grow significantly, achieving a projected value of $120 billion by 2034, reflecting a robust Compound Annual Growth Rate (CAGR) of 7.2% during the forecast period from 2025 to 2034. Bispecific T Cell Engager Therapeutics Future Trends The bispecific T cell engager (BiTE) therapeutics market is valued at approximately $7.5 billion, driven by rising incidences of hematologic malignancies and solid tumors. The market is projected to grow significantly, with an estimated value of around $20 billion by 2034. This represents a compound annual growth rate (CAGR) of about 12.3% over the forecast period from 2025 to 2034. Molecular Cancer Therapeutics Market The global molecular cancer therapeutics market is projected to reach approximately $120 billion in 2024, driven by advancements in personalized medicine and an increasing number of targeted therapies. The market is expected to grow at a robust CAGR of 8.5% from 2025 to 2034, indicating a significant demand for innovative treatments that address specific genetic and molecular profiles of tumors. Single-Cell Dispenser Market The global single-cell dispenser market is valued at approximately $580 million in 2024 and is projected to reach around $1.2 billion by 2034, reflecting a robust Compound Annual Growth Rate (CAGR) of about 7.5% during the forecast period from 2025 to 2034. CONTACT: Irfan Tamboli (Head of Sales) Phone: + 1704 266 3234 Email: sales@ in to access your portfolio
Yahoo
30-05-2025
- Business
- Yahoo
Immunovant Provides Corporate Updates and Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2025
Immunovant's new management team is focused on rapid clinical execution for the six announced indications for IMVT-1402, including a second potentially registrational study in Graves' disease (GD) and a potentially registrational study in Sjögren's disease (SjD), both expected to start in summer 2025 Positive data from first-generation batoclimab trials in myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) demonstrated that deeper IgG reductions correlated with improved clinical outcomes across a range of assessments and timepoints suggesting a potential best-in-class efficacy profile for IMVT-1402 Current cash balance provides runway for announced indications through GD readout expected in 2027 NEW YORK, May 29, 2025 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported corporate updates and financial results for its fourth quarter and fiscal year ended March 31, 2025. Recent Highlights and Upcoming Milestones: In April 2025, Immunovant announced changes to its leadership team as part of a broader strategic transition with Roivant increasing operational involvement and oversight of Immunovant. Eric Venker, M.D. was appointed as CEO of Immunovant, and Tiago Girao as CFO of Immunovant. Given the strength of its potential best-in-class profile, IMVT-1402 is being developed in six announced indications, including potentially registrational trials in Graves' disease (GD), difficult-to-treat rheumatoid arthritis (D2T RA), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP) and Sjögren's disease (SjD), and a proof-of-concept trial in cutaneous lupus erythematosus (CLE). In March 2025, Immunovant announced positive results from its batoclimab MG and CIDP studies. The potentially registrational study in MG met its primary endpoint of change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in the AChR+ population at week 12, with the higher dose arm achieving a 5.6-point improvement (with 74% mean IgG reduction) and the lower dose arm achieving a 4.7-point improvement (with 64% mean IgG reduction). Initial results from week 12 of the Phase 2b CIDP study demonstrated a mean improvement in the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score of 1.8 across batoclimab arms and an 84% responder rate in those patients who achieved an IgG lowering greater than 70%. In both batoclimab studies, deeper IgG reductions correlated with improved clinical outcomes across a range of assessments and timepoints. Potentially registrational trials for IMVT-1402 in both MG and CIDP are actively enrolling. In March 2025, Immunovant initiated a potentially registrational trial of IMVT-1402 in adult participants with active, anti-citrullinated protein autoantibody (ACPA) positive D2T RA and a proof-of-concept study in CLE. Both indications represent potential first-in-class and best-in-class opportunities based on positive in-class competitor data (D2T RA) and promising efficacy data from patients dosed with IMVT-1402 as part of an open-label case study program (CLE). Immunovant plans to initiate a potentially registrational trial evaluating IMVT-1402 in SjD and a second potentially registrational trial in GD in the summer of 2025. Immunovant expects to report batoclimab six-month remission data from the proof-of-concept study in GD in the summer of 2025 and Phase 3 thyroid eye disease (TED) data in the second half of calendar year 2025. Financial Highlights for Fiscal Fourth Quarter Ended March 31, 2025: Cash Position: As of March 31, 2025, Immunovant's cash and cash equivalents totaled approximately $714 million, providing runway for announced indications through GD readout expected in 2027. R&D Expenses: Research and development expenses were $93.7 million for the three months ended March 31, 2025, compared to $66.1 million for the three months ended March 31, 2024. The increase was primarily due to activities related to our clinical trials of IMVT-1402, including contract manufacturing costs and elevated personnel-related expenses. The increase was partially offset by lower overall costs related to our IMVT-1402 Phase 1 trial and nonclinical studies. G&A Expenses: General and administrative expenses were $20.2 million for the three months ended March 31, 2025, compared to $14.8 million for the three months ended March 31, 2024. The increase was primarily due to higher personnel-related expenses, information technology costs, legal and other professional fees, and market research costs. Net Loss: Net loss was $106.4 million ($0.64 per common share) for the three months ended March 31, 2025, compared to $75.3 million ($0.52 per common share) for the three months ended March 31, 2024. Net loss for the three months ended March 31, 2025 and March 31, 2024 included $11.7 million and $9.7 million, respectively, related to non-cash stock-based compensation expense. Common Stock: As of March 31, 2025, there were 170,111,593 shares of common stock issued and outstanding. Financial Highlights for Fiscal Year Ended March 31, 2025: R&D Expenses: Research and development expenses were $360.9 million for the fiscal year ended March 31, 2025, compared to $212.9 million for the fiscal year ended March 31, 2024. The increase was primarily due to activities related to our clinical trials of IMVT-1402, including contract manufacturing costs, elevated personnel-related expenses, and higher overall clinical trial costs related to our batoclimab pivotal clinical trials. The increase was partially offset by lower overall costs related to our IMVT-1402 Phase 1 trial and nonclinical studies. IPR&D Expenses: There were no acquired in-process research and development expenses for the fiscal year ended March 31, 2025. During the fiscal year ended March 31, 2024, acquired in-process research and development expenses were $12.5 million related to the achievement of development and regulatory milestones for batoclimab under the terms of the HanAll in-license agreement. G&A Expenses: General and administrative expenses were $77.2 million for the fiscal year ended March 31, 2025, compared to $57.3 million for the fiscal year ended March 31, 2024. The increase was primarily due to higher personnel-related expenses, professional fees, information technology costs, and market research costs. Net Loss: Net loss was $413.8 million ($2.73 per common share) for the fiscal year ended March 31, 2025, compared to $259.3 million ($1.88 per common share) for the fiscal year ended March 31, 2024. Net loss for the fiscal year ended March 31, 2025 and 2024 included $49.5 million and $41.1 million, respectively, related to non-cash stock-based compensation expense. About Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit Forward-Looking StatementsThis press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "can," 'may,' 'might,' 'will,' 'would,' 'should,' 'expect,' 'believe,' 'estimate,' 'design,' 'plan,' "intend," and other similar expressions are intended to identify forward-looking statements. Such forward looking statements include statements regarding Immunovant's expectations regarding the timing, design, and results of clinical trials of IMVT-1402; Immunovant's plan to develop IMVT-1402 and batoclimab across a broad range of indications; the number and timing of potentially registrational programs and clinical trials Immunovant plans to initiate for IMVT-1402; and potential benefits of IMVT-1402's unique product attributes and potential best-in-class and first-in-class profile. All forward-looking statements are based on estimates and assumptions by Immunovant's management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: Immunovant may not be able to protect or enforce its intellectual property rights; initial results or other preliminary analyses or results of early clinical trials may not be predictive final trial results or of the results of later clinical trials; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant's product candidates, including the number and timing of the commencement of additional clinical trials; Immunovant's scientific approach, clinical trial design, indication selection, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant's product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of global factors, such as international trade tariffs, geopolitical tensions, and adverse macroeconomic conditions on Immunovant's business operations and supply chain, including its clinical development plans and timelines; Immunovant's business is heavily dependent on the successful development, regulatory approval, and commercialization of IMVT-1402 or batoclimab; Immunovant is at various stages of clinical development for IMVT-1402 and batoclimab; and Immunovant will require additional capital to fund its operations and advance IMVT-1402 and batoclimab through clinical development. These and other risks and uncertainties are more fully described in Immunovant's periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled 'Risk Factors' in Immunovant's Annual Report on Form 10-K filed with the SEC on May 29, 2025, and Immunovant's subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or INC. Consolidated Statements of Operations (In thousands, except share and per share data) Three Months EndedMarch 31, Years EndedMarch 31, 2025 2024 2025 2024 Operating expenses: Research and development $ 93,652 $ 66,056 $ 360,917 $ 212,928 Acquired in-process research and development — — — 12,500 General and administrative 20,174 14,823 77,235 57,281 Total operating expenses 113,826 80,879 438,152 282,709 Interest income (6,889 ) (8,379 ) (24,732 ) (24,948 ) Other (income) expense, net (1,071 ) 2,587 (471 ) 1,008 Loss before provision for income taxes (105,866 ) (75,087 ) (412,949 ) (258,769 ) Provision for income taxes 583 232 891 567 Net loss $ (106,449 ) $ (75,319 ) $ (413,840 ) $ (259,336 ) Net loss per common share – basic and diluted $ (0.64 ) $ (0.52 ) $ (2.73 ) $ (1.88 ) Weighted-average common shares outstanding – basic and diluted 166,732,686 145,355,546 151,573,553 138,100,577 IMMUNOVANT, Balance Sheets(In thousands, except share and per share data) March 31, 2025 2024 Assets Current assets: Cash and cash equivalents $ 713,971 $ 635,365 Accounts receivable 2,084 5,337 Prepaid expenses and other current assets 51,180 24,902 Income tax receivable 427 166 Total current assets 767,662 665,770 Operating lease right-of-use assets 98 133 Property and equipment, net 844 462 Other assets 7,618 — Total assets $ 776,222 $ 666,365 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 17,656 $ 7,155 Accrued expenses 50,748 41,300 Current portion of operating lease liabilities 98 138 Due to Roivant Sciences Ltd. 273 15 Total current liabilities 68,775 48,608 Total liabilities 68,775 48,608 Commitments and contingencies Stockholders' equity: Series A preferred stock, par value $0.0001 per share, 10,000 shares authorized, issued and outstanding at March 31, 2025 and March 31, 2024 — — Preferred stock, par value $0.0001 per share, 10,000,000 shares authorized, no shares issued and outstanding at March 31, 2025 and March 31, 2024 — — Common stock, par value $0.0001 per share, 500,000,000 shares authorized, 170,111,593 shares issued and outstanding at March 31, 2025 and 500,000,000 shares authorized, 145,582,999 shares issued and outstanding at March 31, 2024 16 14 Additional paid-in capital 1,945,495 1,441,518 Accumulated other comprehensive income 1,459 1,908 Accumulated deficit (1,239,523 ) (825,683 ) Total stockholders' equity 707,447 617,757 Total liabilities and stockholders' equity $ 776,222 $ 666,365 Contacts:Investors Keyur Media Stephanie 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
Daily Mail
23-05-2025
- Entertainment
- Daily Mail
Michael Klim eyes off a return to Australia after a decade in Bali: 'I am being enticed'
Michael Klim has revealed that he is planning a permanent move back to Australia, after living in Bali for more than a decade. The Aussie swimming legend, 47, moved to Bali in 2012, and currently lives on the Indonesian island with partner Michelle Owen. Following his ex wife Lindy's recent move from Bali to Australia, Michael says he's being 'enticed' back Down Under. 'At the moment I'm still in Bali and coming back-and-forth, but definitely at some point in the near future we will be heading back to Oz to be with both of the kids,' Michael told the Daily Telegraph. '[Daughter] Stella is with me here in Bali, so we're kind of still in limbo at the moment.' From A-list scandals and red carpet mishaps to exclusive pictures and viral moments, subscribe to the DailyMail's new showbiz newsletter to stay in the loop. Michael added, that while he calls Bali 'home' after 13 years, the opportunity to be in the country, particularly for the 2032 Olympics in Brisbane, could be too good to pass up. 'We have been in Bali for 13 years, so it feels like home, but with Brisbane 2032 happening and so many exciting things up in Queensland, I think I am being enticed back,' he said. Michael's revelation comes after he recently gave an update on his health. The Olympian was diagnosed with the neurological disorder chronic inflammatory demyelinating polyneuropathy (CIDP) in 2020 and told The Project this week that he was doing well. Asked how he was doing in terms of his health battle, Michael was optimistic. 'I'm feeling really well. My life has stabilised physically and mentally' he explained, before answering a question on whether he was in any pain. 'My mobility is compromised. But I've got some great AFOs, are kind of prosthetics. Some of my favourite things like surfing and playing tennis are out of the question, but I had a ski for the first time in 12 years last year' he said. Michael said there were 'a lot of things' he couldn't do, but many he could, and added that he was now focused on his foundation, The KLIM Foundation, which is raising funds and awareness for CIDP. 'With the foundation, it's what we're trying to do, enable a lot of sufferers, give them their life back' he said. 'Not only can we do it through blood donations, AFOs, having the right physio, having that support, and also counselling.' Michael recently detailed his 'tough' four-year battle with the disorder and spoke about the mental challenge of going from being an Olympian to not being able to walk. Speaking at Drew Barrymore and Wanderlust's True North event in Sydney in July, Michael explained how his leg muscles began 'disappearing' as he deteriorated. 'I had a lot of neural symptoms early on - most people would get cold feet at night time or you'd get a tingling on your quad - but I started getting these random feelings in my legs and they started progressing and getting worse,' he shared. 'Towards the end, my legs would give way on me when I was walking back. All my other aches and pains started popping up even more, affecting my everyday lifestyle from my ankle to my back. Michael - who is now able to walk with the assistance of a cane - admitted the diagnosis also took a mental toll as he struggled to come to terms with his physical symptoms. 'It was really confronting mentally, not just physically,' he explained while speaking to press ahead of actress Drew's talk event at the ICC Theatre. 'I could look down and see these sticks hanging off my body, which for someone that used to pride myself on my physical ability, that was taken away within six months.' Michael undergoes rehabilitation including plasma treatment, which has helped him to become more mobile by reducing inflammation and restoring nerve damage. He also praised his girlfriend Michelle Owen for her support over the past four years as he admitted it has been a difficult journey. Klim first unveiled his romance with DJ Michelle in October 2019, three years after his split from his model ex-wife Lindy Klim in 2016 after 10 years of marriage. Meanwhile, Lindy recently moved back to Australia following her split with husband of six years, Adam Ellis with whom the Balinese Princess shares daughter Goldie, seven. Michael and Lindy share three children - Stella, 18, Rocco, 16, and Frankie, 13.
Sky News AU
20-05-2025
- Sport
- Sky News AU
'I'm mixing it up': Aussie swimming legend Michael Klim rocks striking new look as he bravely opens up about his rare autoimmune disease
Australian swimming great Michael Klim has debuted a bold new look as he launches a foundation dedicated to raising awareness and funding research into Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), the rare autoimmune condition he was diagnosed with in 2020. The 47-year-old, best known for his stellar performance at the Sydney 2000 Olympics, where he took home gold in the 4x100m and 4x200m freestyle relays, as well as silver in the 100m butterfly and 4x100m medley relay, first began noticing symptoms several years ago. Initially attributing them to the toll of elite sport, further testing revealed Klim had CIDP - a disease that causes progressive muscle weakness, particularly in the lower limbs. Appearing on The Project on Tuesday night from his home in Bali, the father-of-three showcased his new facial hair and opened up about the challenges of living with the condition. "I'm just mixing it up, you know?" he said of the goatee. "I've had one look for 47 years, so I had to come up with something different." Despite his diagnosis, Klim said he's now in a good place physically and mentally. "I'm feeling really well. Life has really stabilised physically and mentally since the diagnosis five years ago," he said, adding that the launch of his new charity, The Klim Foundation, felt like the natural next step. "I feel like I'm up for the challenge- it's going to be a big one- but I think my history has given me a lot of insight and knowledge which I can now pass onto others that are going through this pretty tough journey." The Polish-born Australian also spoke about how CIDP has affected his mobility. "My mobility is compromised," he said, explaining he uses AFOs, ankle-foot orthoses, to help him stay mobile. "With that assistance, I can still do most things. Unfortunately, some of my favourite things like surfing and playing tennis are kind of out of the question. "But I had a ski for the first time in 12 years last year, so there are still a lot of things that you can do." The goal of The Klim Foundation, he said, is to empower others living with CIDP and help them reclaim their lives. "That can be achieved through things like blood donations, AFOs, the right physios, and also having the support of counsellors," he said. "For me, mentally coming out of that hole and realising that life still had a lot to give was probably the biggest win." The foundation was founded by Klim alongside his partner of two years, Michelle Owen. It's board includes some of the biggest names in sport- Ian Thorpe, Grant Hackett and even Klim's former rival, American swimmer Gary Hall Jr, who once famously said he would "smash him like a guitar". "The boys just wanted to help me raise the awareness of this condition," Klim said. "We do have a board that's got a lot of experience," he added, referencing key members like Paul Bird from Mission Australia, Mark Saubi from Mark Sowerby, and his best friend, former Olympic table tennis player David Zalcberg. "…It's going to take a group of champions to find not only a cure but to overcome this challenge." Reflecting on Hall Jr's involvement, Klim laughed as he recalled their former rivalry. "Gary - he's a diabetic, he's been in the medical field most of this life. He is probably the only Olympic gold medallist with diabetes," Klim said. "He loves Australia, even though some of the Aussies don't like him. "I'm going to make it my mission he'll be a favoured Aussie very soon."
Herald Sun
19-05-2025
- Health
- Herald Sun
Swimmer Micheal Klim launches charity and gives CIDP auto-immune condition health update
Don't miss out on the headlines from Health. Followed categories will be added to My News. Champion swimmer Michael Klim has revealed his 'favourite things' are 'out of the question' as he continues to battle a rare auto-immune condition. Klim has launched a charity which funds research into Chronic Inflammatory Demyelinating Polyneuropathy – the same condition which is attacking the former Olympian's nerves. The gold medallist appeared on Channel 10's The Project to launch the Klim Foundation and give an update on his health. Fans were stunned to see the handsome athlete, who normally sports a completely bald look, pulling off an impressive goatee. 'I'm mixing it up. I had one look for 47 years. I had to come up with something different,' Klim joked when asked about his new crop of facial hair. He also added he was 'feeling really well' despite ongoing health challenges. 'My life has stabilised physically and mentally. It's become a – the right time now for myself, Michelle (his partner), the family, and, the board we put together, to launch the Klim Foundation and get out and help other sufferers. I feel up to the challenge,' Klim said. Speaking from his home in Bali, Klim added CIDP continues to wreak havoc on his body. 'My mobility is compromised. But I've got some great AFOs, are kind of prosthetics,' he said. 'Some of my favourite things like surfing and playing tennis are out of the question, but I had a ski for the first time in 12 years last year. 'Still a lot of things you can do. So, with the foundation, it's what we're trying to do, enable a lot of sufferers, give them their life back.' Klim said he not only signed up swimming pals Ian Thorpe and Grant Hackett to join the foundation board, but also recruited former rival, American Gary Hall Jr who once threatened to 'smash him like a guitar.' 'Gary – he's a diabetic, he's been in the medical field most of this life. He is probably the only Olympic gold medallist with diabetes,' Klim said. 'He loves Australia, even though some of the Aussies don't like him. 'I'm going to make it my mission he'll be a favoured Aussie very soon.' People can donate to the Klim Foundation here. Originally published as Michael Klim sports handsome goatee as he launches charity
