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Immunovant Provides Corporate Updates and Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2025
Immunovant Provides Corporate Updates and Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2025

Yahoo

time5 days ago

  • 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

Biohaven Highlights Innovation and Advancement Across MoDE and TRAP Degrader Platform at R&D Day, Announcing Positive TRAP Degrader Data Achieving > 80% Sustained Reductions in Galactose-Deficient IgA1 (Gd-IgA1) with Potential First-in-Class BHV-1400 for IgA Nephropathy (IgAN)
Biohaven Highlights Innovation and Advancement Across MoDE and TRAP Degrader Platform at R&D Day, Announcing Positive TRAP Degrader Data Achieving > 80% Sustained Reductions in Galactose-Deficient IgA1 (Gd-IgA1) with Potential First-in-Class BHV-1400 for IgA Nephropathy (IgAN)

Yahoo

time6 days ago

  • Business
  • Yahoo

Biohaven Highlights Innovation and Advancement Across MoDE and TRAP Degrader Platform at R&D Day, Announcing Positive TRAP Degrader Data Achieving > 80% Sustained Reductions in Galactose-Deficient IgA1 (Gd-IgA1) with Potential First-in-Class BHV-1400 for IgA Nephropathy (IgAN)

Optimized subcutaneous (SC) administration of BHV-1400 achieved rapid, deep, selective, and sustained lowering of Gd-IgA1, differentiating Biohaven's leading TRAP degrader for IgAN from the complement and BLyS/APRIL inhibitor competition. Up to 81% reduction of Gd-IgA1 was observed, with reductions from baseline sustained for weeks after a single SC dose administration. BHV-1400 brings precision immunology to the treatment landscape of IgAN as it was rationally designed to selectively remove galactose-deficient IgA1 (Gd-IgA1), the pathogenic antibody driver of the disease while sparing healthy antibodies IgA, IgG, IgE, and IgM. Preservation of immunoglobulins, the complement system, and cell-mediated and humoral immunity offers key differentiation against immunosuppressive BLyS/APRIL inhibitors, complement inhibitors, and budesonide. Based upon the rapid and deep reductions of Gd-IgA1 observed with subcutaneous BHV-1400, Biohaven plans to study BHV-1400 in patients with IgAN, initiating a pivotal trial in 2026 using urine protein-creatinine ratio (UPCR) as a surrogate endpoint for accelerated approval. Optimized SC administration of BHV-1300 has continued to demonstrate rapid, deep, and sustained lowering of total IgG in Phase 1 studies. Recently generated clinical data shows that BHV-1300 achieved rapid, deep, and sustained lowering of total IgG, with reductions up to 87%. Median maximum reductions of 83% were observed within 18 days of the first subcutaneous dose. The range of IgG reductions possible with varying dosing paradigms of BHV-1300 allows for tunable dosing regimens tailored for acute and chronic disease management, with higher doses for acute disease management and lower, less frequent dosing for chronic disease management. Based upon the rapid and deep reductions of IgG and favorable tolerability profile observed with BHV-1300, Biohaven plans to study BHV-1300 in patients with Graves' Disease and initiate pivotal trials in 2H 2025. NEW HAVEN, Conn., May 28, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today highlighted the success of its first MoDE™ and TRAP™ degraders in achieving key target pharmacodynamic endpoints and announced plans to initiate pivotal trials in Graves' Disease and in IgA nephropathy in 2H 2025 and 1H 2026, respectively at Biohaven's 2025 R&D Day, held concurrently with the Yale Innovation Summit in New Haven, Connecticut. The presentation slides from Biohaven's R&D day for the TRAP and MoDE degraders and its other platforms will be available on the Events and Presentations page of the Biohaven website just prior to their presentations. BHV-1400, the Company's potential first-in-class galactose-deficient IgA1 (Gd-IgA1) TRAP degrader for the treatment of IgA nephropathy (IgAN) achieved deep, rapid, and sustained reductions in Gd-IgA1. In the Phase 1 study, a single dose of BHV-1400 was subcutaneously administered at a dose of 500 mg and achieved rapid, deep and sustained reductions in Gd-IgA1 of up to 81%, with a median reduction of 66% (Figure 1). Reductions occurred within hours of each dose, were progressive, and were sustained for weeks after a single dose administration. Effects were selective, with no significant reductions observed in other immunoglobulins: IgA, IgG, IgE, or IgM. Dr. Jonathan Barratt, the Mayer Professor of Renal Medicine at University of Leicester and leading expert in the treatment of IgAN, commented on the new Phase 1 data, "The reason I am excited about BHV-1400 is because it specifically targets the fundamental abnormality in IgA nephropathy while leaving the rest of the immune system untouched. It has the potential to take away the major driver for immune complex formation while leaving other antibodies completely unaffected, which means it has efficacy with unrivaled safety." IgA nephropathy is the leading cause of glomerular disease globally and is commonly diagnosed in individuals in their second and third decades of life, with most individuals progressing to renal failure over the ensuing 10-15 years. As a disease of the immune system, IgA nephropathy frequently returns even after renal transplant. While the 2021 Kidney Disease Improving Global Outcomes (KDIGO) treatment guidelines recommended only standard chronic kidney disease treatments, the 2024 draft guidelines emphasize the importance of treating the underlying immune disease by removing aberrant forms of IgA. "Galactose deficient IgA1 is the fundamental abnormality in IgA nephropathy," Dr. Barratt explained, "It's a group of IgA molecules that have changes to the sugars on the IgA1 hinge region that fundamentally change the way this antibody behaves. It promotes immune complex formation and it's these immune complexes that cause glomerular injury and damage and promote loss of kidney function." BHV-1400's selective approach has the potential to offer an improved safety profile compared to broadly immunosuppressive agents. BHV-1400 has been safe and well-tolerated across the ongoing Phase 1 study. Most adverse events (AEs) were mild and self-resolving, there were no discontinuations due to AEs related to study drug, and there were no serious or severe AEs related to drug. There were no clinically significant increases in ALT, AST or bilirubin, no clinically significant reductions in albumin and no clinically significant increases in cholesterol relative to placebo over the 4-week dosing period. There were no clinically significant reductions in other immunoglobulins including IgG, IgA, IgE, or IgM relative to baseline. With regards to the applicability of Phase 1 data in healthy volunteers to patients with IgAN, Dr. Barratt added, "It's not that the Gd-IgA1 is subtly different, it's the same in both (healthy volunteers and patients with IgAN), but in patients, they just have an excess quantity. And so, what I believe is that because you're seeing a suppressed Gd-IgA1 in healthy subjects you are going to see the same in patients with IgA nephropathy, and indeed that's what some of the drugs targeting BAFF and APRIL have shown. They presented data in their healthy volunteer population that was precisely replicated when they went in to patients." BHV-1400 fundamentally differentiates from alternative approaches by virtue of its precision. While agents targeting the glucocorticoid receptors may have steroid-like side effects, those targeting complement require vaccination for encapsulated bacterial infections, and B-cell-directing therapies cause reductions in all isotypes of immunoglobulin, potentially increasing long-term infection risk. Based upon the rapid and deep reductions of Gd-IgA1 observed with SC dosing of BHV-1400, Biohaven plans to study BHV-1400 in patients with IgAN and initiate pivotal trials in 2026 using UPCR surrogate endpoint via the accelerated approval pathway. At its R&D Day, Biohaven also released new positive data from its completing Phase 1 study of its leading MoDE degrader, BHV-1300, that targets IgG for removal. In the Phase 1 multiple-dose study, SC administered BHV-1300 achieved IgG reductions up to 87%. Median maximum reductions of 83% were achieved within 18 days (Figure 2). Biohaven recently reported the 1000 mg weekly dose achieved rapid, deep and sustained reductions in total IgG of up to 84%, with a median reduction of 80% by Week 4 (Figure 2). Reductions at all doses occurred within hours of administration, were progressive, and effects were durable between dosing intervals. The range of IgG lowering enabled by different dose levels of BHV-1300 offers tunability and flexibility in dosing paradigm, with higher doses planned for management of acute conditions, and lower, less frequent dosing planned for the management of chronic disease. BHV-1300 has been safe and well-tolerated in subcutaneous doses up to 2000 mg with no clinically significant increases in ALT, AST, or bilirubin, no clinically significant reductions in albumin, and no clinically significant increases in cholesterol over the four-week dosing period relative to placebo. There were no clinically significant reductions in IgG3, IgA, IgE, or IgM relative to baseline. Most AEs were mild and self-resolving, and there were no serious or severe AEs. BHV-1300 is a potential first-in-class novel small molecule MoDE degrader in development for the treatment of IgG-mediated diseases, such as Graves' Disease. It is designed for self-administration via an easy-to-use and patient-friendly autoinjector. Biohaven plans to study BHV-1300 in patients with Graves' Disease and initiate a pivotal trial in 2H 2025. Tova Gardin, MD, MPP, Chief Translational Officer at Biohaven, commented, "Our lead MoDE and TRAP degraders, BHV-1300 and BHV-1400, deliver on the promise of ground-breaking chemistry, demonstrating unrivaled selectivity, and profound depletion of potentially disease-causing proteins. With the selectivity of the platform and the initial profile observed in Phase 1, we aim to bring precision immunology to patients with safe and effective treatments that target the core of disease biology. We are incredibly proud of our innovative, agile, and dynamic team that has catalyzed a first of its kind extracellular degrader technology from bench to the clinic. Driven by patient need and leading-edge, mechanistically precise science, Biohaven remains focused on delivering the promise of precision therapies to patients with immune-mediated disease." About BHV-1400BHV-1400 is a potential first-in-class Gd-IgA1 TRAP degrader, rationally designed to leverage the body's natural hepatic clearance mechanisms to selectively target and remove Gd-IgA1, the underlying cause of the IgA nephropathy and IgA vasculitis. BHV-1400 spares IgG, IgA, IgE, and IgM to preserve patient immune protection against bacteria, viruses and parasites. The results of the ongoing Phase 1 study confirm that BHV-1400 produces deep reductions in Gd-IgA1 within hours, is selective, sparing other immunoglobulins, is tunable, and is safe and well-tolerated. About BHV-1300BHV-1300 is a small molecule and potential first-in-class extracellular IgG degrader, rationally designed to leverage the body's natural hepatic clearance mechanisms to selectively target and remove IgG1, IgG2, and IgG4, the underlying cause of many immune-mediated diseases. BHV-1300 spares IgG3 to preserve patient immune protection against bacteria, viruses and parasites. The results of ongoing Phase 1 study confirm that BHV-1300 produces deep reductions in total IgG, is selective, sparing IgG3, is tunable, and is safe and well-tolerated. About BiohavenBiohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. Biohaven is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; TRPM3 antagonism for migraine and neuropathic pain; TYK2/JAK1 inhibition for neuroinflammatory disorders; glutamate modulation for OCD and SCA; myostatin inhibition for neuromuscular and metabolic diseases, including SMA and obesity; antibody recruiting bispecific molecules; and antibody drug conjugates for cancer. For more information, visit Forward-looking Statements This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "potential first-in-class", "potentially", "groundbreaking" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, including the studies of BHV-1300 and BHV-1400; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable US regulatory requirements; the potential commercialization of Biohaven's product candidates; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. MoDE and TRAP are trademarks of Biohaven Therapeutics Ltd. Investor Contact:Jennifer PorcelliVice President, Investor (201) 248-0741 Media Contact:Mike BeyerSam Brown (312) 961-2502 View original content to download multimedia: SOURCE Biohaven Ltd. Sign in to access your portfolio

Force-Feeding May Harm Infants: Research
Force-Feeding May Harm Infants: Research

Time of India

time24-05-2025

  • Health
  • Time of India

Force-Feeding May Harm Infants: Research

New Delhi: Force-feeding lentil-based foods like dal during weaning may lead to a rare but serious lung condition in infants known as Hypersensitivity Pneumonitis (HP), according to new research. The illness, which mimics pneumonia in symptoms, requires a distinct approach to diagnosis and treatment. Doctors at Sir Ganga Ram Hospital conducted a 13-month study, published in the Journal of Paediatric Respirology and Critical Care, that underscores growing concerns in Indian paediatric healthcare about certain weaning practices. The research emphasises the importance of educating caregivers and medical professionals about proper weaning techniques and their associated risks. "Parents need to be aware that a simple act like pushing a child to eat can have serious consequences," the study authors warned. T by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like 2025 Top Trending local enterprise accounting software [Click Here] Esseps Learn More Undo he study examined nine cases of infants under three years old, mostly boys, who exhibited persistent respiratory symptoms—cough, difficulty breathing, and fever—that did not respond to standard treatments. All had a history of forceful feeding of lentil-based foods during weaning. HP is an allergic reaction in the lungs caused by repeated inhalation or aspiration of fine particles. In these cases, lentil particles entered the infants' airways due to aggressive feeding, triggering immune responses and lung inflammation. This condition differs from typical food allergies, which result from ingestion. In HP, the problem arises from aspiration, especially during forced feeding in infants with immature swallowing reflexes. Laboratory tests in the affected children showed elevated levels of lentil-specific IgG antibodies. Chest CT scans revealed persistent lung opacities, initially resembling chronic infections. After ruling out tuberculosis and fungal causes, the allergic origin of the illness was confirmed. All patients improved following cessation of forceful feeding and treatment with oral steroids. The research team from Sir Ganga Ram Hospital's Institute of Child Health included specialists from various departments. Dr Anil Sachdev, senior paediatric pulmonologist and lead author, stressed the importance of thorough clinical assessment and radiological and immunological evaluations in such cases. Co-author of the study, Dr Dhiren Gupta, who is co-director, paediatric pulmonologist, explained how force-feeding can lead to repeated aspiration, particularly in infants with underdeveloped swallowing reflexes. Dr Suresh Gupta, paediatric emergency and allergy specialist, highlighted how force-feeding, while common in Indian households, poses serious health risks. Fellow authors Dr Deepak Kumar and Dr Neeraj Gupta advised medical professionals to consider food-related hypersensitivity when treating persistent pneumonia cases involving lentil consumption.

Dubai Judicial Institute (DJI) organised an insightful workshop titled ‘Management of Partnerships and Their Impact on Community Sustainability,' in alignment with the objectives of the ‘Year of Community' and its theme ‘Hand in Hand.' The workshop aimed to promote a culture of institutional collaboration and shared responsibility across various sectors, while enhancing the effectiveness of partnerships as key drivers of sustainable development. This initiative reflects the UAE leadership's enduring vision for inclusive and resilient community advancement through strategic government collaboration. The workshop mainly focused on partnership management within government entities to reinforce the understanding of the legal and regulatory frameworks that govern public and community partnerships. It also sought to boost institutional capabilities in managing these partnerships, encourage strategic thinking for community sustainability, promote a culture of integration, and offer practical solutions to potential challenges. The program explored three main themes, including the legislative framework for government and community partnerships, governance of partnerships, and its contribution to promoting transparency and accountability, and analysing the community impact of partnerships. Her Excellency Judge Dr Ebtessam Ali Al Bedwawi, Director General of the Dubai Judicial Institute, stated: 'The workshop was organised as part of Dubai's strategic vision to reinforce cross-sector collaboration and lay foundations for effective community partnerships that advance sustainable development and public welfare. Through our dedicated training programs and workshops, we aim to raise legal awareness at both community and institutional levels, while cultivating a culture of shared responsibility. These continuous initiatives support the objectives of the ‘Year of the Community' and offer an interactive platform for participants to exchange ideas and experiences, inspiring conversations around innovative initiatives that reinforce institutional and community collaboration and convert regulatory frameworks into tools for empowering community development.' This workshop is aligned with DJI's relentless efforts to instil a culture of institutional cooperation, underscoring the substantial role of strategic partnerships in strengthening social cohesion and highlighting the significance of public-community collaboration as a key enabler of sustainable development.
Dubai Judicial Institute (DJI) organised an insightful workshop titled ‘Management of Partnerships and Their Impact on Community Sustainability,' in alignment with the objectives of the ‘Year of Community' and its theme ‘Hand in Hand.' The workshop aimed to promote a culture of institutional collaboration and shared responsibility across various sectors, while enhancing the effectiveness of partnerships as key drivers of sustainable development. This initiative reflects the UAE leadership's enduring vision for inclusive and resilient community advancement through strategic government collaboration. The workshop mainly focused on partnership management within government entities to reinforce the understanding of the legal and regulatory frameworks that govern public and community partnerships. It also sought to boost institutional capabilities in managing these partnerships, encourage strategic thinking for community sustainability, promote a culture of integration, and offer practical solutions to potential challenges. The program explored three main themes, including the legislative framework for government and community partnerships, governance of partnerships, and its contribution to promoting transparency and accountability, and analysing the community impact of partnerships. Her Excellency Judge Dr Ebtessam Ali Al Bedwawi, Director General of the Dubai Judicial Institute, stated: 'The workshop was organised as part of Dubai's strategic vision to reinforce cross-sector collaboration and lay foundations for effective community partnerships that advance sustainable development and public welfare. Through our dedicated training programs and workshops, we aim to raise legal awareness at both community and institutional levels, while cultivating a culture of shared responsibility. These continuous initiatives support the objectives of the ‘Year of the Community' and offer an interactive platform for participants to exchange ideas and experiences, inspiring conversations around innovative initiatives that reinforce institutional and community collaboration and convert regulatory frameworks into tools for empowering community development.' This workshop is aligned with DJI's relentless efforts to instil a culture of institutional cooperation, underscoring the substantial role of strategic partnerships in strengthening social cohesion and highlighting the significance of public-community collaboration as a key enabler of sustainable development.

Mid East Info

time21-05-2025

  • Health
  • Mid East Info

Dubai Judicial Institute (DJI) organised an insightful workshop titled ‘Management of Partnerships and Their Impact on Community Sustainability,' in alignment with the objectives of the ‘Year of Community' and its theme ‘Hand in Hand.' The workshop aimed to promote a culture of institutional collaboration and shared responsibility across various sectors, while enhancing the effectiveness of partnerships as key drivers of sustainable development. This initiative reflects the UAE leadership's enduring vision for inclusive and resilient community advancement through strategic government collaboration. The workshop mainly focused on partnership management within government entities to reinforce the understanding of the legal and regulatory frameworks that govern public and community partnerships. It also sought to boost institutional capabilities in managing these partnerships, encourage strategic thinking for community sustainability, promote a culture of integration, and offer practical solutions to potential challenges. The program explored three main themes, including the legislative framework for government and community partnerships, governance of partnerships, and its contribution to promoting transparency and accountability, and analysing the community impact of partnerships. Her Excellency Judge Dr Ebtessam Ali Al Bedwawi, Director General of the Dubai Judicial Institute, stated: 'The workshop was organised as part of Dubai's strategic vision to reinforce cross-sector collaboration and lay foundations for effective community partnerships that advance sustainable development and public welfare. Through our dedicated training programs and workshops, we aim to raise legal awareness at both community and institutional levels, while cultivating a culture of shared responsibility. These continuous initiatives support the objectives of the ‘Year of the Community' and offer an interactive platform for participants to exchange ideas and experiences, inspiring conversations around innovative initiatives that reinforce institutional and community collaboration and convert regulatory frameworks into tools for empowering community development.' This workshop is aligned with DJI's relentless efforts to instil a culture of institutional cooperation, underscoring the substantial role of strategic partnerships in strengthening social cohesion and highlighting the significance of public-community collaboration as a key enabler of sustainable development.

The Pfizer Middle East, Russia and Africa (MERA) Maternal Immunization Summit: Born Ready brought together more than 80 medical experts, physicians, and healthcare professionals together in Cairo, Egypt to share insights on the latest efforts to prevent RSV in newborns The summit highlighted the critical role of maternal vaccinations in the successful prevention of RSV and shed light on global best practices for such vaccination programs. Dubai, UAE –May 2025: More than 80 international and regional healthcare experts have convened at the Pfizer MERA Maternal Immunization Summit: Born Ready to discuss issues pertaining to maternal immunization. The summit, entitled 'RISE: Respiratory Immunization Summit for Excellence' and, held from 16-17 May 2025 in Cairo, Egypt, focused on the growing burden of neonatal respiratory syncytial virus (RSV) and the role of maternal vaccination in its successful prevention. The summit aimed to increase awareness of the virus and its impact, in addition to the importance of maternal immunization in preventing RSV and protecting newborns. Experts addressed the challenges and barriers to the adoption of maternal immunization, shared best practices, and explored how healthcare providers can more effectively implement maternal immunization programs in the region. Professor Irene Cetin, Professor of Obstetrics and Gynecology, University of Milan and Head of Obstetrics, Mangiagalli Policlinico Hospital Fondazione IRCCS Cà Granda, Milan, Italy, said: 'Maternal immunization leverages the natural pregnancy process whereby antibodies – disease-fighting molecules – pass naturally from mother to baby through the placenta, starting in the second trimester and peaking during the third. Maternal antibodies help protect infants at birth and during the first few months of life, before they are eligible to receive vaccinations themselves.' The administration of a vaccine to an expectant mother activates the maternal immune system, triggering the production of immunoglobin G (IgG) antibodies, which pass through the placenta from the parental bloodstream. Professor Mohamed Momtaz, Emeritus Professor of Obstetrics and Gynecology, Kasr Al Ainy Faculty of Medicine, Cairo University, Cairo, Egypt, said: 'Because of the way the placenta pumps antibodies into the fetus during the second and third trimesters of pregnancy, fetal IgG concentration usually exceeds the concentration of antibodies in the maternal circulation in full-term infants, meaning the baby is better protected from infectious diseases than the mother. This highlights the tremendous potential of maternal immunization to help prevent transmission of communicable diseases and reduce the impact of infections such as RSV. Furthermore, events like this summit encourage evidence-based conversations between healthcare providers and expectant mothers, while also highlighting practical approaches to communication and appropriate data sharing.' According to the World Health Organization, RSV – a seasonal virus that leads to infections of the lungs and respiratory tract – is the most common cause of acute lower respiratory infections in children globally[i], responsible for an estimated 33 million such infections, more than three million hospitalizations and almost 60,000 deaths per year in children under 5 years of age[ii]. This trend is reflected regionally, where RSV infections are the leading cause of acute respiratory tract infections in young children, typically peaking during the winter months or the rainy season in humid countries. Professor Hossam Al Tatari, Director of General Pediatrics and Pediatric Infectious Diseases Services at The Heart Medical Center, Al Ain, UAE said: 'RSV infection is very common, affecting almost all children within two years from birth. In adults and older, healthy children, RSV typically produces mild symptoms that mimic the common cold, but in the newborn babies below 6 months, and those otherwise immunocompromised, such as babies born prematurely, the infection can prove life-threatening. It is imperative that we explore every possible avenue to mitigate the risks associated with RSV, and take every step to prevent transmission, especially to the most vulnerable amongst us.' Highlighting the benefits of maternal immunization to newborns and immunocompromised infants, Dr Hammam Haridy, Senior Director Regional Medical & Scientific Affairs at Pfizer MERA said: 'Infections such as RSV, while potentially dangerous, are preventable with vaccination. Despite the significant impact of RSV in the region and across the globe, comprehensive and consistent region-wide surveillance and burden data across the Middle East and North Africa region are currently limited. Forums such as the Maternal Immunization Summit are therefore crucial to drive buy-in of healthcare providers in order to increase awareness and tackle vaccine hesitancy. By providing a platform via which stakeholders can connect and share data and insights, we can drive the conversation around maternal vaccination, ensuring we make best use of available data in our interactions.' Both the World Health Organization and the Strategic Group of Experts on Immunization recommend countries adopt measures to prevent severe RSV in infants[iii], with decisions on whether to use maternal immunization or monoclonal antibodies dependent upon a number of factors. Emphasizing the need for collaboration between the medical community and vaccine developers to ensure maximum success in prevention, Merih Cetinkaya, Professor of Pediatrics, Health Sciences University and Head of Neonatology at Basaksehir Cam Sakura, City Hospital, Istanbul, Turkey, said: 'Communicable diseases such as RSV have considerable impact on neonatal health, affecting both our populations and our healthcare systems, and vaccinations remain a cornerstone in lessening this impact. As healthcare providers, we share responsibility with stakeholders across the healthcare landscape to understand such diseases, to leverage innovation and technology, and to ensure equitable access to life-saving vaccines, especially for the most vulnerable members of our communities.' During the event, Pfizer underscored its ongoing commitment to shaping the future of public health through the power of vaccines. Over the years, Pfizer's vaccines have played a vital role in preventing, controlling, and in some cases nearly eradicating infectious diseases, safeguarding millions of lives around the world and across the MERA region. As a leader in biopharmaceutical innovation, the company remains deeply invested in research and development, driving forward new solutions with the aim of enhancing patient outcomes and advancing global health. About Pfizer: Breakthroughs That Change Patients' Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments, and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at

International and Regional Experts Focus on RSV Prevention at Pfizer MERA Maternal Immunization Summit: Born Ready
International and Regional Experts Focus on RSV Prevention at Pfizer MERA Maternal Immunization Summit: Born Ready

Web Release

time21-05-2025

  • Health
  • Web Release

International and Regional Experts Focus on RSV Prevention at Pfizer MERA Maternal Immunization Summit: Born Ready

More than 80 international and regional healthcare experts have convened at the Pfizer MERA Maternal Immunization Summit: Born Ready to discuss issues pertaining to maternal immunization. The summit, entitled 'RISE: Respiratory Immunization Summit for Excellence' and, held from 16-17 May 2025 in Cairo, Egypt, focused on the growing burden of neonatal respiratory syncytial virus (RSV) and the role of maternal vaccination in its successful prevention. The summit aimed to increase awareness of the virus and its impact, in addition to the importance of maternal immunization in preventing RSV and protecting newborns. Experts addressed the challenges and barriers to the adoption of maternal immunization, shared best practices, and explored how healthcare providers can more effectively implement maternal immunization programs in the region. Professor Irene Cetin, Professor of Obstetrics and Gynecology, University of Milan and Head of Obstetrics, Mangiagalli Policlinico Hospital Fondazione IRCCS Cà Granda, Milan, Italy, said: 'Maternal immunization leverages the natural pregnancy process whereby antibodies – disease-fighting molecules – pass naturally from mother to baby through the placenta, starting in the second trimester and peaking during the third. Maternal antibodies help protect infants at birth and during the first few months of life, before they are eligible to receive vaccinations themselves.' The administration of a vaccine to an expectant mother activates the maternal immune system, triggering the production of immunoglobin G (IgG) antibodies, which pass through the placenta from the parental bloodstream. Professor Mohamed Momtaz, Emeritus Professor of Obstetrics and Gynecology, Kasr Al Ainy Faculty of Medicine, Cairo University, Cairo, Egypt, said: 'Because of the way the placenta pumps antibodies into the fetus during the second and third trimesters of pregnancy, fetal IgG concentration usually exceeds the concentration of antibodies in the maternal circulation in full-term infants, meaning the baby is better protected from infectious diseases than the mother. This highlights the tremendous potential of maternal immunization to help prevent transmission of communicable diseases and reduce the impact of infections such as RSV. Furthermore, events like this summit encourage evidence-based conversations between healthcare providers and expectant mothers, while also highlighting practical approaches to communication and appropriate data sharing.' According to the World Health Organization, RSV – a seasonal virus that leads to infections of the lungs and respiratory tract – is the most common cause of acute lower respiratory infections in children globally[i], responsible for an estimated 33 million such infections, more than three million hospitalizations and almost 60,000 deaths per year in children under 5 years of age[ii]. This trend is reflected regionally, where RSV infections are the leading cause of acute respiratory tract infections in young children, typically peaking during the winter months or the rainy season in humid countries. Professor Hossam Al Tatari, Director of General Pediatrics and Pediatric Infectious Diseases Services at The Heart Medical Center, Al Ain, UAE said: 'RSV infection is very common, affecting almost all children within two years from birth. In adults and older, healthy children, RSV typically produces mild symptoms that mimic the common cold, but in the newborn babies below 6 months, and those otherwise immunocompromised, such as babies born prematurely, the infection can prove life-threatening. It is imperative that we explore every possible avenue to mitigate the risks associated with RSV, and take every step to prevent transmission, especially to the most vulnerable amongst us.' Highlighting the benefits of maternal immunization to newborns and immunocompromised infants, Dr Hammam Haridy, Senior Director Regional Medical & Scientific Affairs at Pfizer MERA said: 'Infections such as RSV, while potentially dangerous, are preventable with vaccination. Despite the significant impact of RSV in the region and across the globe, comprehensive and consistent region-wide surveillance and burden data across the Middle East and North Africa region are currently limited. Forums such as the Maternal Immunization Summit are therefore crucial to drive buy-in of healthcare providers in order to increase awareness and tackle vaccine hesitancy. By providing a platform via which stakeholders can connect and share data and insights, we can drive the conversation around maternal vaccination, ensuring we make best use of available data in our interactions.' Both the World Health Organization and the Strategic Group of Experts on Immunization recommend countries adopt measures to prevent severe RSV in infants[iii], with decisions on whether to use maternal immunization or monoclonal antibodies dependent upon a number of factors. Emphasizing the need for collaboration between the medical community and vaccine developers to ensure maximum success in prevention, Merih Cetinkaya, Professor of Pediatrics, Health Sciences University and Head of Neonatology at Basaksehir Cam Sakura, City Hospital, Istanbul, Turkey, said: 'Communicable diseases such as RSV have considerable impact on neonatal health, affecting both our populations and our healthcare systems, and vaccinations remain a cornerstone in lessening this impact. As healthcare providers, we share responsibility with stakeholders across the healthcare landscape to understand such diseases, to leverage innovation and technology, and to ensure equitable access to life-saving vaccines, especially for the most vulnerable members of our communities.' During the event, Pfizer underscored its ongoing commitment to shaping the future of public health through the power of vaccines. Over the years, Pfizer's vaccines have played a vital role in preventing, controlling, and in some cases nearly eradicating infectious diseases, safeguarding millions of lives around the world and across the MERA region. As a leader in biopharmaceutical innovation, the company remains deeply invested in research and development, driving forward new solutions with the aim of enhancing patient outcomes and advancing global health.

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