Latest news with #Graves'
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
Yahoo
19-05-2025
- Health
- Yahoo
These people were drinking a few cans of soda a day. Here's what happened to their health when they gave it up.
While soda used to be a staple of the American diet, consumption of the fizzy drink in the U.S. has consistently fallen for more than a decade. Americans are currently drinking 25% less soda than they did in 2000. Of course, we're talking about traditional sodas here. Data shows that probiotic and prebiotic sodas are becoming more popular each year, but these tend to have significantly less sugar and additives than their old-school predecessors. A wealth of research over the past two decades has shown that traditional sodas aren't great for your health. 'Regular soda displaces healthier calories because it takes up some room in the stomach, but it also adds a significant amount of calories to someone's diet without any healthful benefit,' Dana Ellis Hunnes, senior dietitian at UCLA Medical Center and assistant professor at the UCLA Fielding School of Public Health, tells Yahoo Life. Regular soda is also packed with sugar. A 20-ounce bottle of Coke contains 240 calories and 65 grams of sugar, for example — that's more than the recommended daily allowance for most people. 'In excess, that sugar can increase your weight, visceral fat and your overall risk for chronic disease — diabetes, heart disease and fatty-liver disease,' Hunnes says. Those realities are pushing some people to give up soda altogether. When that happens, how is their health affected? Yahoo Life talked with with four people who decided to ditch soda for a range of reasons. Here's what we learned. Mina Grace Ward would have six cans of soda or more a day before she finally stopped. 'My mornings always began with a chilled can of Coke for my commute,' she tells Yahoo Life. Her personal office fridge, which held 12 cans of soda, had to be restocked every other day. 'I'd go through a can like it was going out of style,' she says. 'I'd even pop a can at night while going through work emails.' But Ward eventually gave up drinking soda when, a decade ago, she was diagnosed with Graves' disease, an autoimmune condition that causes rapid weight loss, hair loss, high blood pressure, insomnia and more. 'I was sick and tired of feeling like a Mack truck ran me over every day,' she says. After Ward made other significant dietary changes, she started to feel better. 'Even though I continue to live with Graves' disease, I've been able to live with it in full remission for nearly seven years,' she says. 'That's a big deal.' Now she mostly drinks plain water. 'It's the most refreshing, hydrating and good-for-you beverage out there,' she says. Seth Goodman thought about giving up soda for years before he finally ditched the drink in 2018 for one of his New Year's resolutions. 'The choice to give up soda was really inspired by the health, time and financial benefits that I knew would come along with this choice,' the publicist tells Yahoo Life. 'While a single soda is relatively cheap, multiple a day or week add up and were impacting my finances.' Goodman drank soda regularly as a kid, and the habit continued into adulthood. 'This also included really going out of my way to get soda if I was craving it, more specifically Coke,' he says. 'Throughout the days, I would find myself having an urge for McDonald's Coke, leading to multiple trips in a single day.' He admits that it was difficult to avoid soda at first due to constant cravings. 'It took a lot of mental fortitude to resist the urge to drink soda,' he says. But once he stopped drinking soda, Goodman says he immediately noticed he had more energy. 'I was more motivated to move and do activities,' he says. 'It did take time to get past the sugar cravings, but I turned to gum as a way to fight that feeling of needing a soda. After a few weeks, it became natural to not want soda.' Marketing director Terry Wells decided to give up soda in 2020 during the COVID-19 pandemic. At the time, she was drinking two sodas a day — either a Sprite or Orange Crush — although Wells says she would reach for ginger ale if she had an upset stomach. 'I realized during the early days of the COVID pandemic that I was gaining more weight than I wanted sitting home,' she tells Yahoo Life. 'I decided to give up my soda habit and drink more water.' Wells says that it took time, but her cravings for sugar subsided, and she dropped five pounds within three months. 'My husband and I also started walking and working out here at home, which we've continued to do five years later,' she says. Wells says she decided to stick with water, smoothies and chai to satisfy her sweet tooth. Now, when she wants something fizzy, Wells says she'll create soda water with her home machine and add fresh lemon and lime juice. Texas resident Bennett Barrier stopped drinking soda nearly a decade ago after becoming dehydrated at work. The turf installation company owner was working on a stadium when he felt lightheaded in the heat. 'I'd consumed three sodas, but zero water,' he tells Yahoo Life. Before that, Barrier says he would drink up to five sodas a day. 'I had a cola with lunch, orange soda in the taxi and some type of soda reading bids,' he says. 'It was all part of the grind. But it added up, and I didn't like the tightness in my chest at the end of the day.' After Barrier stopped drinking soda, he says the digestion and bloating issues he struggled with in the past went away. 'I no longer had late afternoon headaches,' he says. While Barrier says his sleep was unaffected, his mornings felt more seamless. 'I could wake up, read crew callouts and still carry on a full conversation before coffee,' he says. Barrier says he replaced his soda habit with iced tea, which he makes in bulk. He also adds mint or lemon, based on the season. 'That kept the ritual but took out the syrup,' he says, noting that this swap doesn't make him feel deprived. 'Don't punish yourself for quitting soda,' Barrier says. 'Set it up as a trade — something better that you feel you've earned.' Nutritionists say you needn't give up soda altogether, but it's wise to cut back if it's become part of your routine. 'Soda should be an occasional treat, not a daily habit,' Scott Keatley, a dietitian and co-owner of Keatley Medical Nutrition Therapy, tells Yahoo Life. 'If you drink it every day, your body may be stuck in a cycle of sugar spikes and cravings.' Those can raise your risk of developing type 2 diabetes and also leave you with energy crashes, he says. That's why Keatley suggests cutting back or switching to unsweetened drinks like sparkling water or iced tea. 'It is not about never having soda again,' he says. 'It is about knowing what it does and making choices that support long-term health.' Stacy Cleveland, a dietitian at the Ohio State University Wexner Medical Center, tells Yahoo Life that probiotic sodas may be a good swap for traditional sodas, but says it's important to find options with minimal sugar. And even then, she recommends limiting them. 'When choosing to consume soda, moderation is best. The less, the better,' Cleveland says.
NDTV
06-05-2025
- Health
- NDTV
Bulging Eye Disease Cases Rising Among Women Over 40: Report
Thyroid Eye Disease (TED) is increasingly affecting women over 40, causing bulging eyes due to inflammation and swelling around the eyes. This autoimmune condition often occurs in people with hyperthyroidism (overactive thyroid) or Graves' disease. Common symptoms include: Dry or Gritty Eyes: Irritation and Discomfort Sensitivity to Light: Increased sensitivity Ache Behind the Eyes: Pain that worsens when looking up Bulging Eyes: Eyes protruding from the socket Effects of Proptosis (Bulging Eyes) on Your Well-Being According to the Cleveland Clinic, the condition can affect your appearance, leaving you with a startled expression that doesn't go away. Proptosis (Bulging Eyes) can also make it difficult for you to blink. When you can't blink, the protective outer layer of your eyes (corneas) doesn't receive the lubrication it needs to do its job. You may be at risk for cornea damage. Some people experience other complications, like low vision or double vision (diplopia). Other names for proptosis include bulging eyes, protruding eyes and exophthalmos. TED affects approximately 50,000 people in the UK, with women being five times more likely to develop the condition than men. If left untreated, TED can lead to sight loss and have a devastating impact on mental health. Treatment options include steroids, lubricating eye drops, and surgery. Researchers are exploring new treatments, such as targeted drugs acting on the immune system. Early diagnosis and treatment are crucial to managing symptoms and preventing long-term damage.
Yahoo
29-04-2025
- Business
- Yahoo
Republican chair unveils $15B plan to modernize air traffic control
House Transportation and Infrastructure Committee Chairman Rep. Sam Graves (R-Mo.) released a budget reconciliation proposal Tuesday that would allocate $15 billion for the modernization of air traffic control technology. The funds would go to the Federal Aviation Administration's (FAA) efforts to improve the nation's aviation infrastructure by replacing outdated technology, modernizing the air traffic control radar systems and enhancing the hiring of air traffic controllers. The move comes two months after Transportation Secretary Sean Duffy implemented plans to streamline the air traffic control hiring practices and create a 'supercharge' in staffing amid shortages. 'President Trump and Secretary Duffy are committed to the long-delayed modernization of our antiquated air traffic control system to strengthen American aviation safety, and this proposal begins the work of meeting that goal,' Graves said in a statement. At the start of the year, several aviation accidents, including a deadly collision near Ronald Reagan Washington National Airport and two fatal crashes in Alaska and Pennsylvania, have raised concerns about air safety for travelers, pilots and lawmakers alike. Executive director of the Center for Transportation Jackson Shedelbower called the proposal a 'breath of fresh air' for U.S. travelers. 'Modernizing our nation's aviation infrastructure will ensure that the U.S. maintains its reputation as the global leader in air travel. Congress needs to get a funding package over the finish line so these reforms can get off the ground,' he added. However, the GOP proposal could raise concerns for environmental advocates. If implemented, Graves' plan would eliminate several programs created under former President Biden's Inflation Reduction Act, including the FAA's Alternative Fuel and Low-Emission Aviation Technology Program, and the Federal Highway Administration's Neighborhood Access and Equity Grants, Environmental Review Implementation Funds and Low-Carbon Transportation Materials Grants. It would also require electric vehicle owners to pay into the Highway Trust Fund as proposed by Republican senators in February. Graves' proposal also appropriate $23 billion to the Coast Guard to invest in assets to aid the Trump administration's effort to crack down on illegal immigration as well as drugs coming into the country. The House committee is expected to mull over the proposal on Wednesday. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
The Hill
29-04-2025
- Business
- The Hill
Republican chair unveils $15B plan to modernize air traffic control
House Transportation and Infrastructure Committee Chairman Rep. Sam Graves (R-Mo.) released a budget reconciliation proposal Tuesday that would allocate $15 billion for the modernization of air traffic control technology. The funds would go to the Federal Aviation Administration's (FAA) efforts to improve the nation's aviation infrastructure by replacing outdated technology, modernizing the air traffic control radar systems and enhancing the hiring of air traffic controllers. The move comes two months after Transportation Secretary Sean Duffy implemented plans to streamline the air traffic control hiring practices and create a ' supercharge ' in staffing amid shortages. 'President Trump and Secretary Duffy are committed to the long-delayed modernization of our antiquated air traffic control system to strengthen American aviation safety, and this proposal begins the work of meeting that goal,' Graves said in a statement. At the start of the year, several aviation accidents, including a deadly collision near Ronald Reagan Washington National Airport and two fatal crashes in Alaska and Pennsylvania, have raised concerns about air safety for travelers, pilots and lawmakers alike. Executive director of the Center for Transportation Jackson Shedelbower called the proposal a 'breath of fresh air' for U.S. travelers. 'Modernizing our nation's aviation infrastructure will ensure that the U.S. maintains its reputation as the global leader in air travel. Congress needs to get a funding package over the finish line so these reforms can get off the ground,' he added. However, the GOP proposal could raise concerns for environmental advocates. If implemented, Graves' plan would eliminate several programs created under former President Biden's Inflation Reduction Act, including the FAA's Alternative Fuel and Low-Emission Aviation Technology Program, and the Federal Highway Administration's Neighborhood Access and Equity Grants, Environmental Review Implementation Funds and Low-Carbon Transportation Materials Grants. It would also require electric vehicle owners to pay into the Highway Trust Fund as proposed by Republican senators in February. Graves' proposal also appropriate $23 billion to the Coast Guard to invest in assets to aid the Trump administration's effort to crack down on illegal immigration as well as drugs coming into the country. The House committee is expected to mull over the proposal on Wednesday.
