Core Insights - Quantum BioPharma Ltd. has appointed Dr. Jack Antel as a new clinical advisor for its multiple sclerosis program, Lucid-MS, which is designed to inhibit demyelination in MS [1][4][5] - Dr. Antel is a prominent clinical neurologist and expert in MS, with extensive experience and numerous publications in the field [2] - The company aims to advance Lucid-MS into a Phase 2 clinical trial to assess its efficacy in MS patients [4] Company Overview - Quantum BioPharma is focused on developing innovative biopharmaceutical solutions for neurodegenerative and metabolic disorders, including alcohol misuse [8][9] - The company’s lead compound, Lucid-MS, is a patented new chemical entity that has shown potential in preventing and reversing myelin degradation in preclinical models [9] - Quantum BioPharma retains a 20.10% ownership stake in Unbuzzd Wellness Inc., which is associated with royalty payments from sales of the unbuzzd™ product [9]

An unheralded New York–listed biotech is chasing one of neurology’s biggest goals: a pill that not only tamps down the inflammatory flares of multiple sclerosis but also directly protects the brain from the slow, steady damage that leaves many patients disabled. Immunic Inc (NASDAQ:IMUX) is developing vidofludimus calcium, an oral medicine it says is “first-in-class” because it combines two mechanisms: one to reduce relapses and magnetic resonance imaging (MRI) lesions, and another aimed at shielding neuron ...

Core Insights - Novartis announced new data on Kesimpta® (ofatumumab) for relapsing multiple sclerosis (RMS) to be presented at ECTRIMS 2025 Annual Meeting [1] - The studies demonstrate significant efficacy and safety of Kesimpta in patients who switched from other therapies [2][3] Study Findings - The ARTIOS Phase IIIb study showed a low annualized relapse rate (ARR) of 0.06 over 96 weeks for patients switching to Kesimpta, with over 90% achieving no evidence of disease activity (NEDA-3) [2][6] - The ALITHIOS study indicated that more than 90% of recently diagnosed treatment-naïve patients achieved NEDA-3 at seven years, highlighting long-term efficacy [3][6] Safety Profile - No new safety concerns were reported in both studies after switching to Kesimpta, reinforcing its favorable safety profile [2][3] Product Overview - Kesimpta is a targeted B-cell therapy administered via subcutaneous injection, approved in over 92 countries, with more than 150,000 patients treated as of August 2025 [5][6] Company Background - Novartis has over 80 years of experience in tackling neurological conditions and continues to develop transformative treatments in multiple sclerosis and other neurological diseases [7]

Core Insights - Novartis announced new data on Kesimpta (ofatumumab) for relapsing multiple sclerosis (RMS) at the ECTRIMS 2025 Annual Meeting, highlighting its efficacy and safety in patients who switched from other therapies [1][2][3] Study Findings - The ARTIOS Phase IIIb study demonstrated a low annualized relapse rate (ARR) of 0.06 over 96 weeks for patients switching to Kesimpta after breakthrough disease on fingolimod or fumarate-based therapies, with over 90% achieving no evidence of disease activity (NEDA-3) [2][6] - The ALITHIOS extension study showed that more than 90% of recently diagnosed treatment-naïve patients on first-line Kesimpta maintained NEDA-3 status at seven years, indicating long-term efficacy [3][6] Safety Profile - No new safety concerns were reported in both studies following the switch to Kesimpta, reinforcing its favorable safety profile [2][3][4] Product Information - Kesimpta is a targeted B-cell therapy administered via subcutaneous injection, approved in over 92 countries, with more than 150,000 patients treated as of August 2025 [5][6] Company Background - Novartis has over 80 years of experience in tackling neurological conditions and continues to develop transformative treatments in multiple sclerosis and other neurological diseases [7]

Core Insights - Roche presents new data for OCREVUS and fenebrutinib at ECTRIMS 2025, highlighting significant advancements in multiple sclerosis treatment [1][2][3] Group 1: OCREVUS Efficacy and Safety - OCREVUS shows significant benefits in preventing disability progression in various MS patient groups, including children and pregnant women [2][3] - Phase III data confirm that OCREVUS maintains a consistent benefit-risk profile for up to two years, with near-complete suppression of relapses and disability progression [4][8] - In the ORATORIO-HAND study, OCREVUS demonstrated a 30% reduction in the risk of 12-week composite confirmed disability progression in advanced PPMS patients compared to placebo [6][9] Group 2: Fenebrutinib Development - Phase II data for fenebrutinib indicate near-complete suppression of disease activity at 96 weeks, with ongoing Phase III trials [14][15] - Fenebrutinib is designed to address unmet medical needs in MS by inhibiting both B-cell and microglia activation [19] Group 3: Pediatric and Pregnancy Outcomes - Data from the ocrelizumab pregnancy registry show no increased risk of adverse pregnancy or infant outcomes with OCREVUS exposure [10][11] - Infants exposed to OCREVUS during pregnancy or breastfeeding exhibited strong antibody responses to vaccines, indicating effective immune recognition [11][12] Group 4: Research and Development Focus - Roche is committed to advancing neuroscience research, with over a dozen medicines under investigation for neurological disorders, including multiple sclerosis [22][23]

NEW YORK, Sept. 10, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the upcoming schedule of presentations highlighting BRIUMVI® (ublituximab-xiiy) data in patients with relapsing forms of multiple sclerosis (RMS), at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, being held September 24 - 26, 2025 in Barcelona, Spain. Abstracts are now available online and can be accessed on the ECTRIMS meeting website or at the followin ...

Company Overview - Immunic Therapeutics is a clinical-stage biopharmaceutical company focused on developing oral therapies for chronic inflammatory and autoimmune diseases[5] - The company's lead drug candidate, Vidofludimus Calcium, has a peak sales potential of $3-7 billion in Multiple Sclerosis (MS)[5] - As of June 30, 2025, Immunic had a cash balance of $55.3 million[5] Clinical Pipeline - Vidofludimus Calcium's Phase 2 EMPhASIS trial in Relapsing-Remitting Multiple Sclerosis (RRMS) was successfully completed, showing a reduction in disability worsening[6] - The CALLIPER trial for Progressive Multiple Sclerosis (PMS) with Vidofludimus Calcium also showed substantial reductions in disability worsening[6] - Top-line data for the ENSURE trials (ENSURE-1 and ENSURE-2) in Relapsing Multiple Sclerosis (RMS) are expected by the end of 2026[6] Vidofludimus Calcium Efficacy - The EMPhASIS trial showed a 78% reduction in cumulative unique active (CUA) lesions and a 74% reduction in Gadolinium-enhancing (Gd+) lesions with the 45mg dose compared to placebo[44] - In the CALLIPER trial, Vidofludimus Calcium demonstrated a 24% risk reduction of 24-week confirmed disability worsening (24wCDW) in the overall study population[94] - A 34% reduction of 24wCDW was observed in patients without baseline inflammatory lesions in the CALLIPER trial[95] Market Opportunity - The Multiple Sclerosis (MS) market is large and growing, with many brands generating over $1 billion in global annual sales in 2024[100] - The MS therapies market is currently a $20 billion market growing at 4% year-over-year[101] - Vidofludimus Calcium has a potential peak sales of $1-2 billion for Relapsing MS (RMS), $1-2 billion for non-active Secondary Progressive MS (naSPMS), and $2-3 billion for Primary Progressive MS (PPMS)[108]

Core Insights - Immunic Inc's CEO Dr. Daniel Vitt highlighted the promising results from the Phase 2 CALLIPER trial of vidofludimus calcium, showing a 24% reduction in disability progression across the full study population, with over 30% reduction in patients with primary progressive MS [1][2]. Clinical Progress - The CALLIPER study aimed to analyze the neuroprotective effect of vidofludimus calcium in patients with progressive forms of multiple sclerosis, addressing a significant unmet medical need [2]. - The CALLIPER data is deemed important for various forms of MS, including primary progressive, secondary progressive, and relapsing MS, with ongoing Phase 3 ENSURE studies expected to benefit from the drug's neuroprotective features [3]. Trial Enrollment and Milestones - The company completed enrollment for both ENSURE trials, involving a total of 2,200 patients, marking a significant milestone in the quarter [4]. - The trials are set to read out next year, indicating a step closer to potential new treatment options for patients with relapsing MS [4]. EMPhASIS Trial Results - New data from the Phase 2 EMPhASIS trial indicated that over 90% of patients treated with vidofludimus calcium for 144 weeks were free of disability progression, showcasing the drug's effectiveness [6]. Financial Position - The company strengthened its balance sheet through two financings, positioning itself well to advance its clinical trials, particularly the Phase 3 studies in relapsing MS [7][8].

Core Insights - Immunic, Inc. has made significant clinical advancements with its lead asset, vidofludimus calcium, particularly in multiple sclerosis treatment, showing promising results in various trials [2][11] - The company has completed enrollment for its phase 3 ENSURE trials, with top-line data expected by the end of 2026, indicating progress towards a potential new treatment option for relapsing multiple sclerosis [2][11] - Financially, Immunic has strengthened its balance sheet with two financings totaling $70.1 million in gross proceeds, although it reported a net loss of approximately $27 million for the second quarter of 2025 [6][9] Clinical Developments - The phase 2 CALLIPER trial demonstrated a 23.8% reduction in time to 24-week confirmed disability worsening in the overall progressive multiple sclerosis population compared to placebo, with even higher reductions in specific subgroups [2][7] - Long-term open-label extension data from the phase 2 EMPhASIS trial showed that 92.3% of patients remained free of 12-week confirmed disability worsening at week 144, reinforcing the drug's efficacy [2][6] - Vidofludimus calcium's neuroprotective effects are believed to be mediated through activation of the Nurr1 target, which may address the complex pathophysiology of multiple sclerosis [2][11] Financial Performance - Research and Development (R&D) expenses for the second quarter of 2025 were $21.4 million, an increase from $18.3 million in the same period of 2024, primarily due to higher external development costs related to vidofludimus calcium [6][8] - General and Administrative (G&A) expenses also increased to $5.7 million for the second quarter of 2025, compared to $4.5 million in the prior year [8] - The company reported a net loss of approximately $27 million for the second quarter of 2025, with a net loss per share of $0.20, reflecting a slight improvement from a net loss of $21.4 million in the same quarter of 2024 [9][14] Market Potential - The market for primary progressive multiple sclerosis is estimated to exceed $6 billion, with vidofludimus calcium positioned as a promising treatment option in this underserved area [2][11] - The company is also preparing for further clinical testing of IMU-856, which targets gastrointestinal disorders and may offer a novel therapeutic approach [3][4]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was reported at $141.1 million, which includes U.S. net product revenue of $138.8 million, representing a 91% increase compared to the same period last year and a 16% growth over Q1 2025 [21][22] - GAAP net income for the quarter was $28.2 million, or $0.17 per diluted share, compared to $6.9 million, or $0.04 per diluted share, for Q2 2024 [23] Business Line Data and Key Metrics Changes - The flagship product, BREONVY, generated net sales of approximately $139 million in Q2 2025, exceeding internal expectations and building on robust growth from Q1 [14] - The adoption rate of BREONVY is estimated at nearly one in every three new IV anti-CD20 patients, indicating significant market penetration [7] Market Data and Key Metrics Changes - The CD20 class generates over $8 billion in annual U.S. MS sales, with BREONVY steadily increasing its market share within this expanding market [15] - The company is focused on expanding its addressable market by developing a subcutaneous formulation of BREONVY, which could unlock access to 35% to 40% of the anti-CD20 market segment that prefers self-administered options [8] Company Strategy and Development Direction - The company aims to position BREONVY as the most prescribed anti-CD20 therapy for relapsing MS, with ongoing efforts to enhance patient experience and expand treatment options [6][11] - A national television campaign has been launched to increase patient awareness, with early signs indicating a positive impact on brand recognition [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued growth for BREONVY, raising full-year U.S. revenue guidance to $560 million to $575 million for 2025 [19] - The company anticipates stronger growth from Q3 to Q4, accounting for seasonal trends and increased patient enrollments [27] Other Important Information - The company reported total operating expenses of approximately $71 million for Q2 2025, an increase from $46.9 million in 2024, driven by R&D investments [22][23] - The company closed the quarter with approximately $279 million in cash and equivalents, maintaining a strong capital position for future investments [24] Q&A Session Summary Question: Guidance and Growth Expectations - Management acknowledged seasonality in summer and expects stronger growth from Q3 to Q4, which is reflected in the raised guidance [26][27] Question: Market Dynamics and Competitors - The company captures about one-third of the IV segment, with competitors sharing the remaining market [31] - There are no current signs of demand for subcutaneous options outpacing IV, but the company is actively developing its own subcutaneous formulation [32] Question: Subcutaneous Product Development - The subcutaneous product will initially be tested with a syringe from a vial, followed by a bridging study to an auto-injector [36] Question: Revenue Guidance and Market Trends - Management noted that the overall IV market is stable, with limited enthusiasm for competitor products [43][44] Question: Product Adherence and Q3 Guidance - The company did not provide specific Q3 guidance but indicated strong persistence rates for BREONVY [54][55]