Core Insights - Roche announced that fenebrutinib, an investigational BTK inhibitor, met its primary endpoint of non-inferiority compared to OCREVUS in reducing disability progression in patients with primary progressive multiple sclerosis (PPMS), showing a 12% reduction in risk [1][5][6] Group 1: Study Results - The Phase III FENtrepid study involved 985 adult patients with PPMS, comparing daily oral fenebrutinib to intravenous OCREVUS for at least 120 weeks [7][12] - Fenebrutinib demonstrated a consistent treatment effect on the composite confirmed disability progression (cCDP12) across various patient subgroups, with curves separating as early as 24 weeks [1][2] - A post-hoc analysis indicated fenebrutinib was superior to OCREVUS on a composite endpoint, showing a 22% reduction in risk [3] Group 2: Treatment Effects - The strongest treatment effect was observed on the nine-hole peg test (9HPT), with a 26% reduction in the risk of worsening compared to OCREVUS [2] - Fenebrutinib showed a consistent clinical benefit in upper limb function, which is crucial for maintaining independence [3] Group 3: Safety Profile - Adverse events in the fenebrutinib group were comparable to OCREVUS, with infections occurring in 67.0% of patients on fenebrutinib versus 70.9% on OCREVUS [4] - Transient liver enzyme elevations were more frequent in the fenebrutinib group (13.3% vs 2.9% for OCREVUS), but all cases resolved after discontinuation [4] Group 4: Future Developments - Roche plans to submit regulatory applications for fenebrutinib in both PPMS and relapsing multiple sclerosis (RMS) following the readout of the second pivotal RMS study, FENhance 1, expected in mid-2026 [5][6]

Core Insights - Roche announced that fenebrutinib, an investigational BTK inhibitor, met its primary endpoint of non-inferiority compared to OCREVUS in reducing disability progression in patients with primary progressive multiple sclerosis (PPMS), showing a 12% reduction in risk of disability progression [1][5] - The treatment effect was consistent across patient subgroups and observed as early as 24 weeks, particularly benefiting upper limb function [3][5] Study Details - The FENtrepid study was a Phase III multicenter, randomized, double-blind trial involving 985 adult patients with PPMS, comparing daily oral fenebrutinib to intravenous OCREVUS for at least 120 weeks [7] - The primary endpoint was the time to onset of 12-week composite confirmed disability progression (cCDP12), which included measures of functional disability, walking speed, and upper limb function [8] Treatment Efficacy - Fenebrutinib demonstrated a 26% reduction in the risk of worsening upper limb function compared to OCREVUS [2] - A post-hoc analysis indicated fenebrutinib was superior to OCREVUS on a composite endpoint including two components of cCDP12, with a 22% reduction in risk [3] Safety Profile - Adverse events in the fenebrutinib group were comparable to OCREVUS, with infections occurring in 67.0% of patients on fenebrutinib versus 70.9% on OCREVUS [4] - Transient liver enzyme elevations were more common in the fenebrutinib group (13.3% vs 2.9% for OCREVUS), but all cases resolved after discontinuation of the drug [4] Future Developments - Roche plans to submit regulatory applications for fenebrutinib in both PPMS and relapsing multiple sclerosis (RMS) following the readout of the second pivotal RMS study, FENhance 1, expected in mid-2026 [5][6]

Core Insights - Immunic, Inc. is presenting additional data from its phase 2 CALLIPER trial for vidofludimus calcium at the ACTRIMS Forum 2026, highlighting its potential in treating progressive multiple sclerosis (PMS) [1][2] Group 1: Trial Data and Findings - The CALLIPER trial data indicates that treatment with vidofludimus calcium resulted in a significant reduction in gadolinium-enhancing lesions from 16.4% at baseline to 7.0% at week 72 and 0% at week 120, compared to placebo [1] - The proportion of patients with new and/or enlarging T2 lesions was 18.5% in the vidofludimus calcium group versus 30.0% in the placebo group at week 72, with statistically significant differences in mean change of T2 lesion volume at weeks 48, 72, and 96 [1] - Statistically significant reductions in slowly expanding lesions (SEL) were observed at week 96, with least squares means of 2.935 for vidofludimus calcium and 3.840 for placebo (p<0.05) [1] Group 2: Antiviral Effects - Data from a subset of 87 participants showed that patients treated with vidofludimus calcium experienced a progressive decline in EBV-specific T-cell receptor matches over time, indicating reduced EBV reactivations during treatment, with a statistically significant difference (p=0.0004) compared to placebo [2] - The findings support the hypothesis that vidofludimus calcium's broad-spectrum antiviral effects may lower EBV reactivations, potentially addressing MS disease progression related to ongoing EBV reactivations [2] Group 3: Drug Profile and Company Overview - Vidofludimus calcium is an investigational oral small molecule drug targeting chronic inflammatory and autoimmune diseases, currently in late-stage clinical trials for multiple sclerosis [2] - The drug combines neuroprotective, anti-inflammatory, and antiviral effects by activating the Nurr1 transcription factor and selectively inhibiting dihydroorotate dehydrogenase (DHODH) [2] - Immunic, Inc. is a late-stage biotechnology company focused on developing novel oral therapies for neurologic and gastrointestinal diseases, with its lead program in phase 3 trials for relapsing multiple sclerosis [2]

Core Viewpoint - AB Science has received a Japanese patent for the use of masitinib in treating progressive forms of multiple sclerosis (MS), providing intellectual property protection until February 2041, marking Japan as the first country to grant this patent [1][2]. Group 1: Patent and Market Position - The patent granted in Japan (JP 7788154) is the first for masitinib in progressive MS, following a similar successful patent strategy for amyotrophic lateral sclerosis (ALS) [2]. - AB Science is optimistic about obtaining global patent protection for masitinib in progressive MS, similar to its ALS patent [2]. - The company is pursuing a secondary medical use patent strategy for various indications, including progressive MS, Alzheimer's Disease, and prostate cancer, with protection extending into the 2040s [3]. Group 2: Clinical Studies and Efficacy - Masitinib has shown a unique and competitive positioning in treating both primary progressive multiple sclerosis (PPMS) and non-active secondary progressive multiple sclerosis (nSPMS) [3]. - The development of masitinib is supported by positive results from phase 2b/3 study (AB07002) and the confirmatory phase 3 MAXIMS study (AB20009), with the former showing a statistically significant reduction in disability progression [3][4]. - In study AB07002, masitinib 4.5 mg/kg/day reduced the risk of first disability progression by 42% and improved manual dexterity, with a significant reduction in the risk of reaching an EDSS score of 7.0 [3][4]. Group 3: Safety Profile - The safety profile of masitinib is well characterized, based on data from over 4,300 patients, with no increased risk of infection observed [5][6]. - Masitinib is the first and only drug in phase 3 trials designed to target both mast cells and microglia, which is an effective strategy for treating progressive forms of MS [8]. - Unlike BTK inhibitors, masitinib does not target B-cells, which are associated with increased infection risk, making it a safer option for patients with progressive MS [6][8]. Group 4: Medical Need and Market Context - There is a significant medical need for treatments targeting progressive forms of MS, which affect over 100,000 people in France alone, with no definitive treatment currently available [10]. - Progressive forms of MS account for approximately 50% of all MS cases, highlighting the unmet medical need in this patient population [13]. - Recent failures of BTK inhibitors in clinical trials for MS further emphasize the demand for effective therapies like masitinib [14].

BRIUMVI Market Position and Growth - BRIUMVI is the first and only anti-CD20 therapy for Relapsing forms of Multiple Sclerosis (RMS) delivered in a 1-hour infusion every 6 months after the starting dose[9, 21] - Anti-CD20s capture approximately 50% of the dynamic and overall Multiple Sclerosis (MS) market share, representing a ~$10 billion market in the U S today[12] - BRIUMVI has achieved significant uptake, with >97% of the top 200 MS centers using it and ~90% of high decile Healthcare Professionals (HCPs) prescribing it[16] - The company's goal is to become the 1 prescribed anti-CD20 in RMS based on dynamic market share[14] Financial Performance and Guidance - Cumulative BRIUMVI U S net revenue LTD is approximately $992 million[19] - BRIUMVI U S net revenue for Q4 2025 was approximately $182 million, and for FY 2025, it was approximately $594 million[19] - Total global revenue for FY 2025 was approximately $616 million, representing ~90% growth from FY 2024 to FY 2025 and ~20% growth from Q3 2025 to Q4 2025[19] - The company projects FY 2026 total global net revenue to be approximately $875-900 million, with U S net revenue of approximately $825-850 million[45] Pipeline Expansion and Future Launches - The company is developing a consolidated dosing schedule for IV BRIUMVI, with a target launch in 2027, pending top-line data from the ENHANCE pivotal study expected in mid-2026[27, 33] - A self-administered subcutaneous (SubQ) formulation of BRIUMVI is in development, with a target launch in 2028, pending top-line data expected by YE26/Q1 27[27, 38] - The SubQ formulation is expected to significantly increase the total addressable market by reaching a distinct patient segment, augmenting the current IV business[39, 41]

Preliminary total global full year 2025 revenue of approximately $616 million Preliminary BRIUMVI U.S. fourth quarter and full year 2025 net product revenue of approximately $182 million and $594 million, respectivelyFull Year 2026 target total global revenue of approximately $875-900 million, including BRIUMVI U.S. net product revenue of approximately $825-850 million NEW YORK, Jan. 13, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics), today announced prelimina ...

Core Insights - Immunic Inc's CEO highlighted significant milestones in 2025, particularly the phase 2 CALLIPER study, which showed a 31% reduction in confirmed disability worsening in progressive multiple sclerosis (MS) patients and a 34% reduction in those without baseline gadolinium lesions, indicating a potential neuroprotective effect of vidofludimus calcium [1][5] Clinical Developments - The CALLIPER study results suggest that vidofludimus calcium can address both inflammatory and non-inflammatory processes driving disability progression in MS, benefiting patients with relapsing forms of the disease [6] - Long-term data from the EMPhASIS study indicated that 92.3% of relapsing-remitting MS patients remained free of 12-week confirmed disability worsening after 144 weeks, with only 13.8% of events being independent of relapses, supporting the drug's efficacy [2][7] Patent and Strategic Positioning - Immunic has strengthened its patent position for vidofludimus calcium, potentially securing exclusivity until 2041 in key markets, which provides a significant competitive advantage [3][8] - Early findings on IMU-856 in celiac disease showed increases in natural GLP-1 levels, suggesting potential applications in gut health and weight management [3][8] Future Outlook - Enrollment in the phase 3 ENSURE trials is complete, with top-line data expected by the end of 2026, which is crucial for FDA submission and potential market launch [9][10] - The company is preparing for a New Drug Application (NDA) submission and aims for a commercial launch in 2028, contingent on FDA approval [11]

Core Insights - Sanofi's regulatory submission for tolebrutinib in non-relapsing secondary progressive multiple sclerosis (nrSPMS) is expected to face delays, with further guidance from the FDA anticipated by the end of Q1 2026 [1][2] - The company has submitted an expanded access protocol for tolebrutinib, demonstrating its commitment to providing access to this investigational therapy for eligible patients [2] - Tolebrutinib is an oral, brain-penetrant Bruton's tyrosine kinase inhibitor designed to target neuroinflammation, a key factor in disability progression in multiple sclerosis [5][6] Company Overview - Sanofi is an R&D driven biopharma company focused on improving lives through innovative treatments, particularly in neurology and immunoscience [7] - The company is committed to addressing significant unmet needs in multiple sclerosis and other neuro-inflammatory and neuro-degenerative conditions [6][7] - Sanofi's neurology pipeline includes several projects in phase 3 studies across various diseases, indicating a robust commitment to advancing treatment options [6]

Core Insights - Immunic Inc emphasizes the long-term clinical potential of its lead compound, vidofludimus calcium, in treating multiple sclerosis (MS), focusing on disease progression rather than just symptom relief [1][5]. Group 1: Importance of Long-term Focus - The fear of losing independence due to MS is significant for patients, as the disease often affects young adults at critical life stages [2]. - Long-term disease progression is crucial to understand, as MS is a chronic autoimmune disease that impacts patients' lives over decades [4]. - Focusing on long-term progression allows for better treatment options that help patients maintain independence and improve quality of life [9]. Group 2: Clinical Outcomes and Research - Vidofludimus calcium shows promise in protecting nerve cells and reducing nerve damage, with clinical studies indicating it can slow down disease progression [5][7]. - The compound has demonstrated the ability to delay and halt progression in some patients, with some even experiencing improvements in abilities [6]. - Long-term data suggests that vidofludimus calcium can reduce the risk of confirmed disability worsening, addressing underlying processes of long-term disability in MS [7]. Group 3: Future of MS Research - Progress in understanding the biology and pathophysiology of MS provides hope for developing better protective approaches for neurological function and quality of life [10]. - The work of Immunic is aimed at enabling individuals with MS to maintain independence and lead fulfilling lives for as long as possible [11].

Core Insights - Immunic Inc's CEO Dr. Daniel Vitt highlighted the company's advancements in its oral MS treatment, vidofludimus calcium, during the third quarter and at the 2025 ECTRIMS conference, showcasing significant clinical study data [1][5]. Clinical Study Results - The CALLIPER study demonstrated a statistically significant effect on confirmed disability improvement in patients, indicating the treatment's efficacy [2][6]. - In the EMPhASIS phase 2 open-label extension trial, 92.3% of patients remained free of 12-week confirmed disability worsening after 144 weeks, showcasing the drug's durability and favorable safety profile [3][7]. Upcoming Trials and Goals - The ENSURE phase 3 trials in relapsing MS are set to provide topline data in 2026, with the primary endpoint focusing on time to first relapse, which is crucial for drug approval [4][10]. - Secondary endpoints aim to confirm the drug's neuroprotective potential, consistent with findings from previous studies [11][12]. Intellectual Property and Market Position - Recently granted US patents enhance the commercial protection for vidofludimus calcium in both relapsing and progressive MS, potentially extending market exclusivity beyond 2041 [4][13]. Future Milestones - The most significant upcoming milestone is the phase 3 data readout from the ENSURE studies at the end of next year, which is expected to be pivotal for the company and MS patients [14].