Teriflunomide

Statistically significant and clinically meaningful results seen in RemIND trial with complete responses achieved in 3 CIndU types 1 Remibrutinib, a highly selective oral BTK inhibitor, was well-tolerated and demonstrated a favorable safety profile, including no liver safety concerns 1 Oral remibrutinib has potential to be first targeted therapy approved for CIndU, which affects estimated 29 million adults worldwide 2,3 Basel, February 18, 2026 – Novartis today announced positive topline results from its pivotal Phase III RemIND trial of oral remibrutinib in chronic inducible urticaria (CIndU) 1 . The primary endpoint was met for the three most prevalent types of CIndU: symptomatic dermographism, cold urticaria and cholinergic urticaria, achieving significantly higher complete response rates versus placebo at Week 12 1 . These data represent an important advance in the treatment of CIndU, demonstrating the potential of remibrutinib to be the first targeted therapy for CIndU and address a major unmet need. “The positive RemIND trial results across three different types of CIndU underscore the potential of oral remibrutinib to achieve complete symptom relief for people living with CIndU and build on its recent FDA approval in chronic spontaneous urticaria (CSU),” said Angelika Jahreis, Global Head, Immunology Development, Novartis. “Today’s findings reinforce that remibrutinib could be the first targeted therapy to improve spontaneous and inducible forms of chronic urticaria, helping address a major gap in care for people living with these conditions.” Novartis has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of remibrutinib for the treatment of symptomatic dermographism, the most prevalent type of CIndU. In the coming months, the full data set will be submitted to health authorities globally, and the RemIND trial findings will be presented in upcoming medical congresses. About remibrutinib Remibrutinib is a highly selective, oral BTK inhibitor that blocks the BTK pathway involved in the release of histamine, a key driver of hives (wheals) and swelling 4 - 6 . By reducing histamine release, remibrutinib helps relieve the symptoms of CIndU 1, 7 . In the US and China, remibrutinib is approved for the treatment of adult patients with CSU who have an inadequate response to H1-antihistamines, under the brand name Rhapsido ® . Remibrutinib is being investigated in other immune-mediated conditions, such as hidradenitis suppurativa (HS) and food allergy, in addition to other indications in the company’s Neuroscience portfolio 8 - 11 . About RemIND trial The RemIND trial (NCT05976243) is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy, safety, and tolerability of remibrutinib in adults with CIndU inadequately controlled by H1-antihistamines 1 2 . The primary endpoint of RemIND is the proportion of complete responders at Week 12 assessed through provocation tests specific to three CIndU subtypes 1 2 . About Chronic Inducible Urticaria (CIndU) CIndU is a chronic skin condition affecting an estimated 0.5 percent of the population or 29 million people worldwide 2,3 . It is a form of chronic urticaria characterized by hives and/or swelling, with identifiable external triggers, like pressure, sunlight, friction, heat, cold or water 1 3 . CIndU differs from chronic spontaneous urticaria (CSU), which has no specific triggers 1 4 . CIndU places a significant burden on daily life, with many patients cycling through antihistamines without adequate relief 1 5 . With no approved targeted therapies available today, there remains a clear and longstanding gap in effective treatment options for these patients 1 5 ,1 6 . The most prevalent CIndU subtypes are symptomatic dermographism, cold urticaria, and cholinergic urticaria 1 7 . Symptomatic dermographism manifests with itchy hives caused by shear force on skin, such as friction or light scratching, which appear in less than 5 minutes after contact and usually last 30 minutes 13 . Cold urticaria occurs after skin exposure to cold, leading to wheals or angioedema that develop within minutes after exposure and are usually limited to exposed areas 1 3 . Cholinergic urticaria manifests with characteristic small, punctate hives triggered by active or passive heating of the body, including exercise, strong emotions, or bathing in hot water 1 3 . About Novartis Immunology At Novartis, we’re advancing bold science with the goal of bringing relief and a renewed sense of hope to people living with autoimmune diseases. Building on our legacy of first-in-class innovation across rheumatology, dermatology and allergy, and a diverse industry-leading pipeline, we’re committed to shaping what’s next in Immunology. Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn , Facebook , X/Twitter and Instagram . References Data on files Maurer M, et al. How to approach Chronic Inducible Urticaria, The Journal of Allergy and Clinical Immunology , 2018, Volume 6, Issue 4, Pages 1119-1130 World Population Prospects, Department of Economic and Social Affairs Population Division, United Nations. Available from: [Last accessed: February 2026] Maurer M, Berger W, Giménez-Arnau A, et al. Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria. J Allergy Clin Immunol 2022 ; 150: 1498-1506. Angst D, Gessier F, Janser P, et al. Discovery of LOU064 (remibrutinib), a potent and highly selective covalent inhibitor of Bruton's Tyrosine Kinase. J Med Chem 2020 ; 63: 5102-5118. Powell RJ, Leech SC, Till S, et al. BSACI guideline for the management of chronic urticaria and angioedema. Clin Exp Allergy 2015; 45: 547-565. Patient. Antihistamines. Last updated 12 October 2022. Available from: [Last accessed: February 2026]. ClinicalTrials.gov. NCT03827798. Study of efficacy and safety of investigational treatments in patients with moderate to severe hidradenitis suppurativa. Available from: . [Last accessed: February 2026] ClinicalTrials.gov. NCT05432388. Study of efficacy, safety and tolerability of remibrutinib in adult participants with an allergy to peanuts. Available from: [Last accessed: February 2026]. ClinicalTrials.gov. NCT05147220. Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis (RMS) (REMODEL-1). Available from: [Last accessed: February 2026]. ClinicalTrials.gov. NCT05156281. Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis (RMS) (REMODEL-2). Available from: [Last accessed: February 2026]. ClinicalTrials.gov. NCT05976243. A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines. Available from: [Last accessed: February 2026]. Pozderac I, et al. Chronic inducible urticaria: classification and prominent features of physical and non-physical types. Acta Dermatovenerol Alp Pannonica Adriat . 2020;29(3):141–8 Zuberbier et al. The international EAACI/GA 2 LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis and management of urticaria. Allergy. 2022;77(3):734–66 M Kern B, et al. Physician estimation of the prevalence and clinical impact of chronic urticaria: results of the global, multicenter UCARE CU-PAPER study, Frontiers in allergy , 2026, volume 6:1732893 Munoz M, et al. New insights into chronic inducible urticaria. Current Allergy and Asthma Reports , 2024 volume 24, 457-469 Kolkhir P, et al. Urticaria. Nat Rev Dis Primers . 2022;8(61) # # # Novartis Media Relations E-mail: media.relations@novartis.com Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: investor.relations@novartis.com

During year 5 of treatment with BRIUMVI the annualized relapse rate was 0.020, equivalent to one relapse occurring every 50 years of patient treatment Overall safety pro BRIUMVI remained consistent over 5 years of continuous treatment, with no new safety signals emerging with prolonged treatment NEW YORK, Feb. 17, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the publication of long term/five-year data from the ongoing open-label extension (OLE) of the Phase 3 ULTIMATE I and II studies evaluating BRIUMVI (ublituximab-xiiy) in adults with relapsing forms of multiple sclerosis (RMS). The manuscript, authored by Bruce A. C. Cree, MD, PhD, MAS, of the University of California, San Francisco, and colleagues, was published in JAMA Neurology . The publication presents a comprehensive long-term evaluation of BRIUMVI and demonstrates durable clinical efficacy, low relapse rates, and a consistent safety pro up to five years of continuous treatment. Additional details from the publication are included below. Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, “Acceptance of these five-year ULTIMATE I & II results in JAMA Neurology represents a major milestone for TG Therapeutics and the MS field. These data underscore not only the durable clinical efficacy and consistent safety of BRIUMVI through extended treatment, but also our commitment to advancing long-term evidence that helps clinicians and patients make informed treatment decisions. We believe these findings support BRIUMVI’s continued role as a valuable option for people living with relapsing MS.” Bruce Cree, MD, PhD, MAS, Zimmermann Endowed Professor in Multiple Sclerosis, and Professor of Neurology at UCSF Weill Institute for Neurosciences, University of California, San Francisco and lead author of this publications noted, “The long-term results from the ULTIMATE I & II open-label extension demonstrate that continued treatment over five years provided sustained clinical benefits, with relapse rates declining further over time and disability progression remaining low. Importantly, the overall safety experience remained consistent over extended follow-up. Together, these findings confirm the long-term benefits of ublituximab and support the early initiation of high-efficacy therapy in relapsing multiple sclerosis to help optimize long-term outcomes for patients.” The manuscript can be accessed at the JAMA Neurology website or at our TG Therapeutics publication page . Title: Five Years of Ublituximab in Multiple Sclerosis: ULTIMATE I and II Open-Label Extension Study The research article reports clinical outcomes from more than 3,600 participant-years of ublituximab exposure. Following completion of the original 96-week double-blind period, more than 85% of eligible participants elected to enroll in the long-term OLE, where they either continued ublituximab or switched from teriflunomide to ublituximab. More than 70% remained on treatment at Year 5, underscoring strong long-term tolerability and treatment adherence. Key Efficacy Results Patients who continued BRIUMVI treatment exhibited low and decreasing annualized relapse rate (ARR) throughout the observation period, ARR: 0.053, 0.032, and 0.020 for Years 3, 4, and 5, respectively. During Year 1 of the open label extension (OLE), patients who switched from teriflunomide to BRIUMVI experienced a significant reduction (-58.4%) in ARR (0.182 vs 0.076). At Year 5, 97.7% of continuous-treatment participants and 95.0% of switch participants remained relapse-free. After 5 years of continuous BRIUMVI treatment, 8% of patients had Confirmed Disability Progression (CDP) lasting 24 weeks compared to 14.3% of patients who switched from teriflunomide to BRIUMVI [HR (95% CI): 0.612 (0.414, 0.904); p=0.0126], and 92% remained progression free with continuous BRIUMVI treatment. 17% of patients treated with BRIUMVI continuously for 5 years achieved Confirmed Disability Improvement (CDI) lasting at least 24 weeks compared to 12.2% of patients who switched from teriflunomide to BRIUMVI [HR (95% CI): 1.472 (1.048, 2.067); p=0.0249], resulting in one in six patients experiencing improvement in disability after 5 years of continuous BRIUMVI treatment. The overall safety pro BRIUMVI remained consistent over 5 years of continuous treatment in an exposure-adjusted analysis of adverse events (AEs), with no new safety signals emerging with prolonged treatment. Immunoglobulin levels remained stable with prolonged BRIUMVI treatment, and the mean IgM and IgG levels remained above the lower limit of normal. There was no association between decreased immunoglobulin levels and risk of serious infections. ABOUT THE ULTIMATE I & II PHASE 3 TRIALS ULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or teriflunomide, the active comparator, given orally as a 14 mg daily dose with IV placebo administered on the same schedule as BRIUMVI. Both studies enrolled patients who had experienced at least one relapse in the previous year, two relapses in the previous two years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline. The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University. Additional information on these clinical trials can be found at (NCT03277261; NCT03277248). ABOUT TG THERAPEUTICS TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI ® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval from several regulatory agencies outside of the U.S. for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. For more information, visit , and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn . BRIUMVI ® is a registered trademark of TG Therapeutics, Inc. ABOUT BRIUMVI ® (ublituximab-xiiy) 150 mg/6 mL Injection for IV BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses. BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in several countries outside of the U.S. for the treatment of adult patients with RMS with active disease defined by clinical or imaging features. A list of authorized specialty distributors can be found at . IMPORTANT SAFETY INFORMATION Contraindications: BRIUMVI is contraindicated in patients with: Active Hepatitis B Virus infection A history of life-threatening infusion reaction to BRIUMVI WARNINGS AND PRECAUTIONS Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization. Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended premedication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment. Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved. Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI. Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment. Progressive Multifocal Leukoencephalopathy (PML): Although no cases of PML have occurred in BRIUMVI-treated MS patients, JC virus infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies. If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis. If PML is confirmed, treatment with BRIUMVI should be discontinued. Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines, at least 4 weeks and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy : In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19 + B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted. Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose. Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy, until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins. Liver Injury: Clinically significant liver injury, without findings of viral hepatitis, has been reported in the postmarketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of MS, including BRIUMVI. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred from weeks to months after administration. Patients treated with BRIUMVI found to have an alanine aminotransaminase (ALT) or aspartate aminotransferase (AST) greater than 3x the upper limit of normal (ULN) with serum total bilirubin greater than 2x ULN are potentially at risk for severe drug-induced liver injury. Obtain liver function tests prior to initiating treatment with BRIUMVI, and monitor for signs and symptoms of any hepatic injury during treatment. Measure serum aminotransferases, alkaline phosphatase, and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. If liver injury is present and an alternative etiology is not identified, discontinue BRIUMVI. Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections. Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit ABOUT BRIUMVI PATIENT SUPPORT in the U.S. BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at ABOUT MULTIPLE SCLEROSIS Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS. 1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS. 1 Cautionary Statement This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below. Such forward-looking statements include but are not limited to statements regarding expectations for the timing and success of the commercialization and availability of BRIUMVI ® (ublituximab-xiiy) for RMS in the United States, or any jurisdictions outside of the United States; anticipated healthcare professional (HCP) and patient acceptance and use of BRIUMVI for the approved indications; expectations of future revenue for BRIUMVI, or TG expenses or profit estimates or targets; expectations and timing for our clinical trials of subcutaneous ublituximab (the active ingredient in BRIUMVI), and sometimes referred to as subcutaneous BRIUMVI, including feasibility, approvability and commercial acceptance; expectations and timing for our ENHANCE Phase 3 trial combining day 1 and day 15 doses, including, feasibility, approvability and commercial acceptance and impact on BRIUMVI sales; and expectations and timing for any of our pipeline products or programs, including Azer-cel or BRIUMVI in MG. Additional factors that could cause our actual results to differ materially include the following: the Company’s ability to continue to commercialize BRIUMVI; the risk that trends in prescriptions are not maintained or that prescriptions are not filled; the failure to obtain and maintain payor coverage; the risk that HCP interest in BRIUMVI will not be sustained; the risk that momentum in sales for BRIUMVI will not be sustained during the course of the year; the risk that the commercialization of BRIUMVI does not continue to exceed expectations; the risk that our BRIUMVI revenue targets will not be achieved; the uncertainties generally inherent in research and development; regulatory developments, legislative actions, executive orders, including the imposition of tariffs and policy changes in the U.S. and other jurisdictions; and general political, economic and business conditions. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our other filings with the SEC. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at . The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. CONTACT: Investor Relations: Email: ir@tgtxinc.com Telephone: 1.877.575.TGTX (8489), Option 4 Media Relations: Email: media@tgtxinc.com Telephone: 1.877.575.TGTX (8489), Option 6 1. MS Prevalence. National Multiple Sclerosis Society website. . Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Datamonitor p. 236.