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Techday NZ
4 days ago
- Business
- Techday NZ
Netskope named leader in SASE & SSE by major industry analysts
Netskope has been recognised by several industry analysts for its performance in the Security Service Edge (SSE) and Secure Access Service Edge (SASE) markets. The company received the highest scores in three out of four Use Cases in the 2025 Gartner Critical Capabilities report for Secure Access Service Edge (SASE) Platforms. In addition, Netskope was ranked among the top two vendors for all Use Cases in both the 2025 Critical Capabilities report for SSE and the 2025 Critical Capabilities report for SASE Platforms. Gartner also recognised Netskope as a Leader for the second consecutive year in its 2025 Magic Quadrant for SASE Platforms, and as a Leader for the fourth consecutive year in its 2025 Magic Quadrant for Security Service Edge. Gartner positioned Netskope furthest in its vision axis in both Magic Quadrants for SASE Platforms and SSE. The company also achieved Leader status in the 2025 IDC MarketScape for Data Loss Prevention (DLP) and was acknowledged as a Leader in SSE by Forrester Research in 2024. Netskope supports organisations in modernising for the cloud and artificial intelligence era by combining security, network, and analytics products within its unified Netskope One platform. This architecture incorporates zero trust principles and SkopeAI, the company's suite of proprietary AI technologies, to optimise access, safeguard data, mitigate threats, and facilitate secure connectivity from any location. Netskope One operates via the NewEdge network, which the company describes as a large-scale global private security cloud network. The Netskope One platform encompasses requirements for SSE and SASE, integrating features such as Software-Defined Wide Area Networking (SD-WAN), Cloud Access Security Broker (CASB), Next-Generation Secure Web Gateway (Next-Gen SWG), Zero Trust Network Access (ZTNA), Remote Browser Isolation (RBI), Enterprise Browser, Data Security Posture Management (DSPM), Data Loss Prevention (DLP), Firewall-as-a-Service (FWaaS), and Digital Experience Management (DEM). Gartner recognition The 2025 Gartner Critical Capabilities report assessed the solutions from 11 vendors across four key Use Cases for SASE platforms. Netskope scored highest in the Foundational SASE Platform Use Case, Zero Trust SASE Platform Use Case, and "Coffee Shop" Networking Use Case. For the Secure Branch Network Modernisation Use Case, Netskope recorded the second highest score among the evaluated vendors. "We are very proud of our continued leadership in SASE, SSE, and other high-growth market categories," said Parag Thakore, Chief Product Officer, SASE, Netskope. "The power of our Netskope One platform means customers can benefit from advanced capabilities without trade-offs between security and network performance." Ed Fox, Chief Technology Officer at MetTel, commented on the collaboration between the organisations and Netskope's reputation in the SASE and SSE markets. "We've worked with Netskope on integrating our global networks to deliver their leading SASE platform with our fully managed services and providing award-winning, AI-powered SASE solutions to enterprise and government teams worldwide," said Fox. "We believe that Netskope's leadership in SASE and SSE pairs very well with MetTel's 5-time Leader recognition in the Gartner Magic Quadrant for Managed Network Services." Recent product enhancements Netskope has made several recent enhancements to its SASE offerings. The Netskope One Orchestrator, referred to as One Console, is a unified SASE console with scalable four-tier multi-tenant management. It supports centralised policy, data, and analytics management for SD-WAN and SSE from a single interface, scaling from midmarket to global enterprise environments with advanced security, networking, observability, and granular role-based access control. One Gateway provides wireless connectivity options such as 5G with eSIM and Wi-Fi 6, supporting deployment as physical or virtual appliances in branches, data centres, or across multiple clouds. These gateways are designed to reduce the reliance on multiple point products and can run SD-WAN and additional AI-powered services, supporting both Netskope and third-party networking and security services. The Netskope One Client is a unified SASE client that consolidates SD-WAN and Endpoint DLP with SSE, including ZTNA, SWG, RBI, and CASB. This eliminates the need for multiple agents and provides secure, optimised access to all applications. It also supports full VPN retirement and universal ZTNA capabilities to ensure a consistent experience regardless of user location. Netskope's NewEdge infrastructure, comprising the One Network, offers global coverage with full-compute SSE and SD-WAN capabilities at every data centre. It delivers route control to address ISP issues rapidly and provides integrated secure SD-WAN services for a range of networking requirements, including site-to-site, site-to-cloud, and cloud-to-cloud connections. The Zero Trust Engine, or One Engine, is designed to analyse applications and cloud services to manage content, context, application, device, and user risk. The intelligence generated feeds into SSE and SD-WAN for detailed, context-aware policies, and references a database of more than 83,000 applications rated by the Netskope Cloud Confidence Index. The platform supports automated application prioritisation, including for Software-as-a-Service (SaaS) and generative AI applications. Netskope One Gateway and SSE features are also integrated with switches and access points from multiple vendors, embedding AI-driven controls and enforcing segmentation policies dynamically.
Yahoo
08-04-2025
- Business
- Yahoo
TG Therapeutics Announces Data Presentations for BRIUMVI in Multiple Sclerosis at the American Academy of Neurology 2025 Annual Meeting
NEW YORK, April 08, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the presentation of data highlighting BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the American Academy of Neurology 2025 annual meeting. Links to each presentation are included below. Michael S. Weiss, Chief Executive Officer and Chairman of TG Therapeutics stated, "We were pleased to share three presentations yesterday which we believe demonstrate our continued commitment to improving the patient experience and understanding the long term and real-world profile of BRIUMVI.' Mr. Weiss continued, 'The results of the retrospective ENAMOR survey, which includes data from approximately 400 individuals across 21 MS centers who have been treated with BRIUMVI in the real-world setting, showed a favorable tolerability profile, including a lower rate of infusion related reactions at the first BRIUMVI dose than was observed in the ULTIMATE Phase 3 trials. Interestingly, approximately 90% of surveyed patients were given acetaminophen as a pre-medication in this real-world setting, whereas it was excluded as a premed as per protocol in the ULTIMATE Phase 3 trials potentially offering a rationale for the lower rate of infusion related reactions observed. We plan to further evaluate the efficacy and tolerability of BRIUMVI in the real world setting through the ENABLE Phase 4 96-week observational study which will enroll approximately 500 patients across approximately 100 MS centers in the United States. Lastly, we were encouraged to see in the presentation by Dr. Steinman, that after five years of BRIUMVI treatment, the frequency of serious infections remained consistent with the ULTIMATE Phase 3 trials and there were no observed cases of PML.' TG PRESENTATIONS:Poster Title: Retrospective Evaluation of Infusion Tolerability: Ublituximab Real-World Observational Survey (ENAMOR) Lead Author: Dr. Ed Fox – TG Therapeutics - National Physician Liaison – VP, MS Global Operations Poster Title: ENABLE: The First Phase 4 Observational Study for Patients with Relapsing MS Treated with Ublituximab in Real World Clinical Setting Lead Author: Dr. Ed Fox – TG Therapeutics - National Physician Liaison – VP, MS Global Operations Poster Title: No Association Between Decreases in Serum Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN) and Serious Infections (SI) with Long-term Ublituximab (UBL) Treatment in Patients with Relapsing Multiple Sclerosis (RMS) Lead Author: Lawrence Steinman, MD, Standford University, Standford, CA The above presentations are also available on the Publications page, located within the Pipeline section, of the Company's website at ABOUT THE ULTIMATE I & II PHASE 3 TRIALSULTIMATE 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 BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IVBRIUMVI 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 for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing- remitting disease, and active secondary progressive disease. A list of authorized specialty distributors can be found at IMPORTANT SAFETY INFORMATIONContraindications: 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 pre-medication 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. 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. Although no cases of PML have occurred in BRIUMVI-treated MS patients, JCV 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. 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. 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. A pregnancy test is recommended in females of reproductive potential prior to each infusion. 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. 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 SUPPORTBRIUMVI 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 SCLEROSISRelapsing 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 ABOUT TG THERAPEUTICSTG 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 has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. For more information, visit and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn. BRIUMVI® is a registered trademark of TG Therapeutics, Inc. Cautionary StatementThis 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 the results of the ULTIMATE I & II Phase 3 studies, the ENHANCE Phase 3b study, and BRIUMVI as a treatment for relapsing forms of multiple sclerosis (RMS). Additional factors that could cause our actual results to differ materially include the following: the risk that the data from the ULTIMATE I & II or ENHANCE trials that we announce or publish may change, or the product profile of BRIUMVI may be impacted, as more data or additional endpoints are analyzed; the risk that data may emerge from future clinical studies or from adverse event reporting that may affect the safety and tolerability profile and commercial potential of BRIUMVI; the risk that any individual patient's clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials such as ULTIMATE I and II; the risk that BRIUMVI will not be commercially successful; our ability to expand our commercial infrastructure, and successfully market and sell BRIUMVI in RMS; the Company's reliance on third parties for manufacturing, distribution and supply, and a range of other support functions for our commercial and clinical products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements; the uncertainties inherent in research and development; and general political, economic and business conditions, including the risk that the ongoing COVID-19 pandemic could have on the safety profile of BRIUMVI and any of our other drug candidates as well as any government control measures associated with COVID-19 that could have an adverse impact on our research and development plans or commercialization efforts. 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 U.S. Securities and Exchange Commission. 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 RelationsEmail: ir@ (8489), Option 4 Media Relations:Email: media@ (8489), Option 6 1. MS Prevalence. National Multiple Sclerosis Society website: Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Datamonitor in to access your portfolio
Associated Press
27-03-2025
- Business
- Associated Press
MetTel SD-WAN Soars to New Heights over Starlink as 2025 TMC Internet Telephony Product of the Year
NEW YORK, March 27, 2025 /PRNewswire/ -- MetTel, a leading digital transformation and communications solutions provider, today announced that MetTel SD-WAN solution, delivered over Starlink's laser mesh satellite network, won the 2025 Internet Telephony Product of the Year Award by TMC and Internet Telephony magazine. This award recognizes that MetTel SD-WAN is among the most innovative and groundbreaking products in the communications industry. MetTel SD-WAN is a comprehensive and flexible solution designed to optimize network performance, enhance security, and simplify management for large and mid-sized enterprises and government organizations. Leveraging innovative technology, MetTel SD-WAN intelligently routes traffic across multiple network connections, including MPLS, broadband internet, cellular, and even satellite links like Starlink, ensuring optimal application performance and minimizing latency. MetTel's role as an Authorized Starlink Reseller serves as a key differentiator, delivering reliable, ubiquitous connectivity to even the most remote locations. This integration extends the reach of managed network services globally, offering high-performance solutions for businesses operating in areas with limited terrestrial infrastructure. This capability is particularly valuable for industries such as energy, mining, and maritime, or government missions with far-flung operations, where reliable connectivity is essential for operational efficiency and safety. In one real-world application, MetTel's SD-WAN over Starlink proved to be a game-changer for a large energy company operating in remote oil fields where traditional connectivity was unreliable. By implementing the solution, the energy company established a robust and reliable network connection across its remote sites, enabling real-time monitoring and management of field operations, improving communication, coordination, and enhancing the safety of field personnel. 'This recognition further underscores MetTel's commitment to seeing the future and bringing it to our customers today,' said MetTel Chief Technology Officer Ed Fox. 'Our SD-WAN solution, enhanced by Starlink's satellite connectivity, represents a next generation network configuration, designed to meet the evolving needs of businesses in today's dynamic market, providing them with the performance, security, and flexibility they need to succeed.' About MetTel MetTel is a global communications solutions provider for businesses and government agencies. We design, deploy and manage tailored connectivity and networking solutions for voice, data, mobility, and IoT by leveraging our global private network and the industry's broadest portfolio. MetTel delivers unparalleled customer experience with enhanced productivity and cost-savings, freeing organizations to focus on their core operations. For more information visit follow us on X (@OneMetTel) and LinkedIn, or call us directly at (877) 963-8663. MetTel. Connect Smarter. ™ 347.420.0957
Yahoo
07-03-2025
- Business
- Yahoo
TG Therapeutics Announces Schedule of Data Presentations for BRIUMVI® (ublituximab) in Multiple Sclerosis at the American Academy of Neurology 2025 Annual Meeting
NEW YORK, March 07, 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 American Academy of Neurology 2025 annual meeting, being held April 5 - 9, 2025, in San Diego, California. Abstracts are now available online and can be accessed on the AAN meeting website at Details of the upcoming presentations are outlined below. TG PRESENTATIONS: Poster Presentation Title: No Association Between Decreases in Serum Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN) and Serious Infections (SI) with Long-term Ublituximab (UBL) Treatment in Patients with Relapsing Multiple Sclerosis (RMS) Presentation Date/Time: Monday, April 7, from 5:00 PM–6:00 PM PT Session: P7: Multiple Sclerosis: Disease-modifying Therapies: Real-world Evidence and Adverse Events 1 Abstract Number/Poster Number: 4695/P017 in Neighborhood 1 Lead Author: Dr. Bruce Cree - Weill Institute for Neurosciences, University of California, San Francisco, CA Poster Presentation Title: Retrospective Evaluation of Infusion Tolerability: Ublituximab Real-World Observational Survey (ENAMOR) Presentation Date/Time: Monday, April 7, from 5:00 PM–6:00 PM PT. Session: P7: Multiple Sclerosis: Disease-modifying Therapies: Real-world Evidence and Adverse Events 1 Abstract Number/Poster Number: 5121/P015 in Neighborhood 1. Lead Author: Dr. Ed Fox – TG Therapeutics - National Physician Liaison – VP, MS Global Operations Poster Presentation Title: ENABLE: The First Phase 4 Observational Study for Patients with Relapsing MS Treated with Ublituximab in Real World Clinical Setting Presentation Date/Time: Monday, April 7, from 5:00 PM–6:00 PM PT. Session: P7: Multiple Sclerosis: Disease-modifying Therapies: Real-world Evidence and Adverse Events 1 Abstract Number/Poster Number: 4773/P014 in Neighborhood 1 Lead Author: Dr. Ed Fox – TG Therapeutics - National Physician Liaison – VP, MS Global Operations Poster Presentation Title: Five years of Ublituximab in Relapsing Multiple Sclerosis: Additional Results from the Open-label Extension of ULTIMATE I and II Studies Presentation Date/Time: Wednesday, April 9, from 8:00 AM–9:00 AM PT Session: P11: Multiple Sclerosis: Clinical and Translational Research in MS 1 Abstract Number/Poster Number: 2928/P006 in Neighborhood 1 Lead Author: Dr. Bruce Cree - Weill Institute for Neurosciences, University of California, San Francisco, CA Poster Presentation Title: Efficacy and Safety of a Modified Ublituximab Regimen (ENHANCE) Presentation Date/Time: Wednesday, April 9, from 8:00 AM–9:00 AM PT Session: P11: Multiple Sclerosis: Clinical and Translational Research in MS 1 Abstract Number/Poster Number: 4799/P009 in Neighborhood 1 Lead Author: Dr. John Foley – Rocky Mountain Multiple Sclerosis, Salt Lake City, Utah Following the presentations, the data presented will be available on the Publications page, located within the Pipeline section, of the Company's website at ABOUT THE ULTIMATE I & II PHASE 3 TRIALSULTIMATE 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 BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IVBRIUMVI 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 for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing- remitting disease, and active secondary progressive disease. A list of authorized specialty distributors can be found at IMPORTANT SAFETY INFORMATIONContraindications: 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 pre-medication 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. 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. Although no cases of PML have occurred in BRIUMVI-treated MS patients, JCV 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. 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. 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. A pregnancy test is recommended in females of reproductive potential prior to each infusion. 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. 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 SUPPORTBRIUMVI 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 SCLEROSISRelapsing 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 ABOUT TG THERAPEUTICSTG 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 has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. For more information, visit and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn. BRIUMVI® is a registered trademark of TG Therapeutics, Inc. Cautionary StatementThis 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 the results of the ULTIMATE I & II Phase 3 studies, the ENHANCE Phase 3b study, and BRIUMVI as a treatment for relapsing forms of multiple sclerosis (RMS). Additional factors that could cause our actual results to differ materially include the following: the risk that the data from the ULTIMATE I & II or ENHANCE trials that we announce or publish may change, or the product profile of BRIUMVI may be impacted, as more data or additional endpoints are analyzed; the risk that data may emerge from future clinical studies or from adverse event reporting that may affect the safety and tolerability profile and commercial potential of BRIUMVI; the risk that any individual patient's clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials such as ULTIMATE I and II; the risk that BRIUMVI will not be commercially successful; our ability to expand our commercial infrastructure, and successfully market and sell BRIUMVI in RMS; the Company's reliance on third parties for manufacturing, distribution and supply, and a range of other support functions for our commercial and clinical products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements; the uncertainties inherent in research and development; and general political, economic and business conditions, including the risk that the ongoing COVID-19 pandemic could have on the safety profile of BRIUMVI and any of our other drug candidates as well as any government control measures associated with COVID-19 that could have an adverse impact on our research and development plans or commercialization efforts. 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, 2023 and in our other filings with the U.S. Securities and Exchange Commission. 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 RelationsEmail: ir@ (8489), Option 4 Media Relations:Email: media@ (8489), Option 6 1. MS Prevalence. National Multiple Sclerosis Society website: Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Datamonitor in to access your portfolio
