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TG Therapeutics Announces Data Presentations for BRIUMVI in Multiple Sclerosis at the 2025 Consortium of Multiple Sclerosis Centers Annual Meeting
NEW YORK, May 30, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the presentations of data highlighting BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting. Links to each presentation are included below. 'We were pleased to present three encore presentations yesterday during the CMSC conference. We continue to be impressed by the BRIUMVI data and look forward to continuing to present updated data throughout the year.'TG PRESENTATIONS:Title: No Association between Decreases in Serum Immunoglobulin Levels and Serious Infections with Long-Term Ublituximab Treatment in Patients with Relapsing Multiple Sclerosis Presenting Author: Dr. Bruce Cree - Weill Institute for Neurosciences, University of California, San Francisco, CA Title: Retrospective Evaluation of Infusion Tolerability: Ublituximab Real-World Observational Survey (ENAMOR) Presenting Author: Dr. Edward Fox – TG Therapeutics - National Physician Liaison – VP, MS Global Operations Title: Safety and Tolerability of 30-Minute Ublituximab Infusions: Updates from the ENHANCE Study Presenting 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. i 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 retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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7 days ago
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TG Therapeutics Announces Schedule of Data Presentations for BRIUMVI® in Multiple Sclerosis at the 2025 Consortium of Multiple Sclerosis Centers Annual Meeting
NEW YORK, May 27, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the upcoming schedule of presentations highlighting BRIUMVI® (ublituximab-xiiy) data in patients with relapsing forms of multiple sclerosis (RMS), at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting, being held May 28-31, 2025 in Phoenix, Arizona. Abstracts are now available online and can be accessed on the CMSC meeting website at Details of the upcoming presentations are outlined below. TG PRESENTATIONS:Poster Presentation Title: No Association between Decreases in Serum Immunoglobulin Levels and Serious Infections with Long-Term Ublituximab Treatment in Patients with Relapsing Multiple Sclerosis Presentation Date/Time: Thurs. May 29, 4:40pm MST/7:40pm ET Session: North 122 ABC Abstract & Poster Number: Platform Presentation – PLA-B6 Presenting 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: Poster Session Thurs. May 29, 5:00 - 7:00 pm MST/8pm ET Session: Disease Modifying Therapy - North Exhibit Hall C-E Abstract & Poster Number: DMT08 Presenting Author: Dr. Edward Fox – TG Therapeutics - National Physician Liaison – VP, MS Global Operations Poster Presentation Title: Safety and Tolerability of 30-Minute Ublituximab Infusions: Updates from the ENHANCE Study Presentation Date/Time: Poster Session Thurs. May 29, 5:00 - 7:00 pm MST/8pm ET Session: Disease Modifying Therapy - North Exhibit Hall C-E Abstract & Poster Number: DMT18 Presenting 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 p.236.
Wales Online
09-05-2025
- Wales Online
UK tourist in Majorca 'bites back' calling island 'non tourist friendly'
Our community members are treated to special offers, promotions and adverts from us and our partners. You can check out at any time. More info A UK tourist has slammed the island of Majorca for being too "expensive" and "non-tourist friendly" in a letter written to a local Spanish publication. Edward Fox, a regular holidaymaker in the Spanish islands, hit out at the island following the recent string of anti-tourism protests which have swept much of Spain, including the Balearic Islands, and the Canary Islands. Demonstrations from local people have urged tourists to "go home," with some protests even reported to have grown violent, as one resident held up a sign threatening to "Kill a Tourist" in Tenerife, according to The Mirror. READ MORE: UK tourists in Canary Islands warned 'enough is enough' by anti-tourism activist In response, Edward, who often visits Majorca for up to nine weeks at a time, outlined his feelings over the continued anti-tourism marches in a brutal letter written to the Majorca Daily Bulletin, a Spanish news site for English readers. According to the publication, the Brit's "damning" letter surrounds the protests which occurred in Soller, Majorca recently. Edward explained how he has visited Majorca for 30 years and it has since become "unaffordable" for most British tourists. He said: "Over the last five or six years of me coming to Mallorca I have noticed a drastic increase in not only hotel/apartment accommodation prices but also the increase in food, drink , restaurant prices which is not reflected in the global inflation increases. "It is not in a real comparison to these increases, also the increase of the ' tourist tax' up to approx €4 per person per night is subject to an additional 10 per cent tax ( proposed ) is incredible and unaffordable for most British tourists coming to Mallorca." Edward added he believed the price hikes in Majorca had contributed to the island "losing out to South East Asian countries," for example, Thailand, Vietnam, Cambodia, Philippines and Malaysia. He said: "I would say in South Asian countries it is much cheaper by as much at 60-70 per cent per night, and also a higher standard in South Asian countries, which are an emerging tourist market." READ MORE: Foreign Office urge UK tourists in Spain to claim 'necessary' health item Rounding off his letter, the holidaymaker left the bulletin with a bold comment, stating "us tourists do bite back, and me personally and many hundreds of thousands of tourists have bitten back." The full section read: 'So go ahead Mallorca, bite the hand that has come to this island, put so much money into your tourism, infrastructure, government, hoteliers pockets etc etc for the best part of 40 years. "Us tourists do bite back, and me personally and many hundreds of thousands of tourists have bitten back. "As a seasoned traveller to Mallorca it is getting far to expensive and non tourist friendly and every thing is so not worth visiting or holidaying in this island until your Balearic Government and the people of Mallorca realise this.' During the last protest on the island, it was reported by the Majorca Daily Bulletin that some holidaymakers and expats confronted residents wearing shirts with the word "guiris" on, with some non-Spanish residents calling the word racist. The word is used to described English-speaking foreigners, but according to The Mirror, that has slowly expanded to include northern European tourists as a whole.
Daily Mirror
09-05-2025
- Daily Mirror
Tourist slams Spanish island in brutal 'rip-off' letter as Brits priced out
Riled by 'drastic' price increases on hotels and restaurants, a passionate British tourist has slammed Spain for making one of its most popular islands completely 'unaffordable' The extent of Spain's escalating anti-tourist rhetoric has been laid bare - and it seems Brits are paying the full price quite literally. Last year, the country witnessed a record-breaking 94 million international visitors flock to its mainland, and slew of insatiably popular islands. It was an unprecedented tourist boom that quickly descended into chaos, motivating droves of fed-up locals to take to the street and demand holidaymakers 'go home'. The string of confrontational protests has kept their momentum, with activists vowing to 'intensify' their efforts ahead of the looming summer season. Demonstrations have even taken a violent spin in recent months- with one shocking sign threatening to 'Kill a Tourist' popping up in Tenerife. Reports also suggest anonymous locals set fire to rental cars - often used by tourists to explore the island - to make their message clear. Despite the furore, it seems some Brits are willing to persevere - unable to image a world without their beloved Costa del sun. Edward Fox, who has been holidaying in Mallorca for more than three decades, visits the island for up to nine weeks every single year. In a brutal letter sent to Majorca Daily Bulletin - a Spanish news site for English readers - Edward passionately argued the island has undergone a 'drastic' up-charge on accommodation as well as food and drink prices. He insists these rising prices are 'not reflective' of global inflation figures, and is worsened by growing 'tourist tax' levies that can sting travellers with up to €4 fees per night. The Spain-enthusiast went on to claim Mallorca is now 'unaffordable' for most British tourists - who are now opting to visit cheaper destinations such as 'Thailand, Vietnam, Cambodia, and the Philippines'. "So go ahead Mallorca, bite the hand that has came to this island put so much money into your tourism, infrastructure, government , hoteliers pockets etc etc for the best part of 40 years," Edward wrote. "Us tourists 'Do Bite Back', and me personally and many hundreds of thousands of tourists have bitten back. As a seasoned traveller to Mallorca it is getting far too expensive and non tourist friendly and everything is so not worth visiting or holidaying on this island until your Balearic Government and the people of Mallorca realise this." Edward also raised issue with locals referring to tourists as 'guiris'. This is a word that describes English-speaking foreigners, but has slowly expanded to include northern European tourists as a whole. Article continues below Despite Edward's concerns, it seems most Brits aren't fazed by rising costs or growing hostility. New data published by Spain's National Institute of Statistics (Instituto Nacional de Estadistica) found a staggering 810,045 international visitors flocked to the Balearics during the first three-months of 2025 - a 3.6 per cent increase compared to the year before. However, with threats of more planned protests in the summer - Brits may start listening to the demands of frustrated locals, who argue that over-tourism is worsening the country's housing crisis. In fact, hotel bookings in Tenerife - one of Spain's most popular hotspots - have already warned of a hotel booking 'slump' ahead of the peak season.
Associated Press
07-04-2025
- Entertainment
- Associated Press
Celebrity birthdays for the week of April 13-19
Celebrity birthdays for the week of April 13-19: April 13: Actor Edward Fox is 88. Singer Lester Chambers of The Chambers Brothers is 85. Composer Bill Conti ('Rocky' film theme) is 83. Musician Jack Casady of Jefferson Airplane is 81. Musician Al Green is 79. Actor Ron Perlman is 75. Actor William Sadler ('Wonderfalls,' ″Roswell') is 75. Singer Peabo Bryson is 74. Drummer Max Weinberg of the E Street Band (and 'Late Night With Conan O'Brien') is 74. Keyboardist Jimmy Destri (Blondie) is 71. Comedian Gary Kroeger ('Saturday Night Live') is 68. Actor Saundra Santiago ('Miami Vice') is 68. Guitarist Joey Mazzola (Sponge) is 64. Actor Page Hannah (TV's 'Fame') is 61. Actor-comedian Caroline Rhea ('Sabrina the Teenage Witch,' ″The Biggest Loser') is 61. Bassist Lisa Umbarger (The Toadies) is 60. Guitarist Marc Ford (Black Crowes) is 59. Actor Ricky Schroder is 55. Singer Aaron Lewis of Staind is 53. Actor Bokeem Woodbine (TV's 'Fargo,' ″Saving Grace') is 52. Singer Lou Bega is 50. Actor Glenn Howerton ('It's Always Sunny in Philadelphia') is 49. Actor Kyle Howard ('Royal Pains') is 47. Actor Kelli Giddish ('Law & Order: SVU') is 45. Actor Courtney Peldon ('Boston Public') is 44. Singer Nellie McKay is 43. Rapper Ty Dolla $ign is 43. Actor Allison Williams ('Girls') is 37. Actor Hannah Marks ('Necessary Roughness') is 32. April 14: Actor Julie Christie is 85. Guitarist Ritchie Blackmore is 80. Actor John Shea ('Gossip Girl,' ″Lois and Clark') is 77. Actor Peter Capaldi ('Dr. Who,' ″The Musketeers') is 67. Actor-turned-racecar driver Brian Forster ('The Partridge Family') is 65. Actor Brad Garrett ('Everybody Loves Raymond') is 65. Actor Robert Carlyle ('Once Upon a Time') is 64. Singer-guitarist John Bell of Widespread Panic is 63. Actor Catherine Dent ('The Shield') is 60. Drummer Barrett Martin (Screaming Trees) is 58. Actor Anthony Michael Hall is 57. Actor Adrien Brody is 52. Singer David Miller of Il Divo is 52. Rapper Da Brat is 51. Actor Antwon Tanner ('One Tree Hill') is 50. Actor Sarah Michelle Gellar is 48. Actor Rob McElhenney ('It's Always Sunny in Philadelphia') is 48. Musician JD McPherson is 48. Singer Win Butler of Arcade Fire is 45. Actor Claire Coffee ('Grimm') is 45. Actor Nick Krause ('The Descendants') is 33. Actor Graham Phillips ('The Good Wife') is 32. Actor Vivien Cardone ('Everwood') is 32. Actor Skyler Samuels ('Scream Queens') is 31. Actor Abigail Breslin ('Little Miss Sunshine') is 29. April 15: Actor Claudia Cardinale ('Pink Panther' films) is 87. Singer-guitarist Dave Edmunds is 82. Actor Michael Tucci ('Diagnosis Murder,' 'It's Garry Shandling's Show') is 79. Actor Lois Chiles ('Austin Powers,' 'Moonraker') is 78. Actor Amy Wright is 75. Actor Sam McMurray ('The King of Queens,' 'The Tracey Ullman Show') is 73. Actor Emma Thompson is 66. Singer Samantha Fox is 59. Guitarist Ed O'Brien of Radiohead is 57. Actor Flex Alexander ('One on One') is 55. Actor Danny Pino ('Cold Case') is 51. Country singer Chris Stapleton is 47. Actor Luke Evans ('The Hobbit') is 46. Drummer Patrick Carney of The Black Keys is 45. Bassist Zach Carothers of Portugal. The Man is 44. Actor Seth Rogen is 43. Actor Alice Braga ('I Am Legend') is 42. Singer-songwriter Margo Price is 42. Drummer De'Mar Hamilton of Plain White T's is 41. Actor Samira Wiley ('Orange Is the New Black') is 38. Actor Leonie Elliott ('Call the Midwife') is 37. Actor Emma Watson ('Harry Potter' movies) is 35. Actor Maisie Williams ('Game of Thrones') is 28. April 16: Singer Bobby Vinton is 90. Midnight Oil singer-turned-politician Peter Garrett is 72. Actor Ellen Barkin is 71. Actor Michel Gill ('Mr. Robot,' 'House of Cards') is 65. Singer-bassist Jason Scheff (Chicago) is 63. Singer Jimmy Osmond is 62. Singer David Pirner of Soul Asylum is 61. Actor Jon Cryer is 60. Actor-comedian Martin Lawrence is 60. Actor Peter Billingsley ('A Christmas Story') is 54. Actor Lukas Haas is 49. Broadway actress Kelli O'Hara is 49. Actor Sadie Sink ('Stranger Things') is 23. April 17: Actor David Bradley ('Game of Thrones') is 83. Musician Jan Hammer is 77. Actor Clarke Peters ('Treme') is 73. Rapper Afrika Bambaataa is 68. Actor Sean Bean ('Lord of the Rings') is 66. Actor Joel Murray ('Dharma and Greg,' ″The Artist') is 63. Singer Maynard James Keenan of Tool and of Puscifer is 61. Actor Lela Rochon is 61. Actor William Mapother ('Lost') is 60. Actor Leslie Bega ('The Sopranos') is 58. Actor Henry Ian Cusick ('Scandal,' ″Lost') is 58. Actor Kimberly Elise is 58. Singer Liz Phair is 58. Rapper-actor Redman is 55. Actor Jennifer Garner is 53. Singer-designer Victoria Beckham of the Spice Girls is 51. Actor Lindsay Korman ('All My Children,' 'Passions') is 47. Actor Tate Ellington ('The Brave,' 'Quantico') is 46. Actor Charlie Hofheimer ('24: Legacy') is 44. Actor Rooney Mara ('The Girl With the Dragon Tattoo') is 40. Actor Dee Dee Davis ('The Bernie Mac Show') is 29. April 18: Actor Robert Hooks is 88. Actor Hayley Mills is 79. Actor Dorothy Lyman ('Mama's Family') is 78. Actor Cindy Pickett ('Ferris Bueller's Day Off') is 78. Keyboardist Walt Richmond of The Tractors is 78. Actor James Woods is 78. Bassist Jim Scholten of Sawyer Brown is 73. Actor Rick Moranis is 72. Actor Eric Roberts is 69. Actor Melody Thomas Scott ('The Young and the Restless') is 69. Actor John James ('Dynasty,' ″The Colbys') is 69. Bassist Les Pattinson of Echo and the Bunnymen is 67. Actor Jane Leeves ('Hot In Cleveland,' ″Frasier') is 64. Ventriloquist Jeff Dunham is 63. Actor Eric McCormack ('Will and Grace') is 62. Talk show host Conan O'Brien is 62. Actor Maria Bello is 58. Actor Mary Birdsong ('Reno 911!') is 57. Actor David Hewlett ('Stargate: SG-1') is 57. Actor-rapper Fredro Starr of Onyx ('Moesha') is 54. Actor David Tennant ('Harry Potter and the Goblet of Fire') is 54. Guitarist Mark Tremonti of Creed and of Alter Bridge is 51. Singer Trina of Trina and Tamara is 51. Actor Melissa Joan Hart ('Sabrina the Teenage Witch') is 49. Actor Bryce Johnson ('Pretty Little Liars') is 48. TV personality Kourtney Kardashian is 46. Actor America Ferrera (film's 'Barbie,' TV's 'Ugly Betty') is 41. Actor Tom Hughes ('Victoria') is 40. Actor Ellen Woglom ('Marvel's Inhumans') is 38. Actor Vanessa Kirby ('The Crown') is 37. Actor Alia Shawkat ('Arrested Development') is 36. Actor Britt Robertson ('Under the Dome') is 35. Actor Chloe Bennet ('Marvel's Agents of S.H.I.E.L.D.,' ″Nashville') is 33. Singer Nathan Sykes of The Wanted is 32. Actor Moises Arias ('Hannah Montana') is 31. April 19: Actor Elinor Donahue ('Dr. Quinn, Medicine Woman,' 'Father Knows Best') is 88. Keyboardist Alan Price of The Animals is 83. Actor Tim Curry is 79. Singer Mark 'Flo' Volman of The Turtles is 78. Actor Tony Plana ('Ugly Betty') is 73. Actor Tom Wood ('The Fugitive,' 'Ulee's Gold') is 62. Death Row Records co-founder Suge Knight is 60. Country singer Bekka Bramlett of Bekka and Billy is 57. Actor Kim Hawthorne ('Greenleaf') is 57. Actor Ashley Judd is 57. Singer Luis Miguel is 55. Actor Jennifer Esposito ('Blue Bloods') is 53. Actor Jennifer Taylor ('Two and a Half Men') is 53. Singer Madeleine Peyroux is 51. Actor James Franco is 47. Actor Kate Hudson is 46. Actor Hayden Christensen ('Star Wars Episodes II and III') is 44. Actor Catalina Sandino Moreno ('Che,' ″Maria Full of Grace') is 44. Actor Ali Wong ('American Housewife') is 43. Actor Victoria Yeates ('Call the Midwife') is 42. Drummer Steve Johnson of Alabama Shakes is 40. Actor Courtland Mead ('Kirk') is 38.
