On January 13, 2026 Bayer AG reported the strategic focus for its Pharmaceuticals Division in 2026 on the occasion of the 44th J.P. Morgan Healthcare Conference in San Francisco.

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Capitalizing on new launch momentum, the company will drive significant global regulatory expansions and market penetration across its pharmaceutical portfolio. High-value commercial products and an accelerating modality-rich pipeline across oncology, cardiology, neurology, and immunology have firmly cemented the Pharmaceuticals Division’s growth for the coming years. Five pivotal worldwide approvals in 2025 underscore a landmark year of strategic execution, validating the successful advancement of Bayer’s ambitious pharmaceutical growth strategy.

"We are now clearly seeing the success of our strategy. We have fundamentally accelerated Bayer Pharmaceutical’s growth runway with multiple high-impact launches across oncology, cardiology, and women’s health," said Stefan Oelrich, Member of the Board of Management, Bayer AG, and President of Bayer’s Pharmaceuticals Division. "Our strategic focus remains on delivering transformative medicines to patients faster, powered by our cutting-edge R&D expertise, dynamic operating model, partnership-driven innovation, AI-enabled development, and commitment to commercial excellence. Our Pharmaceuticals Division is poised for sustainable growth over the coming years."

Innovating to capture additional market opportunity in cardiovascular and cerebrovascular medicine

Bayer is advancing its global leadership in cardiovascular disease management through world-class science, strategic partnerships, and a high-value pipeline designed to deliver both patient and shareholder impact.

Asundexian, an investigational, once daily, oral Factor XIa inhibitor, has been investigated as a potential treatment for secondary stroke prevention. Each year, approximately 12 million people worldwide will experience a stroke. Of these, 20-30% will be a recurrent stroke.1,2 Despite available secondary stroke prevention options, the risk of secondary stroke remains high; one in five stroke survivors will have another stroke within five years.3 Stroke is the second leading cause of death globally, and recurrent ischemic strokes tend to be more disabling and carry a higher mortality risk than the first stroke.2,4,5 Topline data from the Phase III OCEANIC-STROKE study showed it met its primary safety and efficacy endpoints. OCEANIC-STROKE is the first successfully completed Phase III study of a Factor XIa inhibitor and these results underscore the blockbuster potential of asundexian in secondary stroke prevention. Asundexian has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke.

Additionally, Bayer is driving forward its global leadership in cardiovascular and renal disease, leveraging integrated capabilities and robust partnerships to unlock new value streams. The FDA and Japan’s Ministry of Health, Labour and Welfare (MHLW), among other regulatory authorities, have approved finerenone (marketed as Kerendia) for patients with heart failure with left ventricular ejection fraction (LVEF) of ≥40%, based on the positive results from the pivotal Phase III study FINEARTS-HF, further building on its established efficacy in chronic kidney disease (CKD) associated with type 2 diabetes. Applications in HF with LVEF ≥40% are under review in additional markets, including the EU and China. Ongoing, dedicated Phase III heart failure and chronic kidney disease programs (MOONRAKER and THUNDERBALL) continue to evaluate Kerendia’s potential across a broad spectrum of patients and clinical settings of Cardiovascular-Kidney-Metabolic (CKM) conditions. In November 2025, late-breaking, topline data from the Phase III study FINE-ONE presented at the American Society of Nephrology’s Kidney Week showed it met its primary safety and efficacy endpoints. For important risk and use information about KERENDIA, please see the full Prescribing Information.

The European Commission granted marketing authorization for Beyonttra (acoramidis), marketed by Bridge Bio in the U.S., to treat wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Beyonttra slows the amyloidogenic process that results in ATTR-CM.

Beyond current successes, Bayer is actively shaping the future of cardiology with a robust and diversified pipeline, strategically positioned to address critical unmet needs and drive significant long-term value. This includes AB-1002, an investigational single-dose gene therapy in development for congestive heart failure (CHF) developed together with AskBio Inc., a wholly owned subsidiary of Bayer. AB-1002 is progressing well in Phase II. Its Phase I results were published in Nature Medicine and it has been granted Pioneering Regenerative Medical Product designation (SAKIGAKE) by Japan’s MHLW.

Additionally, Bayer has initiated the Phase II SIRIUS study of BAY-3018250, a first-in-class anti–alpha-2 antiplasmin (α2AP) antibody designed to enable targeted thrombolysis in deep vein thrombosis (DVT), and a Phase I clinical study of BAY-3670549, an investigational, highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor, with the potential to help control the electrical activity of heart cells in patients with atrial fibrillation. Bayer’s commitment to cutting-edge science is further underscored by the company’s licensed dilated cardiomyopathy program with Dewpoint Therapeutics, which leverages condensate biology to develop genotype-guided therapies for dilated cardiomyopathy patients with specific genetic mutations. Concurrently, securing exclusive rights in Japan to aficamten from Cytokinetics—a cardiac myosin inhibitor in development for hypertrophic cardiomyopathy—strengthens Bayer’s precision cardiology footprint and expands its strategic market access.

Oncology growth engine: Leveraging blockbuster assets and precision pipeline for future leading position

Bayer’s oncology portfolio is delivering significant patient benefit and commercial success, with blockbuster Nubeqa (darolutamide) continuing its exceptional global uptake, progressing towards a market-leading position. With over 200,000 patients treated worldwide and a third approval in prostate cancer in both the U.S. and Europe, Nubeqa continues its strong growth trajectory. Total global sales are on the rise in all markets. Third approval in China is anticipated in 2026. Its comprehensive clinical development program is exploring Nubeqa’s potential in earlier prostate cancer settings, with two additional Phase III readouts expected in 2027 and 2028. Darolutamide, under the brand name Nubeqa is approved for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with ADT, with or without chemotherapy, and with ADT alone in non-metastatic castration-resistant prostate cancer (nmCRPC) in patients who are at high risk of developing metastatic disease. For important risk and use information about Nubeqa, please see the full Prescribing Information.

Adding to this momentum in oncology, the FDA granted accelerated approval for Bayer’s Hyrnuo (sevabertinib) for adult patients with locally advanced or metastatic non-squamous HER2-mutant non-small cell lung cancer (NSCLC), who have received prior systemic therapy. Approval followed Breakthrough Therapy Designations from both the FDA and China’s CDE and was based on results from the SOHO-01 study. Bayer received Breakthrough Therapy Designation in the US and China for sevabertinib as a first-line treatment for patients with HER2-mutant non-small cell lung cancer. The Breakthrough Therapy Designations are supported by preliminary clinical evidence from cohort F (patients who had not previously received treatment) of the ongoing Phase I/II SOHO-01 study. Sevabertinib addresses unmet needs for a patient population with limited treatment options. In addition to SOHO-01 the clinical program for sevabertinib includes ongoing trials evaluating its effectiveness as a first-line treatment for HER2-mutant NSCLC and in patients with metastatic solid tumors harboring HER2 activating mutations, excluding advanced NSCLC. For important risk and use information about Hyrnuo, please see the full Prescribing Information.

As pioneers in Targeted Radionuclide Therapy (TRT), Bayer was instrumental in helping establish Targeted Alpha Therapies (TATs) as a standard of care for patients with metastatic castration resistant prostate cancer (mCRPC) with bone metastases. The EORTC PEACE III study evaluating radium-223 dichloride (marketed as Xofigo) in combination with enzalutamide met its primary endpoint. An additional Phase III clinical study with radium-223 dichloride will be completed in 2026 and will guide decisions regarding future regulatory steps. Radium-223 dichloride is approved under the brand name Xofigo in over 50 countries for mCRPC patients with symptomatic bone metastases and no known visceral metastatic disease. For important risk and use information about Xofigo, please see the full Prescribing Information.

Bayer’s oncology pipeline is advancing precision-driven therapies, making pivotal progress by targeting challenging tumor types and previously undruggable mechanisms, proteins or pathways resistant to current therapies. This includes multiple investigational agents for KRAS-mutant cancers (an internal SOS1 inhibitor, and a partnership with Kumquat for a KRAS G12D inhibitor), next-generation TATs (225Ac-GPC3 for advanced hepatocellular carcinoma), and a PRMT5 inhibitor (from Suzhou Puhe BioPharma) for MTAP-deleted tumors, all of which have entered Phase I. Further strengthening its discovery engine, Bayer secured worldwide rights to the clinical-stage Werner helicase inhibitor (VVD 214) via Vividion, whose R&D capabilities were expanded through new facilities and the acquisition of Tavros Therapeutics. These strategic investments underscore Bayer’s commitment to driving groundbreaking innovation and securing long-term growth in oncology.

Menopause management: advancing care for women with diverse needs

Bayer achieved a big step forward in women’s health with the recent regulatory approvals of Lynkuet (elinzanetant) for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. It is the only hormone-free therapy approved in the EU for both moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy for breast cancer. These milestones follow consistent positive results across all four Phase III clinical studies (OASIS 1- 4). For important risk and use information about Lynkuet, please see the full Prescribing Information.

Developing a comprehensive cell and gene therapy (CGT) portfolio

Multiple regulatory priority designations granted by authorities in the U.S., Europe and Japan and across Bayer’s CGT portfolio reflect the potential of these programs to deliver transformative patient impact. Bemdaneprocel, an investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson’s disease, developed with Bayer’s wholly owned subsidiary BlueRock Therapeutics, entered pivotal evaluation in a Phase III study. AskBio’s ametefgene parvec (AB-1005), an investigational gene therapy, is being assessed in a Phase II study in moderate stage Parkinson’s disease. The first participant has been randomized in Germany while recruitments in the U.S., UK and Poland are ongoing. In ophthalmology, BlueRock’s OpCT-001, an iPSC-derived photoreceptor cell therapy for primary photoreceptor diseases, received FDA Fast Track designation and is progressing in its Phase I/IIa study.

Radiology: Advancing innovation and expanding into Molecular Imaging

Bayer continues to advance innovation in medical imaging with gadoquatrane, its investigational low-dose magnetic resonance imagining (MRI) contrast designed to reduce the gadolinium dose by up to 60% compared to other macrocyclic MRI contrast agents. Building on positive Phase III results, Bayer has submitted marketing authorization applications in key markets worldwide, including the U.S., EU, Japan, and China. Complementing progress in its existing portfolio, Bayer announced the strategic acquisition of two investigational radiotracers – AT-01 (a Positron Emission Tomography or PET tracer in Phase III of clinical development) and AT-05 (a tracer for Single Photon Emission Computed Tomography, or SPECT, currently in Phase I) – for the diagnosis of cardiac amyloidosis. This step marks Bayer’s entry into diagnostic tracers and underscores its ambition to expand in molecular imaging, aiming to broaden diagnostic options and enhance patient outcomes.

(Press release, Bayer, JAN 13, 2026, View Source [SID1234662029])

On January 13, 2026 Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, reported the continued expansion of its molecular residual disease (MRD)i portfolio designed to help clinicians detect cancer recurrence earlier than traditional imaging. The expanded offerings include Labcorp Plasma Detect ID, a whole exome sequence-guided, personalized panel for patients with stage I–III breast cancer or stage I–IIIA non-small cell lung cancer, and the nationwide availability of Labcorp Plasma Detect Genome, a whole-genome MRD test for stage III colon cancer.

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Despite advancements in treatment, cancer recurrence rates remain a significant concern for patients and clinicians. Approximately 35% of stage III colon cancer patients will experience recurrence after treatment, along with 10% to 40% of patients with stage I-III breast cancer, and 10% to 55% of patients with stage I–III non-small cell lung cancer.

MRD testing helps clinicians track a patient’s risk of cancer recurrence by detecting small traces of circulating tumor DNA (ctDNA) in a patient’s bloodstream following treatment. This can signal molecular recurrence months before clinical relapse appears on traditional imaging or causes symptoms. Both Labcorp Plasma Detect ID and Labcorp Plasma Detect Genome MRD tests can detect ctDNA down to a limit of detection (LOD95) of 0.005%. Earlier detection allows oncologists to tailor surveillance strategies and helps inform next steps, offering patients greater clarity during a critical period of uncertainty.

"For patients who have completed cancer treatment with curative intent, ongoing monitoring is essential to understand their risk of recurrence," said Shakti Ramkissoon, M.D., Ph.D., vice president, medical lead for oncology at Labcorp. "By expanding the Labcorp Plasma Detect portfolio, we’re giving clinicians advanced tools to track molecular residual disease and detect recurrence risk earlier, supporting more personalized and proactive care, while increasing patient access to non-invasive testing options."

Labcorp has several ongoing and completed clinical studies that highlight the clinical utility of Labcorp Plasma Detect to track early disease progression, predict long-term outcomes, and identify residual cancer. Two peer-reviewed publications recently featured clinical studies of Labcorp Plasma Detect that focus on the test’s utility in patients diagnosed with diffuse pleural mesothelioma and head and neck cancer, adding to a growing body of research that supports MRD testing as a critical component of personalized cancer care. In addition, data were presented at the recent AMP 2025 Annual Meeting outlining the continued development of Labcorp Plasma Detect Genome MRD.

The expanded Labcorp Plasma Detect portfolio builds on Labcorp’s leadership in oncology diagnostics, supporting cancer care from screening and risk assessment, through diagnosis and prognosis, therapy selection and monitoring and surveillance. Through a full spectrum of clinical and oncology tests, including liquid biopsy, tissue-based comprehensive genomic profiling, and companion diagnostics, Labcorp partners with oncologists, health systems and biopharma companies to drive precision medicine, improving outcomes and expanding access for patients globally.

(Press release, LabCorp, JAN 13, 2026, View Source [SID1234662015])

On January 13, 2026 Modella AI, a leader in artificial intelligence for life sciences, reported that it has been acquired by AstraZeneca, expanding the companies’ existing collaboration to advance the application of multi-modal AI foundation models and AI agents across AstraZeneca’s global oncology portfolio.

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The acquisition follows a multi-year agreement with AstraZeneca announced in July 2025 and will integrate Modella AI’s generative and agentic AI platform into AstraZeneca’s oncology research and development organization, supporting efforts to accelerate clinical development, enhance biomarker discovery, and enable the next wave of data-driven decision-making across the pipeline.

"Oncology drug development is becoming more complex, more data-rich, and more time-sensitive, and our companies expect AI solutions that are not only powerful but truly deployable in global trials and clinical settings," said Gabi Raia, Chief Commercial Officer of Modella AI. "By joining AstraZeneca, we can apply our multimodal foundation models and agentic AI platform across a world-class oncology pipeline to accelerate development and help improve outcomes for patients with cancer," added Jill Stefanelli, PhD, co-founder and Chief Executive Officer of Modella AI.

"Modella AI was built at the intersection of pathology, clinical data, and advanced generative AI to tackle some of the hardest problems in oncology," said Faisal Mahmood, PhD, co-founder of Modella AI and Professor at Mass General Brigham. "Integrating our foundation models directly into AstraZeneca’s research ecosystem will help translate methodological advances into real-world impact faster."

"AstraZeneca is transforming its drug discovery and clinical development through the deployment of innovative and impactful AI solutions. The acquisition of Modella AI provides state-of-the-art frontier pathology foundation models and AI agents that will continue to enable the development of targeted therapeutics along with diagnostics in our oncology portfolio," said Jorge Reis-Filho, Chief of AI for Science Innovation at AstraZeneca.

The acquisition will embed Modella AI’s multi-modal foundation models and AI agents into AstraZeneca’s oncology R&D environment, enabling the generation of new biological and clinical insights, as well as greater automation, scalability, and consistency across data-intensive workflows. The financial details of the transaction were not disclosed.

(Press release, AstraZeneca, JAN 13, 2026, View Source [SID1234662030])

On January 13, 2026 TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics), reported preliminary U.S. net product revenue for BRIUMVI for the fourth quarter and full year ended December 31, 2025 (unaudited), as well as 2026 financial guidance and development milestones, during a preannounced presentation at the 44th Annual J.P Morgan Healthcare Conference. An audio replay of the event, as well as the corresponding slide presentation, are available on the Investors and Media section of the TG corporate website at ir.tgtherapeutics.com/events.

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Michael S. Weiss, the Company’s Chairman and Chief Executive Officer stated, "BRIUMVI continued to deliver strong commercial performance in 2025, reinforcing our confidence in the multi-billion dollar opportunity for BRIUMVI. With significant market share capture since launch, we believe TG Therapeutics is well positioned to drive long-term revenue growth and cash flow. Additionally, our development programs for consolidated IV BRIUMVI dosing and self-administered subcutaneous form of BRIUMVI are expected to drive revenue acceleration over the short and mid-term if approved. In parallel, we plan to initiate multiple exploratory studies that could expand BRIUMVI beyond MS, providing an additional lever for growth and underscoring its potential as a ‘pipeline-in-a-product.’ We also remain excited about the potential of azer-cel, our allogeneic CAR-T in autoimmune indications, starting with progressive forms of MS. Taken together, we believe we are executing a strategy designed to deliver sustained growth and long-term value for patients and shareholders."

Preliminary Fourth Quarter and Full Year 2025 Updates (based on unaudited financial information)

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BRIUMVI U.S. net product revenue expected to be approximately $182 million and $594 million for the fourth quarter and full year of 2025, respectively

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Total global full year 2025 revenue of approximately $616 million

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Preliminary selected financial information presented in this release are unaudited, subject to financial closing procedures and adjustment, and provided as an approximation in advance of the Company’s announcement of complete financial results.

2026 Financial Guidance

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Full Year 2026 target total global revenue of approximately $875-900 million, including BRIUMVI U.S. net product revenue of approximately $825-850 million

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Full year 2026 target operating expense, defined as R&D and SG&A, of approximately $350 million excluding non-cash compensation, and approximately $100 million in expenses associated with the subcutaneous BRIUMVI inventory build and secondary manufacturer start-up costs

2026 Development Pipeline Anticipated Milestones

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Announce pivotal topline data for ENHANCE trial combining Day 1 and Day 15 doses of IV BRIUMVI mid-year 2026

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Present preliminary Phase 1 azer-cel data in Progressive MS in the second half of 2026

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Announce pivotal topline data for subcutaneous BRIUMVI (ublituximab) year-end 2026/1Q 2027

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Commence registration-directed trial for BRIUMVI in an indication outside of MS

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Commence additional exploratory studies for BRIUMVI and azer-cel in autoimmune disease (outside MS)

ABOUT BRIUMVI (ublituximab-xiiy) 150 mg/6 mL Injection for IV

BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.

BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in several countries outside of the U.S. for the treatment of adult patients with RMS with active disease defined by clinical or imaging features.

A list of authorized specialty distributors can be found at www.briumvi.com.

IMPORTANT SAFETY INFORMATION

Contraindications: BRIUMVI is contraindicated in patients with:

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Active Hepatitis B Virus infection

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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.

Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.

Progressive Multifocal Leukoencephalopathy (PML): Although no cases of PML have occurred in BRIUMVI-treated MS patients, JC virus infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies.

If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.

MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.

If PML is confirmed, treatment with BRIUMVI should be discontinued.

Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines, at least 4 weeks and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.

Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.

Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.

Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy, until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.

Liver Injury: Clinically significant liver injury, without findings of viral hepatitis, has been reported in the postmarketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of MS, including BRIUMVI. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred from weeks to months after administration.

Patients treated with BRIUMVI found to have an alanine aminotransaminase (ALT) or aspartate aminotransferase (AST) greater than 3x the upper limit of normal (ULN) with serum total bilirubin greater than 2x ULN are potentially at risk for severe drug-induced liver injury.

Obtain liver function tests prior to initiating treatment with BRIUMVI, and monitor for signs and symptoms of any hepatic injury during treatment. Measure serum aminotransferases, alkaline phosphatase, and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. If liver injury is present and an alternative etiology is not identified, discontinue BRIUMVI.

Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections.

Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com.

ABOUT BRIUMVI PATIENT SUPPORT in the U.S.
BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com.

ABOUT MULTIPLE SCLEROSIS
Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.

(Press release, TG Therapeutics, JAN 13, 2026, View Source [SID1234662016])

On January 13, 2026 Tahoe Therapeutics and Alloy Therapeutics reported that they are forming a jointly seeded new company focused on developing first-in-class antibody-drug conjugates (ADCs) for patients with hard-to-treat cancers.

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The joint venture will advance two ADC programs directed at novel tumor targets discovered by Tahoe using its proprietary Mosaic platform and large-scale, perturbative single-cell datasets. The collaboration reflects a strong strategic fit between Tahoe’s ability to identify high-confidence, tumor-selective targets using its AI-powered virtual cell models and Alloy’s end-to-end capabilities in biologic drug engineering, ADC design, and company creation through its venture studio 82VS.

Over the past year, Tahoe analyzed a subset of its proprietary multi-million-cell datasets and identified tens of tumor-specific surface antigens, many of which had taken decades to discover previously, and most of which are novel. Tahoe subsequently validated the most promising targets across multiple independent assays and clinical samples. After rigorous evaluation, Alloy recognized the exceptional therapeutic potential of these targets, catalyzing the decision to jointly spin out a dedicated ADC development company around two of them.

"We are excited to partner with Tahoe and were immediately impressed by the depth and quality of biological insight generated by the Mosaic platform," said Errik Anderson, Founder and CEO of Alloy Therapeutics. "With our track record of 20 clinical programs discovered with Alloy platforms and services, including multiple drugs in Phase III, we are well positioned to translate the cutting-edge biology from world-class target rich companies like Tahoe into optimized therapeutics."

Under the structure of the joint venture, Tahoe and Alloy will co-invest, co-build, and co-lead the new company. Tahoe will contribute its novel targets and biomarker insights, while Alloy will provide its ADC engineering platforms, translational development expertise, and 82VS company creation infrastructure. Together, the team aims to efficiently advance both ADC programs to key value-inflection points suitable for independent financing or pharma partnerships.

"Our datasets and AI models are enabling the discovery of novel targets," said Nima Alidoust, co-founder and CEO of Tahoe Therapeutics. "Alloy, which has had a strong track record in developing first-in-class biologics, shares this excitement with us, and that is a strong validation of the biology discovered by our platform. This joint venture is also a preview of the business model our platform enables: building new companies alongside partners with complementary capabilities."

Combining Tahoe’s AI-powered approach to understanding novel tumor biology with Alloy’s fully integrated drug discovery, development, and company creation capabilities creates a highly efficient path to translate novel biologic insights into first-in-class drugs for patients in need.

(Press release, Tahoe Therapeutics, JAN 13, 2026, View Source [SID1234662031])