NEW YORK, Nov. 19, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced it ranked number 27 on the Deloitte Technology Fast 500™, a ranking of the 500 fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies in North America, now in its 31st year. The Company’s growth between fiscal years 2021 to 2024 was fueled by BRIUMVI® revenues, which was approved in the United States by the Food and Drug Administration (FDA) to treat adult indiv ...

Core Insights - Jade Biosciences, Inc. is advancing its investigational anti-APRIL monoclonal antibody, JADE101, for the treatment of immunoglobulin A nephropathy (IgAN), presenting new data at the ASN Kidney Week 2025 [1][2] Group 1: Product Overview - JADE101 selectively inhibits APRIL, a key factor in IgAN, which can lead to end-stage kidney disease [2] - The drug is designed for subcutaneous dosing, with a favorable pharmacokinetic and pharmacodynamic profile demonstrated in non-human primates (NHPs) [2][7] - JADE101 has shown a serum half-life of approximately 27 days, allowing for infrequent dosing [7] Group 2: Clinical Development - A Phase 1 trial is currently evaluating JADE101 in healthy volunteers, with interim data expected in the first half of 2026 to inform future studies in IgAN patients [2][8] - The trial aims to establish optimal dosing based on biomarker responses that correlate with clinical activity in IgAN patients [8] Group 3: Safety and Efficacy Data - Preclinical studies indicate that JADE101 is well tolerated in NHPs, with no observed adverse effects at the highest doses tested [5] - JADE101 treatment resulted in significant reductions in serum immunoglobulins, including IgA and IgM reductions of approximately 55–68% and 62–75%, respectively, without broad immunosuppression [5][6] - The drug demonstrated no off-target binding and did not affect immune cell populations, supporting its potential as a safe treatment option [5][6] Group 4: Biomarker Insights - Analyses suggest that pharmacokinetic and biomarker responses in healthy volunteers can predict therapeutic outcomes in IgAN patients [6][11] - The depth and duration of APRIL suppression are linked to reductions in total IgA and proteinuria, which are associated with preserving kidney function [6][11] Group 5: Company Background - Jade Biosciences focuses on developing therapies for autoimmune diseases, with JADE101 as its lead candidate targeting APRIL [9] - The company also has other candidates in its pipeline, including JADE201 and JADE-003, currently in preclinical development [9]

Core Insights - Boehringer Ingelheim has licensed a pre-clinical program from Kyowa Kirin to develop a potential first-in-class small molecule for autoimmune diseases [1][3] - Autoimmune diseases affect approximately one in ten people globally, highlighting a significant unmet medical need for effective treatments [2][6] - The agreement allows Boehringer Ingelheim exclusive worldwide rights to develop the small molecule, with Kyowa Kirin eligible to receive up to €640 million in various payments and royalties [3] Company Overview - Boehringer Ingelheim is a biopharmaceutical company focused on human and animal health, emphasizing innovative therapies for high unmet medical needs [4] - Kyowa Kirin is a Japan-based Global Specialty Pharmaceutical Company with over 70 years of experience in drug discovery and biotechnology innovation [5]

Core Insights - Telitacicept has shown significant improvement in quality of life for patients with generalized myasthenia gravis (gMG), with 100% of patients achieving a ≥2-point improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) after 48 weeks [1][2] - The drug demonstrated sustained efficacy and a favorable safety profile, suggesting it may have a global best-in-disease profile for gMG [1][2] Study Results - In the 48-week open-label extension (OLE) study, patients on telitacicept achieved a mean reduction of -7.5 points in MG-ADL, while those who crossed over from placebo achieved a -6.3 point reduction [6] - At week 48, 96.2% of continuous telitacicept patients and 90.2% of crossover patients reached a ≥3-point improvement in MG-ADL [6] - The mean change in Quantitative Myasthenia Gravis (QMG) was -9.8 for continuous patients and -9.3 for crossover patients, with 94.2% and 90.2% achieving a ≥5-point improvement, respectively [6] Mechanism of Action - Telitacicept is a recombinant fusion protein that selectively inhibits BLyS (BAFF) and APRIL, two cytokines crucial for B cell and plasma cell survival, thereby reducing autoreactive B cells and autoantibody production [5] Regulatory Status - Telitacicept is already approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG) [7] - A global Phase 3 clinical trial for gMG is currently ongoing across 14 countries, aiming for potential approval in the United States, Europe, and Japan [7] Disease Context - Generalized myasthenia gravis (gMG) is a rare autoimmune neuromuscular disorder affecting approximately 90,000 people in the United States, 140,000 in Europe, and 29,000 in Japan, characterized by muscle weakness due to autoantibodies [8]

Core Insights - Cabaletta Bio, Inc. announced positive clinical data from its RESET trials for autoimmune diseases, highlighting the efficacy of rese-cel in achieving significant clinical responses without immunomodulators [1][2][3] RESET-Myositis Trial - The Phase 1/2 DM/ASyS cohort showed that all patients with sufficient follow-up met the primary endpoint, achieving major TIS responses without immunomodulators [1][4] - A registrational trial for myositis is set to begin this quarter, targeting 14 patients with a primary endpoint of moderate or major TIS response over 16 weeks [1][4] - The trial aims to address the approximately 60,000 DM patients and 15,000 ASyS patients in the U.S. who currently lack effective FDA-approved treatments [4] RESET-SSc Trial - Preliminary data from the RESET-SSc trial indicated that all patients with at least three months of follow-up achieved rCRISS-25 responses off immunomodulators and steroids [7][8] - The trial included six patients, with three experiencing low-grade CRS and one ICANS event [7] RESET-SLE Trial - In the RESET-SLE trial, three out of four SLE patients achieved DORIS, and significant renal responses were observed in lupus nephritis patients [9][10] - The trial is expanding to include a no preconditioning cohort, with initial clinical data expected in 2026 [2][11] - A total of 76 patients have been enrolled across 77 clinical trial sites globally as of October 24, 2025 [1] Rese-cel Overview - Rese-cel is an investigational CAR T cell therapy designed to reset the immune system in autoimmune diseases, administered as a single, weight-based infusion [13] - The therapy aims to transiently deplete CD19-positive cells, potentially leading to durable clinical responses without the need for chronic therapy [13][14]

Core Insights - Novartis is set to present data from 27 abstracts related to its Immunology portfolio at the 2025 ACR Convergence, including pivotal Phase III results for ianalumab in Sjögren's disease and biomarker data for rapcabtagene autoleucel in systemic lupus erythematosus [1][7] Group 1: Ianalumab and Sjögren's Disease - Ianalumab is an investigational therapy that may become the first targeted treatment for Sjögren's disease, which currently lacks FDA-approved options [2] - The NEPTUNUS-1 and NEPTUNUS-2 trials demonstrated significant reductions in disease activity for patients with Sjögren's disease [5][7] - Presentations will include insights into the dual mode of action of ianalumab, focusing on B cell depletion and blockade of B cell activating factor receptor signaling [3][5] Group 2: Rapcabtagene Autoleucel - Rapcabtagene autoleucel is a novel CAR-T cell therapy being evaluated for its potential to reset the immune system in severe refractory systemic lupus erythematosus [3][7] - Biomarker data from an ongoing Phase 1/2 study will be presented, suggesting a reset of the B cell compartment in patients with severe refractory SLE [8] Group 3: Cosentyx Data - Real-world data on Cosentyx (secukinumab) will be shared, particularly in relation to its use in psoriatic arthritis [3][8] - The data will compare the incidence of psoriatic arthritis in patients treated with different interleukin inhibitors [8] Group 4: Investor Engagement - Following the ACR event, Novartis will host a conference call for investors to discuss updates on its Immunology pipeline [4]

Core Insights - Novartis is set to present data from 27 abstracts related to its Immunology portfolio at the 2025 ACR Convergence, including pivotal Phase III results for ianalumab in Sjögren's disease and biomarker data for rapcabtagene autoleucel in systemic lupus erythematosus [1][6] Group 1: Ianalumab and Sjögren's Disease - Ianalumab is an investigational therapy that may become the first targeted treatment for Sjögren's disease, which currently has no FDA-approved therapies [2][5] - The NEPTUNUS-1 and NEPTUNUS-2 trials demonstrated significant reductions in disease activity for patients with Sjögren's disease [5][6] - The dual mode of action of ianalumab involves targeting B cells and blocking B cell activating factor receptor signaling [7] Group 2: Rapcabtagene Autoleucel - Rapcabtagene autoleucel is a novel CAR-T cell therapy being evaluated for its potential to reset the immune system in several refractory autoimmune diseases [3][6] - Biomarker data from a Phase 1/2 study suggests a reset of the B cell compartment in severe refractory systemic lupus erythematosus [6][7] Group 3: Cosentyx Data - Real-world data on Cosentyx (secukinumab) will be presented, focusing on its use in psoriatic arthritis [3][6] - A retrospective study comparing the incidence of psoriatic arthritis in patients treated with different interleukin inhibitors will also be discussed [7] Group 4: Investor Engagement - Following the ACR event, Novartis will host a conference call on October 30, 2025, to update investors on its Immunology pipeline [4][6]

Core Insights - Jade Biosciences, Inc. is presenting new preclinical safety and translational data for its lead investigational candidate, JADE101, at the ASN Kidney Week 2025 [1][7] - JADE101 is designed to selectively inhibit APRIL in patients with immunoglobulin A nephropathy (IgAN), a serious autoimmune disease [2][4] - The company is currently conducting a Phase 1 clinical trial for JADE101, with interim data expected in the first half of 2026 [2][5] Company Overview - Jade Biosciences is a clinical-stage biotechnology company focused on developing therapies for autoimmune diseases, with JADE101 as its lead candidate targeting APRIL [6] - The company also has a second development candidate, JADE201, and an undisclosed antibody discovery program, JADE-003, both in preclinical development [6] Product Details - JADE101 is a fully human monoclonal antibody with ultra-high binding affinity for APRIL, engineered for extended half-life, showing a serum half-life of approximately 27 days in preclinical studies [4] - The therapy aims for infrequent and convenient subcutaneous dosing, which is crucial for patients often diagnosed in young adulthood [4] Clinical Trial Information - A Phase 1 randomized, double-blind, placebo-controlled trial is ongoing to evaluate single ascending subcutaneous doses of JADE101 in healthy adult volunteers [5] - The trial aims to define dose and dosing interval selection for later-stage studies based on biomarker responses [5] Presentation Details - JADE101's preclinical safety profile and translational framework will be highlighted in two poster sessions during ASN Kidney Week 2025 [3][7] - Presentations will occur on November 8, 2025, with specific titles and presenters listed [3]

Core Insights - Vor Bio announced significant results from a Phase 3 study of telitacicept for systemic lupus erythematosus (SLE), achieving a primary endpoint with 67.1% of patients responding compared to 32.7% with placebo [1][2] - The dual inhibition of BAFF and APRIL is validated as a transformative approach for B-cell targeting, indicating telitacicept's potential as a disease-modifying therapy for SLE [1][2] Company Overview - Vor Bio is a clinical-stage biotechnology company focused on transforming the treatment of autoimmune diseases, particularly through the development of telitacicept [8] - The company aims to advance telitacicept through Phase 3 clinical development and potential commercialization to address serious autoantibody-driven conditions globally [8] Study Details - The Phase 3 study was conducted at 42 hospitals in China, involving 335 patients with active SLE despite standard therapy [2] - The study met its primary endpoint with a statistically significant improvement in disease activity, as measured by the modified SLE Responder Index-4 (SRI-4) response at week 52 [1][2] Efficacy and Safety Findings - Telitacicept demonstrated improvements across multiple secondary measures, including a 70.1% reduction in SELENA-SLEDAI score compared to 40.5% for placebo [4] - The safety profile of telitacicept was consistent with previous studies, with serious adverse events occurring less frequently compared to placebo [3] Mechanism of Action - Telitacicept is designed to selectively inhibit BAFF and APRIL, two cytokines essential for B cell and plasma cell survival, thereby reducing autoreactive B cells and autoantibody production [6] - This dual-target mechanism is believed to restore immune balance in patients, potentially reducing the burden of lupus [2][6] Regulatory Status - Telitacicept is already approved in China for SLE, rheumatoid arthritis, and generalized myasthenia gravis, with ongoing global Phase 3 trials to support potential approval in the United States, Europe, and Japan [7]

Core Insights - DNTH212 is a bifunctional fusion protein designed to target plasmacytoid dendritic cell (pDC) BDCA2, reducing Type 1 interferon production while inhibiting BAFF/APRIL to suppress B cell function, indicating its potential as a first-line biologic for severe autoimmune diseases [1][2][3] - The drug has shown superior inhibition of pDCs compared to litifilimab and superior immunoglobulin reductions compared to povetacicept in non-human primates, suggesting improved clinical benefits [1][4] - Dianthus Therapeutics has entered an exclusive licensing agreement with Nanjing Leads Biolabs for DNTH212, which is being developed in China as LBL-047, with a total potential payment of up to $1 billion [1][7] Company Overview - Dianthus Therapeutics is a clinical-stage biotechnology company focused on developing next-generation therapies for severe autoimmune diseases, with a strong pipeline including DNTH212 [10] - The company has an estimated pro forma cash balance of approximately $525 million, ensuring a cash runway into 2028 for ongoing development [8] Development Timeline - The IND for DNTH212 was cleared by the FDA in September 2025, with a Phase 1 study expected to begin in Q4 2025 and top-line results anticipated in the second half of 2026 [1][5] - The Phase 1 study will consist of two parts: one involving healthy volunteers and the other involving patients with systemic lupus erythematosus [5] Collaboration Details - The licensing agreement includes an upfront payment of $30 million and potential milestone payments totaling up to $962 million, along with tiered royalties on net sales outside Greater China [7]