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Novartis 
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📢 Press Releases
| Date | Press release |
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| 2026-06-12 05:36:00 | Novartis Remind Data At Eaaci Show Rhapsido® Potential As First Targeted Therapy For Chronic Inducible Urticaria (cindu) Basel, june 12, 2026 – novartis today presented data from the remind trial at the european academy of allergy and clinical immunology (eaaci) congress showing that rhapsido® (remibrutinib) met its primary endpoints across the three most common chronic inducible urticaria (cindu) subtypes, becoming the first-ever treatment to demonstrate efficacy in a global phase iii cindu clinical trial7. in the remind trial, higher rates of complete responses were observed at week 12, with responses seen as early as week 2 in two subtypes. these results demonstrate that rhapsido may provide sustained relief for patients whose disease remains inadequately controlled after treatment with second-generation h1-antihistamines7. “chronic inducible urticaria (cindu) is a form of chronic hives in which everyday triggers—such as pressure, heat, cold, or sunlight—can lead to itchy wheals, and there are currently no approved targeted treatment options,” said prof. dr. med. martin metz, deputy director, institute of allergology, charitÉ–universitÄtsmedizin berlin, germany. “the remind results across the three most common cindu subtypes highlight the potential of rhapsido as an important new treatment option for patients with significant unmet need.” the three most prevalent cindu subtypes are symptomatic dermographism (sd), cold urticaria, and cholinergic urticaria, with sd being the most common8. novartis has submitted a supplemental new drug application (snda) to the u.s. food and drug administration (fda) seeking approval of rhapsido for the treatment of sd subtype and will continue additional filings to health authorities globally throughout 2026. rhapsido is approved for use in the u.s., european union, china and several other countries for the treatment of chronic spontaneous urticaria (csu), in adult patients with inadequate response to h1-antihistamines. “rhapsido significantly improves symptom control for patients living with the three most common subtypes of chronic inducible urticaria, and it has the potential to become the first approved targeted therapy. this is a major step forward for cindu patients who have limited options,” said angelika jahreis, global head, immunology development, novartis. “the cindu data presented today are consistent with rhapsido’s proven efficacy and favorable safety profile in chronic spontaneous urticaria and demonstrate novartis’ commitment to developing truly meaningful innovation for patients with complex immune-mediated diseases.” primary endpoint results at week 12 in the remind trial1 |
| 2026-06-11 01:00:00 | Novartis Delpacibart Braxlosiran (del-brax) Phase I/ii Study In Facioscapulohumeral Muscular Dystrophy (fshd) Meets Primary Biomarker Endpoint Ad hoc announcement pursuant to art. 53 lr fortitude study met primary and key secondary endpoints of reduction in khdc1l and creatine kinase levels, with safety profile consistent with previous results del-brax indicates potential to become the first disease-modifying treatment for fshd, a progressive and irreversible neuromuscular disease affecting approximately 45-87k people in the us and eu novartis plans to engage global regulatory authorities on phase i/ii data; phase iii study currently enrolling basel, june 11, 2026 – novartis announced today that the biomarker cohort of the fortitude phase i/ii study of del-brax met its primary and key secondary endpoints, with reductions in khdc1l (cdux) and creatine kinase biomarker levels indicating both strong target engagement and reduction in muscle damage in patients with facioscapulohumeral muscular dystrophy (fshd). |
| 2026-06-10 07:00:00 | Orionis Biosciences Announces Strategic Collaboration With Novartis To Discover And Develop Molecular Glue Medicines Boston & ghent, belgium--(business wire)--orionis biosciences, a privately held, clinical-stage life sciences company pioneering proximity-induced therapeutic modalities, today announced a multi-year collaboration with novartis to discover and design molecular glue drugs for challenging therapeutic targets across multiple disease areas. the collaboration expands the existing relationship between the companies and reflects a shared commitment to unlock the full value of induced proximity approac. |
| 2026-06-08 03:00:00 | Novartis To Highlight Rhapsido® Data Across Multiple Immune-mediated Diseases At Eaaci Congress 2026 Basel, june 8th, 2026 – novartis will present data from 10 abstracts at the european academy of allergy and clinical immunology (eaaci) congress 2026, spanning rhapsido® (remibrutinib) clinical trial results and real-world evidence on patient burden and treatment experience. highlights include two late-breaking oral presentations; the phase iii remind trial for rhapsido in chronic inducible urticaria (cindu) and extension data from the phase iiib remixed trial in chronic spontaneous urticaria (csu). “the rhapsido presentations at eaaci 2026 expand our understanding of btk inhibition across multiple immune-mediated diseases and provide evidence of its potential to make a meaningful impact for patients who continue to face significant burden and limited treatment options,” said angelika jahreis, global head, immunology development, novartis. “novartis will present rhapsido data from a long-term extension trial in chronic spontaneous urticaria, phase iii data in three types of chronic inducible urticaria, and early phase ii dose-response analysis for food allergy – together providing scientific evidence for its impact across numerous diseases.” abstracts accepted by eaaci include: |
| 2026-06-04 06:15:00 | Novartis Igan Data In The Lancet Show Clinically Meaningful Slowing Of Kidney Function Decline With Vanrafia® Over 2.5 Years Basel, june 4, 2026 – novartis reported final 2.5-year phase iii align results showing slower kidney function decline with vanrafia® (atrasentan) versus placebo in adults with iga nephropathy (igan)1 ,2. results were published in the lancet and presented at the european renal association (era) congress. estimated glomerular filtration rate (egfr) change from baseline favored vanrafia, alongside sustained reductions of protein in the urine through end of treatment. benefits were consistent across different measures of kidney function and in patients additionally receiving sodium-glucose co-transporter-2 (sglt2) inhibitors1,2. “these results provide robust evidence of clinically meaningful slowing of kidney function decline over more than two years of treatment, reinforcing findings from the earlier analysis of proteinuria reduction,” said richard lafayette, md, facp, professor of medicine, nephrology, director of the glomerular disease center at stanford university medical center, and align study investigator and steering committee member. “they highlight the role of a highly selective endothelin a receptor antagonist as part of an evolving treatment approach for igan.” |
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