Novartis' $12 Billion Bet Pays Off With Encouraging Data From Rare Neuromuscular Disease Study

Novartis AG (NYSE:NVS) said Thursday that the biomarker cohort of its Phase 1/2 FORTITUDE study evaluating investigational therapy del-brax met both its primary and key secondary endpoints in patients with facioscapulohumeral muscular dystrophy (FSHD), a rare neuromuscular disease.

Benzinga • 34 minutes ago

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).

GlobeNewsWire • 9 hours ago

Healthcare ETFs: From Broad Exposure to Big Breakthroughs

With AI and space dominating many of the market's most popular investment themes, it can be difficult to find differentiated opportunities. Healthcare is often viewed as one of the more defensive sectors, supported by relatively steady demand regardless of the economic environment.

ETF Trends • 3 hours ago

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.

Business Wire • Jun 10, 2026

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:

GlobeNewsWire • Jun 8, 2026

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.”

GlobeNewsWire • Jun 4, 2026

Novartis Cosentyx® PMR data in New England Journal of Medicine showed sustained remission vs placebo in twice as many patients

Basel, June 3, 2026 – Novartis presented today new Cosentyx® (secukinumab) data in polymyalgia rheumatica (PMR) demonstrating a statistically significant, clinically meaningful difference in sustained remission rates vs placebo and significant steroid sparing8. Published in the New England Journal of Medicine and simultaneously presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress, Phase III REPLENISH data showed that the effect of Cosentyx treatment was sustained through week 52 in this investigational use8.

GlobeNewsWire • Jun 3, 2026

Novartis data at EULAR 2026 demonstrates momentum for broad immunology portfolio for complex, high unmet need diseases

Basel, June 1, 2026 – Novartis will present new data from 31 abstracts across its industry-leading immunology portfolio at the European Alliance of Associations for Rheumatology (EULAR) Congress on June 3-6 in London, advancing scientific insight into high-burden autoimmune diseases.

GlobeNewsWire • Jun 1, 2026

Experimental Novartis radiopharma drug shows promise in early study

Novartis said on Sunday that early data from ‌its experimental actinium-based drug showed signs of anti-tumour activity against prostate cancer, including in patients previously treated with its older drug Pluvicto.

Reuters • May 31, 2026

Pluvicto™ demonstrated consistent efficacy across key patient subgroups in metastatic hormone-sensitive prostate cancer

Basel, May 31, 2026 – Novartis today announced results showing consistent radiographic progression-free survival (rPFS) improvement across key subgroups with Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) plus standard of care (SoC; androgen receptor pathway inhibitor [ARPI] + androgen deprivation therapy [ADT]) compared to SoC alone in PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC). These PSMAddition data were presented as an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.

GlobeNewsWire • May 31, 2026