Novartis delivered sales growth in Q2 and further advanced the pipeline; Full-year guidance reaffirmed
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Ad hoc announcement pursuant to Art. 53 LR
Second quarter
Novartis Fabhalta® (iptacopan) receives FDA traditional approval as first and only complement inhibitor to significantly slow kidney function decline in primary IgAN
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- Fabhalta slowed eGFR decline by 48% vs placebo over two years, demonstrating kidney function preservation1
- Clinically meaningful improvements of protein in urine observed as early as two weeks, with sustained reduction over treatment period1
- Fabhalta targets the alternative complement pathway; activation is a key driver of inflammation associated with IgAN2-4
Novartis Fabhalta® (iptacopan) receives FDA traditional approval as first and only complement inhibitor to significantly slow kidney function decline in primary IgAN
arcticnovartis
- Fabhalta slowed eGFR decline by 48% vs placebo over two years, demonstrating kidney function preservation1
- Clinically meaningful improvements of protein in urine observed as early as two weeks, with sustained reduction over treatment period1
- Fabhalta targets the alternative complement pathway; activation is a key driver of inflammation associated with IgAN2-4
Novartis marks 30 years of breakthroughs, building on 250 years of discovery to reimagine what medicine can do next
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Novartis agrees to acquire Myricx Bio, advancing next-generation antibody-drug conjugate innovation with a novel NMTi payload, expanding options for cancer patients
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- Adds potential first-in-class, N-myristoyltransferase inhibitor (NMTi) antibody-drug conjugate (ADC) payload platform, designed to address resistance to current payloads
- Strengthens the Novartis oncology pipeline with two lead ADC assets and a broader payload platform with potential impact across multiple solid tumor settings
Novartis receives European Commission approval for Itvisma® for spinal muscular atrophy (SMA)
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- First gene replacement therapy in the EU for broad population with SMA, including children two years and older, teens and adults
- Fixed, one-time dose designed to replace the faulty SMN1 gene, providing a distinct option from ongoing dosing approaches
Novartis RemIND data at EAACI show Rhapsido® potential as first targeted therapy for chronic inducible urticaria (CIndU)
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- Rhapsido demonstrated statistically significant and clinically meaningful symptom control in twice as many patients vs placebo1, with favorable safety profile and no observed liver safety concerns2
- With global CIndU prevalence of 29 million3,4; greater than 50% of patients experience significant disease burden despite treatment with H1-antihistamines; no approved targeted therapies exist5,6
Novartis delpacibart braxlosiran (del-brax) Phase I/II study in facioscapulohumeral muscular dystrophy (FSHD) meets primary biomarker endpoint
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Ad hoc announcement pursuant to Art. 53 LR
Novartis to highlight Rhapsido® data across multiple immune-mediated diseases at EAACI Congress 2026
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- Results from Rhapsido (remibrutinib) pivotal Phase III RemIND trial, the largest study in chronic inducible urticaria, to be highlighted in late-breaker oral presentation
- New Phase IIIb REMIXED extension data in chronic spontaneous urticaria to provide additional efficacy and safety data for Rhapsido
- Phase II Rhapsido food allergy dose-response analysis in adults with IgE-mediated peanut allergy also to be presented
Basel, June 8th, 2026 – Novartis will present data from 10 abstracts at the European Academy of A
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