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FDA approves Pluvicto for PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC), advancing potential new standard of care across metastatic disease

FDA approves Pluvicto for PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC), advancing potential new standard of care across metastatic disease
arcticnovartis

  • Pluvicto now approved across PSMA+ metastatic prostate cancer, nearly doubling eligible patient population

  • PSMAddition updated results show Pluvicto reduced risk of progression or death by 33% in combination with standard of care (ADT + ARPI) vs. SoC alone, with positive overall survival trend (HR=0.80)

  • mHSPC is incurable and about half of men progress within 20 months, highlighting need for differentiated, precision approaches earlier in disease journey
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Small shifts. Big impact. The leadership choices that matter most in the age of AI

Small shifts. Big impact. The leadership choices that matter most in the age of AI
halesmi2

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How Novartis R&D is advancing the next breakthrough innovations

How Novartis R&D is advancing the next breakthrough innovations
halesmi2

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Novartis verzeichnete im zweiten Quartal Umsatzsteigerungen und baute die Pipeline weiter aus; Prognose für das Geschäftsjahr bekräftigt

Novartis verzeichnete im zweiten Quartal Umsatzsteigerungen und baute die Pipeline weiter aus; Prognose für das Geschäftsjahr bekräftigt
arcticnovartis

Ad-hoc-Mitteilung gemäss Art. 53 KR

Zweites Quartal

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Novartis delivered sales growth in Q2 and further advanced the pipeline; Full-year guidance reaffirmed

Novartis delivered sales growth in Q2 and further advanced the pipeline; Full-year guidance reaffirmed
arcticnovartis

Ad hoc announcement pursuant to Art. 53 LR

Second quarter

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Novartis Fabhalta® (iptacopan) receives FDA traditional approval as first and only complement inhibitor to significantly slow kidney function decline in primary IgAN

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
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Novartis Fabhalta® (iptacopan) receives FDA traditional approval as first and only complement inhibitor to significantly slow kidney function decline in primary IgAN

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
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Novartis marks 30 years of breakthroughs, building on 250 years of discovery to reimagine what medicine can do next

Novartis marks 30 years of breakthroughs, building on 250 years of discovery to reimagine what medicine can do next
weberfr8

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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

Novartis agrees to acquire Myricx Bio, advancing next-generation antibody-drug conjugate innovation with a novel NMTi payload, expanding options for cancer patients
arcticnovartis

  • 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
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Novartis receives European Commission approval for Itvisma® for spinal muscular atrophy (SMA)

Novartis receives European Commission approval for Itvisma® for spinal muscular atrophy (SMA)
arcticnovartis

  • 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
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