Novartis

NVS

Market cap $250B

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It earned FDA approval for a spinal muscular atrophy drug. This is a version of its existing commercialized SMA treatment, Zolgensma.

Novartis secures FDA approval for Itvisma, a one-time gene therapy designed to boost motor function across a broad SMA patient group.

On Monday, the U.S. Food and Drug Administration (FDA) approved Novartis AG's (NYSE: NVS) Itvisma (onasemnogene abeparvovec-brve) for children two years and older, teens, and adults with spinal muscular atrophy (SMA).

Novartis said on Tuesday up to 550 full-time jobs could be cut by the end of 2027 at the Swiss pharmaceutical company's Stein facility near Basel in northern Switzerland.

Basel, November 25, 2025 – Novartis will present data from over 70 abstracts, including investigator-initiated trials at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition and 2025 San Antonio Breast Cancer Symposium® (SABCS). Featured among these latest advances in hematology and oncology are 11 oral presentations, with the Phase III VAYHIT2 trial for ianalumab in immune thrombocytopenia (ITP) accepted as a late-breaker abstract. “For decades, Novartis has redefined the future of hematology and oncology, and we're building on that foundation with compelling new data presented at ASH and SABCS,” said Mark Rutstein, M.D., Global Head, Oncology Development, Novartis. “These data underscore how we seek to set new standards for transformative care, with the aim of turning cutting-edge innovation into meaningful impact for patients.” Key highlights of data accepted by ASH include:

The only gene replacement therapy for children two years and older, teens, and adults with spinal muscular atrophy (SMA). The only gene replacement therapy for children two years and older, teens, and adults with spinal muscular atrophy (SMA).

U.S. Food and Drug Administration has approved Novartis' gene therapy for a type of rare muscle disorder, the drugmaker said on Monday.

Ad hoc announcement pursuant to Art. 53 LR Itvisma (onasemnogene abeparvovec-brve) demonstrated improved motor function and stabilization in patients regardless of SMA treatment history in Phase III studies One-time dose of Itvisma replaces SMN1 gene, potentially reducing the need for chronic SMA treatment Gene replacement therapy now available to eligible people of all ages living with SMA Basel, November 24, 2025 – Novartis today announced that the US Food and Drug Administration (FDA) has approved Itvisma® (onasemnogene abeparvovec-brve) for the treatment of children two years and older, teens and adults living with spinal muscular atrophy (SMA) with a confirmed mutation in the survival motor neuron 1 (SMN1) gene, making it the first and only gene replacement therapy available for this broad population.

Novartis AG ( NVS ) Shareholder/Analyst Call November 20, 2025 4:15 AM EST Company Participants Victor Bulto - President of US Angelika Jahreis - Global Head of Development Unit Immunology, Hepatology & Dermatology Richard Siegel Ingrid Zhang Patrick Horber - President of International Dianne Auclair Rocha Ruchira Glaser Shaun Coughlin Shreeram Aradhye - President of Development & Chief Medical Officer Shiva Malek Dushen Chetty Reshema Kemps-Polanco Fiona Marshall - President of BioMedical Research Norman Putzki - Global Program Head of Neuroscience Tracey Dawson Robert Baloh Aharon Gal - Chief Strategy & Growth Officer Harry Kirsch - Chief Financial Officer Vasant Narasimhan - Chief Executive Officer Steffen Lang - President of Operations Conference Call Participants Michael Leuchten - Jefferies LLC, Research Division Thibault Boutherin - Morgan Stanley, Research Division Florent Cespedes - Sanford C. Bernstein & Co., LLC.