Novartis receives positive CHMP opinion for Itvisma® for spinal muscular atrophy (SMA) [Yahoo! Finance]
Novartis AG (NVS)
Last novartis ag earnings: 4/28 01:00 am
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Source: Yahoo! Finance
Itvisma demonstrated clinically meaningful and statistically significant improvement in motor function in Phase III STEER study One-time dose of Itvisma replaces SMN1 gene, with potential to reduce need for chronic SMA treatment Basel, April 24, 2026 – Novartis today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for Itvisma ® (intrathecal onasemnogene abeparvovec). The opinion supports its use for the treatment of children two years and older, teens, and adults living with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the survival motor neuron 1 ( SMN1 ) gene. Itvisma is uniquely designed to address the genetic root cause of SMA with a one-time fixed dose that does not need to be adjusted for age or body weight. By replacing the SMN1 gene, Itvisma can improve motor function, offering the potential to reduce the need for chronical
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NVS
Earnings
- 2/4/26 - Beat
NVS
Sec Filings
- 3/18/26 - Form 6-K
- 3/17/26 - Form FWP
- 2/12/26 - Form 144
- NVS's page on the SEC website