Novartis Secures Positive EU Backing for SMA Gene Therapy Itvisma [Yahoo! Finance]
Novartis AG (NVS)
Last novartis ag earnings: 4/28 01:00 am
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Source: Yahoo! Finance
for Human Use has issued a favourable opinion recommending approval of Itvisma, an intrathecal gene therapy for spinal muscular atrophy (SMA). The recommendation covers use in children aged two and above, as well as adolescents and adults with 5q SMA carrying a bi-allelic mutation in the survival motor neuron 1 (SMN1) gene. The treatment is designed as a one-time fixed-dose therapy aimed at replacing the defective SMN1 gene. Clinical Data Supports Efficacy The positive opinion is based on findings from the pivotal STEER trial, alongside supporting data from the Phase IIIb STRENGTH and Phase I/II STRONG studies. In the STEER study, Itvisma delivered a statistically significant improvement of 2.39 points on the Hammersmith Functional Motor Scale, compared with a 0.51-point gain in the control group, achieving a p-value of 0.0074. These benefits were maintained over a 52-week follow-up period. “Itvisma met the primary endpoint showing motor function improvement versus placebo,”
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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