Novartis AG announced top‐line results from its Phase 3b STRENGTH trial of intrathecal onasemnogene abeparvovec (OAV101 IT) in a broad pediatric population aged 2 to under 18 with spinal muscular atrophy (SMA). Patients previously treated with Biogen’s Spinraza or Roche’s Evrysdi showed stabilization of motor function over 52 weeks, with no new safety signals identified. The study enrolled 68 subjects across 12 countries and met its primary endpoint, with a mean change in Hammersmith Functional Motor Scale Expanded score of –0.3 points (95% CI: –1.1 to 0.5) at one year, supporting a favorable risk-benefit profile for OAV101 IT in later‐onset SMA. Novartis plans to submit these data to regulators in mid-2026 and expects potential approval by year-end, which could expand its SMA franchise beyond its Zolgensma intravenous platform.

In a sector report compiled by 3 Axis Advisors and Reuters, Novartis AG is among at least 5 major pharmaceutical companies planning U.S. list‐price increases on branded medicines in 2026. While the median planned hike across all companies is about 4%, Novartis has signaled single-digit increases for its oncology and cardiovascular portfolio effective January 1, 2026. This follows its 2025 average list‐price rise of 3.8%, below overall inflation. The company emphasized that these adjustments support ongoing investment in R&D, including its cell and gene therapy pipeline, and noted that negotiated rebates and patient assistance programs will moderate net cost impacts for payers.