Novartis AG (NVS) Announces US FDA Approval of Itvisma®

Core Insights - Novartis AG is currently considered one of the most undervalued stocks, particularly following the FDA approval of Itvisma® for treating spinal muscular atrophy (SMA) [1][2] - Itvisma® is designed to address the genetic cause of SMA with a one-time fixed dose, which is a significant advancement over existing therapies that require chronic administration [2] Financial Performance - In Q3 2025, Novartis reported net sales of US$13.9 billion, reflecting an 8% increase (7% in constant currency), with volume contributing 16 percentage points to this growth [3] - The company's operating income reached US$4.5 billion, marking a 24% increase (27% in constant currency), driven by higher net sales and reduced impairments, although this was partially offset by increased R&D investments [4] - Generic competition negatively impacted sales by 7 percentage points, particularly affecting products like Promacta, Tasigna, and Entresto in the US [3]