Novartis (NVS) said the U.S. Food and Drug Administration has concluded that OAV-101 intrathecal or IT clinical trials for spinal muscular atrophy or SMA patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019.
The FDA's decision was based on data from Novartis' comprehensive nonclinical toxicology study in non-human primates that addressed all issues identified, including questions of dorsal root ganglia injury following intrathecal administration.
Novartis said it now plans to initiate STEER, a global pivotal Phase 3 registration-enabling study to evaluate the clinical efficacy, safety, and tolerability of OAV-101 IT in treatment naïve patients who are between two and 18 years of age, able to sit, but have never walked. While disease progression is slower in patients with later-onset SMA, there are significant unmet needs.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.