Key Takeaways SNY's NDA for tolebrutinib in nrSPMS is under FDA priority review with a decision pushed to Dec. 28, 2025.Extension follows submission of new analyses, deemed a major amendment to SNY's application by the FDA.In phase III studies, tolebrutinib delayed confirmed disability progression versus placebo and Aubagio.Sanofi (SNY) announced that the FDA has extended the target action date for its new drug application (NDA) for tolebrutinib by three months. The NDA is seeking approval of tolebrutinib, ...