On Monday, the U.S. Food and Drug Administration (FDA) extended the review date for Sanofi SA’s (NASDAQ:SNY) new drug application (NDA) of tolebrutinib for non-relapsing, secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity in adult patients.

Based on the submission of additional analyses during the review, the FDA has determined that the additional information constituted a major amendment to the NDA and extended the target action date accordingly. The revised target action date for the FDA decision is December 28, 2025.

The FDA review of tolebrutinib is based on data from the global, double-blinded randomized HERCULES ...