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Sanofi: Tolebrutinib Accepted For Priority Review In U.S. For Patients With Multiple Sclerosis

ReutersMar 25, 2025 6:02 AM

- Sanofi SA SASY.PA:

  • PRESS RELEASE: TOLEBRUTINIB REGULATORY SUBMISSION ACCEPTED FOR PRIORITY REVIEW IN THE US FOR PATIENTS WITH MULTIPLE SCLEROSIS

  • TOLEBRUTINIB SUBMISSION ACCEPTED FOR PRIORITY REVIEW IN US FOR MS

  • FDA TARGET ACTION DATE FOR TOLEBRUTINIB DECISION IS SEPT 28, 2025

  • PERSEUS PHASE 3 STUDY RESULTS EXPECTED IN H2 2025

  • TOLEBRUTINIB SAFETY AND EFFICACY NOT YET EVALUATED BY REGULATORS

  • TOLEBRUTINIB REGULATORY SUBMISSION UNDER REVIEW IN EU

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