PARIS (dpa-AFX) - Sanofi (SNY, SNYNF, SAN.PA) announced that results from the PERSEUS Phase 3 study showed tolebrutinib did not meet its primary endpoint in delaying time to 6-month composite confirmed disability progression (cCDP) in participants with primary progressive multiple sclerosis (PPMS), which accounts for approximately 10% of the overall multiple sclerosis patient population. Based on these findings, the company will not pursue regulatory registration for PPMS.
Tolebrutinib was provisionally approved in the United Arab Emirates in July 2025 for the treatment of non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity in adults. The therapy remains under regulatory review in the European Union and other jurisdictions worldwide. In December 2024, the U.S. FDA granted tolebrutinib breakthrough therapy designation.
Sanofi noted that it will conduct an impairment test in accordance with IFRS (IAS 36) on the intangible asset value attached to tolebrutinib, with results to be provided alongside Q4 and FY 2025 reporting in January 2026. The company confirmed that the outcome of this test will have no impact on business net income or business EPS, and its financial guidance for 2025 remains unchanged.
For More Such Health News, visit rttnews.com.
Copyright(c) 2025 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2025 AFX News
