Press Release: Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis [Yahoo! Finance]
Sanofi - American Depositary Shares (SNY)
US:NYSE Investor Relations:
sanofi.com/en/investors
Company Research
Source: Yahoo! Finance
Paris, December 24, 2025 . The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the new drug application of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) in adult patients. On December 15, 2025, Sanofi provided an update on the ongoing review which stated that: (i) FDA was expecting the review to go beyond the previously communicated revised US target action date of December 28, 2025; (ii) further guidance from the FDA was expected by the end of the first quarter of 2026; and (iii) in response to an FDA request, Sanofi had submitted an expanded access protocol for tolebrutinib in nrSPMS. The announcement was based on the latest discussions with the FDA, which took place just before the update was provided. “ Today's FDA decision is a significant and meaningful change in direction from the feedback the agency previously provided to Sanofi. We are very disappointed by the FDA's action. Disability progressi
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SNY
Sec Filings
- 12/23/25 - Form 6-K
- 12/22/25 - Form 6-K
- 12/15/25 - Form 6-K
- SNY's page on the SEC website