Sanofi Faces Delay in FDA Review for Tolebrutinib in MS

Sanofi ( (SNY) ) has shared an announcement.

Sanofi announced on December 15, 2025, that the U.S. regulatory review process for tolebrutinib, a treatment for non-relapsing secondary progressive multiple sclerosis (nrSPMS), is expected to extend beyond the initial target action date of December 28, 2025. The company is in ongoing discussions with the FDA and anticipates further guidance by the end of the first quarter of 2026. Sanofi has submitted an expanded access protocol for tolebrutinib, emphasizing its commitment to providing access to this investigational therapy, which targets smoldering neuroinflammation, a key driver of disability progression in multiple sclerosis.

The most recent analyst rating on (SNY) stock is a Buy with a $56.00 price target. To see the full list of analyst forecasts on Sanofi stock, see the SNY Stock Forecast page.

Spark’s Take on SNY Stock

According to Spark, TipRanks’ AI Analyst, SNY is a Outperform.

Sanofi’s overall stock score reflects its strong earnings performance and attractive valuation, which are the most significant factors. The company’s financial stability and positive earnings call guidance further support the score, despite some technical analysis indicators suggesting a neutral trend.

To see Spark’s full report on SNY stock, click here.

More about Sanofi

Sanofi is a research and development-driven, AI-powered biopharmaceutical company focused on improving lives through innovative medicines and vaccines. The company leverages its deep understanding of the immune system to address urgent healthcare challenges, with a pipeline that spans neurology and immunoscience, targeting diseases such as multiple sclerosis, Alzheimer’s, and Parkinson’s.

Average Trading Volume: 2,953,536

Technical Sentiment Signal: Hold

Current Market Cap: $119.3B

For an in-depth examination of SNY stock, go to TipRanks’ Overview page.