Sanofi Announces Delay in Regulatory Decision for Tolebrutinib
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 15 2025
0mins
Source: NASDAQ.COM
Regulatory Review Update: Sanofi anticipates that the US regulatory review process for tolebrutinib in non-relapsing secondary progressive multiple sclerosis will extend beyond the target action date of December 28, 2025, with further guidance expected by the end of Q1 2026.
Expanded Access Protocol: In response to an FDA request, Sanofi has submitted an expanded access protocol for tolebrutinib, an investigational oral medication designed to target neuroinflammation in multiple sclerosis.
Analyst Views on SNY
Wall Street analysts forecast SNY stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for SNY is 78.52 USD with a low forecast of 57.00 USD and a high forecast of 116.57 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
5 Analyst Rating
2 Buy
3 Hold
0 Sell
Moderate Buy
Current: 46.500
Low
57.00
Averages
78.52
High
116.57
Current: 46.500
Low
57.00
Averages
78.52
High
116.57
About SNY
Sanofi SA is a France-based healthcare company based in France. The Company focuses on patient needs and engages in the research, development, manufacture, and marketing of therapeutic solutions. Its three operating segments are: Pharmaceuticals, Consumer Healthcare (CHC), and Vaccines. The Pharmaceuticals includes: Immunology, Multiple Sclerosis / Neurology, Oncology, Rare Diseases, Rare Blood Disorders, Cardiovascular, Diabetes, Established Prescription Products. The Vaccines segment comprises, for all geographical territories, the commercial operations of Sanofi Pasteur, together with research, development, and production activities dedicated to vaccines. The CHC segment comprises the commercial operations for Sanofi’s Consumer Healthcare products, together with research, development and production activities dedicated to those products. The Company’s products developed in collaboration or franchise include Dupixent, Aubagio, Lemtrada, Cerezyme, Lumizyme, Jevtana, Fabrazyme.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
