Delayed MS Decision and Trial Miss Add to Sanofi’s R&D Challenges

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Sanofi (NASDAQ:SNY) said on December 15 that a US regulatory decision for its experimental multiple sclerosis drug will be delayed again. On the same day, the company also disclosed weaker-than-expected results from a late-stage clinical study, adding to a difficult stretch for its research pipeline.

Analysts said the latest setbacks could weigh on confidence in Sanofi (NASDAQ:SNY)’s future drug portfolio. Earlier this year, the company reported weak results from experimental treatments for eczema and smokers’ lungs. That track record has increased pressure on management to find new growth drivers beyond its blockbuster asthma drug Dupixent.

Sanofi said the US Food and Drug Administration decision on tolebrutinib, which is being reviewed for non-relapsing secondary progressive multiple sclerosis, will now come after the December 28 action date. That marks a second delay, after the decision was initially expected in September. The company said it expects additional guidance from the FDA by the end of the first quarter of 2026.

BofA analysts said the delay could reduce the drug’s chances of approval and raise questions around the roughly €1.4 billion in peak annual sales that had been projected for tolebrutinib. Sanofi (NASDAQ:SNY) also reported that the drug failed to slow disability progression in a late-stage trial involving patients with primary progressive multiple sclerosis. This form of the disease accounts for about 10% of cases, according to the company. Analysts described the results as a negative surprise, especially when viewed against recent data from a competing treatment developed by Roche. That rival drug showed a meaningful reduction in the annualised relapse rate compared with another therapy.

Despite the challenges, tolebrutinib received breakthrough therapy designation from the FDA in December 2024 and remains under regulatory review in the European Union. It was also provisionally approved in the United Arab Emirates in July to treat non-relapsing secondary progressive multiple sclerosis and to slow disability accumulation independent of relapse activity in adults.

Sanofi (NASDAQ:SNY) is an R&D-driven, AI-powered biopharma company focused on improving patient outcomes while pursuing sustainable growth.

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