Sanofi (SAN) News Today

Sanofi (SAN) stock has decreased amid mixed updates: positive regulatory strides for Dupixent and SAR446268, neutral clinical study completions and review date resets, and multiple FDA delays for its oral multiple sclerosis candidate tolebrutinib.

• Positive Sentiment: SAR446268, Sanofi’s oral therapy for non-congenital myotonic dystrophy type 1, received US Fast Track designation, potentially accelerating its path to market. Sanofi’s SAR446268 earns US fast track designation
• Positive Sentiment: Europe’s CHMP issued a positive opinion recommending approval of Dupixent for chronic spontaneous urticaria, marking regulatory progress for the blockbuster. Sanofi’s Dupixent Advances in EU with Positive CHMP Opinion
• Neutral Sentiment: Sanofi completed a non-interventional national pediatric study on unexplained splenomegaly, expanding its rare-disease research but with no immediate commercial impact. Sanofi’s Pediatric Study on Unexplained Splenomegaly
• Neutral Sentiment: MarketWatch reports Sanofi saw progress for its hives treatment in the EU while the FDA reset the US review deadline for its oral MS drug to December. Sanofi Sees Progress for Hives Treatment in EU, Longer U.S. Review for MS Drug
• Neutral Sentiment: BioSpace notes the FDA has bumped its action date for Sanofi’s oral multiple sclerosis candidate to December, a standard extension rather than a refusal. FDA Action Date for Sanofi’s Oral Multiple Sclerosis Drug Bumped to December
• Negative Sentiment: The FDA has extended its review of Sanofi’s tolebrutinib for progressive multiple sclerosis, delaying a decision until December and clouding near-term launch expectations. FDA extends review of Sanofi’s tolebrutinib
• Negative Sentiment: FierceBiotech reports Sanofi’s flagship MS candidate tolebrutinib was hit by an FDA delay, heightening concerns over its approval timeline. Sanofi's troubled MS hopeful tolebrutinib hit by FDA delay
• Negative Sentiment: Multiple Sclerosis News Today confirms the FDA pushed back its decision on tolebrutinib to December, extending regulatory uncertainty. FDA pushes back to December its decision on Sanofi’s tolebrutinib
• Negative Sentiment: Benzinga reports the FDA has delayed its key decision on Sanofi’s oral MS drug, further postponing its market entry. FDA Delays Key Sanofi Multiple Sclerosis Drug Decision
• Negative Sentiment: Medical Dialogues reports the FDA set a new target action date of December 28 for tolebrutinib, signaling additional regulatory hurdles. Sanofi Tolebrutinib faces USFDA review delay; new target action date set for December 28