The U.S. FDA has pushed back the target action date for Sanofi’s investigational multiple sclerosis therapy Tzield by more than one month, citing new safety data that include reports of seizures and a treatment-related fatality. The original Prescription Drug User Fee Act (PDUFA) target was in early February, but the agency has reset the review clock to mid-March 2026. This marks a significant setback for Sanofi’s immunology pipeline, where Tzield represented one of three late-stage programs expected to contribute up to €500 million in peak annual revenue by 2028. Regulatory consultants note that the FDA’s extended review—stretching beyond the agency’s standard 10-month timeline for priority applications—underscores ongoing scrutiny of neurological adverse events and could delay market launch and subsequent revenue recognition by at least one quarter.

On January 15, 2026, China’s National Medical Products Administration granted marketing approval for Myqorzo (aficamten) in obstructive hypertrophic cardiomyopathy (oHCM) and Redemplo (plozasiran) in familial chylomicronemia syndrome (FCS). Myqorzo’s approval, based on positive SEQUOIA-HCM phase 3 data showing a 40% improvement in exercise capacity and a 55% reduction in left ventricular outflow tract gradient, addresses a population of over 180,000 symptomatic oHCM patients in Greater China. Redemplo’s nod follows PALISADE phase 3 results demonstrating a mean 76% triglyceride reduction from baseline in genetically confirmed FCS patients, a market of approximately 12,000 adults at risk of recurrent pancreatitis events. Analysts estimate combined peak China sales of €300 million by 2030, reinforcing Sanofi’s strategy to deepen its presence in high-unmet-need cardiovascular and rare disease segments.