Sanofi

SNY

Market cap $106B

Sanofi secures FDA priority review for venglustat in GD3, setting up a November decision on a potential first U.S. therapy for neurological symptoms.

Sanofi's venglustat accepted for priority review in the US to treat type 3 Gaucher disease Paris, May 28, 2026. The US Food and Drug Administration (FDA) has granted priority review to the new drug application (NDA) for venglustat, a novel, investigational oral glucosylceramide synthase inhibitor (GCSi), for the treatment of type 3 Gaucher disease (GD3), a rare lysosomal storage disorder.

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French drugmaker Sanofi said on Monday ‌a trial showed its rare disease therapy was better than standard care in raising levels of a key protein in patients with a genetic form of lung disease.

ATS: phase 2 data demonstrate the superiority of efdoralprin alfa over a standard-of-care augmentation therapy in achieving higher fAAT levels in AATD

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Sanofi (SNY) is rated a Strong BUY, with a robust pipeline, strong FCF, and a compelling turnaround under new leadership. SNY offers a 5.5%+ dividend yield, undervalued multiples, and projected 16–20% annualized total returns over the next five years. Recent product launches drove 14% of Q1 revenue, with 80 pipeline products and 23 in mid-to-late stage development supporting future growth.

Denali narrows its Q1 loss and gains FDA approval for Avlayah, the first new Hunter syndrome treatment option in nearly 20 years.

Sanofi has asked the U.S. Food and Drug Administration to pull its diabetes drug out of the regulator's new fast-track review program, STAT ​News reported on Wednesday.