We recently compiled a list of the 11 Most Undervalued Pharma Stocks to Invest In. Sanofi (NASDAQ:SNY) is among the most undervalued stocks to invest in.
TheFly reported on May 27 that the US Food and Drug Administration (FDA) has granted priority review to SNY’s New Drug Application for venglustat, an investigational oral glucosylceramide synthase inhibitor intended for type 3 Gaucher disease, a rare lysosomal storage disorder with neurological involvement. If approved, the therapy would represent the first U.S. treatment targeting the progressive central nervous system manifestations of GD3.
The submission is supported by Phase 3 LEAP2MONO trial data in patients with stabilized systemic disease, where venglustat met its primary endpoints and most secondary endpoints. The treatment was generally well tolerated with no new safety concerns reported. The FDA has set a target action date of November 25, 2026, under its priority review designation for therapies addressing serious unmet medical needs.
Separately, on May 18, Sanofi (NASDAQ:SNY) reported positive results from its global Phase 2 ElevAATe study of efdoralprin alfa in adults with alpha-1 antitrypsin deficiency–related emphysema. The investigational therapy demonstrated superior performance versus standard augmentation treatment in restoring and maintaining normal functional alpha-1 antitrypsin levels, meeting the primary endpoint. Dosing every three weeks produced more than threefold higher mean trough increases compared with weekly plasma-derived therapy.
All key secondary endpoints were achieved, including sustained normalization of protein levels over the study period, with continuous coverage in the treatment arm versus substantially lower coverage under standard care. The safety profile was consistent with existing therapies, with no discontinuations due to.
Sanofi (NASDAQ:SNY) is a global biopharmaceutical company headquartered in Paris, France. It develops medicines and vaccines, with a strong focus on immunology, oncology, neurology, and rare diseases.
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