Sanofi faces a setback as tolebrutinib fails its Phase 3 PPMS trial, halting regulatory pursuit for this indication. Meanwhile, an approval decision on the candidate has also been delayed. SNY's growth remains robust, with Q3 sales up 7% YoY, net income up 10%, and Dupixent driving ~35% of total revenues. Despite pipeline disappointments, SNY expects high single-digit sales and low-double-digit EPS growth for 2025, supported by new drug launches.
Dren Bio, a private biotech company, said on Monday it has entered into a strategic collaboration with Sanofi to develop therapies for autoimmune diseases in a deal worth up to $1.7 billion.
Shares of Sanofi slumped on Monday as the French drugmaker said a U.S. regulatory review of its multiple-sclerosis drug won't be completed by the end of the year and that a trial for a different form of MS didn't succeed.
French pharmaceutical group Sanofi said on Monday the U.S. Food and Drug Administration's decision on its investigative drug to treat multiple sclerosis was expected to be delayed until the first quarter of 2026, from the previously communicated December 28.
A U.S. regulatory decision on tolebrutinib will again be delayed while a late-stage trial of the drug for a different form of the disease didn't hit its main goal.
Two bleeding disorder treatments for both chronic and acute conditions, Qfitlia and Cablivi, have been approved in China.
Sanofi/Regeneron's Dupixent wins EU nod for chronic spontaneous urticaria, marking its seventh approved indication across inflammatory diseases in the EU.
Texas Attorney General Ken Paxton sued Bristol Myers Squibb and Sanofi , accusing the drugmakers of failing to disclose that Plavix, which is used to prevent blood clots, does not work effectively for many patients.
Sanofi delivered strong Q3 results despite currency headwinds. The company's dependence on Dupixent is increasing. A broad immunology pipeline and the Blueprint Medicines acquisition should help address the issue.
Sanofi (SNY) remains a Buy, driven by Dupixent's robust growth and expanding indications, notably with the recent COPD launch. SNY's Q3 saw total revenues rise 7% CER to €12.43 billion, with Dupixent contributing over €4 billion for the first time. Beyond Dupixent, SNY is diversifying with specialty launches like Altuviiio in hemophilia and Beyfortus in RSV, plus a strong pipeline and share buybacks.
Sanofi's Q3 earnings top forecasts as Dupixent surges past EUR 4B in sales, offsetting weakness in vaccines.
Pharmaceutical launches and increased demand for its blockbuster Dupixent drug lifted net sales by 7% in the third quarter.