SNY News & Events

The FDA has granted priority review to Sanofi's new drug application for venglustat, an investigational oral glucosylceramide synthase inhibitor, for the treatment of type 3 Gaucher disease, a rare lysosomal storage disorder.

Stocks finished mixed to start the week as investors continue to watch climbing oil prices while awaiting more developments out of the Middle East. Investors are increasingly worried that inflation is becoming entrenched due to energy prices, persistent fiscal deficits and resilient economic demand. Markets are now pricing in a meaningful possibility that the Federal Reserve could raise rates again later this year instead of cutting them.Of note, President Trump stated in athat he was asked by the leaders of several Middle Eastern nations to hold off a planned military attack on Iran, which was scheduled for tomorrow, but added that he has instructed the U.S. military leadership "to be prepared to go forward with a full, large scale assault of Iran, on a moment's notice, in the event that an acceptable Deal is not reached."Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:Dominionand NextEra Energyin an all-stock transactionPublicisLiveRampfor $2.2BFordand EDF Group announced the signing of aTrump plans to announce a "dramatic expansion" of discounted prescription medication offerings available on TrumpRx,A U.S. jury on Monday ruled against Elon Musk in his lawsuit against OpenAI, finding the AI company not liable to the Teslafounder for having allegedly strayed from its original mission to benefit humanity,2. WALL STREET CALLS:F5to Outperform from In Line at Evercore ISIZscalerto Buy at B. RileyCoreWeaveand Nebiuswith lowered Neutral ratings as a new analyst took over coverage at DA DavidsonApplied Materialsto Equal Weight at Morgan StanleySalesforcewith an Underperform at BofA amid structural reset3. AROUND THE WEB:NvidiaCEO Jensen Huang told Bloomberg that it is up to China to decide on AI chips and that he looks forward to China being a more open marketTakedahas been ordered to pay hundreds of millions for violating antitrust law by delaying the generic version of its branded Amitiza drug, Bloomberg saysApple'srevamped Siri may launch in beta, and will have an option to auto-delete chats, Bloomberg reportsPresident Trump said he "should have asked for more" of a stake in Intelon behalf of the U.S. government, Fortune saysVinFast'splanned sale of two Vietnamese factories will allow the company to shed $6.9B in debt and obligations to help assist its path to profitability, Bloomberg says4. MOVERS:Hive Digitalwas higher afteris planning to build a new AI infrastructure facility in the Greater Toronto Area with approximately 320 megawatts of utility capacityCourseraincreased after announcing aServiceNowgained after BofAcoverage of the stock with a Buy ratingDesign Therapeuticswas lower afterRegeneronfell after its Phase 3 trial of fianlimab5. EARNINGS/GUIDANCE:Bradyand raised its guidance for FY26iQiyi, with EPS and revenue lower year-over-yearGossamer Bio, with CEO Faheem Hasnain commenting, "We are executing across multiple fronts at Gossamer"RedCloudreportedand reaffirmed guidance for FY26Baidu, with EPS and revenue lower year-over-yearINDEXES:The Dow rose 159.95, or 0.32%, to 49,686.12, the Nasdaq lost 134.41, or 0.51%, to 26,090.73, and the S&P 500 declined 5.45, or 0.074%, to 7,403.05.

Sanofi announced data from the global ElevAATe phase 2 study demonstrated superiority of investigational efdoralprin alfa over standard-of-care therapy in achieving and maintaining normalized functional alpha-1 antitrypsin levels in adult patients with alpha-1 antitrypsin deficiency-related emphysema. These results are being presented at the 2026 American Thoracic Society International Conference in Orlando. Efdoralprin alfa, dosed every three weeks, achieved mean increases in fAAT trough levels more than three times greater than plasma-derived protein dosed weekly, meeting the primary endpoint . All key secondary endpoints in the study were also met, highlighting the potential for efdoralprin alfa to be the first therapy to sustain normal fAAT levels for patients and do so with less frequent dosing. In patients dosed Q3W, fAAT levels remained above the normal threshold for 100% of days during the 32-week study compared to 41% of days in patients on a standard-of-care augmentation therapy. AATD is an underdiagnosed, rare genetic condition that can cause considerable respiratory illness and is characterized by low levels or absence of AAT, a protein designed to protect the lungs from damaging inflammation. Without adequate fAAT levels, patients often experience progressive deterioration of the lung tissue and may develop emphysema, the most common form of chronic obstructive pulmonary disease, accounting for up to 72% of deaths in people with AATD. An estimated 90% of individuals with AATD are believed to be undiagnosed. Efdoralprin alfa was well tolerated with a safety profile comparable to pdAAT, with no participants experiencing treatment-emergent adverse events leading to permanent discontinuation of study intervention. The most common TEAEs in the efdoralprin alfa Q3W, efdoralprin alfa Q4W and pdAAT therapy arms were COPD exacerbations, headache and COVID-19 infection. Notably, the incidence of grade greater than or equal to 2 COPD exacerbations, which were captured as an adverse event of special interest in the ElevAATe study, were numerically lower for the efdoralprin alfa Q3W arm versus the efdoralprin alfa Q4W and pdAAT arms. Efdoralprin alfa anti-drug antibodies were detected in two participants and were transient and non-neutralizing. Sanofi is engaging with global regulatory authorities on the appropriate next steps for efdoralprin alfa.