SANOFI overview

Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines Designation granted for warm autoimmune hemolytic anemia and IgG4-related disease Rilzabrutinib is currently under regulatory review in the US, EU and China for potential use in immune thrombocytopenia Paris, April 3, 2025 . The US Food and Drug Administration (FDA) has granted orphan drug designation to rilzabrutinib, an investigational, novel, advanced, oral, reversible Bruton’s tyrosine...

Chlamydia vaccine candidate granted fast track designation by the US FDA Chlamydia infection can contribute to pelvic inflammatory diseases in women, which can lead to pregnancy complications or infertility A phase 1/2 clinical study evaluating the immunogenicity and safety of the vaccine candidate is due to start in coming days Paris, March 26, 2025 . The US Food and Drug Administration has granted fast track designation to Sanofi’s mRNA vaccine candidate for the prevention of chlamydia...

Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor to both treat non-relapsing secondary progressive multiple sclerosis (MS) and slow disability accumulation independent of relapse activity Tolebrutinib has the potential to be the first therapy to target smoldering neuroinflammation, a key driver of disability accumulation in MS Tolebrutinib was granted...

Sanofi to acquire Dren Bio’s bispecific myeloid cell engager for deep B-cell depletion, broadening immunology pipeline Dren Bio deep B-cell depleter program has the potential to reset the immune system Acquisition underpins path for Sanofi becoming leading immunology company Sanofi to pay $600 million up front Paris, March 20, 2025. Sanofi and Dren Bio, Inc., a private clinical-stage biopharmaceutical company, have entered into a definitive agreement under which Sanofi has agreed to acquire...

Sanofi successfully prices EUR 1.5 billion of bond issue Paris, March 5, 2025. Sanofi announces that it has successfully priced its offering of EUR 1.5 billion of notes across 2 tranches: €850 million floating rate notes, due March 2027, bearing interest at 3-month Euribor plus 0.300% €650 million fixed rate notes, due March 2031, bearing interest at an annual rate of 2.750%. The notes are being issued off the company's Euro Medium Term Note Program. Sanofi intends to use the net proceeds of...

ECCO 2025: new duvakitug data reinforce best-in-class potential in ulcerative colitis and Crohn’s disease New detailed data from the RELIEVE UCCD study support overall efficacy and safety of duvakitug in all pre-specified subgroups across the different doses New endpoints presented include findings on clinical and endoscopic outcomes and histological-endoscopic mucosal improvement Findings to form the basis for a phase 3 program, anticipated to start in H2 2025 Paris and Parsippany, NJ,...