Sanofi NV SNY has been showcasing its strength in biotechnology, catching the attention of investors. The stock is currently performing well, having recently created a Golden Cross, which is a traditional technical indicator that usually suggests more increases ahead.
On March 5, 2025, Sanofi announced that it has successfully priced a bond issue worth EUR 1.5 billion. This includes €850 million in floating rate notes that will mature in March 2027, with an interest rate of 3-month Euribor plus 0.300%, and €650 million in fixed rate notes maturing in March 2031, with an annual interest rate of 2.750%.
Sarclisa has been approved in Japan for adults with newly diagnosed multiple myeloma. This approval provides new treatment options for these patients, based on positive findings from the IMROZ phase 3 study, which showed that Sarclisa combined with VRd significantly improved progression-free survival compared to VRd alone. The Ministry of Health, Labour and Welfare (MHLW) made this decision on February 25, 2025.
ECCO 2025: New data on duvakitug shows strong potential for treating ulcerative colitis and Crohn's disease. The RELIEVE UCCD study provides evidence of the drug's effectiveness and safety across various groups and doses, with new results on clinical and endoscopic outcomes. These findings will support the upcoming phase 3 program, expected to begin in the second half of 2025.
Recent detailed results from the RELIEVE UCCD study confirm the effectiveness and safety of duvakitug in all planned subgroups and doses. New endpoints include results on clinical and endoscopic outcomes, as well as improvements in histological-endoscopic mucosal health. These findings will support the upcoming Phase 3 program, expected to begin in the second half of 2025.
On February 19, 2025, in Paris, Sanofi and CD&R announced that they have signed an agreement to sell a 50% controlling stake in Opella to CD&R. This comes after completing the necessary social and corporate procedures.
The FDA plans to announce its decision on SNY and REGN's supplemental Biologics License Application for Dupixent, which is intended for treating bullous pemphigoid, by June 20, 2025.
Alnylam's Amvuttra and Sanofi's fitusiran are set to have their PDUFA dates with the FDA next month, which could lead to new revenue for the company. Alnylam anticipates a slight increase in growth for its TTR franchise in 2025, mainly due to the expected approval of Amvuttra. If fitusiran is approved, it could provide Alnylam with significant annual royalties from Sanofi, improving long-term profits and cash flow.
On February 13, 2025, Sanofi announced that it has submitted its 2024 U.S. Form 20-F to the Securities and Exchange Commission (SEC) and its "Document d'Enregistrement Universel," which includes the Annual Financial Report, to the French market regulator, Autorité des marchés financiers (AMF).
An independent interim analysis of the E.mbrace phase 3 study has revealed that the vaccine candidate for extraintestinal pathogenic E. coli did not show enough effectiveness in preventing invasive E. coli infections.