[6-K] Sanofi Current Report (Foreign Issuer)
Sanofi furnished a report summarizing two recent regulatory milestones. One press release describes a pivotal study of Dupixent in allergic fungal rhinosinusitis that met all primary and secondary endpoints and reduced signs and symptoms of the disease, and notes that a supplemental Biologics License Application has been accepted for FDA priority review. A second press release states that Teizeild has been recommended for European Union approval by the CHMP for patients with stage 2 type 1 diabetes.
- Dupixent pivotal study success and FDA priority review: The pivotal study in allergic fungal rhinosinusitis met all primary and secondary endpoints, reduced signs and symptoms, and the related sBLA was accepted for FDA priority review, signaling a potentially important label expansion opportunity.
- Teizeild recommended for EU approval: Teizeild received a positive CHMP recommendation for patients with stage 2 type 1 diabetes, a major step toward potential EU market authorization in a significant disease area.
- None.
Insights
Sanofi reports positive US and EU regulatory momentum for two key therapies.
Sanofi highlights that Dupixent achieved all primary and secondary endpoints in a pivotal study for allergic fungal rhinosinusitis and reduced signs and symptoms in this setting. The associated supplemental Biologics License Application has been accepted for FDA priority review, indicating that US regulators see potential clinical importance and will evaluate it on an expedited timetable.
The company also reports that Teizeild has been recommended for EU approval by the CHMP for patients with stage 2 type 1 diabetes. A positive CHMP opinion is typically a key step toward a European Commission marketing authorization. If approvals follow, these therapies could expand Sanofi’s portfolio in immunology and diabetes, though actual commercial impact will depend on final decisions and subsequent market uptake.
FAQ
What is the main purpose of Sanofi’s November 2025 Form 6-K for SNY?
The report informs investors that Sanofi has published two press releases, one on positive pivotal data and FDA priority review for Dupixent, and another on a positive EU recommendation for Teizeild.
What did Sanofi announce about Dupixent in this 6-K for SNY?
Sanofi reported that a pivotal study of Dupixent in allergic fungal rhinosinusitis met all primary and secondary endpoints, reduced signs and symptoms, and led to an sBLA being accepted for FDA priority review.
Which indication is covered by Dupixent’s pivotal study mentioned by Sanofi?
The pivotal study for Dupixent covered patients with allergic fungal rhinosinusitis, and the treatment reduced signs and symptoms in this condition.
What regulatory progress did Sanofi report for Teizeild in the EU?
Sanofi stated that Teizeild has been recommended for EU approval by the CHMP for patients with stage 2 type 1 diabetes, an important step toward potential EU authorization.
Does this Sanofi 6-K for SNY include financial results or earnings data?
No. The report focuses on regulatory and clinical milestones for Dupixent and Teizeild and does not present financial results or earnings information.
