The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Acoziborole Winthrop, a single‑dose oral therapy for both early and advanced‑stage gambiense sleeping sickness. The decision, released on February 27 2026, represents a critical regulatory milestone that could enable market entry in the Democratic Republic of Congo and other endemic regions.
Phase 2/3 studies of Acoziborole demonstrated a 96 % cure rate at 18 months, with a safety profile that met regulatory expectations. The single‑dose regimen offers a simpler, more patient‑friendly alternative to the multi‑day or injectable treatments that have historically been used for this disease.
The approval is the culmination of a long‑standing partnership between Sanofi and the Drugs for Neglected Diseases initiative (DNDi). Together, the two organizations have advanced the drug from discovery through clinical development, and Sanofi has committed to donating the medicine to the World Health Organization through its Foundation S, supporting the WHO’s goal of eliminating gambiense sleeping sickness by 2030.
Sanofi’s broader financial performance provides context for the significance of this regulatory win. In Q4 2025, the company reported a 20.5 % year‑over‑year increase in total revenue to $14.3 billion, but operating and net losses persisted. In Q4 2024, adjusted earnings missed estimates at $0.70 per share and net sales fell short of expectations at $11.27 billion. These results illustrate the company’s ongoing transition toward a more focused biopharmaceutical model, with new launches such as Dupixent and Beyfortus driving growth while legacy products face competitive headwinds.
CEO Paul Hudson emphasized the strategic importance of the Acoziborole approval, noting that “the positive opinion for Acoziborole Winthrop expands our neglected‑disease portfolio and reinforces our commitment to delivering life‑saving therapies to underserved populations.” He added that Sanofi’s transformation into a “development‑driven, tech‑powered biopharma company” is supported by the company’s expanding pipeline and its focus on high‑impact therapeutic areas.
The regulatory endorsement positions Sanofi to strengthen its neglected‑disease portfolio, diversify revenue streams, and advance its global health mission. It also signals to investors that Sanofi is successfully leveraging public‑private partnerships to bring innovative treatments to market, a strategy that aligns with the company’s broader goal of becoming a leading biopharma organization.
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