Regeneron Pharmaceuticals received U.S. Food and Drug Administration approval for its antibody Dupixent (dupilumab) in the treatment of allergic fungal rhinosinusitis (AFRS) for patients six years of age and older, adding a ninth indication to the drug’s portfolio.
The approval was based on the Phase 3 LIBERTY‑AFRS‑AIMS study, which demonstrated a 92% reduction in the combined risk of systemic corticosteroid use or surgery over 52 weeks and a significant decrease in bone erosion in the sinuses.
The new indication is expected to broaden Dupixent’s market reach and provide an additional revenue source. In Q4 2025, Dupixent generated $4.9 billion in global net sales, a 34% year‑over‑year increase, and $17.8 billion for the full year, a 26% rise. The approval adds a new therapeutic area for a drug that already drives a substantial portion of Regeneron’s revenue.
Regeneron’s strong Q4 2025 earnings—non‑GAAP EPS of $11.44 versus analyst expectations of $9.69—were largely driven by robust sales of Dupixent and EYLEA HD, and by increased collaboration revenue from Sanofi. The company’s VelocImmune platform underpins its multi‑indication strategy, and it plans to launch 18 new Phase III studies in 2026.
The AFRS approval reinforces Regeneron’s leadership in type‑2 inflammatory diseases and positions the company to capture a growing market projected to exceed $30 billion by 2035. The new indication complements existing indications and supports the company’s broader pipeline, strengthening its competitive moat in the biologics space.
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