Regeneron announced that the U.S. Food and Drug Administration accepted its supplemental biologics license application for Dupixent (dupilumab) in adults and children with allergic fungal rhinosinusitis (AFRS) and granted the drug priority review status. The acceptance, made on November 7 2025, could shorten the approval timeline to six months and positions Dupixent as the first biologic specifically indicated for AFRS.
The decision follows the LIBERTY‑AFRS‑AIMS phase 3 trial, which enrolled 62 patients and demonstrated significant reductions in sinus opacification, nasal congestion, and nasal polyps compared with placebo. The trial’s positive outcomes support the FDA’s view that Dupixent offers a meaningful therapeutic benefit for a disease that currently relies on surgery and systemic steroids, both of which carry high recurrence rates.
If approved, Dupixent would become the first biologic for AFRS and would represent the drug’s ninth FDA‑approved indication. The new indication expands the addressable market for a product that already generates $4.86 billion in global net sales in Q3 2025, and it reinforces Regeneron’s leadership in type‑2 inflammatory diseases. The addition also diversifies revenue streams and mitigates concentration risk in the already crowded chronic rhinosinusitis with nasal polyps (CRSwNP) market.
Regeneron’s Q3 2025 earnings, released on October 28 2025, showed total revenue of $3.75 billion—up 1% year‑over‑year—and GAAP earnings per share of $13.62, with non‑GAAP EPS of $11.83. Dupixent sales grew 27% to $4.86 billion, a growth rate that exceeded analyst expectations and contributed to the earnings beat. The strong performance was driven by robust demand in the U.S. and international markets, while the company maintained disciplined cost control, allowing it to preserve margins despite modest price increases.
CFO Christopher Fenimore highlighted the quarter’s results, noting that “the commercial strength of Dupixent, EYLEA HD, and Libtayo reinforces our momentum toward delivering solid financial performance for the year while advancing transformative therapies to patients around the world.” The comment underscores Regeneron’s focus on leveraging its type‑2 inflammation expertise to sustain growth and support future pipeline development.
The priority review for AFRS signals a strategic expansion of Dupixent’s portfolio and positions Regeneron to capture a new patient segment that has limited treatment options. The move is expected to strengthen the company’s competitive moat in the biologics space and provide a new revenue engine that complements its existing blockbuster products.
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