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Source document· November 25, 2025

Press Release: Sanofi and Regeneron’s Dupixent approved as the first targeted medicine in the EU in over a decade for chronic spontaneous urticaria

View original at globenewswire.com
Press Release: Sanofi and Regeneron’s Dupixent approved as the first targeted medicine in the EU in over a decade for chronic spontaneous urticaria Sanofi and Regeneron’s Dupixent approved as the first targeted medicine in the EU in over a decade for chronic spontaneous urticaria Approval based on phase 3 studies showi…
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  • The approval of Dupixent for certain adults and adolescents with chronic spontaneous urticaria in the European Union represents the first innovation for patients with this disease in over a decade. Physicians now have a new approach for CSU with Dupixent, as the only treatment that inhibits IL4 and IL13. This approval further demonstrates the ability of Dupixent to advance the treatment landscape for yet another chronic type 2 inflammatory disease.

    80% confidence
  • Standard-of-care, first-line treatment options like antihistamines offer limited relief for many people living with uncontrolled chronic spontaneous urticaria. Dupixent significantly reduced symptoms of CSU and led to more patients experiencing well-controlled disease or a complete response compared to placebo in two phase 3 studies.

    80% confidence
  • The unpredictable nature of chronic spontaneous urticaria leaves patients guessing when they'll have their next outbreak of disruptive, debilitating hives and itch, which can make life challenging. Dupixent is proven to reduce these intense symptoms and has the potential to make a positive impact on people struggling to control this disease.

    80% confidence
  • IL4 and IL13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases

    80% confidence
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Q4 2026 Biopharma Catalyst Cluster: Late-Stage Readouts and Regulatory Milestones
October 2026 brings a dense run of Phase 3 wins (ALOFT-IPF, RESTORE-3), new data presentations (Roche, Bayer, Lilly, Vertex, Galderma) and regulatory steps (FDA acceptance of Roche's vamikibart BLA, Scholar Rock's EMA resubmission). The next big catalyst is the ivonescimab FDA PDUFA date on 2026-11-14. Obesity combination studies (REDEFINE 4, TOGETHER-PsO) and the 2027 Maritime-1 completion point to more catalysts ahead. QAIAx's speculative AI-linked trial claims (the QIII pilot, targeted for 2027) are an unrelated micro-cap sideshow with weak evidence, and have little in common with the large-cap pipeline news.
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EPKINLY Regulatory-Clinical Success Cascade
High probability of expanded label indications, additional combination approvals, and competitive positioning strength in follicular lymphoma market. Predicts positive commercial uptake and potential accelerated review for related indications.
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ING Group
Both facts record the same metric (shares_outstanding) for ING Group at the identical observation date (2025-12-31). FACT A states 2,902,437,688 shares; FACT B states 2,902 million shares (2,902,000,000). The difference is 437,688 shares (~0.015%). This is a genuine value conflict, though the discrepancy appears to result from FACT B rounding to the nearest million while FACT A provides the precise count.
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