C5 Combo (pozelimab and cemdisiran) - (NIMBLE)

Jan. 30, 2026: Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported Q4/FY2025 results and highlighted multiple regulatory catalysts and upcoming 2026 milestones.

Regulatory approvals/filings:

• EYLEA HD (aflibercept 8 mg): FDA approved EYLEA HD for macular edema following retinal vein occlusion (RVO) with up to q8w dosing after an initial monthly period, and approved a monthly dosing option across wAMD, DME, DR, and RVO (Nov 2025). EC approved EYLEA 8 mg for RVO (Jan 2026). FDA approved a new vial-filling manufacturer (Dec 2025); an application for a new pre-filled syringe manufacturer is under FDA review with a decision expected in Q2 2026.
• Libtayo (cemiplimab): FDA (Oct 2025) and EC (Nov 2025) approved adjuvant treatment for adults with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery and radiation; Japan filing submitted Dec 2025.
• Dupixent (dupilumab): EC approved chronic spontaneous urticaria (CSU) for ages ≥12 (Nov 2025); Japan approved severe/refractory asthma in children 6–11 (Dec 2025). Positive Phase 3 results reported for allergic fungal rhinosinusitis (AFRS); FDA accepted a priority-review sBLA with a Feb 2026 target action date.

Other notable filings/BD:

• DB-OTO: BLA submitted (Dec 2025) for profound genetic hearing loss due to OTOF variants; FDA decision expected 1H 2026.
• Garetosmab (Activin A antibody) in fibrodysplasia ossificans progressiva (FOP): U.S. and EU applications submitted (Dec 2025); FDA BLA and EC MAA decisions expected 2H 2026.
• Collaboration with Tessera for TSRA-196 (AATD) became effective Jan 2026; Tessera leads first-in-human study, Regeneron leads subsequent development/commercialization.

Select upcoming milestones cited for 2026 include: Phase 3 fianlimab + Libtayo melanoma results (1H 2026); cemdisiran NDA submission in myasthenia gravis (1Q 2026); additional Phase 2 obesity combo data (2026); and Phase 3 pozelimab+c emdisiran PNH results (Q4 2026/Q1 2027).