Regeneron Pharmaceuticals, Inc. REGN
Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) is an ophthalmology drug developer. Its lead program, EYLEA HD / EYLEA (aflibercept), is in Phase 3 for Neovascular AMD, diabetic macular edema, other retinal diseases. Its next catalyst on record is Fianlimab: Phase 3 results vs pembrolizumab in adjuvant melanoma (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Fianlimab — Phase 3 results vs pembrolizumab in adjuvant melanoma (Q4 2026). 7 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| EYLEA HD / EYLEA | Retinal diseases | protein/peptide | Approved |
| Dupixent (with Sanofi) | Atopic dermatitis, asthma, other type 2 inflammatory diseases | antibody | Approved |
| Libtayo | Oncology (skin cancers and others) | antibody | Approved |
| Praluent, Evkeeza, Lynozyfic, Ordspono, Otarmeni (gene therapy), Kevzara | Various | biologic-other | Approved |
| Garetosmab | Fibrodysplasia ossificans progressiva | antibody | Phase 3 |
| Cemdisiran | Generalized myasthenia gravis | RNA (siRNA/ASO/mRNA) | Phase 3 |
| Cemdisiran + pozelimab | PNH; geographic atrophy | biologic-other | Phase 3 |
| Fianlimab + cemiplimab | Adjuvant melanoma | antibody | Phase 3 |
| Factor XI antibodies | Anticoagulation | antibody | Phase 3 |
| Olatorepatide / trevogrumab (obesity) | Obesity | protein/peptide | Phase 2 |
Recent results and decisions
- Jul 30, 2026missed Phase 3 of fianlimab + cemiplimab (two fianlimab doses) vs pembrolizumab did not reach statistical significance on PFS (announced May 2026).
The trial did not reach statistical significance for the primary endpoint of improvement in progression-free survival (PFS) compared to pembrolizumab monotherapy.
Filing - Jul 30, 2026accepted FDA accepted cemdisiran NDA for gMG under priority review (June 2026); target action date November 2026; EMA also accepted, EC decision 2H 2027.
The FDA will review the New Drug Application (NDA) under priority review with a target action date in November 2026, following use of a Priority Review Voucher.
Filing - Jul 30, 2026positive Positive Phase 1/2 LINKER-AL2 results presented at ASCO 2026; Phase 2 portion with registrational intent underway.
The Company announced positive results from the Phase 1/2 LINKER-AL2 trial for Lynozyfic® (linvoseltamab) in adults with second-line-plus systemic amyloid light chain amyloidosis.
Filing
13 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 ophthalmology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.