Regeneron Pharmaceuticals, Inc. REGN
Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) is a cardio-renal-metabolic drug developer. Its lead program, Olatorepatide (HS-20094), is in Phase 2 for Obesity. Its next catalyst on record is Cemdisiran: FDA decision on New Drug Application for gMG (November 2026).
Upcoming catalysts
- November 2026Cemdisiran — FDA decision on New Drug Application for gMG
FDA decision on New Drug Application (NDA) (November 2026) and EC decision on MAA (second half 2027) for gMG
- February 2027Ordspono (odronextamab) — FDA decision on BLA for relapsed/refractory DLBCL
FDA decision on BLA for relapsed/refractory DLBCL (February 2027)
- March 2027Libtayo (cemiplimab) — FDA decision on supplemental Biologics License Application for every 6-week dosing regimen
FDA decision on supplemental Biologics License Application (sBLA) (March 2027) and EC decision on regulatory submission (fourth quarter 2026) for every 6-week dosing regimen for approved indications
Next further out: EYLEA HD — FDA decision for pre-filled syringe (Q4 2026). 13 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Dupixent (dupilumab) | Asthma in pediatrics (2–5 years of age), chronic pruritus of unknown origin, CSU in pediatrics (2–11 years of age), AFRS | antibody | Approved |
| EYLEA HD (aflibercept) 8 mg | Retinal vascular occlusion, wet age-related macular degeneration, diabetic macular edema | protein/peptide | Approved |
| Otarmeni (lunsotogene parvec) | Hearing loss associated with variants in OTOF gene | gene therapy | Approved |
| Cenvacibart (REGN7508) | Venous thromboembolism, stroke prevention in atrial fibrillation, peripheral artery disease, PICC-associated thrombosis | antibody | Phase 3 |
| Cemdisiran | Generalized myasthenia gravis | RNA (siRNA/ASO/mRNA) | Phase 3 |
| Ordspono (odronextamab) | Relapsed/refractory DLBCL | antibody | Phase 3 |
| Cemdisiran + pozelimab | Paroxysmal nocturnal hemoglobinuria | RNA (siRNA/ASO/mRNA) | Phase 3 |
| Fianlimab + Libtayo | Adjuvant melanoma | antibody | Phase 3 |
| Nexiguran ziclumeran (nex-z) | Transthyretin amyloidosis with cardiomyopathy, hereditary transthyretin amyloidosis with polyneuropathy | gene therapy | Phase 3 |
| Freneslerbart-mevonlerbart (REGN1908-1909) | Cat allergy | antibody | Phase 3 |
| Amrecibart (REGN9933) | Stroke prevention in atrial fibrillation, peripheral artery disease, PICC-associated thrombosis | antibody | Phase 3 |
| Olatorepatide (HS-20094) | Obesity | protein/peptide | Phase 2 |
Recent results and decisions
- Oct 30, 2026accepted FDA accepted BLA resubmission for Ordspono in relapsed or refractory DLBCL with action date in February 2027.
The FDA accepted for review the resubmission of the BLA for Ordspono™ (odronextamab) in relapsed or refractory diffuse large B-cell lymphoma (DLBCL), which has a target action date in February 2027.
Filing - Oct 30, 2026started Phase 3 study for CIDEB RNAi therapy in MASH/MASLD to initiate in fourth quarter 2026.
The Company plans to present interim results at the American Association for the Study of Liver Diseases (AASLD) Meeting in November 2026 and to initiate a Phase 3 study in metabolic dysfunction-associated steatohepatitis (MASH)/MASLD in the fourth quarter of 2026.
Filing - Oct 30, 2026started Phase 3 study for baloncibart in POTS to initiate in first half 2027 pending regulatory feedback.
Additionally, the Company plans to initiate a Phase 3 study in POTS in the first half of 2027, pending regulatory feedback.
Filing
24 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 2 cardio-renal-metabolic 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.