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Regeneron Pharmaceuticals, Inc.

REGN
$75.16BLarge Cap

Next catalyst

Phase 2November 2026

Dupilumab

Atopic Dermatitis (AD)

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Track Regeneron Pharmaceuticals (REGN) and we email you when an FDA date moves, 7 days and 1 day before the decision when the exact day is known, and when it is announced. Free account, no card.

Plus 31 more upcoming events in our data (earnings, Phase 2 readout, PDUFA date and more).See the timeline

Catalyst Timeline

33 upcoming, 5 past

Earnings

REGN Earnings Report

Oct 30, 2026

EPS Est: $13.76 | FQ end Sep/2026 | Call: bmo

Phase 2Next

Dupilumab Phase 2 Est. Readout

November 2026~Dupilumab96

Estimated primary completion for Dupilumab trial (NCT05720325) in Asthma, Allergic. Topline data typically follows completion by weeks to months.

Source
Phase 2

cemiplimab Phase 2 Est. Readout

November 2026~Fixed Dose Combination (FDC) cemiplimab+fianlimab151

Primary completion for cemiplimab trial (NCT06190951) in Melanoma

Source
Phase 3
✓Positive

Cemiplimab Phase 3 Est. Readout

November 2026~cemiplimab415

Primary completion for Cemiplimab trial (NCT03969004) in Cutaneous Squamous Cell Carcinoma

Late-breaking Phase 3 C-POST data provide longer-term survival outcomes for adjuvant Libtayo in high-risk CSCC

Source
Phase 2

Olatorepatide Phase 2 Est. Readout

November 2026~Olatorepatide120

Estimated primary completion for Olatorepatide trial (NCT07431086) in Overweight or Obesity. Topline data typically follows completion by weeks to months.

Source
Phase 2

REGN2810 Phase 2 Est. Readout

November 2026~REGN281026

Estimated primary completion for REGN2810 trial (NCT03951831) in Prostate Cancer Metastatic. Topline data typically follows completion by weeks to months.

Source
PDUFA

FDA PDUFA Date cemdisiran

November 2026~Cemdisiran

For Anti-AChR antibody-positive generalized myasthenia gravis. NDA, Priority Review; company gives November 2026, no exact day. Verified against the company announcement on 2026-10-16.

Source
Phase 2

REGN7999 Phase 2 Est. Readout (FERVENT-1)

December 2026~REGN799919

Primary completion for REGN7999 trial (NCT06421636) in Non-Transfusion Dependent Beta-Thalassemia (NTDT)

Source

How REGN's past catalysts played out

Market Overview

Stock performance and key metrics

NASDAQPharmaceutical PreparationsPharmaceuticals🇺🇸North AmericaTARRYTOWN15.4K employees

Regeneron Pharmaceuticals, Inc. is an American biotechnology company headquartered in Westchester County, New York. The company was founded in 1988. Originally focused on neurotrophic factors and their regenerative capabilities, giving rise to its present name; the company has since expanded operations into the study of both cytokine and tyrosine kinase receptors, which gave rise to their first product, which is a VEGF-trap.

Website
Drug Pipeline

Dupixent

Dupilumab

Approved

Atopic Dermatitis

ranibizumab

Phase 3

Macular Degeneration

mibavademab

Phase 3

Generalized Lipodystrophy

Suptavumab

Phase 3

Respiratory Syncytial Virus Infections

REGN7508

Phase 3

Venous Thromboembolism (VTE)

REGN9933

Phase 3

Venous Thromboembolism

Oral corticosteroids (OCS)

Phase 3

Bullous Pemphigoid

Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)

Phase 3

Diabetic Macular Edema

REGN1908

Phase 3

Allergic Conjunctivitis

Alirocumab

Phase 3

Homozygous Familial Hypercholesterolemia

Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)

Phase 3

Branch Retinal Vein Occlusion

Statin

Phase 3

Hypercholesterolemia

Sarilumab

Phase 3

COVID-19

aflibercept injection (VEGF Trap-Eye, BAY86-5321)

Phase 3

Macular Degeneration

Intravitreal Aflibercept

Phase 3

Neovascular Age-related Macular Degeneration

LMT (atorvastatin, simvastatin, or rosuvastatin)

Phase 3

Heterozygous Familial Hypercholesterolemia

REGN-2Cat

Phase 3

Allergic Conjunctivitis

REGN10933 + REGN10987

Phase 3

Healthy Participants

Rivaroxaban

Phase 3

Peripheral Artery Disease (PAD)

Dupilumab

Phase 3

Atopic Dermatitis (AD)

REGN5715

Phase 3

Allergic Conjunctivitis

Odronextamab

Phase 3

Diffuse Large B-cell Lymphoma (DLBCL)

REGN475

Phase 3

Sciatica

REGN2810

Phase 3

Non-small Cell Lung Cancer

Acetylsalicylic Acid (ASA)

Phase 3

Symptomatic Venous Thromboembolism (VTE)

aflibercept

Phase 3

Diabetic Macular Edema

REGN5713

Phase 3

Allergic Rhinitis

Fluorouracil

Phase 3

Colorectal Cancer Metastatic

Atorvastatin

Phase 3

Hypercholesterolemia

Indomethacin

Phase 3

Acute Gout Flare

Cemdisiran

Phase 3

Paroxysmal Nocturnal Hemoglobinuria

Folic acid

Phase 3

Rheumatoid Arthritis

2-mg Intravitreous Aflibercept Injection

Phase 3

Proliferative Diabetic Retinopathy

Rilonacept

Phase 3

Gout

Eylea (Aflibercept, BAY86-5321)

Phase 3

Retinopathy of Prematurity (ROP)

Prompt aflibercept

Phase 3

Diabetic Macular Edema

Simvastatin

Phase 3

Hypercholesterolemia

Investigator Choice (IC) Chemotherapy

Phase 3

Squamous Cell Carcinoma (SCC)

Non-statin Lipid-Modifying Therapy

Phase 3

Hypercholesterolemia

aflibercept PFS

Phase 3

Diabetic Macular Edema (DME)

cemiplimab

Phase 3

Advanced Cutaneous Squamous Cell Carcinoma

REGN5714

Phase 3

Allergic Rhinitis

Dupilumab Prefilled Syringe

Phase 3

Asthma Control

Prednisone/Prenisolone

Phase 3

Follicular Lymphoma (FL)

Elotuzumab

Phase 3

Relapsed Refractory Multiple Myeloma (RRMM)

Garetosmab

Phase 3

Fibrodysplasia Ossificans Progressiva

Fasinumab

Phase 3

Osteoarthritis of the Knee or Hip

VEGF Trap-Eye (BAY86-5321)

Phase 3

Diabetes Mellitus

Albuterol/Salbutamol

Phase 3

Asthma

Pozelimab + Cemdisiran

Phase 3

Generalized Myasthenia Gravis

sulfasalazine

Phase 3

Rheumatoid Arthritis

Nicotinic acid

Phase 3

Hypercholesterolaemia

Ramucirumab

Phase 3

Recurrent Lung Non-Small Cell Carcinoma

Deferred aflibercept

Phase 3

Diabetic Retinopathy

Libtayo

Cemiplimab

Phase 3

Non-Small Cell Lung Cancer

Fast Track

Etoposide Phosphate

Phase 3

B-cell Non Hodgkin Lymphoma

Omega-3 fatty acids

Phase 3

Hypercholesterolaemia

Evinacumab

Phase 3

Hypercholesterolemia

Lovastatin

Phase 3

Hypercholesterolaemia

Cholestyramine

Phase 3

Hypercholesterolaemia

CAR T-cells (TBC)

Phase 3

B-cell Non Hodgkin Lymphoma

Linvoseltamab

Phase 3

Monoclonal Gammopathy of Undetermined Significance (MGUS)

Naproxen

Phase 3

Osteoarthritis, Knee

Fianlimab

Phase 3

Melanoma

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Phase 3

Macular Edema

Ravulizumab

Phase 3

Paroxysmal Nocturnal Hemoglobinuria

Intravitreal Aflibercept Injection (IAI)

Phase 3

Neovascular Age-Related Macular Degeneration

VEGF Trap-Eye

Phase 3

Macular Edema Secondary to Central Retinal Vein Occlusion

Inhaled Long-Acting Beta Agonist

Phase 3

Chronic Obstructive Pulmonary Disease

Intravitreal Aflibercept Injection

Phase 3

Diabetic Macular Edema

Inhaled Corticosteroid

Phase 3

Chronic Obstructive Pulmonary Disease

Inhaled Long-Acting Muscarinic Antagonist

Phase 3

Chronic Obstructive Pulmonary Disease

Suptavumab - 2 Doses

Phase 3

Respiratory Syncytial Virus Infections

Suptavumab - 1

Phase 3

Respiratory Syncytial Virus Infections

Levalbuterol/Levosalbutamol

Phase 3

Asthma

Pozelimab

Phase 3

CD55-deficient Protein-losing Enteropathy

Trevogrumab-Part B and Part C

Phase 2

Obesity

Encorafenib + Binimetinib

Phase 2

Melanoma BRAF V600E/K Mutated

Fluticasone or Fluticasone/salmeterol combination

Phase 2

Asthma

Platinum based chemotherapy

Phase 2

Carcinoma, Non-Small-Cell Lung

cemiplimab plus fianlimab

Phase 2

Colo-rectal Cancer

Cemiplimab-Rwlc

Phase 2

Non-small Cell Lung Cancer Stage III

Fluticasone/Salmeterol combination therapy

Phase 2

Asthma

Chimeric Antigen Receptor T-Cell Therapy

Phase 2

Recurrent Diffuse Large B-Cell Lymphoma

Topical imiquimod

Phase 2

Cutaneous Basal Cell Carcinoma

Sub-tenon injection of hyaluronidase (HA) followed by a sub-tenon injection of aflibercept

Phase 2

Thyroid Eye Disease

Sarilumab, SAR153191 IV

Phase 2

Rheumatoid Arthritis

cemiplimab + REGN7075

Phase 2

Colo-rectal Cancer

REGN17372+Linvoseltamab

Phase 2

Relapsed Refractory Multiple Myeloma (RRMM)

Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]

Phase 2

Ovarian Cancer

REGN5458

Phase 2

Multiple Myeloma

OrphanFast TrackBreakthrough

REGN4336

Phase 2

Metastatic Castration-resistant Prostate Cancer

ALN-ANG3

Phase 2

Diabetic Kidney Disease (DKD)

High-dose aflibercept

Phase 2

Neovascular (Wet) Age-Related Macular Degeneration

REGN5678

Phase 2

Metastatic Castration-resistant Prostate Cancer

REGN15505

Phase 2

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

FLT PET/CT

Phase 2

Prostate Cancer

S095024

Phase 2

Non-small Cell Lung Cancer (NSCLC)

SAR440340

Phase 2

Chronic Obstructive Pulmonary Disease

pTVG-AR

Phase 2

Prostate Cancer

S095018 Recommended Dose Expansion (RDE)

Phase 2

Non-small Cell Lung Cancer (NSCLC)

S095024 RDE

Phase 2

Non-small Cell Lung Cancer (NSCLC)

S095029

Phase 2

Non-small Cell Lung Cancer (NSCLC)

S095029 RDE

Phase 2

Non-small Cell Lung Cancer (NSCLC)

REGN7075

Phase 2

Advanced Solid Tumors

REGN22530

Phase 2

Primary Open Angle Glaucoma (POAG)

REGN7041

Phase 2

Active Noninfectious Uveitis Affecting the Posterior Segment

REGN1908-1909

Phase 2

Cat Allergy

Marlotamig

Phase 2

Non-Small Cell Lung Cancer

REGN5668

Phase 2

Ovarian Cancer

Platinum-based chemotherapy

Phase 2

Non-Small Cell Lung Cancer

REGN7544

Phase 2

Postural Orthostatic Tachycardia Syndrome (POTS)

VEGF Trap Eye

Phase 2

Macular Degeneration

REGN10933+REGN10987 combination therapy

Phase 2

COVID-19

REGN910-3

Phase 2

Diabetic Macular Edema

REGN7945+Linvoseltamab

Phase 2

Relapsed/Refractory Multiple Myeloma

Low-Dose REGN4461

Phase 2

Generalized Lipodystrophy

REGN10597

Phase 2

Melanoma

REGN1500

Phase 2

Homozygous Familial Hypercholesterolemia

AR101

Phase 2

Peanut Allergy

REGN3918

Phase 2

Paroxysmal Nocturnal Hemoglobinuria (PNH)

ALN-CFB

Phase 2

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Olatorepatide

Phase 2

Overweight or Obesity

REGN2477

Phase 2

Fibrodysplasia Ossificans Progressiva

Timothy Grass SCIT

Phase 2

Allergic Rhinitis

casirivimab+imdevimab

Phase 2

Healthy

PB

Phase 2

Sepsis-Induced Hypotension

REGN5381

Phase 2

Heart Failure

REGV131

Phase 2

Hemophilia B

REGN7999

Phase 2

Non-Transfusion Dependent Beta-Thalassemia (NTDT)

ISA101b

Phase 2

Cervical Cancer

Fixed Dose Combination (FDC) cemiplimab+fianlimab

Phase 2

Melanoma

REGN1033 (SAR391786)

Phase 2

Sarcopenia

Vonsetamig

Phase 2

Chronic Kidney Disease (CKD)

REGN5093

Phase 2

NSCLC

Ubamatamab

Phase 2

Ovarian Cancer

REGN5459

Phase 2

Relapsed Multiple Myeloma

ALN-SOD

Phase 2

Amyotrophic Lateral Sclerosis (ALS)

REGN13335

Phase 2

Pulmonary Arterial Hypertension (PAH)

Trevogrumab-Part A

Phase 2

Obesity

BNT116

Phase 2

Advanced Non-Small Cell Lung Cancer

Tocilizumab

Phase 2

Recurrent Ovarian Cancer

ALN-HSD

Phase 2

Metabolic Dysfunction-associated Steatohepatitis (MASH)

Platinum Doublet

Phase 2

Non-small Cell Lung Cancer

REGN15505+Cemiplimab

Phase 2

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

ALN-CIDEB

Phase 2

Metabolic Dysfunction-Associated Steatotic Liver Disease

ALN-PNP

Phase 2

Healthy Volunteers

FDC fianlimab+cemiplimab

Phase 2

Head and Neck Squamous Cell Carcinoma (HNSCC)

Aflibercept Injection

Phase 2

Diabetic Retinopathy

Cemiplimab i.v. on day 1 of cycle

Phase 2

Merkel Cell Carcinoma, Stage I

Pemetrexed (Alimta)

Phase 2

Pleural Mesotheliomas

Enoxaparin

Phase 2

Venous Thromboembolism

Cemiplimab Plus Gemcitabine

Phase 2

Pancreatic Ductal Adenocarcinoma (mPDAC)

ZIV-Aflibercept

Phase 2

Metastatic Uveal Melanoma

Sirolimus

Phase 2

Cutaneous Squamous Cell Carcinoma

Aspirin Challenge

Phase 2

Aspirin-exacerbated Respiratory Disease

RP1

Phase 2

Cutaneous Squamous Cell Carcinoma

Motixafortide

Phase 2

Pancreatic Cancer

Pexastimogene Devacirepvec (Pexa-Vec)

Phase 2

Renal Cell Carcinoma

Platinum Doublet Chemotherapy (PDC)

Phase 2

NSCLC

VV1

Phase 2

Melanoma

Dupilumab (blinded)

Phase 2

Eosinophilic Gastritis

Cemiplimab Intravenous

Phase 2

Clear Cell Renal Cell Carcinoma

Carboplatin (AUC 5)

Phase 2

Pleural Mesotheliomas

REGN15505+REGN4336

Phase 2

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Frequently asked questions

What is in Regeneron Pharmaceuticals, Inc.'s drug pipeline?→

CatalystAlert tracks 165 drug candidates in Regeneron Pharmaceuticals, Inc.'s (REGN) pipeline across Phase 3, Phase 2, Approved. Its lead program is Cemdisiran (Phase 3). Each drug's phase, indication and upcoming catalysts are listed on this page.

When is Regeneron Pharmaceuticals, Inc.'s next FDA catalyst?→

Regeneron Pharmaceuticals, Inc.'s (REGN) next tracked catalyst is a Phase 2 readout expected November 2026. See the catalyst timeline on this page for the full schedule of PDUFA dates, trial readouts and FDA events.

How do I track REGN biotech catalysts?→

Add REGN to your CatalystAlert watchlist for alerts ahead of each catalyst, and follow Regeneron Pharmaceuticals, Inc.'s live catalyst calendar, drug pipeline and clinical-trial timeline on this page — sourced from ClinicalTrials.gov, FDA and SEC filings.

Data is aggregated from public sources (FDA, SEC, ClinicalTrials.gov). While we strive for accuracy, information may be incomplete, delayed, or contain errors. Terms apply