Regeneron (REGN) — Upcoming Catalysts
FDA PDUFA dates, advisory-committee meetings, and Phase 2/3 readout windows for Regeneron, built from public data lanes (ClinicalTrials.gov and official sources). Each row links to its source.
For informational purposes only — not investment advice. Track REGN live on Mooboard →
31–90 days3
- Oct 7, 2026ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutDupilumab · Phase 3 · Atopic DermatitisNCT02612454: Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD). Primary completion 2026-10-07 (estimated); status ACTIVE_NOT_RECRUITING.
- Oct 12, 2026ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutRavulizumab · Phase 3 · Paroxysmal Nocturnal HemoglobinuriaNCT05133531: A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment. Primary completion 2026-10-12 (estimated); status ACTIVE_NOT_RECRUITING.
- Nov 2, 2026ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutcemiplimab · Phase 2 · MelanomaNCT06190951: A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma. Primary completion 2026-11-02 (estimated); status ACTIVE_NOT_RECRUITING.
Later22
- Nov 13, 2026ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutOlatorepatide · Phase 2 · Overweight or ObesityNCT07431086: Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the US. Primary completion 2026-11-13 (estimated); status ACTIVE_NOT_RECRUITING.
- Nov 13, 2026ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutREGN7075 · Phase 1 / Phase 2 · Advanced Solid TumorsNCT04626635: A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers. Primary completion 2026-11-13 (estimated); status ACTIVE_NOT_RECRUITING.
- Dec 3, 2026ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutREGN7999 · Phase 2 · Non-Transfusion Dependent Beta-Thalassemia (NTDT)NCT06421636: A Study to Test the Safety, Tolerability, and Efficacy of an Antibody, REGN7999, Injected Under the Skin for the Treatment of Iron Overload in Adult Participants With Non-Transfusion Dependent β-thalassemia, Using MRI Scans to Measure Iron Levels in the Body. Primary completion 2026-12-03 (estimated); status ACTIVE_NOT_RECRUITING.
- Dec 29, 2026ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutAlirocumab · Phase 2 · HypercholesterolemiaNCT07477704: A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia. Primary completion 2026-12-29 (estimated); status RECRUITING.
- Feb 9, 2027ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutREGN7508 · Phase 2 · Atrial Fibrillation (AF)NCT07175428: Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation. Primary completion 2027-02-09 (estimated); status RECRUITING.
- Feb 20, 2027ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutREGN7508 · Phase 3 · Venous Thromboembolism (VTE)NCT07015905: REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults. Primary completion 2027-02-20 (estimated); status RECRUITING.
- Feb 28, 2027ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutREGN5713 · Phase 3 · Allergic ConjunctivitisNCT07309432: Study of Bet v1 Antibodies Effect on Eye Allergy Symptoms in Adolescents and Adults With Birch Pollen Allergy. Primary completion 2027-02-28 (estimated); status RECRUITING.
- Mar 22, 2027ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutfianlimab · Phase 3 · MelanomaNCT06246916: A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head). Primary completion 2027-03-22 (estimated); status RECRUITING.
- Mar 25, 2027ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutREGN5668 · Phase 1 / Phase 2 · Ovarian Cancer; Fallopian Tube CancerNCT04590326: A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab. Primary completion 2027-03-25 (estimated); status RECRUITING.
- May 10, 2027ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutUbamatamab · Phase 1 / Phase 2 · Recurrent Ovarian Cancer; Recurrent Fallopian Tube CancerNCT03564340: Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers. Primary completion 2027-05-10 (estimated); status RECRUITING.
- May 15, 2027ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutALN-CIDEB · Phase 1 / Phase 2 · Metabolic Dysfunction-Associated Steatotic Liver Disease; Metabolic Dysfunction-Associated SteatohepatitisNCT06836609: A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH). Primary completion 2027-05-15 (estimated); status RECRUITING.
- May 17, 2027ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutREGN7508 · Phase 3 · Symptomatic Venous Thromboembolism (VTE)NCT07213778: REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants. Primary completion 2027-05-17 (estimated); status RECRUITING.
- May 20, 2027ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutCemiplimab · Phase 2 · Non-Small Cell Lung CancerNCT06465329: A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC). Primary completion 2027-05-20 (estimated); status RECRUITING.
- Jun 18, 2027ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutMibavademab · Phase 3 · Monogenic ObesityNCT07220772: A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults. Primary completion 2027-06-18 (estimated); status RECRUITING.
- Aug 10, 2027ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutALN-PNP · Phase 1 / Phase 2 · Healthy Volunteers; Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)NCT05648214: A Trial to Learn if ALN-PNP is Safe and Well Tolerated in Healthy Adults and Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). Primary completion 2027-08-10 (estimated); status RECRUITING.
- Aug 20, 2027ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutMibavademab · Phase 2 · Functional Hypothalamic Amenorrhea (FHA)NCT07235917: A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea. Primary completion 2027-08-20 (estimated); status RECRUITING.
- Sep 24, 2027ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutALN-ANG3 · Phase 2 · Diabetic Kidney Disease (DKD)NCT07271186: Study to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney Disease. Primary completion 2027-09-24 (estimated); status RECRUITING.
- Sep 28, 2027ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutfianlimab · Phase 2 / Phase 3 · Advanced Non-Small Cell Lung CancerNCT05785767: A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC). Primary completion 2027-09-28 (estimated); status ACTIVE_NOT_RECRUITING.
- Oct 16, 2027ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutREGN-2Cat · Phase 3 · Allergic ConjunctivitisNCT07675811: A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy. Primary completion 2027-10-16 (estimated); status NOT_YET_RECRUITING.
- Nov 15, 2027ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutREGN5678 · Phase 1 / Phase 2 · Metastatic Castration-Resistant Prostate Cancer (mCRPC); Clear Cell Renal Cell Carcinoma (ccRCC)NCT03972657: A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors. Primary completion 2027-11-15 (estimated); status RECRUITING.
- Nov 22, 2027ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutVonsetamig · Phase 1 / Phase 2 · Chronic Kidney Disease (CKD)NCT05092347: A Study to Learn How Safe and Tolerable Vonsetamig is in Adult Patients With Chronic Kidney Disease (CKD) Who Need Kidney Transplantation and Are Highly Sensitized to Human Leukocyte Antigen (HLA). Primary completion 2027-11-22 (estimated); status ACTIVE_NOT_RECRUITING.
- Jan 7, 2028ClinicalTrials.gov ↗Regeneron(REGN)Phase 2/3 readoutCemiplimab · Phase 3 · Cutaneous Squamous Cell CarcinomaNCT03969004: Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma. Primary completion 2028-01-07 (estimated); status ACTIVE_NOT_RECRUITING.
How Regeneron has moved — past-year price reactions
How binary is REGN? Its typical daily move, how often it swings ±10%, and its biggest single-day moves over the last year — useful context for sizing around a catalyst.
1.1%
typical day (1Y)
1
±10% days
33.6%
annualized vol
250
trading days
Largest single-day moves
- +11.8%2025-10-28no matched headline
- -9.8%2026-05-18no matched headline
- +6.7%2025-10-01no matched headline
- -6.2%2026-04-29no matched headline
- +6.2%2026-07-30no matched headline
- +4.9%2025-11-20no matched headline
Real daily price moves over the past year — not every move is a catalyst, and headlines (where shown) are a possible same-day driver, not confirmed causation.
Regeneron — active clinical pipeline
Regeneron's registered Phase 1–3 programs by asset and indication, derived from ClinicalTrials.gov.
49 assets94 programsPh1 16Ph2 44Ph3 30· 4 post-marketing (Ph4)
AreasOncologyAutoimmuneImmunologyMetabolicNeuroscienceCardiovascularOphthalmologyRare / GeneticOther
AssetPhase 1Phase 2Phase 3
linvoseltamabOncology
Phase 1
Phase 2
CemiplimabOncology · PD-1
OdronextamabOncology · CD20×CD3
REGN7508Cardiovascular
Phase 2
fianlimabOncology · LAG-3
dupilumabImmunology · IL-4Rα
Phase 2
MibavademabMetabolic · LEPR
PozelimabRare / Genetic · C5
Phase 1
GaretosmabOther · activin A
Aflibercept 8 mgOphthalmology · VEGF/PGF
Pozelimab + CemdisiranAutoimmune
RavulizumabRare / Genetic · C5
REGN-2CatImmunology
Phase 3
REGN5713Immunology
Phase 3
UbamatamabOncology
ALN-CIDEBMetabolic
AlirocumabOther · PCSK9
Phase 2
ALN-CFBRare / Genetic
ALN-HSDMetabolic
ALN-PNPMetabolic
ALN-SODNeuroscience
BNT116Oncology
DB-OTOOther
FDC fianlimab+cemiplimabOncology
Fianlimab+cemiplimabOncology
Phase 2
OlatorepatideMetabolic
Phase 2
REGN10597Oncology
Phase 2
REGN13335Cardiovascular
REGN15505Oncology
REGN22530Ophthalmology
REGN4336Oncology
REGN5093Oncology
Phase 2
REGN5668Oncology
Phase 2
REGN5678Oncology
REGN7041Ophthalmology
REGN7075Oncology
Phase 2
REGN7999Other
REGV131Rare / Genetic
Phase 2
Trevogrumab-Part AMetabolic
Phase 2
89Zr˗DFO˗REGN5054Oncology
Phase 1
ALN-F1202Other
Phase 1
ALN-SNCANeuroscience
Phase 1
BPX-601Oncology
Phase 1
REGN17235Other
REGN20423Immunology
Phase 1
REGN20934Metabolic
Phase 1
REGN22044Other
Phase 1
Active registered Phase 1–3 trials from ClinicalTrials.gov — not the company's official IR pipeline (no preclinical or undisclosed assets). Grouped by trial intervention name; therapeutic area is auto-categorized. Each indication links to its trial. Molecular targets sourced from ChEMBL (EMBL-EBI).
See the full biopharma catalyst calendar across all covered companies.