Regeneron Pharmaceuticals (REGN): next trial readout expected around 2026-08-24
Trials that could report in the next 12 months: 22BiopharmaCTG
Catalyst timeline
Dates are estimated from each trial's registered completion date — none are FDA decision dates. Counts trials that fit our shared poll budget, not everything REGN is running — see methodology.
- 2026-08-24in 5dA Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery
- 2026-10-07in 7wStudy to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)
- 2026-10-12in 8wA 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
- 2026-11-02in 11wA 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
- 2026-11-13in 12wStudy of Olatorepatide in Adult Participants Living With Overweight or Obesity in the US
- 2026-11-13in 12wA Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers
- 2026-12-03in 15wA 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
- 2026-12-04in 15wA First In Human (FIH) Study to Learn if Different Doses of ALN-ANG3 Are Safe and Well Tolerated in Healthy Adults
- 2026-12-29in 19wA Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia
- 2027-01-06in 20wA Study of ImmunoPet Imaging Using 89Zr-DFO-REGN5054 in Adult Participants With Solid Cancers Treated With Cemiplimab
- 2027-02-09in 25wSafety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
- 2027-02-20in 26wREGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
- 2027-02-22in 27wSafety and Drug Concentrations of REGN20934 in Adults With Overweight or Obesity
- 2027-02-28in 28wStudy of Bet v1 Antibodies Effect on Eye Allergy Symptoms in Adolescents and Adults With Birch Pollen Allergy
- 2027-03-22in 31wA Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
- 2027-03-25in 31wA 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
- 2027-03-25in 31wStudy of 3 Monoclonal Antibodies (REGN9933, REGN7508, and REGN9533) in Adult Participants With End-Stage Kidney Disease on Hemodialysis
- 2027-04-24in 35wEfficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma
- 2027-05-10in 38wStudy 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
- 2027-05-15in 38wA Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
- 2028-01-26in 75wA Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1)
- 2034-08-14in 417wA Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) in Pediatric, Adolescent and Adult Participants With Hemophilia B
Pipeline
| Program | Phase | Status | Primary completion | Trial |
|---|---|---|---|---|
| A Study to Investigate the Safety and Effectiveness of a Coagulation F… | Phase 1 | Recruitingstill enrolling patients | 2034-08-14 | NCT06379789 |
| A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cem… | Phase 2 | Active Not Recruitingenrolled, still running | 2028-01-26 | NCT05557591 |
| A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dys… | Phase 1 | Recruitingstill enrolling patients | 2027-05-15 | NCT06836609 |
| Study of REGN4018 (Ubamatamab) Administered Alone or in Combination Wi… | Phase 1 | Recruitingstill enrolling patients | 2027-05-10 | NCT03564340 |
| Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long… | Phase 4 | Active Not Recruitingenrolled, still running | 2027-04-24 | NCT06572228 |
| Study of 3 Monoclonal Antibodies (REGN9933, REGN7508, and REGN9533) in… | Phase 1 | Not Yet Recruitingnot open yet | 2027-03-25 | NCT07759167 |
| A Study to Find Out How Safe REGN5668 is and How Well it Works In Adul… | Phase 1 | Recruitingstill enrolling patients | 2027-03-25 | NCT04590326 |
| A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Ad… | Phase 3 | Recruitingstill enrolling patients | 2027-03-22 | NCT06246916 |
+ 14 more tracked trials
| Program | Phase | Status | Primary completion | Trial |
|---|---|---|---|---|
| Study of Bet v1 Antibodies Effect on Eye Allergy Symptoms in Adolescen… | Phase 3 | Recruitingstill enrolling patients | 2027-02-28 | NCT07309432 |
| Safety and Drug Concentrations of REGN20934 in Adults With Overweight … | Phase 1 | Recruitingstill enrolling patients | 2027-02-22 | NCT07594093 |
| REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After T… | Phase 3 | Recruitingstill enrolling patients | 2027-02-20 | NCT07015905 |
| Safety in Adult Participants With Atrial Fibrillation Who Are Treated … | Phase 2 | Recruitingstill enrolling patients | 2027-02-09 | NCT07175428 |
| A Study of ImmunoPet Imaging Using 89Zr-DFO-REGN5054 in Adult Particip… | Phase 1 | Recruitingstill enrolling patients | 2027-01-06 | NCT05259709 |
| A Study to See How Safe and Effective Alirocumab is When Given Weekly … | Phase 2 | Recruitingstill enrolling patients | 2026-12-29 | NCT07477704 |
| A First In Human (FIH) Study to Learn if Different Doses of ALN-ANG3 A… | Phase 1 | Active Not Recruitingenrolled, still running | 2026-12-04 | NCT06452771 |
| A Study to Test the Safety, Tolerability, and Efficacy of an Antibody,… | Phase 2 | Active Not Recruitingenrolled, still running | 2026-12-03 | NCT06421636 |
| Study of Olatorepatide in Adult Participants Living With Overweight or… | Phase 2 | Active Not Recruitingenrolled, still running | 2026-11-13 | NCT07431086 |
| A Trial to Find Out How Safe REGN7075 is and How Well it Works in Comb… | Phase 1 | Active Not Recruitingenrolled, still running | 2026-11-13 | NCT04626635 |
| A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better … | Phase 2 | Active Not Recruitingenrolled, still running | 2026-11-02 | NCT06190951 |
| A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therap… | Phase 3 | Active Not Recruitingenrolled, still running | 2026-10-12 | NCT05133531 |
| Study to Assess the Long-term Safety of Dupilumab Administered in Part… | Phase 3 | Active Not Recruitingenrolled, still running | 2026-10-07 | NCT02612454 |
| A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chem… | Phase 2 | Active Not Recruitingenrolled, still running | 2026-08-24 | NCT06161441 |
Status-change history
Every ClinicalTrials.gov change recorded for REGN's trials — a running history no other tracker shows.
No status changes detected yet for this ticker.
Frequently asked
When is REGN's next PDUFA date?
No disclosed PDUFA date is currently tracked for this ticker.
What phase is REGN's lead program in?
Phase 3 — active not recruiting.
Where does this data come from?
ClinicalTrials.gov v2 API (trial status + diffs) and company 8-K/press-release disclosures (PDUFA dates). Every number links to its source.