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Regeneron Pharmaceuticals (REGN)
NASDAQ:REGN
Itepekimab, Regn3500
Chronic Rhinosinusitis With Nasal Polyps
Phase III
Enrolling By Invitation
An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps
Feb 13, 2026
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Dexamethasone, Daratumumab, Carfilzomib, Pomalidomide, Bortezomib, Linvoseltamab
Relapsed And/Or Refractory Multiple Myeloma (Rrmm)
Phase III
Recruiting
A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
Oct 28, 2025
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Regeneron Pharmaceuticals (REGN) have in its pipeline
REGN is currently developing the following drugs: Itepekimab, Regn3500, Regn7508, Linvoseltamab, Daratumumab, Regn5458, Darzalex Faspro. These drug candidates are in various stages of clinical development as the company works toward FDA approval.