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Company

Regeneron

Pharmaceutical intelligence for Regeneron with 24 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals
13
Catalysts
11
Assets
13

Recent signals(13)

RegulatoryAugust 5, 2026

FDA Accepts Supplement for LYNOZYFIC (BLA761400) from Regeneron

The FDA has accepted a supplemental application for LYNOZYFIC (BLA761400) submitted by Regeneron Pharmaceuticals.

ClinicalJuly 30, 2026

Regeneron initiates study on linvoseltamab for high-risk monoclonal gammopathy

Regeneron Pharmaceuticals is conducting a proof-of-concept study to evaluate linvoseltamab's efficacy in eliminating abnormal plasma cells in patients at risk of multiple myeloma.

RegulatoryJuly 28, 2026

FDA grants supplemental application approval for Dupixent (BLA761055)

The FDA has approved the supplemental application for Dupixent (BLA761055) submitted by Regeneron Pharmaceuticals.

ClinicalJuly 28, 2026

Regeneron initiates trial for ubamatamab and REGN7075 in advanced NSCLC

Regeneron is conducting a study to evaluate the efficacy and safety of ubamatamab and REGN7075 in advanced/metastatic NSCLC.

ClinicalJuly 10, 2026

Regeneron initiates dose escalation study of bispecific antibodies for Lupus Nephritis

Regeneron Pharmaceuticals is conducting a dose escalation study of bispecific antibodies in adult participants with Lupus Nephritis.

RegulatoryJuly 5, 2026

FDA Accepts Supplemental Application for Dupixent (Dupilumab)

The FDA has accepted a supplemental application for Dupixent (dupilumab) from Regeneron Pharmaceuticals.

CompetitiveJuly 4, 2026

Regeneron initiates trial for pozelimab + cemdisiran in PNH patients unresponsive to C5 inhibitors

Regeneron is conducting a study to evaluate the efficacy of pozelimab and cemdisiran in PNH patients inadequately controlled by existing therapies.

ClinicalJune 24, 2026

Regeneron initiates study of REGN13335 for Pulmonary Arterial Hypertension

Regeneron Pharmaceuticals is conducting a clinical trial to evaluate the safety and efficacy of REGN13335 in adults with Pulmonary Arterial Hypertension (PAH).

ClinicalJune 23, 2026

Phase III Trial of Cemiplimab in NSCLC Post-Surgery Shows Promise for Disease-Free Survival

A phase III trial is assessing the efficacy of cemiplimab in patients with surgically removed non-small cell lung cancer who have not received prior chemotherapy.

ClinicalJune 20, 2026

Regeneron and Sanofi Study Dupilumab for Bullous Pemphigoid in Adults

A study is underway to evaluate the efficacy and safety of dupilumab in treating bullous pemphigoid, an autoimmune blistering disease.

ClinicalJune 17, 2026

Phase I/II Trial of Adipose-derived Stem Cells for Burn Scarring Initiated in Denmark

A phase I/II trial (ScarASC) is underway to evaluate the efficacy of allogeneic adipose-derived stem cells for treating hypertrophic scars in burn survivors.

ClinicalJune 17, 2026

Phase III Trial Evaluates Cemiplimab with Surgery for Advanced Skin Cancer

A phase III trial is testing the addition of cemiplimab to standard surgery for resectable stage III/IV squamous cell skin cancer.

ClinicalJune 16, 2026

CMP-001 and Nivolumab Show Promise in Advanced Melanoma Phase 2/3 Trial

A Phase 2/3 study is evaluating CMP-001 in combination with nivolumab against nivolumab monotherapy in advanced melanoma.

Upcoming catalysts(1)

PDUFA Date

Regeneron — Dupixent

COPD label expansion would open multi-billion TAM beyond atopic indications.

June 27, 2026 · NDA/BLA

Regulatory activity(3)

RegulatoryAugust 5, 2026

FDA Accepts Supplement for LYNOZYFIC (BLA761400) from Regeneron

The FDA has accepted a supplemental application for LYNOZYFIC (BLA761400) submitted by Regeneron Pharmaceuticals.

RegulatoryJuly 28, 2026

FDA grants supplemental application approval for Dupixent (BLA761055)

The FDA has approved the supplemental application for Dupixent (BLA761055) submitted by Regeneron Pharmaceuticals.

RegulatoryJuly 5, 2026

FDA Accepts Supplemental Application for Dupixent (Dupilumab)

The FDA has accepted a supplemental application for Dupixent (dupilumab) from Regeneron Pharmaceuticals.

Clinical activity(9)

ClinicalJuly 30, 2026

Regeneron initiates study on linvoseltamab for high-risk monoclonal gammopathy

Regeneron Pharmaceuticals is conducting a proof-of-concept study to evaluate linvoseltamab's efficacy in eliminating abnormal plasma cells in patients at risk of multiple myeloma.

ClinicalJuly 28, 2026

Regeneron initiates trial for ubamatamab and REGN7075 in advanced NSCLC

Regeneron is conducting a study to evaluate the efficacy and safety of ubamatamab and REGN7075 in advanced/metastatic NSCLC.

ClinicalJuly 10, 2026

Regeneron initiates dose escalation study of bispecific antibodies for Lupus Nephritis

Regeneron Pharmaceuticals is conducting a dose escalation study of bispecific antibodies in adult participants with Lupus Nephritis.

ClinicalJune 24, 2026

Regeneron initiates study of REGN13335 for Pulmonary Arterial Hypertension

Regeneron Pharmaceuticals is conducting a clinical trial to evaluate the safety and efficacy of REGN13335 in adults with Pulmonary Arterial Hypertension (PAH).

ClinicalJune 23, 2026

Phase III Trial of Cemiplimab in NSCLC Post-Surgery Shows Promise for Disease-Free Survival

A phase III trial is assessing the efficacy of cemiplimab in patients with surgically removed non-small cell lung cancer who have not received prior chemotherapy.

ClinicalJune 20, 2026

Regeneron and Sanofi Study Dupilumab for Bullous Pemphigoid in Adults

A study is underway to evaluate the efficacy and safety of dupilumab in treating bullous pemphigoid, an autoimmune blistering disease.

ClinicalJune 17, 2026

Phase I/II Trial of Adipose-derived Stem Cells for Burn Scarring Initiated in Denmark

A phase I/II trial (ScarASC) is underway to evaluate the efficacy of allogeneic adipose-derived stem cells for treating hypertrophic scars in burn survivors.

ClinicalJune 17, 2026

Phase III Trial Evaluates Cemiplimab with Surgery for Advanced Skin Cancer

A phase III trial is testing the addition of cemiplimab to standard surgery for resectable stage III/IV squamous cell skin cancer.

ClinicalJune 16, 2026

CMP-001 and Nivolumab Show Promise in Advanced Melanoma Phase 2/3 Trial

A Phase 2/3 study is evaluating CMP-001 in combination with nivolumab against nivolumab monotherapy in advanced melanoma.

Competitive activity(1)

CompetitiveJuly 4, 2026

Regeneron initiates trial for pozelimab + cemdisiran in PNH patients unresponsive to C5 inhibitors

Regeneron is conducting a study to evaluate the efficacy of pozelimab and cemdisiran in PNH patients inadequately controlled by existing therapies.

Assets

Acelity →
Cemiplimab →
CMP-001 →
dupilumab →
Dupixent →
eculizumab →
Eylea →
linvoseltamab →
Lupus Nephritis →
LYNOZYFIC →
REGN13335 →
Trial Update →
ubamatamab →

Therapeutic areas

Autoimmune Disease →
Biologic →
Cardiovascular →
Cardiovascular · Pulmonary Arterial Hypertension →
Dermatology →
Dermatology · Autoimmune Disease →
Dermatology · Stem Cell Therapy →
Hematology →
Hematology · Paroxysmal Nocturnal Hemoglobinuria (PNH) →
IL-13 →
IL-4 →
Immunology →
Immunology · Lupus Nephritis →
Immunotherapy →
Lupus Nephritis →
Melanoma →
Multiple Myeloma →
NSCLC →
Oncology →
Oncology · Immunotherapy →
Oncology · Melanoma →
Oncology · Skin Cancer →
Ophthalmology · Age-related Macular Degeneration →
Ophthalmology · Anti-VEGF →
Paroxysmal Nocturnal Hemoglobinuria (PNH) →
Pulmonary Arterial Hypertension →
Skin Cancer →
Stem Cell Therapy →

Indications

Autoimmune Disease →
Chronic obstructive pulmonary disease →
Melanoma →
NSCLC →
Skin Cancer →

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