SNY and REGN's Dupixent sBLA for Skin Disease Gets FDA's Priority Tag
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Sanofi (SNY) and Regeneron Pharmaceuticals (REGN) have received FDA priority review for their supplemental Biologics License Application (sBLA) for Dupixent, targeting bullous pemphigoid. The FDA decision is expected by June 20, 2025.
February 18, 2025 | 2:00 pm
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POSITIVE IMPACT
Regeneron's Dupixent, developed with Sanofi, is under FDA priority review for its sBLA for bullous pemphigoid. The FDA's decision by June 20, 2025, could enhance Regeneron's dermatology offerings and market share.
The priority review status indicates a high potential for Dupixent in treating bullous pemphigoid, which could boost Regeneron's dermatology segment and revenue.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 80
POSITIVE IMPACT
Sanofi's Dupixent, co-developed with Regeneron, has received FDA priority review for its sBLA targeting bullous pemphigoid. A decision is expected by June 20, 2025, which could significantly impact Sanofi's market position in dermatology.
The FDA's priority review status suggests a significant potential for Dupixent in treating bullous pemphigoid, which could enhance Sanofi's dermatology portfolio and drive revenue growth.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 80