Regeneron Pharmaceuticals And Sanof's Dupixent (dupilumab) sBLA Accepted For FDA Priority Review For Treatment Of Adolescents With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
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The FDA has accepted a supplemental Biologics License Application (sBLA) for priority review of Dupixent (dupilumab), developed by Regeneron Pharmaceuticals and Sanofi, for treating adolescents aged 12-17 with inadequately controlled Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP). If approved, Dupixent would be the first treatment indicated for this age group in the U.S., addressing a significant unmet medical need.
May 13, 2024 | 7:00 am
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POSITIVE IMPACT
Regeneron Pharmaceuticals' Dupixent, if approved for adolescents with CRSwNP, could expand its market, addressing a significant unmet need and potentially boosting sales.
The acceptance of Dupixent for priority review by the FDA for a new patient demographic could significantly expand its market and usage, likely leading to increased sales and positive investor sentiment towards Regeneron's stock in the short term.
CONFIDENCE 80
IMPORTANCE 85
RELEVANCE 90
POSITIVE IMPACT
Sanofi, as a co-developer of Dupixent, stands to benefit from expanded approval into the adolescent CRSwNP market, potentially enhancing its revenue and market position.
Sanofi's collaboration with Regeneron on Dupixent, if successful in gaining approval for the adolescent CRSwNP market, could significantly boost its financial performance and strengthen its position in the pharmaceutical market, positively impacting its stock in the short term.
CONFIDENCE 80
IMPORTANCE 85
RELEVANCE 90