Regeneron/Sanofi's Largest Selling Drug Dupixent Scores FDA Approval For Infants With Esophagus Inflammation
Portfolio Pulse from Vandana Singh
The FDA has approved Regeneron Pharmaceuticals Inc and Sanofi SA's Dupixent for treating eosinophilic esophagitis (EoE) in children aged 1 to 11 years. This expands on the initial approval for patients 12 years and older. The approval is based on a Phase 3 trial showing significant efficacy. Approximately 21,000 U.S. children are treated for EoE with unapproved therapies, indicating a substantial market for Dupixent. REGN shares saw a slight increase of 0.14% in premarket trading, while SNY shares rose by 0.92%.
January 26, 2024 | 1:53 pm
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POSITIVE IMPACT
Regeneron's Dupixent received FDA approval for treating children with EoE, potentially increasing its market and addressing unmet medical needs. REGN stock saw a slight premarket increase.
The FDA approval of Dupixent for a new pediatric indication is likely to boost investor confidence in Regeneron's growth prospects, as it opens up a new market segment. The premarket stock movement suggests a positive investor response, although the impact may be moderate given the size of the new market relative to the company's overall revenue.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 90
POSITIVE IMPACT
Sanofi's partnership with Regeneron on Dupixent has led to FDA approval for pediatric EoE, potentially expanding its revenue sources. SNY stock experienced a premarket rise.
Sanofi's collaboration with Regeneron on Dupixent continues to bear fruit with the latest FDA approval, which could lead to increased sales and a broader treatment portfolio. The positive premarket stock movement for SNY indicates investor optimism, but as with REGN, the overall impact may be tempered by the broader context of Sanofi's diverse product lineup.
CONFIDENCE 85
IMPORTANCE 75
RELEVANCE 90