FDA Accepts SNY and REGN's Dupixent Re-Submitted sBLA for Urticaria
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The FDA has accepted the re-submitted supplemental Biologics License Application (sBLA) for Dupixent, a drug developed by Sanofi (SNY) and Regeneron Pharmaceuticals (REGN), for the treatment of chronic spontaneous urticaria. The FDA's decision is expected by April 18, 2025.
November 18, 2024 | 9:15 pm
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POSITIVE IMPACT
Regeneron's re-submitted sBLA for Dupixent has been accepted by the FDA, with a decision expected by April 18, 2025. Approval could enhance Dupixent's market presence.
The FDA's acceptance of the sBLA is a positive development for Regeneron, suggesting potential for increased market presence of Dupixent if approved. This could lead to a positive impact on Regeneron's stock price.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 80
POSITIVE IMPACT
Sanofi's re-submitted sBLA for Dupixent has been accepted by the FDA, with a decision expected by April 18, 2025. This could potentially expand Dupixent's market if approved.
The acceptance of the sBLA by the FDA is a positive regulatory step for Sanofi, indicating potential for market expansion of Dupixent if approved. This could positively impact Sanofi's stock price in anticipation of the decision.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 80