FDA Accepts Arcutis' Supplemental New Drug Application For ZORYVE Foam For The Treatment Of Scalp And Body Psoriasis In Adults And Adolescents Ages 12 and Over
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The FDA has accepted Arcutis Biotherapeutics' supplemental new drug application for ZORYVE foam, targeting scalp and body psoriasis in individuals aged 12 and over. The PDUFA target action date is set for May 22, 2025.
September 24, 2024 | 12:13 pm
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Arcutis Biotherapeutics' sNDA for ZORYVE foam has been accepted by the FDA, with a PDUFA target action date of May 22, 2025. This development is supported by positive trial data and could expand treatment options for psoriasis.
The acceptance of the sNDA by the FDA is a positive regulatory milestone for Arcutis Biotherapeutics. The PDUFA date provides a timeline for potential approval, which could lead to expanded market opportunities for ZORYVE foam. The positive trial data supporting the application further strengthens the likelihood of approval, potentially boosting investor confidence and the stock price in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100