FDA accepts Arcutis' Zoryve sNDA for infant atopic dermatitis; PDUFA set for Feb 2027
ARQT has more than doubled off its 52-week low of $13.06.
Summary
The FDA has accepted Arcutis' supplemental New Drug Application for ZORYVE cream 0.05% and will review it for the treatment of mild to moderate atopic dermatitis in infants aged 3 to 24 months. This action follows the FDA's recent approval of ZORYVE for plaque psoriasis in children as young as two years and its existing approval for atopic dermatitis in children 2-5 years. Expanding the indication to infants addresses a significant unmet need for steroid-free treatment options in a vulnerable patient population, which could materially increase ZORYVE's market potential. The PDUFA target action date for this review is February 23, 2027.
At the time of this announcement, ARQT was trading at $27.47 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $3.5B. The 52-week trading range was $13.06 to $31.77. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.