FDA Approves Arcutis Biotherapeutics' Lead Drug For Scaly Skin Disorder
Portfolio Pulse from Vandana Singh
The FDA has approved Arcutis Biotherapeutics' Zoryve for seborrheic dermatitis in individuals nine years and older. Zoryve is a steroid-free foam and the first drug with a new mechanism of action for this condition in over 20 years. The STRATUM trial showed rapid disease clearance and significant itch relief. Arcutis plans to make Zoryve available by January 2024. The company also reported positive Phase 3 trial results for roflumilast cream in young children with atopic dermatitis. Following the news, ARQT shares rose 22.54% in premarket trading.
December 18, 2023 | 12:03 pm
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POSITIVE IMPACT
Arcutis Biotherapeutics' Zoryve has been approved by the FDA for seborrheic dermatitis, showing strong trial results and expected availability by January 2024. The company's stock surged in premarket trading.
The FDA approval of Zoryve is a significant milestone for Arcutis, likely to boost investor confidence and drive stock prices up in the short term. The positive trial results and the plan to make the drug available by January 2024 further strengthen the company's market position. The premarket share price increase indicates strong investor response to the news.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100