ARQT - Arcutis stock pops on getting FDA review for skin disorder cream roflumilast

2023-04-18 08:54:20 ET

• The U.S. Food and Drug Administration (FDA) has accepted for review Arcutis Biotherapeutics' ( NASDAQ: ARQT ) application seeking approval for roflumilast foam 0.3% to treat  seborrheic dermatitis in patients nine years of age and older.
• Seborrheic dermatitis is a skin condition which mainly affects the scalp and causes scaly patches, inflamed skin and dandruff.
• The FDA is expected to make a decision on the company’s new drug application (NDA) by Dec. 16.
• Roflumilast is a once-daily, steroid-free, topical foam treatment, as per the company
• "If approved, roflumilast foam would be the first topical drug with a new mechanism of action for this condition in over two decades, highlighting the unique formulation and deep dermatological expertise that Arcutis brings to immuno-dermatology," said Arcutis' President and CEO Frank Watanabe.
• The NDA was backed by data from phase 2 trials and a phase 3 study called STRATUM.
• ARQT +3.36% to $14.45 premarket April 18

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