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Monday, June 6, 2022

Arcutis: Positive Topline Results in Pivotal Phase 3 Trial

 

  • Study met its primary endpoint with 80.1% of individuals treated with roflumilast foam achieving Investigator Global Assessment (IGA) Success compared to 59.2% of patients treated with vehicle (P<0.0001)
  • More than 50% of patients treated with roflumilast foam achieved an IGA score of clear at week eight
  • Roflumilast foam was well-tolerated with a favorable safety and tolerability profile
  • Data further support the potential of roflumilast foam as a best-in-class, once-daily, non-steroidal topical treatment for seborrheic dermatitis
  • New drug application (NDA) submission anticipated in 1H of 2023
  • Company to host a conference call today at 8:30 a.m. EDT
Management will host a conference call today at 8:30 a.m. EDT to discuss these results. To access the call, please dial (833) 614-1393 (domestic) or (914) 987-7114 (international) and provide the conference ID# 7384524. A live webcast of the call will also be available on the “ Events ” section of the Company's Investor website. An archived replay of the webcast will be available on the Arcutis website following the call.

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