regulatory
confidence high
sentiment positive
materiality 0.90
Arcutis gets FDA approval for ZORYVE (roflumilast) cream 0.3% for plaque psoriasis; draws $125M in debt
Arcutis Biotherapeutics, Inc.
- FDA approved ZORYVE (roflumilast) cream 0.3% for plaque psoriasis, including intertriginous areas, in patients 12+.
- First and only topical PDE4 inhibitor approved for plaque psoriasis; once-daily, steroid-free, no duration limit.
- Commencing $125M drawdown of Tranche B term loans from SLR Investment Corp. to fund launch and pipeline.
- Product expected to be available via wholesalers and dermatology pharmacies by mid-August 2022.
- DERMIS-1/2 Phase 3 trials: 42% and 37% IGA success at Week 8 (P<0.0001); itch reduction as early as Week 2.