Arcutis Biotherapeutics, Inc. ARQT
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a dermatology drug developer. Its lead program, ZORYVE (roflumilast) topical, is in Phase 1 for Plaque psoriasis, seborrheic dermatitis, atopic dermatitis. Its next catalyst on record is ZORYVE cream 0.05% (infants 3 months to <2 years, atopic dermatitis): FDA PDUFA action on sNDA (February 23, 2027).
Upcoming catalysts
- February 23, 2027ZORYVE cream 0.05% (infants 3 months to <2 years, atopic dermatitis) — FDA PDUFA action on sNDA
We submitted a Supplemental New Drug Application (sNDA) to the FDA based on the results of this trial to potentially expand the indication for ZORYVE cream 0.05% for the treatment of infants with atopic dermatitis down to the age of 3 months, which has been assigned a Prescription Drug User Fee Act (PDUFA) target actio
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| ZORYVE cream 0.3% (plaque psoriasis, down to age 2 approved June 2026) | Plaque psoriasis | small molecule | Approved |
| ZORYVE foam 0.3% (seborrheic dermatitis; scalp and body psoriasis) | Seborrheic dermatitis; plaque psoriasis of scalp and body | small molecule | Approved |
| ZORYVE cream 0.15% / 0.05% (atopic dermatitis) | Atopic dermatitis | small molecule | Approved |
| ARQ-234 (CD200R agonist fusion protein) | Atopic dermatitis | protein/peptide | Phase 1 |
Recent results and decisions
- Aug 5, 2026approval FDA approved sNDA expanding ZORYVE cream 0.3% in plaque psoriasis to children down to age 2 (June 2026).
Received approval to expand the indication for ZORYVE cream 0.3% for the topical treatment of plaque psoriasis to children down to the age of 2, the seventh FDA approval in four years
Filing - Aug 5, 2026accepted FDA accepted sNDA for ZORYVE cream 0.05% in infants 3-24 months with AD; PDUFA date February 23, 2027.
The FDA accepted an sNDA for ZORYVE cream 0.05% to expand the indication for the treatment of mild to moderate atopic dermatitis in infants aged 3 to 24 months with a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027.
Filing - Aug 5, 2026completed enrollment Completed enrollment of the Phase 2 proof-of-concept trial of ZORYVE foam 0.3% in vitiligo.
Completed enrollment of the Phase 2 trial of ZORYVE foam 0.3% in individuals with vitiligo with disclosure of topline results and decision on program advancement anticipated in Q4 of 2026
Filing
4 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 1 dermatology companies
- Absci Corp ABSI
- FibroBiologics, Inc. FBLG
- Azitra, Inc. AZTR
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.