Arcutis Biotherapeutics, Inc. ARQT
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a dermatology drug developer. Its lead program, ARQ-234, is in Phase 1 for moderate-to-severe 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
- February 2027ZORYVE cream 0.05% infant indication — PDUFA target action date for sNDA to expand indication to infants 3 months to <2 years with atopic dermatitis
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
Next further out: ARQ-234 — Phase 1a/1b study ongoing, MAD portion enrollment in atopic dermatitis patients (date not stated). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| ZORYVE (roflumilast) cream 0.3% | plaque psoriasis, ages 2+ | small molecule | Approved |
| ZORYVE foam 0.3% | seborrheic dermatitis and plaque psoriasis (scalp/body), ages 9+ | small molecule | Approved |
| ZORYVE cream 0.15% | atopic dermatitis, ages 6+ | small molecule | Approved |
| ZORYVE cream 0.05% | atopic dermatitis in children 2-5 years | small molecule | Approved |
| ZORYVE cream 0.05% infant expansion | atopic dermatitis in infants 3 months to <2 years | small molecule | Phase 2 |
| ZORYVE foam MUSE | plaque psoriasis in children 2-11 years (scalp/body) | small molecule | Phase 2 |
| ARQ-234 | moderate-to-severe atopic dermatitis | protein/peptide | Phase 1 |
Recent results and decisions
- Nov 4, 2026started Arcutis initiated a pivotal Phase 3 trial with ZORYVE cream 0.3% for moderate to severe atopic dermatitis.
The Company initiated a pivotal Phase 3 trial with ZORYVE cream 0.3% for the treatment of adults and children with moderate to severe atopic dermatitis.
Filing - Nov 4, 2026accepted FDA set target action date of February 23, 2027, for supplemental NDA of ZORYVE cream 0.05% for infants aged 3 to 24 months.
The FDA has set a target action date of February 23, 2027, for the supplemental New Drug Application to expand the indication for ZORYVE cream 0.05% for mild to moderate atopic dermatitis to infants aged 3 to 24 months.
Filing - 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
6 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
- Bambusa Therapeutics, Inc. BBTX
- 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.