ZORYVE (roflumilast) is an Arcutis Biotherapeutics Inc. program in atopic dermatitis, infants 3-24 months. Its PDUFA date is Feb 23, 2027, the FDA's goal date to complete review of the application. 3 FDA decisions on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approval tracked on pdufa.bio: plaque Psoriasis in Children Ages 2 to 5 (approved Jun 29, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Indication under review: Atopic dermatitis, infants 3-24 months. Sponsor: Arcutis Biotherapeutics Inc. (ARQT). Market-cap tier at the time we tracked it: Mid. We track 4 catalyst events for this program: 1 upcoming and 3 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| OrbiMed Advisors | 2,042,000 | $53.5 million | filed August 14, 2026 |
| Cormorant Asset Management | 175,000 | $4.6 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
ZORYVE (roflumilast)'s PDUFA date is Feb 23, 2027. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
On Jun 29, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records ZORYVE (roflumilast) is FDA-approved for plaque Psoriasis in Children Ages 2 to 5 (approved Jun 29, 2026), and under review or in development for Atopic dermatitis, infants 3-24 months. Other approved uses may not be tracked here; the FDA label is the full record.
Arcutis Biotherapeutics Inc. (ARQT).
Yes. The FDA approved an application for ZORYVE (roflumilast) on Jun 29, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.