NEW YORK, December 30, 2025, 14:45 ET — Regular session
- Arcutis Biotherapeutics shares are lower in afternoon trade after opening near the prior close.
- Biotech exchange-traded funds are also down, weighing on smaller growth drugmakers.
- Investors remain focused on Zoryve sales momentum and the next FDA review milestone.
Arcutis Biotherapeutics shares fell 2.9% to $27.74 in afternoon trading on Tuesday, after moving between $27.72 and $28.65. Volume was about 0.6 million shares.
The drop outpaced broader biotech gauges, with the SPDR S&P Biotech ETF down about 1.5% and the iShares Nasdaq Biotechnology ETF off about 1.1%.
That matters for Arcutis because it trades as a growth story tied to one product franchise, leaving the stock prone to outsized moves when sentiment sours across biotech and high-multiple names.
Arcutis is a commercial-stage medical dermatology company whose main product, Zoryve (roflumilast), is a topical treatment for inflammatory skin diseases. Zoryve is a PDE4 inhibitor — meaning it blocks an enzyme linked to inflammation — offering a non-steroid option.
In its most recent quarterly update in late October, Arcutis reported $99.2 million in third-quarter net product revenue for Zoryve and issued initial 2026 net product sales guidance of $455 million to $470 million. The company also pointed to improving gross-to-net pricing — the share of a drug’s list price the company actually collects after rebates and discounts — and said it had begun enrolling patients in phase 2 studies of Zoryve foam in vitiligo and hidradenitis suppurativa while preparing a phase 1 study of ARQ-234.
Those targets imply roughly $114 million to $118 million per quarter in 2026 net product revenue, a pace investors will pressure-test the next time the company updates on prescriptions, reimbursement and spending.
A key longer-dated catalyst is an FDA review of a supplemental New Drug Application, or sNDA, for Zoryve cream 0.3% to expand plaque psoriasis treatment to children ages 2 to 5. The FDA set a June 29, 2026 target action date under PDUFA, the agency’s review deadline, and Northwestern University dermatologist Amy Paller said, “Effective and well-tolerated treatment options that are gentle enough for these areas are critical.” Arcutis Biotherapeutics
Arcutis operates in a crowded inflammatory-skin market that includes Incyte’s Opzelura and Organon’s Vtama, both positioned as steroid-sparing options in their approved uses. Incyte shares were down about 0.4% on Tuesday.
