Breakout Bulletin: July 6-July 10

You’re busy. Between patients, prior authorizations, inbox messages, and everything else on your plate, keeping up with the literature is the first thing that slips. Dermatology Times NP/PA Connect is here to make sure it doesn’t. Each week, we pull the most clinically relevant news from across dermatology and bring it straight to your inbox — what’s new, what it means, and what’s worth watching. This week: a long-awaited pediatric indication moves toward FDA action, an oral TYK2 inhibitor posts head-to-head data that could reshape psoriasis prescribing, and early pipeline signals emerge in atopic dermatitis and vitiligo.

A Non-Steroidal Option May Finally Reach Your Youngest AD Patients

The FDA has accepted Arcutis' supplemental New Drug Application for roflumilast cream 0.05% (Zoryve), seeking to extend the approved indication for mild to moderate atopic dermatitis down from age 2 years to infants as young as 3 months. The agency has set a PDUFA target action date of February 23, 2027. The filing is supported by a phase 1 pharmacokinetic study and the phase 2 open-label INTEGUMENT-INFANT trial, both evaluating once-daily use over 4 weeks in infants aged 3 months to younger than 24 months.¹

This is an acceptance for review, not an approval. The label change is not yet in effect, and the supporting data are open-label rather than placebo-controlled. Still, the unmet need is real: an estimated 1 million children younger than age 2 are currently treated topically for atopic dermatitis in the US, and options for this age group remain sparse and steroid-heavy.¹ If cleared, roflumilast 0.05% would become just the second FDA-approved topical nonsteroidal anti-inflammatory therapy available for infants.¹

MORE ON DRUG WATCH

This sNDA acceptance underscores the gap in approved treatments for very young children with atopic dermatitis.— Frank Watanabe, President and CEO, Arcutis

▶ Why it matters: Expect questions from caregivers now — start flagging this pending indication so families know a steroid-free option may be coming, not yet available.

An Oral Pill Just Outperformed Another Oral Pill for Psoriasis

Takeda's zasocitinib, a highly selective oral TYK2 inhibitor, showed statistical superiority over deucravacitinib across all primary and key secondary end points in a head-to-head phase 3 study in moderate to severe plaque psoriasis, with skin clearing separating between the 2 drugs by week 8.² By week 16, 35% of zasocitinib patients reached complete clearance (PASI 100), roughly 2.5 times the rate seen with deucravacitinib.²

This follows an earlier placebo- and apremilast-controlled phase 3 readout in which zasocitinib met all 44 ranked secondary end points, including PASI 90 and sPGA 0.² The most common adverse events were upper respiratory infection, nasopharyngitis, and acne, with no new safety signals reported. Takeda plans to submit a New Drug Application starting in its current fiscal year.²

We saw separation of zasocitinib from deucravacitinib as early as week 8.— Linda Stein Gold, MD

MORE ON PSORIASIS

▶ Why it matters: If approved, this becomes a genuine oral competitor to injectable biologics for patients who want to avoid needles. It's worth watching for the NDA filing.

A Topical in Development Might Work Beyond Severe AD

Turn Therapeutics has completed an interim analysis of its adaptive phase 2 trial of GX-03, a non-systemic topical under investigation for atopic dermatitis, and is expanding enrollment to cover the full baseline EASI severity spectrum rather than moderate to severe disease alone.³ Stage 1 enrolled patients by Investigator's Global Assessment of moderate-to-severe disease, but analysis found efficacy signals, including vIGA-AD success and complete clearance at weeks 4 and 8 versus vehicle, in the subgroup with EASI scores of 1.1 to 7.0, a range that typically reflects mild to moderate disease.⁴

This is phase 2 interim data with a small pilot-scale subgroup finding, not a confirmed indication. The final Stage 2 design will formally test 4 end points using the Hochberg procedure rather than a single primary outcome. Baseline pruritus severity was also flagged as a possible biomarker of response, which will inform how Stage 2 patients are enrolled.³

MORE ON ATOPIC DERMATITIS

▶ Why it matters: A non-systemic option effective across mild-to-severe AD, not just severe disease, would fill a real gap in the topical armamentarium. However, this needs a controlled Stage 2 readout before it changes practice.

An Oral A3 Agonist Clears an Enrollment Hurdle in Psoriasis

Can-Fite BioPharma has completed enrollment of the first 247 patients in its pivotal phase 3 trial of piclidenoson, an oral A3 adenosine receptor agonist, in moderate to severe plaque psoriasis, triggering a prespecified interim analysis under an FDA- and EMA-agreed protocol.⁴ Results from that interim analysis are expected in the fourth quarter of 2026 or first quarter of 2027.⁴

This is an enrollment milestone, not an efficacy readout. The actual data are still pending. Piclidenoson has previously shown a favorable safety profile across more than 1,500 treated subjects and met its primary end point in an earlier phase 3 study (COMFORT-1) against placebo and apremilast.⁴

▶ Why it matters: Nothing to act on yet, but this is a pipeline oral option to watch for patients who haven't tolerated or responded to apremilast.

A Quarterly Injectable Could Change the Vitiligo Conversation

Teva plans to advance TEV-'408, an investigational anti-IL-15 monoclonal antibody dosed quarterly, into a phase 2b study in non-segmental vitiligo in the fourth quarter of 2026, following encouraging interim results from an ongoing open-label phase 1b trial.⁵ At week 24, nearly 75% of evaluable patients reported improvement in facial vitiligo, with half describing themselves as much or very much improved; 42% achieved F-VASI50 and 21% reached F-VASI75.⁵

This is small, open-label phase 1b data with no placebo comparator, and no safety signals have been reported so far. However, it's a notable signal in a disease where only 1 topical therapy is currently approved, and that therapy is restricted to limited body surface area.⁵ IL-15 is thought to help maintain the tissue-resident memory T cells that drive vitiligo's tendency to recur after treatment stops.⁵

▶ Why it matters: A quarterly subcutaneous option could be a meaningful convenience upgrade over daily topical therapy for patients with more extensive disease. It's worth tracking as phase 2b begins enrolling.

Microneedling Gets a Broader Green Light for Periorbital Wrinkles

The FDA has cleared the SkinStylus SteriLock MicroSystem, a Class II microneedling device, for improvement of periorbital wrinkles, including crow's feet, in adults aged 22 years and older across all Fitzpatrick skin types I through VI.¹³ The device now carries 3 FDA-cleared indications: periorbital wrinkles, facial acne scars in Fitzpatrick skin types I through III, and surgical or traumatic hypertrophic abdominal scars.¹³

It's now the only microneedling device cleared for all 3 of those indications and the only one cleared for periorbital wrinkles across the full Fitzpatrick range. A prior device holding that indication was limited to Fitzpatrick skin types I through IV.¹³

▶ Why it matters: If periorbital microneedling is part of your practice, this widens the population you can treat on-label, including patients with deeper skin tones who were previously outside the cleared indication.

References

1. FDA accepts supplemental new drug application for Arcutis' Zoryve (roflumilast) cream 0.05% for the treatment of mild to moderate atopic dermatitis in infants down to 3 months. News release. Arcutis Biotherapeutics. July 8, 2026. Accessed July 9, 2026. https://www.arcutis.com/fda-accepts-supplemental-new-drug-application-for-arcutis-zoryve-roflumilast-cream-0-05-for-the-treatment-of-mild-to-moderate-atopic-dermatitis-in-infants-down-to-3-months/
2. Takeda reports positive phase 3 zasocitinib results. News release. Takeda Pharmaceuticals. June 11, 2026. https://www.takeda.com/newsroom/newsreleases/2026/zasocitinib-outperforms-deucravacitinib-study/
3. Turn Therapeutics announces final stage 2 design and data-driven expansion of GX-03 phase 2 program in atopic dermatitis. News release. Turn Therapeutics. July 7, 2026. Accessed July 9, 2026. https://ir.turntherapeutics.com/news-releases/news-release-details/turn-therapeutics-announces-final-stage-2-design-and-data-driven
4. Can-Fite achieves key pivotal phase 3 psoriasis milestone with completion of patient enrolment. StockTitan. Published 2026. https://ir.canfite.com/news-events/press-releases/detail/1118/can-fite-achieves-key-pivotal-phase-3-psoriasis-milestone
5. Teva to advance its anti-IL-15 antibody, designed for quarterly dosing, into phase 2b development in vitiligo, following encouraging phase 1b results. News release. Teva Pharmaceutical Industries. July 7, 2026. Accessed July 7, 2026 https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/Teva-to-Advance-Its-Anti-IL-15-Antibody-Designed-for-Quarterly-Dosing-Into-Phase-2b-Development-in-Vitiligo-Following-Encouraging-Phase-1b-Results/default.aspx
6. Papp KA, Beyska-Rizova S, Gantcheva M, et al; COMFORT-1 Study Investigators. Efficacy and safety of piclidenoson in plaque psoriasis: results from a randomized phase 3 clinical trial (COMFORT-1). J Eur Acad Dermatol Venereol. 2024;38(6):1112-1120. doi:10.1111/jdv.19811.
7. SkinStylus receives new FDA clearance for the improvement of periorbital wrinkles for all skin types. News release. July 7, 2026 https://www.globenewswire.com/news-release/2026/07/07/3323153/0/en/skinstylus-receives-new-fda-clearance-for-the-improvement-of-periorbital-wrinkles-for-all-skin-types.html

Dermatology Times NP/PA Connect | The Breakout Bulletin