Breakout Bulletin: April 26-May 1

You’re busy. Between patients, prior authorizations, 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 psoriasis biologic that may only need to be dosed twice a year, a potential second JAK inhibitor for alopecia areata, a phase 3 win for optimized oral minoxidil, and 2 pipeline stories that could reshape how we treat infants with eczema and patients with lichen planus. A lot moved this week.

The Psoriasis Biologic That Could Rewrite the Dosing Conversation

Phase 2a data for ORKA-001, Oruka Therapeutics’ half-life extended IL-23p19 inhibitor, landed this week with numbers that stopped readers mid-scroll: 63.5% of patients achieved complete skin clearance (PASI 100) at week 16. PASI 90 hit 83%, and IGA 0/1 reached 84%. In a cross-trial comparison, the company stated those figures numerically exceed every currently approved IL-23 inhibitor — and sit alongside the highest clearance rates reported for any mechanism of action in plaque psoriasis.¹

Those efficacy numbers alone would generate attention. But the real story is the pharmacokinetics. A single 600 mg dose kept drug concentrations above effective trough levels for a full year, with sustained IL-23 pathway suppression throughout. The trial only required 2 doses — at weeks 0 and 4 — to produce those week 16 results. If phase 3 confirms the profile, ORKA-001 could become the first psoriasis biologic dosed once or twice a year.

“It is really exciting to see the phase 2a data from ORKA-001 showing remarkable, field-moving achievement of 63.5% PASI-100 in just 16 weeks,” said Christopher Bunick, MD, PhD, associate professor of dermatology at Yale School of Medicine, Dermatology Times’ editor in chief. “This level of efficacy, if repeated in phase 3 trials and combined with safety, could redefine our clinical algorithm for treating moderate to severe psoriasis and do it in fewer doses per year. A huge win for psoriasis patients.”

Safety was essentially indistinguishable from placebo — no serious adverse events in the ORKA-001 group, no injection site reactions, and an overall adverse event rate of 51% versus 57% for placebo. Longer-term data including week 28 efficacy and 52-week follow-up for a subset are expected in the second half of 2026. Phase 2b (EVERLAST-B (NCT07290569)) data are anticipated in 2027.

▶ Why it matters: Once- or twice-yearly dosing at this efficacy level would be a genuine paradigm shift for adherence, access, and patient quality of life. Watch the phase 3 closely.

MORE ON PSORIASIS

Upadacitinib Filed for Alopecia Areata — With the Strongest Hair Regrowth Data on Record

AbbVie has submitted an sNDA to the FDA for upadacitinib (Rinvoq) in severe alopecia areata in adults and adolescents aged 12 and older, based on results from the phase 3 UP-AA (NCT06012240) program. If approved, it would become the second JAK inhibitor indicated for AA in the US, following baricitinib’s 2022 approval.²

The efficacy data are notable. In the UP-AA trials, SALT ≥20 — representing at least 80% scalp coverage — was achieved by approximately 45% of patients on the 15 mg dose and 55% on the 30 mg dose at week 24, versus 1.5% to 3.4% on placebo. By week 52, those rates climbed to 55% to 64%. Complete scalp hair regrowth (SALT = 0) was achieved by approximately 21% of patients on the 30 mg dose at week 24, rising to 27% to 37% by week 52. AbbVie notes this is the first JAK inhibitor to meet a ranked secondary endpoint of complete scalp regrowth in a phase 3 program.

The enrolled population was severe: mean baseline SALT score of 84, with roughly half of patients at SALT 95 or above — near-total or total scalp hair loss. The safety profile through week 52 was consistent with upadacitinib’s known profile across its other approved indications, including the class boxed warning for serious infections, malignancy, cardiovascular events, and thrombosis.

▶ Why it matters: Baricitinib set the benchmark in 2022. Upadacitinib is now making a case for a higher efficacy ceiling — including complete regrowth as a realistic clinical target. The AA treatment conversation with patients is about to get more nuanced.

MORE ON ALOPECIA

Optimized Oral Minoxidil Just Hit Its Phase 3 Endpoints

Veradermics has reported positive topline results from Study ‘302’, a 519-patient phase 2/3 trial of VDPHL01 — an extended-release oral minoxidil tablet developed specifically for androgenetic alopecia. Both co-primary endpoints were met with statistical significance at month 6: non-vellus target area hair count and patient-reported improvement on the AAIRS.³

The numbers are meaningful. Patients on once-daily dosing gained a mean of 30.3 hairs/cm² versus 7.3 in the placebo group. On the patient-reported measure, 79.3% of once-daily patients reported any hair improvement versus 35.6% on placebo, with nearly half achieving the higher threshold of “improved” or “much improved.” Investigators corroborated these findings, grading 72% of once-daily patients as improved. Statistically significant separation from placebo appeared as early as month 2.

The pharmacokinetic rationale is straightforward: conventional oral minoxidil peaks and clears within hours, potentially overwhelming the sulfotransferase enzyme that converts it to its active form at the hair follicle. VDPHL01’s extended-release system maintains steadier plasma levels, giving the follicle sustained exposure to drive that conversion more efficiently. No cardiac adverse events were observed, and discontinuation rates were lower in the active arms than in placebo.

“At Veradermics, we asked the question: Why is the best tool in our toolkit as dermatologists, a 40-year-old blood pressure medication that no one has aimed to optimize?” said Reid Waldman, MD, a dermatologist and chief executive officer of Veradermics, in a recent interview at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, Colorado.²

A second phase 3 male trial (Study ‘304’) is expected to report in the second half of 2026. A female AGA trial (Study ‘306’) is currently enrolling. If approved, VDPHL01 would be the only FDA-approved oral non-hormonal AGA therapy for both men and women.

▶ Why it matters: Dermatologists have been using off-label oral minoxidil for years without optimized data behind it. A purpose-built formulation with phase 3 evidence and a cleaner cardiac profile would change the prescribing conversation entirely.

MORE DRUGS TO WATCH

Roflumilast Eyes the Youngest Eczema Patients Yet

Arcutis has submitted an sNDA seeking to expand roflumilast cream 0.05% (Zoryve) to infants as young as 3 months with mild to moderate atopic dermatitis — a population with almost no nonsteroidal topical options. The supporting INTEGUMENT-INFANT trial enrolled 101 infants aged 3 to 24 months and evaluated once-daily treatment over 4 weeks.⁴

The results hold up. By week 4, 34.4% of infants achieved vIGA-AD success (clear or almost clear skin with at least a 2-grade improvement), and 49% reached clear or almost clear overall. More than half achieved EASI-75 by week 4, with responses appearing as early as week 2. Among infants with scalp involvement, two-thirds achieved vIGA-scalp success. On the itch side — which matters enormously in this age group for both infants and exhausted caregivers — improvement was reported as early as 10 minutes in some patients, and nearly three-quarters achieved Worst Scratch Itch NRS success by week 4.

Safety was consistent with prior roflumilast pediatric data. The most common adverse events were diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting — no unexpected signals. The 0.05% formulation was specifically developed for younger children, with attention to immature skin barrier characteristics and tolerability on sensitive areas including the face and skin folds. Roflumilast was approved for AD in children ages 2 to 5 in October 2025; this sNDA would push that floor down to 3 months.

▶ Why it matters: Parents of infants with eczema are desperate for options that aren’t steroids. A nonsteroidal, once-daily topical with rapid itch relief in this age group — if approved — would be a meaningful addition to a nearly empty shelf.

MORE ON ATOPIC DERMATITIS

Two Early-Stage Molecules Worth Knowing About

Aclaris Therapeutics reported phase 1a results for ATI-052, a bispecific antibody targeting both TSLP and IL-4 receptor alpha simultaneously — hitting the top of the type 2 inflammatory cascade and downstream IL-4/IL-13 signaling at the same time. The mechanism is designed to raise the efficacy ceiling in diseases like atopic dermatitis and asthma beyond what single-target biologics can achieve. The phase 1 data showed dose-proportional pharmacokinetics, sustained suppression of TSLP- and IL-4-driven biomarkers, and no safety signals — including notably no conjunctivitis, a side effect that has shaped the dupilumab prescribing conversation. An estimated half-life of approximately 45 days supports potential quarterly dosing. Phase 2b is planned for Q4 2026.⁵

In the same announcement, Aclaris named lichen planus as the lead indication for ATI-2138, a selective dual ITK/JAK3 inhibitor targeting pathogenic T-cell signaling. Lichen planus has no FDA-approved therapies despite significant symptom burden across cutaneous, mucosal, and scalp subtypes. A phase 2b basket study is planned for the second half of 2026, beginning with erosive mucosal and cutaneous LP before expanding to lichen planopilaris.

▶ Why it matters: ATI-052 is one to bookmark as the AD pipeline continues to expand beyond IL-4/IL-13 blockade alone. And for APPs managing lichen planus patients on patchwork off-label regimens, the first controlled phase 2b trial in the indication would be a long-overdue development.

LATEST NP/PA NEWS

References

1. Oruka Therapeutics announces positive week 16 data for ORKA-001 from the ongoing EVERLAST-A phase 2a trial in moderate-to-severe plaque psoriasis. News release. Oruka Therapeutics. Published April 27, 2026. Accessed April 30, 2026. https://ir.orukatx.com/news-releases/news-release-details/oruka-therapeutics-announces-positive-week-16-data-orka-001
2. AbbVie submits application to FDA for upadacitinib (Rinvoq) for adults and adolescents with severe alopecia areata. News release. AbbVie. April 28, 2026. Accessed April 30, 2026. https://news.abbvie.com/2026-04-28-AbbVie-Submits-Application-to-FDA-for-Upadacitinib-RINVOQ-R-for-Adults-and-Adolescents-with-Severe-Alopecia-Areata
3. Veradermics’ oral VDPHL01 achieved early, consistent, and robust hair growth in positive phase 2/3 ‘302’ clinical trial in male pattern hair loss. News release. Veradermics. April 27, 2026. Accessed April 30, 2026. https://ir.veradermics.com/news-releases/news-release-details/veradermics-oral-vdphl01-achieved-early-consistent-and-robust
4. Arcutis submits supplemental New Drug Application to the FDA for ZORYVE® (roflumilast) cream 0.05% to expand indication for treatment of atopic dermatitis to infants down to 3 months. News release. Arcutis. April 27, 2026. Accessed April 30, 2026. https://www.arcutis.com/arcutis-submits-supplemental-new-drug-application-to-the-fda-for-zoryve-roflumilast-cream-0-05-to-expand-indication-for-treatment-of-atopic-dermatitis-to-infants-down-to-3-months/
5. Aclaris Therapeutics announces positive full top line first-in-human results from phase 1a healthy volunteer clinical trial of ATI-052, a novel potential first-in-class anti-TSLP/IL-4Rα bispecific antibody, and announces lichen planus as lead indication for ATI-2138, an oral ITK/JAK3 inhibitor. News release. Aclaris Therapeutics. Published April 28, 2026. Accessed April 30, 2026. https://www.globenewswire.com/news-release/2026/04/28/3282383/37216/en/aclaris-therapeutics-announces-positive-full-top-line-first-in-human-results-from-phase-1a-healthy-volunteer-clinical-trial-of-ati-052-a-novel-potential-first-in-class-anti-tslp-il.html