Breakout Bulletin: September 14-18

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: an oral therapy for 2 rare photosensitivity disorders clears FDA priority review, a topical BCC-prevention gel for Gorlin syndrome finishes its phase 3 follow-up, GLP-1 receptor agonists get serious consideration as adjunctive psoriasis therapy, and the workforce data behind National APP Week's growing recognition of NPs and PAs in dermatology

An Oral Therapy for Sunlight-Induced Pain Clears Its Biggest Regulatory Hurdle Yet

The FDA has accepted the New Drug Application for dersimelagon and granted Priority Review, with a PDUFA action date expected by the end of February 2027. Dersimelagon is an oral, once-daily small-molecule melanocortin 1 receptor (MC1R) agonist being developed for erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), 2 rare genetic disorders in which protoporphyrin IX accumulation causes severe, sunlight-induced skin pain. Neither condition currently has an FDA-approved oral treatment; if approved, dersimelagon would be the first.¹

The submission is built on the phase 3 INSPIRE trial, a global, randomized, double-blind, placebo-controlled study that met its primary and secondary end points, including a statistically significant prolongation of the average daily sunlight exposure time patients tolerated before prodromal symptoms, the pain precursor that drives most patients with EPP and XLP to avoid daylight altogether. The company has not released effect sizes, P values, or confidence intervals, so the magnitude of benefit remains unclear pending fuller data disclosure.

Patients living with EPP or XLP face a devastating lifelong burden of sunlight-induced pain.— Christophe Bourdon, CEO, LEO Pharma

LEO Pharma acquired worldwide rights to dersimelagon from Tanabe Pharma for up to $435 million in upfront and near-term milestone payments, plus potential downstream milestones and tiered royalties.

▶ Why it matters: For patients whose disease management has revolved around avoiding sunlight entirely, an oral option that has already met its phase 3 end points signals a shift in what's worth counseling at the point of care, once approval catches up to the data.

The First Topical BCC-Prevention Therapy for Gorlin Syndrome Is One Step From Answers

The phase 3 SGT-610-01 trial (NCT06050122) of patidegib gel 2% (SGT-610) has completed its last patient last visit, meaning all 113 enrolled patients have finished or exited the randomized, double-blind, vehicle-controlled study.² Of those enrolled, 102 completed the full 12-month course of twice-daily facial application. The primary end point is new facial basal cell carcinoma (BCC) count at month 12 versus vehicle, with surgically eligible BCCs, lesions that would otherwise require excision rather than observation, tracked as a secondary end point.

No efficacy results have been released. The company is moving to database lock and statistical analysis, with topline data expected in late November 2026, so this milestone marks the end of data collection, not a readout. Blinding was maintained for patients, investigators, and the company through last patient last visit, and no interim safety signal prompted early unblinding. SGT-610 carries FDA Orphan Drug and Breakthrough Therapy designations, and no topical therapy is currently approved to prevent BCCs in Gorlin syndrome.

Reaching last patient last visit represents an important milestone for the SGT-610 program and brings us closer to understanding its potential to address the significant unmet need in patients with Gorlin syndrome.— Mori Arkin, Executive Chairman and CEO, Sol-Gel Technologies

▶ Why it matters: Patients with Gorlin syndrome currently have no approved topical option to slow the steady accumulation of facial BCCs. Watch for topline data this winter to see whether that changes.

GLP-1 Receptor Agonists Enter the Psoriasis Conversation

At Maui Derm NP+PA Fall 2026, held September 17 at The Greenbrier in White Sulphur Springs, West Virginia, Willa Hsueh, MD, led a session examining semaglutide and liraglutide as adjunctive therapy for psoriasis, framing the rationale around the drugs' effects on obesity-related inflammation and the proinflammatory pathways that overlap with psoriatic disease.³ The session reflects a broader shift toward treating psoriasis as a systemic inflammatory condition rather than a skin-limited one, particularly in patients who also carry metabolic comorbidities.

The same day's inflammation and immunology workshop, moderated by Melissa Bruno, PA-C, with Alisa Charrow, MD; Jerry Hawkes, MD; and Alisa Femia, MD, covered connective tissue disease, hidradenitis suppurativa, and chronic spontaneous urticaria alongside obesity-related inflammatory disease. A separate infectious disease and grand rounds track, with Ted Rosen, MD; Vikash Oza, MD; Phoebe Rich, MD; and Lawrence Wine Lee, MD, PhD, reinforced the same message across viral, bacterial, fungal, and parasitic presentations: keep the differential wide when a case does not fit the expected pattern.

▶ Why it matters: If a GLP-1 receptor agonist is already on a psoriasis patient's medication list for weight or metabolic disease, it may be doing more than treating diabetes or obesity. Ask about it before assuming a biologic is the next step.

The Dermatology PA Workforce Has Nearly Doubled Since 2013

The number of certified PAs practicing in dermatology grew from 2323 in 2013 to 4580 in 2021, according to workforce data highlighted for National APP Week 2026, observed September 21 to 25 under the theme “The Pulse of Progress: APPs Powering Tomorrow.” Researchers suggest that growth may help ease workforce capacity constraints in a specialty facing rising patient demand. NPs and PAs in dermatology practice across the full scope of skin disease, evaluating and diagnosing patients, performing procedures, and managing acute and chronic conditions including atopic dermatitis, psoriasis, hidradenitis suppurativa, acne, and skin cancer.⁴

The observance is timed to recognize contributions that extend beyond the exam room, including research presentations, colleague education, patient resource development, mentoring, and community care initiatives.

▶ Why it matters: The data confirms what clinic schedules already show: NPs and PAs are carrying a growing share of dermatologic care, and workforce planning, staffing, and scope-of-practice conversations should reflect it.

MORE ON SKIN CANCER

References

1. Campbell P. Dersimelagon NDA accepted, FDA grants priority review for EPP, XLP. Dermatology Times. September 18, 2026. Accessed September 21, 2026. https://www.dermatologytimes.com/view/dersimelagon-nda-accepted-fda-priority-review-epp-xlp
2. Bader K. Patidegib gel completes phase 3 follow-up in Gorlin syndrome. Dermatology Times. September 17, 2026. Accessed September 21, 2026. https://www.dermatologytimes.com/view/patidegib-gel-completes-phase-3-follow-up-in-gorlin-syndrome
3. Heaning S. Maui Derm NP/PA Fall 2026 day 2: GLP-1s, inflammatory disease, and diagnostic challenges. Dermatology Times. September 21, 2026. Accessed September 21, 2026. https://www.dermatologytimes.com/view/maui-derm-np-pa-fall-2026-day-2-glp-1s-inflammatory-disease-and-diagnostic-challenges
4. Heaning S. National APP Week 2026: celebrating the growing impact of APPs in dermatology. Dermatology Times. September 21, 2026. Accessed September 21, 2026. https://www.dermatologytimes.com/view/national-app-week-2026-celebrating-the-growing-impact-of-apps-in-dermatology