Drug Watch

The novel oral helicase-primase inhibitor demonstrated significantly higher rates of complete lesion healing compared with investigator’s choice treatment in the phase 3 PRIOH-1 trial.

By week 36, combination therapy altered 482 proteins and 467 genes vs 140 and 16 with ixekizumab alone in exploratory TOGETHER-PsO data.

The supplemental New Drug Application seeks to expand the use of Ameluz with red light photodynamic therapy beyond the face and scalp to actinic keratoses on the extremities, neck, and trunk.

The approval of the oral BTKi rests on a phase 3 result of 29.3% complete response from hives vs 14.0% with placebo at week 12.

Celltrion’s US launch of omalizumab-igec adds an interchangeable biosimilar option for eligible patients with chronic spontaneous urticaria.

The FDA approved therapies for melanoma, dermatomyositis, superficial basal cell carcinoma, and adolescent alopecia areata, while TYK2 inhibitors and rare disease filings advanced toward 2027 decisions.

The FDA approval, based on 36-week data from the phase 3 BRAVE-AA-PEDS trial, extends baricitinib access to patients as young as 12 years old with severe alopecia areata.

Week 28 data from the phase 2a EVERLAST-A trial showed PASI 100 responses increased to 71.4% despite no additional ORKA-001 dosing after week 4.

Immunovant will discontinue development of imeroprubart in cutaneous lupus erythematosus after the phase 2b study failed to meet its primary endpoint.

Both barzolvolimab doses improved UAS7 at week 12 in EMBARQ-CSU1 and EMBARQ-CSU2, with up to 54% of patients reaching complete response by week 24.

The designation marks the first FDA Fast Track status granted to a therapy for peeling skin syndrome, which currently has no approved treatment.

LEO Pharma has closed its acquisition of dersimelagon from Tanabe Pharma after the FDA accepted the drug's NDA for filing and granted Priority Review, with a PDUFA date expected by the end of February 2027.

Sol-Gel Technologies has completed patient follow-up in its pivotal phase 3 trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, with top-line results expected in late November 2026.

Two small clinical studies evaluated skincare and dermabrasion for changes in skin quality among individuals taking medical weight loss medications.

The FDA has set a PDUFA target action date of June 29, 2027, based on APEX trial data showing a 65% overall response rate in advanced systemic mastocytosis.

The expanded indication makes Ameluz with RhodoLED the first FDA-approved photodynamic therapy for the treatment of a skin cancer.

Takeda’s investigational oral TYK2 inhibitor is supported by phase 3 LATITUDE data demonstrating significant skin clearance versus placebo and apremilast.

Phase 2 SkinJect data support the 200-µg dose and inform Medicus’ FDA-authorized registrational program in Gorlin syndrome.

A twice-rejected melanoma immunotherapy finally won accelerated approval, acne's decades-long innovation drought moved a step closer to ending, and 2 rare, sun-triggered skin diseases picked up a deep-pocketed new sponsor.

Week 52 data show ixekizumab plus tirzepatide sustained or improved disease activity and metabolic outcomes in psoriasis and psoriatic arthritis.

The FDA approval, based on phase 3 VALOR trial data, makes brepocitinib the first targeted therapy specifically indicated for dermatomyositis.

Verrica Pharmaceuticals has completed enrollment in COVE-2, its first pivotal phase 3 trial of YCANTH for common warts, with topline data expected in the first quarter of 2027.

Rezpegaldesleukin improved EASI, itch, and other outcomes in phase 2b REZOLVE-AD, supporting continued phase 3 development.

Preclinical data show GX-03 reduced IL-31 by nearly 68% and dermatitis severity by 66% in a murine model of atopic dermatitis.

LEO Pharma will acquire worldwide rights to dersimelagon, an investigational oral therapy under FDA review for EPP and XLP.