Top 5 Articles of the Month: November 2025

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1. Oral C5aR Inhibitor INF904 Shows Early Efficacy in HS and CSU Phase 2a Trials

InflaRx has reported encouraging topline results from its phase 2a study of INF904, an oral small-molecule C5a receptor antagonist, in patients with hidradenitis suppurativa (HS) and chronic spontaneous urticaria. Across both conditions, INF904 demonstrated early signs of efficacy comparable to established biologics, including reductions in inflammatory lesions, draining tunnels, and disease activity scores, alongside meaningful improvements in patient-reported outcomes such as pain and quality of life. The treatment was well tolerated, with no serious adverse events observed. These preliminary findings support further clinical development of INF904 and highlight the potential of complement pathway inhibition as a new oral therapeutic strategy in chronic inflammatory skin diseases.

2. Alys Pharmaceuticals Doses First Patient in Phase 1/1b Trial of ALY-301 for Chronic Urticaria

Alys Pharmaceuticals has dosed the first patient in a phase 1/1b study of ALY-301, a first-in-class, mast cell–selective c-Kit inhibitor being developed for cold urticaria, a model for chronic urticaria. ALY-301 is a bispecific antibody designed to selectively deplete mast cells while sparing other c-Kit–expressing cells, potentially enabling safe, long-term treatment of mast cell–driven diseases. The randomized, placebo-controlled trial will evaluate safety, tolerability, and pharmacology in both healthy volunteers and patients refractory to antihistamines, marking a key milestone in Alys’s mission to deliver precision-targeted therapies for chronic urticaria and related immune-dermatology conditions.

3. FDA Alerts Clinicians to Serious Complications with Radiofrequency Microneedling Devices

The FDA has issued a safety alert regarding radiofrequency (RF) microneedling devices used in aesthetic dermatology, highlighting reports of serious complications including burns, scarring, subcutaneous fat loss, nerve injury, and disfigurement. While most treatments are tolerated, risks increase with operator inexperience, aggressive treatment parameters, or use in sensitive areas. The agency emphasizes that RF microneedling is a medical procedure, not a cosmetic treatment, and encourages clinicians to carefully select patients, adhere to device-specific guidelines, and report adverse events via MedWatch. Patients are advised to seek treatment from licensed, trained providers and to be aware of potential risks. The FDA is investigating causes of complications and working with manufacturers to improve safety and post-market surveillance.

4. Psoriasis Care Evolves as Oral IL-23 Blockers Show Lasting Control

At the 2025 European Academy of Dermatology and Venereology Congress, oral therapies emerged as a potential game-changer in psoriasis care, with phase 3 data showing that icotrokinra, an oral IL-23 receptor blocker, outperforms deucravacitinib. Experts highlighted its mechanistic innovation, durable efficacy, and favorable safety profile, emphasizing the appeal of a needle-free option for patients, including adolescents and needle-averse populations. While clinicians remain focused on defining remission, balancing long-term safety, and applying real-world considerations, the excitement underscores a broader shift toward oral peptide–based biologics as a transformative approach in inflammatory dermatology.

5. Castle Biosciences Launches 487-Gene Test for AD Care

Castle Biosciences has launched AdvanceAD-Tx, a 487-gene expression profile test designed to guide systemic therapy selection in patients aged 12 and older with moderate to severe atopic dermatitis (AD). By identifying molecular signatures that predict response to JAK inhibitors versus Th2-targeted biologics, the test aims to enable precision, biology-driven treatment decisions, potentially reducing the trial-and-error approach that often delays disease control. Early validation from the IDENTITY study suggests that JAKi responders identified by AdvanceAD-Tx achieve faster and greater clinical improvement, highlighting the promise of molecular profiling as a next-generation tool in dermatology.