Bar what it described as a “placebo wobble,” Moonlake Therapeutics AG turned in positive results from the phase III trials of sonelokimab in treating hidradenitis suppurativa (HS), only to see its share price take a complete battering. The stock (Nasdaq:MLTX) fell 90%, or $55.75, to close Sept. 29 at $6.24, after the Zug Switzerland-based company published 16-week data from two identical trials, Vela-1 and Vela-2.
The Human Cell Atlas project has delivered a fresh tranche of data mapping fibroblasts in healthy and diseased skin and pointing to drug targets with potential in multiple diseases across a range of tissues. Using single cell sequencing and spatial genomics, a technique for showing how gene expression varies at different locations within a tissue, nine different subpopulations of fibroblasts were identified, six in healthy skin and three in disease samples.
Resvita Bio Inc. has held a pre-IND meeting with the FDA for RVB-003, its lead investigational therapy for Netherton syndrome. The FDA’s feedback gives the company a pathway to submit an IND for RVB-003 in the first half of next year, with a clinical efficacy read-out anticipated by early 2027.
The Human Cell Atlas project has delivered a fresh tranche of data mapping fibroblasts in healthy and diseased skin and pointing to drug targets with potential in multiple diseases across a range of tissues. Using single cell sequencing and spatial genomics, a technique for showing how gene expression varies at different locations within a tissue, nine different subpopulations of fibroblasts were identified, six in healthy skin and three in disease samples.
Almirall SA has disclosed tyrosine-protein kinase ITK/TSK (EMT) inhibitors reported to be useful for the treatment of atopic dermatitis, psoriasis, alopecia areata, vitiligo, T-cell lymphoma, asthma, inflammatory bowel disease and multiple sclerosis, among others.
Fibrobiologics Inc. has announced IND-enabling updates from its psoriasis research program demonstrating the potential of human dermal fibroblast (HDF) spheroids as a novel therapeutic approach for chronic-relapse psoriasis.
The U.S. Office of Inspector General posted an analysis of Medicare spending on skin substitutes, remarking that the data suggest a disproportionate use of these products for patients enrolled in fee-for-service (FFS) care.
Phase III results from Sanofi SA’s study of amlitelimab in treating atopic dermatitis met the primary and key secondary endpoints, but investors took a step back.
Onco3r Therapeutics BV has obtained clinical trial application (CTA) approval by the Belgian regulatory authorities for its SIK3 inhibitor O3R-5671. A first-in-human trial will be conducted in Belgium and is expected to open enrollment in the coming weeks. Final data are expected in the first half of next year and will inform subsequent patient trials across a range of autoimmune diseases, which are planned to commence next year.
Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.
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