The U.S. FDA signaled during a Type B meeting that existing data could support a BLA filing for Moonlake Immunotherapeutics AG’s sonelokimab to treat the skin disease hidradenitis suppurativa (HS), despite one of two pivotal phase III trials missing the mark.
Takeda Pharmaceuticals Co. Ltd.’s oral tyrosine kinase 2 inhibitor, zasocitinib (TAK-279), met the co-primary endpoints and all ranked secondary endpoints in two pivotal phase III studies in patients with moderate to severe plaque psoriasis.
A would-be psoriasis winner began taking more distinct shape in the competitive oral tyrosine kinase 2 (TYK2) inhibitor space, and shares of Alumis Inc. (NASDAQ:ALMS) closed Jan. 6 at $16.23, up $7.92, or 95% – having traded as high as $22.30 – after unveiling positive top-line results from the phase III Onward1 and Onward2 trials with envudeucitinib (envu). Alumis CEO Martin Babler called 2026 “a value-inflection year. It starts today.”
Jiangsu Simcere Pharmaceutical Co. Ltd. has identified antibody-drug conjugates (ADCs) comprising antibody or antigen-binding fragments linked to a cytotoxic drug through a linker reported to be useful for the treatment of atopic dermatitis.
Fibrobiologics Inc. has filed an IND application with the FDA seeking to begin first-in-human trials of CYPS-317, an investigational allogeneic fibroblast spheroid-based therapy for the treatment of moderate to severe psoriasis.
The strategy of taking aim at IL-4Ra (type I and II receptors) and IL-31 by way of a bispecific antibody in atopic dermatitis (AD) has not worked out as well as Johnson & Johnson (J&J) hoped when, last May, the firm paid $1.25 billion to bring the product aboard by acquiring Yellow Jersey Therapeutics, a wholly owned subsidiary of Numab Therapeutics AG.
Much has been made of the recent skyrocketing of Medicare spending on skin substitutes, but a new enforcement action by the U.S. Department of Justice might help to explain some of those spending increases.
Recludix Pharma Inc. has obtained IND clearance from the FDA to advance REX-8756 (SAR-448755), an oral STAT6 inhibitor for inflammatory diseases, into phase I testing. REX-8756 is an oral, selective STAT6 inhibitor that employs a novel therapeutic approach by targeting STAT6’s SH2 domain.
Peptidream Inc. has announced progression of an oral dual IL-17A and IL-17F macrocyclic peptide inhibitor for psoriasis, with the program entering the company’s clinical development portfolio.
Absci Corp. has released new preclinical data for ABS-201, an AI-designed antibody targeting the prolactin receptor (PRLR) designed to stimulate hair follicle regeneration and promote durable hair regrowth for the potential management of androgenetic alopecia.
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