secwatch.observer — SEC 8-K summary ====================================== Issuer: Jade Biosciences, Inc. (JBIO) CIK: 0001798749 Form: 8-K Filed at: 2026-09-30T11:13:31+00:00 Accession: 0001193125-26-408287 Event type: other_material Sentiment: positive Materiality: 0.55 Item codes: 8.01 LLM model: deepseek-v4.1-flash:cloud@v2 Jade Biosciences reports preclinical JADE301 data in dermatomyositis; Phase 1 in 24 healthy volunteers to start Q4 2026 -------------------------------------------------------------------------------- - JADE301 binds IFN-β with KD of 11.3 pM, ~2.5-fold higher affinity than the dazukibart comparator, with no detectable binding to other interferon family proteins. - Inhibited pSTAT induction with IC50 of 13 pM (~2.5-fold more potent than dazukibart) and MX-1 in human dermal fibroblasts with IC50 of 11 pM (~8-fold more potent). - NHP data: ~30-day half-life after 30 mg/kg IV (~3x longer than dazukibart) and ~25-day SC half-life; modeled human SC bioavailability ~73%-75% vs dazukibart's ~43%-44%. - GLP NHP toxicology: SC JADE301 every two weeks at 0, 50, 100 and 200 mg/kg was well tolerated; no treatment-related adverse clinical, lab or histopathology findings. - Phase 1 placebo-controlled single ascending-dose SC trial in 24 healthy volunteers to start Q4 2026; interim data anticipated in the second half of 2027. Source: EDGAR index: https://www.sec.gov/Archives/edgar/data/1798749/000119312526408287/0001193125-26-408287-index.htm Primary doc: https://www.sec.gov/Archives/edgar/data/1798749/000119312526408287/d936098d8k.htm HTML page: https://secwatch.observer/filing/0001193125-26-408287 License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer