Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- 3 days ago
- 2 min read
Updated: 11 hours ago
15/06/2026
SynAct Pharma reported Phase 2b data of resomelagon in Rheumatoid Arthritis (Ref)
SynAct Pharma AB reported data from the Phase 2b, ADVANCE study which evaluated resomelagon in combination with methotrexate in newly diagnosed, treatment naïve patients with highly active Rheumatoid Arthritis (RA).
The safety profile of the compound was very good and the compound was well tolerated and no signs of immune suppression were observed.
Ultomiris granted Priority Review in the US as treatment for adults with immunoglobulin A nephropathy (Ref)
Alexion, Astrazeneca Rare Disease’s supplemental Biologics License Application (sBLA) for Ultomiris (ravulizumab; C5 complement inhibitor) was accepted and granted Priority Review by the US FDA for the treatment of adults with immunoglobulin A nephropathy (IgAN).
The sBLA was based on data from the prespecified interim analysis of the Phase 3, I CAN/ NCT06291376 study in which Ultomiris demonstarated 43.4% reduction in proteinuria vs placebo at 34 weeks.
The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for its regulatory decision is anticipated during Q4 2026.
XBiotech launched Phase 2 trial evaluating vilamakitug for the treatment of active axial spondyloarthritis (Ref)
XBiotech announced that its Investigational New Drug (IND) application for V-SPINE (PT064), a Phase 2 study of vilamakitug (XB2001; Natrunix™; IgG4 mAb neutralizes IL-1α) in participants with active axial spondyloarthritis, had successfully completed the US FDA 30-day review period without a clinical hold.
The study was authorized to proceed with patient enrollment in the US.
Spyre announced Part A results from Phase 2 trial of SPY002 in moderate-to-severe UC (Ref)
Spyre Therapeutics announced positive 12 week induction data from Part A of the Phase 2, SKYLINE trail of SPY002 (an anti-TL1A) which was being investigated for the treatment of moderately-to-severely active ulcerative colitis (UC).
SPY002 met its primary endpoint with a statistically significant reduction of 10.7 points (p<0.0001) from baseline at Week 12 in the Robart’s Histopathology Index (RHI) score.
Secondary endpoints included clinical remission by modified Mayo Score of 33% and endoscopic improvement of 42%.
SPY002 was well tolerated with a safety profile consistent with the TL1A class.
