Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- Feb 27
- 2 min read
Updated: Mar 2
26/02/2026
GSK’s linerixibat accepted for Priority review by China’s NMPA in patients with PBC (Ref)
China’s National Medical Products Administration (NMPA) accepted linerixibat (IBAT inhibitor) for Priority review for the treatment of cholestatic pruritus in patients with primary biliary cholangitis (PBC)
The application was based on positive data from the Phase 3 GLISTEN trial that was presented last year at the European Association for the Study of the Liver (EASL) Congress
The trial met both primary and key secondary endpoints, demonstrating a rapid, significant and sustained improvement in cholestatic pruritus and itch-related sleep interference versus placebo
The safety profile of linerixibat was consistent with previous studies
Boehringer acquired an exclusive license for a novel oral therapeutics program for immune diseases from Sitryx (Ref)
Boehringer Ingelheim and Sitryx Therapeutics announced that Boehringer had acquired an exclusive license for a preclinical small molecule program from Sitryx for a treatment approach across multiple autoimmune and inflammatory disease indications
Under the agreement, Sitryx granted Boehringer an exclusive global license to multiple candidates and associated intellectual property within the small molecule inhibitor program
Boehringer assumed full responsibility for further research, clinical development, and commercialization
Sitryx received upfront and near-term payments and was eligible to receive potential development, regulatory and commercialization milestone payments totaling more than $500 million, in addition to tiered royalties on future sales
Argenx announced topline results from Phase 3 trial of VYVGART in Ocular myasthenia gravis (Ref)
Argenx announced positive topline results from the Phase 3 ADAPT OCULUS/ NCT06558279 study, which evaluated VYVGART® (efgartigimod alfa and hyaluronidase-qvfc; an FcRn blocker) in adult patients with ocular myasthenia gravis (oMG)
The trial met its primary endpoint (p-value=0.012) demonstrating a statistically significant improvement from baseline in MGII, Patient-Reported Outcome (PRO) ocular scores at Week 4 compared to placebo:
Mean change from baseline in MGII PRO
VYVGART: 4.04-point improvement
Placebo: 1.99-point improvement
VYVGART was well tolerated and had a favorable safety profile in patients with oMG, consistent with prior studies; no new safety concerns were identified
The results supported a planned Supplemental Biologics License Application (sBLA) submission to the US FDA to expand the label into oMG
Data from the ADAPT OCULUS study were to be presented at an upcoming medical meeting
Soligenix received a positive opinion from the EMA on its request for orphan drug designation for SGX945 for the treatment of behçet's disease (Ref)
Soligenix announced European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) had issued a positive recommendation on the Company's request for orphan drug designation for dusquetide (the active ingredient in SGX945; an innate defense regulator) for the treatment of patients with Behçet's Disease (BD)
The positive COMP opinion was supported by recently published Phase 2a/ NCT06386744 results that demonstrated biological efficacy and safety in BD
