US biopharmaceutical company Vanda Pharmaceuticals Inc (Nasdaq:VNDA) announced on Tuesday the publication of an original research article titled 'Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis' in the New England Journal of Medicine (NEJM) Evidence.
The findings of this pivotal phase III study are included in the Biologics License Application (BLA) for imsidolimab for the treatment of Generalised Pustular Psoriasis (GPP), submitted to the US Food and Drug Administration (FDA) with a target action date of 12 December 2026.
Imsidolimab is a fully humanised IgG4 monoclonal antibody that inhibits IL-36 receptor signalling and is being developed for GPP, a rare orphan indication. Regulatory and patent exclusivity for imsidolimab is expected to extend into the late 2030s.
Vanda holds an exclusive global licence for the development and commercialisation of imsidolimab from AnaptysBio (Nasdaq:ANAB).
Lilly agrees to acquire Ajax Therapeutics
Novartis secures European approval for remibrutinib in chronic spontaneous urticaria
GSK secures US and EU fast-track designations for efimosfermin in MASH
Shield Therapeutics announces Phase II trial initiation of ACCRUFeR in Japan for PAH
Veradermics reports positive Phase 2/3 results for oral VDPHL01 in pattern hair loss treatment
Thermo Fisher scientific agrees to sell microbiology business to Astorg
Cantargia reports early remission data from nadunolimab trial in MDS and AML
AstraZeneca secures US approval for Saphnelo self-administration in lupus treatment