Also known as: inebilizumab-cdon
UPLIZNA (inebilizumab-cdon) is a CD19-targeted B-cell therapy used in antibody-positive autoimmune neurologic disorders. In December 2025, FDA approved it for generalized myasthenia gravis in adults who are anti-AChR or anti-MuSK antibody positive, adding to earlier approvals in NMOSD and IgG4-related disease. Maintenance dosing is every six months after initial loading doses.
Amgen shares have climbed 35% over six months, trading near $388, as analysts raise price targets following strong fourth-quarter 2025 results and expanding oncology pipeline programs including IMDELLTRA and LUMAKRAS.
Amgen received FDA and European Commission approval for Uplizna to treat generalized myasthenia gravis in adults who are anti-AChR or anti-MuSK antibody positive, offering twice-yearly maintenance dosing after initial loading doses.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06590051 |
AMG 335 Expanded Access Program for IgG4-Related Disease |
AVAILABLE | |
| NCT05909761 |
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy |
RECRUITING |
