Shots:
- The P-III NIMBLE trial enrolled adults with symptomatic gMG & anti-AChR antibodies, randomizing them to cemdisiran (600mg, SC, Q12W, n=64), cemdi-poze (SC, Q4W, n=67), or PBO (n=59), with completion rates of 100%, 96%, & 90%, respectively; FDA’s filing is expected in Q1’26, pending discussions
- Trial met its 1EP of improved MG-ADL total score, showing mean changes of -4.52 & -3.96 vs -2.22 from baseline at 24wks.
- Study also met its 2EPs of QMG with mean changes of -4.24 & -3.32 vs -1.46 from baseline, while MG-ADL ≥3-point reduction was achieved by 76.6% & 65.7% vs 44.1%, & QMG ≥5-point reduction occurred in 48.4% & 35.8% vs 19%; data to be presented in future meeting
Ref: Regeneron | Image: Regeneron | Press Release
Related News:- Regeneron’s Lynozyfic (Linvoseltamab-gcpt) Receives the US FDA’s Accelerated Approval for R/R Multiple Myeloma
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
