Shots:
- The Regeneron‘s P-III (NIMBLE) trial enrolled adults with symptomatic gMG & anti-AChR antibodies, randomizing them to either cemdisiran monotx. (600mg, SC, Q12W), pozelimab monotx. (200 mg, Q4W), cemdi-poze (200mg each, Q4W), or PBO (Q4W)
- cemdisiran (Q12W; n=64) vs PBO (n=59) improved gMG within 2wks., sustained to Wk. 24; MG-ADL (1EP) improved by 4.5 vs 2.2 points, with 76.6% vs 44.1% pts having ≥3-pt improvement, & QMG (2EP) by 4.2 vs 1.5 points, with 48.4% vs 19% having ≥5-pt improvement; data was presented at AAN’26 & published in The Lancet
- Additionally, cemdisiran is under US FDA review following a Q1’26 submission, with further regulatory filings, incl. in the EU, planned for 2026
Ref: Regeneron | Image: Regeneron | Press Release
Related News: Telix Partners with Regeneron to Develop and Commercialize Radiopharmaceutical Therapies for Pain in a ~$2.1B
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