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Regeneron New
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Regeneron Reports P-III (NIMBLE) Trial Data on Cemdisiran for Generalized Myasthenia Gravis (gMG)

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…
April 22, 2026

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Regeneron New
NEWS

Regeneron Reports P-III (NIMBLE) Trial Data of Cemdisiran for Generalized Myasthenia Gravis (gMG)

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…
August 27, 2025

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Enhancing Hematologic Care: Lorah Perlee from Regeneron in a Riveting Dialogue Exchange with PharmaShots
VIEWPOINTS

Enhancing Hematologic Care: Lorah Perlee from Regeneron in a Riveting Dialogue Exchange with PharmaShots

Shots:  At ASH 2024, Regeneron shared data from the P-III exploratory cohort investigating the pozelimab and cemdisiran combination (poze-cemdi) in patients with paroxysmal nocturnal hemoglobinuria  The novel combination (poze-cemdi) achieved meaningful control of intravascular hemolysis compared to ravulizumab   PharmaShots welcomes Lorah Perlee, Vice President, Global Program Head, Hematology and Translational Sciences at Regeneron, for an…
June 23, 2025

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