Johnson & Johnson Reports the CHMP’s Positive Opinion of Nipocalimab for Generalized Myasthenia Gravis (gMG)

Shots:The CHMP has recommended Nipocalimab as an add-on therapy to treat anti-AChR Ab+ & anti-MuSK Ab+ gMG pts (≥12yrs.)Opinion was based on the P-III (Vivacity-MG3) trial assessing nipocalimab (30mg/kg, IV loading dose then 15mg/kg, Q2W) + SoC vs PBO + SoC in gMG pts (N=199; 153 were Ab +ve), which showed improved MG-ADL score…

ByRidhi RastogiSeptember 22, 2025

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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 discussionsTrial met its 1EP of improved MG-ADL total score, showing…

ByRidhi RastogiAugust 27, 2025

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argenx Reports Topline P-III (ADAPT SERON) Trial Data of Vyvgart for AChR-Ab Seronegative Generalized Myasthenia Gravis

Shots:argenx has reported topline P-III (ADAPT SERON) trial data on Vyvgart (efgartigimod alfa; IV) for AChR-Ab seronegative generalized myasthenia gravis (gMG)Trial (n=119) consist of 2 Parts: Part A assessed Vyvgart (QW × 4wks.) vs PBO, followed by 5wk. follow-up, while Part B was an OLE study, where pts received 2 fixed cycles of…

ByRidhi RastogiAugust 25, 2025

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AstraZeneca Reports P-III (PREVAIL) Trial Data of Gefurulimab for Generalised Myasthenia Gravis (gMG)

Shots:AstraZeneca has reported P-III (PREVAIL) trial assessing gefurulimab vs PBO in 260 gMG adults for 26wks. across North America, EU, & APAC region; eligible pts could then enter an ongoing OLE studyTrial met its 1EP & all 2EPs, showing significant improvement in MG-ADL total score from baseline at 26wks. in adults with AChR…

ByRidhi RastogiJuly 24, 2025

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RemeGen’s Telitacicept Receives the NMPA’s Approval for Generalized Myasthenia Gravis (gMG)

Shots:The NMPA has approved telitacicept for the treatment of AChR antibody-positive gMG in combination with standard therapiesIn P-III trial for gMG, telitacicept demonstrated favorable efficacy vs PBO, with 98.1% vs 12% pts achieving ≥3-point MG-ADL reduction (-5.74 vs -0.91) as well as 87% vs 16% pts having ≥5-point QMG reduction (-8.66 vs -2.27) at…

ByRidhi RastogiMay 27, 2025

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Johnson & Johnson Reports the US FDA’s Approval of Imaavy (Nipocalimab-aahu) for Generalized Myasthenia Gravis (gMG)

Shots:The US FDA has approved Imaavy to treat antibody +ve gMG pts (≥12yrs.) under priority review based on the ongoing P-III (Vivacity-MG3) trial assessing Imaavy + SoC vs PBO + SoC in antibody +ve or -ve adults (N=199; 153 were Ab +ve); global regulatory review is ongoingTrial showed superior disease control per MG-ADL…

ByDipanshu DixitMay 1, 2025

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Johnson & Johnson Reports P-III (Vivacity-MG3) Trial Data of Nipocalimab for Generalized Myasthenia Gravis

Shots:J&J has reported additional findings from P-III (Vivacity-MG3) trial & ongoing OLE assessing nipocalimab + SoC (30mg/kg, IV loading dose followed by 15mg/kg, Q2W) vs PBO in anti-AChR+, anti-MuSK+ & anti-LRP4+ adults (n=153) with gMGTrial showed a -4.9 QMG score improvement over 22 & 24wks. & pts were 4x more likely to sustain…

ByRidhi RastogiApril 10, 2025

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Remegen Reports P-III Trial Data of Telitacicept for Generalized Myasthenia Gravis (gMG)

Shots:Remegen has reported P-III trial data assessing Telitacicept (RC18; 240mg; n=57) vs PBO (n=57) in 114 chinese gMG pts, with baseline MG-ADL score ≥6 & QMG score ≥8; trial incl. 24wk. double-blind phase followed by an open-label phase. BLA is under the NMPA’s review, with decision expected in Q2’25Trial showed 98.1% vs 12% pts achieved…

ByRidhi RastogiApril 9, 2025

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Amgen Reveals P-III (MINT) Study Data of Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis (gMG)

Shots:Amgen has reported P-III (MINT) trial data on Uplizna vs PBO in adults (N=238) with AChR+ gMG (n=190) or MuSK+ gMG (n=48), followed for 52 & 28wks., respectively; sBLA under FDA’s priority review for IgG4-RD (PDUFA: Apr 3, 2025), with regulatory filings expected to end by H1’25 Pts received an initial loading dose…

ByRidhi RastogiMarch 17, 2025

Johnson & Johnson Reports the CHMP’s Positive Opinion of Nipocalimab for Generalized Myasthenia Gravis (gMG)

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

argenx Reports Topline P-III (ADAPT SERON) Trial Data of Vyvgart for AChR-Ab Seronegative Generalized Myasthenia Gravis

AstraZeneca Reports P-III (PREVAIL) Trial Data of Gefurulimab for Generalised Myasthenia Gravis (gMG)

RemeGen’s Telitacicept Receives the NMPA’s Approval for Generalized Myasthenia Gravis (gMG)

Johnson & Johnson Reports the US FDA’s Approval of Imaavy (Nipocalimab-aahu) for Generalized Myasthenia Gravis (gMG)

Johnson & Johnson Reports P-III (Vivacity-MG3) Trial Data of Nipocalimab for Generalized Myasthenia Gravis

Remegen Reports P-III Trial Data of Telitacicept for Generalized Myasthenia Gravis (gMG)

Amgen Reveals P-III (MINT) Study Data of Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis (gMG)

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