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Home » Keywords » nipocalimab

Items Tagged with 'nipocalimab'

ARTICLES

Imvaay packaging

With FDA approval, J&J enters the myasthenia gravis fray

April 30, 2025
By Lee Landenberger
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The U.S. FDA approval of Johnson & Johnson’s Imaavy (nipocalimab-aahu) for myasthenia gravis brings the monoclonal antibody into a treatment space that teems with competition, both approved and in-development candidates. The human Fc receptor inhibitor was approved to treat generalized myasthenia gravis in patients who are 12 years and older. Patients must be anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody positive. Anti-AChR and anti-MuSK antibody-positive individuals make up more than 90% of all antibody-positive gMG patients.
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Telitacicept packaging

Remegen’s lupus drug surfaces with phase III myasthenia gravis data

April 15, 2025
By Marian (YoonJee) Chu
Remegen Co. Ltd. emerged as a surprise challenger in the generalized myasthenia gravis space, unveiling positive phase III data of its China-approved lupus drug, telitacicept (RCT-18; Tai’ai), in the rare autoimmune neuromuscular disorder at the 2025 American Academy of Neurology conference.
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Telitacicept packaging

Remegen’s lupus drug surfaces with phase III myasthenia gravis data

April 9, 2025
By Marian (YoonJee) Chu
Remegen Co. Ltd. emerged as a surprise challenger in the generalized myasthenia gravis space, unveiling positive phase III data of its China-approved lupus drug, telitacicept (RCT-18; Tai’ai), in the rare autoimmune neuromuscular disorder at the 2025 American Academy of Neurology conference.
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J&J’s $6.5B investment prompts positive phase II and III data

Feb. 5, 2024
By Lee Landenberger
In August 2020, Johnson & Johnson paid $6.5 billion cash to acquire Momenta Pharmaceuticals Inc. That strengthened J&J’s immune-mediated disease portfolio and grew its interest in autoantibody-driven disease therapies by bringing nipocalimab into the fold. Now the investment is paying off with top-line results of phase II and III studies that hit their primary endpoints using the fully human glycosylated monoclonal antibody targeting the human neonatal Fc receptor. The studies were in treating generalized myasthenia gravis and in Sjögren’s disease.
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M&A cityscape

Gaining momentum, Johnson & Johnson acquires Momenta for $6.5B cash

Aug. 19, 2020
By Lee Landenberger
The pace of biopharma mergers and acquisitions has quickened with Johnson & Johnson’s $6.5 billion all-cash acquisition of Momenta Pharmaceuticals Inc. Bringing Momenta into the fold strengthens the Janssen Pharmaceutical Companies of Johnson & Johnson’s immune-mediated disease portfolio and grows its interest in autoantibody-driven disease therapies.
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