argenx

NEWS
The FDA has four target action dates this week, including ones for Argenx’s subcutaneous efgartigimod in generalized myasthenia gravis and Sarepta’s gene therapy for Duchenne muscular dystrophy.
An advisory committee will meet March 22 to discuss the fate of Biogen and Ionis’ ALS hopeful tofersen. For that and more, see inside.
The FDA granted argenx Priority Review status for the company’s BLA for SC efgartigimod for generalized myasthenia gravis.
Two biologic therapeutic candidates have met their primary endpoints in phase III trials, including AstraZeneca’s Champion-NMOSD trial and Argenx’s Advance trial.
Discover what’s in store for today’s presentations at The American Academy of Neurology’s annual meeting, which will include data for a variety of neurological treatments.
Although it was relatively quiet in COVID-19-related clinical trials, there was plenty of other clinical trial news. Here’s a look.
Data from the Phase III study showed that efgartigimod achieved the primary endpoint of total IgG reduction from the baseline on the 29th day of observation.
FDA
VYVGART is the first-and-only neonatal Fc receptor (FcRn) blocker to be approved by the FDA.
As a result of the termination, argenx will regain worldwide rights to cusatuzumab, its anti-CD70 antibody, from Cilag FmbH International, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
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