Argenx's Flagship Neuromuscular Treatment For Subcutaneous Injection Goes Under Priority FDA Review

The FDA has accepted Argenx SE's ARGX Biologics License Application for subcutaneous (SC) efgartigimod for generalized myasthenia gravis (gMG).
Under the Priority Review status, the FDA has granted a Prescription Drug User Fee Act (PDUFA) target action date of March 20, 2023.
SC efgartigimod is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme Therapeutics Inc's HALO Enhanze drug delivery technology that facilitates the SC administration of biologics that are typically administered via intravenous (IV) infusion.
Related: Argenx's Vyvgart To 'Achieve Blockbuster Status,' This Analyst Says With 6% Price Target Hike.
The BLA submission is supported by data from the Phase 3 ADAPT-SC study.
ADAPT-SC met its primary endpoint of total IgG reduction from baseline at day 29, demonstrating noninferiority of SC efgartigimod to Vyvgart.
Patients treated with SC efgartigimod achieved a mean total IgG reduction of 66.4%, compared to a 62.2% reduction with Vyvgart.
Price Action: ARGX shares are down 1.07% at $370.33 premarket on the last check Tuesday.