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

  • The FDA has accepted Argenx SE's (NASDAQ: 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 (NASDAQ: 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.

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