argenx SE (Nasdaq: ARGX) has received approval from the U.S. Food and Drug Administration (FDA) for VYVGART Hytrulo, a subcutaneous injection used to treat generalized myasthenia gravis (gMG) in adult patients who test positive for anti-acetylcholine receptor (AChR) antibodies. This chronic autoimmune neuromuscular disease is characterized by muscle weakness. 

VYVGART Hytrulo, the first FDA-approved subcutaneous injectable for gMG, combines argenx's VYVGART (efgartigimod alfa) with Halozyme Therapeutics, Inc.'s (Nasdaq: HALO) ENHANZE drug delivery technology (recombinant human hyaluronidase PH20 enzyme, rHuPH20)

In pre-market, $ARGX is trading at $404.18 (+0.72%), while $HALO stands at $35.61 (+3.01%).

In other news, Pfizer Inc. (NYSE: PFE) has announced FDA approval for TALZENNA (talazoparib) in combination with XTANDI (enzalutamide) to treat metastatic castration-resistant prostate cancer (mCRPC) in adult patients with homologous recombination repair (HRR) gene mutations. 

TALZENNA is an oral poly ADP-ribose polymerase (PARP) inhibitor that targets DNA damage repair. 

Metastatic CRPC refers to prostate cancer that has spread beyond the prostate gland and has not responded to previous treatments.

$PFE is trading at $39.29 in pre-market, down $0.05 (0.13%) 

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