Benzinga | Mar 2, 2021 05:40AM EST

Argenx's Efgartigimod US Application In Neuromuscular Disorder Accepted For Review

The FDA has accepted for review Argenx SE's (NASDAQ: ARGX) marketing application seeking approval for intravenous (IV) efgartigimod, for the treatment of generalized myasthenia gravis (gMG).

* Myasthenia gravis is a neuromuscular disorder primarily characterized by muscle weakness and muscle fatigue.

* The agency's target action date is December 17.

* The company is also on track to apply for efgartigimod to Japan's regulatory authority in the first half of 2021 and the European Medicines Agency in the second half of 2021.

* Price Action: ARGX shares closed 2.9% higher at $340.53 on Monday.