Argenx (ARGX) said Tuesday that its supplemental biologics license application for Vyvgart has received the US Food and Drug Administration's acceptance for priority review to treat adults with acetylcholine receptor antibody seronegative generalized myasthenia gravis.

The regulator has assigned May 10 as a Prescription Drug User Fee Act target action date, the company said.

The FDA's decision was based on Argenx's phase 3 Adapt Seron trial data, which evaluated the safety and efficacy of Vyvgart, Argenx said, adding that Vyvgart was "well-tolerated" with "consistent" safety profile.