Shares of Argenx (NASDAQ:ARGX) rose about 3.5% on Tuesday after the U.S. Food and Drug Administration agreed to fast-track the review of an application related to its immune disease treatment, Vyvgart.
The regulator has accepted a supplemental biologics license application that would extend Vyvgart’s indication to adults with acetylcholine receptor antibody–seronegative generalized myasthenia gravis (gMG), a move that would significantly widen the group of patients who could benefit from the therapy.
By granting priority review status, the U.S. Food and Drug Administration has shortened the expected evaluation timeline, potentially bringing a regulatory decision on the expanded use of Vyvgart sooner than under a standard review process.