Argenx Phase 3 Ocular Myasthenia Trial Delivers 4.04-Point Index Gain
Argenx reported Phase 3 ADAPT OCULUS results for ocular myasthenia gravis showing a 4.04-point improvement on Myasthenia Impairment Index versus 1.99 for placebo with no new safety signals. The results support FDA label expansion and follow fourth-quarter EPS of $8.02 and sales growth to $1.32 billion from $761.2 million.
1. Phase 3 Ocular Myasthenia Results
The Phase 3 ADAPT OCULUS study met its primary endpoint, showing a 4.04-point mean improvement on the Myasthenia Impairment Index versus 1.99 for placebo, indicating significant symptom relief in ocular myasthenia gravis patients.
2. Safety Profile and Regulatory Path
Vyvgart’s safety profile remained consistent with prior trials with no new adverse events identified. These results support a supplemental biologics license application submission to the FDA for label expansion into ocular myasthenia gravis.
3. Fourth-Quarter Financial Performance
In the fourth quarter, Argenx delivered earnings per share of $8.02 and sales of $1.32 billion, up from $761.2 million a year earlier. The company also reached 19,000 patients globally with Vyvgart and advanced multiple pipeline programs toward key milestones.