Argenx SE (NASDAQ:ARGX) on Thursday announced positive topline results from the Phase 3 ADAPT OCULUS study evaluating VYVGART in adults with ocular myasthenia gravis (oMG).
It is an autoimmune disorder where antibodies disrupt nerve-muscle communication, causing variable, fatiguing weakness of eye muscles and eyelids (ptosis) and double vision (diplopia).
The study met its primary endpoint, demonstrating statistically significant improvement in patient-reported outcomes.
Argenx Says Vyvgart Improves Double Vision
The ADAPT OCULUS study showed that patients treated with Vyvgart experienced a mean improvement of 4.04 points in Myasthenia Impairment Index scores compared to a 1.99 point improvement in the placebo group, with a p-value of 0.012.
This trial is particularly significant as it is the first registrational study designed to evaluate a targeted therapy for ocular myasthenia gravis, addressing a substantial unmet need in the treatment landscape.
The safety profile of Vyvgart was consistent with prior studies, with no new safety concerns identified.
Patients treated with Vyvgart experienced a marked reduction of key ocular symptoms: diplopia (double vision) and ptosis (drooping of the upper eyelids).
The company on Thursday said the results support the planned Supplemental Biologics License Application submission to the U.S. Food and Drug Administration (FDA) to expand the label into oMG.
Sales Jump Over 70%
Argenx reported fourth-quarter earnings of $8.02 per share, beating the consensus of $6.02.
Sales jumped from $761.2 million to $1.32 billion, surpassing the consensus estimate of $1.29 billion.
"Argenx delivered another standout year of execution in 2025," said Tim Van Hauwermeiren, CEO of Argenx. "We reached 19,000 patients globally with VYVGART, expanded our impact across gMG and CIDP through the successful launch of the pre-filled syringe, and made substantial progress across our development programs, advancing the pipeline towards key milestones."
Analyst View
William Blair on Thursday wrote, "We believe these results will continue to solidify Vyvgart as the preferred biologic therapy across all MG patients and continue to increase first-line biologic market share."
Technical Analysis
Currently, the stock is trading significantly above its 200-day simple moving average (SMA), indicating strong long-term momentum. Shares have increased over the past 12 months, suggesting a positive trend, and are currently positioned closer to their 52-week highs than lows.
The RSI is at a neutral level of 50.00, indicating that the stock is neither overbought nor oversold at this time. Meanwhile, MACD is at 0.15, below its signal line at 0.22, suggesting some bearish pressure on the stock.
The combination of neutral RSI and bearish MACD indicates mixed momentum, suggesting that traders should watch for potential shifts in momentum.
- Key Resistance: $850.00
- Key Support: $750.00
ARGX Price Action: argenx shares were down 1.09% at $808.02 during premarket trading on Thursday, according to Benzinga Pro data.
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