Argenx SE – ADR (NASDAQ:ARGX) shares are up during Monday’s session as the company celebrates a recent FDA approval for its drug, VYVGART, which adult patients with generalized myasthenia gravis can use.
The approval is seen as a significant advancement in treatment options, simplifying decisions for clinicians and expanding the patient base for the drug, which is crucial for the company’s growth strategy.
• Argenx stock is moving in positive territory. What’s pushing ARGX stock higher?
ARGX Stock Rises On FDA Approval For Expanded VYVGART Use
The U.S. Food and Drug Administration (FDA) on Friday approved a label expansion for VYVGART (efgartigimod alfa-fcab) and VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for adult patients with generalized myasthenia gravis, a chronic autoimmune neuromuscular disease characterized by fluctuating weakness in skeletal and respiratory muscles.
The approved supplemental Biologics License Application (sBLA) expands VYVGART’s indication to include all serotypes of adult patients living with gMG – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative.
The FDA’s approval allows VYVGART to be used for all adult gMG patients, enhancing its market potential.
The update follows positive results from the Phase 3 ADAPT SERON study and highlights argenx’s commitment to advancing treatments for autoimmune diseases.
William Blair analyst sees Vyvgart approval in all forms of seronegative patients as the bull case outcome for this PDUFA event and will confer an 18% total addressable expansion in gMG for a franchise annualizing over $5 billion and growing at 64% year-over-year.
ARGX Technical Outlook: Key Support, Resistance and Momentum
Earlier in the day, the Dutch biopharmaceutical company’s shares are trading at $796.82, which is 0.6% below the 20-day simple moving average (SMA) of $802.00 but 5.3% above the 50-day SMA of $756.69.
The stock’s 12-month performance shows a solid gain of 39.45%, indicating a strong upward trend over the past year.
The primary momentum indicator, the Relative Strength Index (RSI), sits at 48.97, suggesting a neutral stance in momentum, which means the stock is neither overbought nor oversold at this time. This level indicates that there is room for movement in either direction, depending on upcoming market catalysts.
- Key Resistance: $852.50 — Nearby level where rebounds can stall.
- Key Support: $755.00 — Nearby level where buyers previously stepped in.
ARGX Price Action: Argenx shares were up 2.33% at $800.41 at the time of publication on Monday, according to Benzinga Pro. Over the past month, the company has gained about 0.3% versus a 9.3% rise in the S&P 500 and is down roughly 5% year-to-date compared to the index’s 7.9% gain.
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