Is argenx SE (ARGX) the Most Profitable Growth Stock to Buy Now?

The biotech sector has seen significant volatility in recent years, but argenx SE (NASDAQ: ARGX) has emerged as a contender for high-growth investors. With its lead product VYVGART dominating autoimmune disease markets and a robust pipeline, the company aims to solidify its position as a leader in immunology therapies. But is now the right time to buy? Let’s dissect the financials, regulatory milestones, and risks to determine if argenx deserves a spot in your portfolio.

Financial Momentum: A Shift to Profitability

argenx’s 2024 results marked a turning point. Full-year revenue surged to $2.2 billion, a 85% increase from 2023’s $1.19 billion, driven by sales of its FcRn blocker, VYVGART. The therapy is approved for generalized myasthenia gravis (gMG), chronic inflammatory demyelinating polyneuropathy (CIDP), and immune thrombocytopenia (ITP).

A one-time tax benefit of $725 million in 2024 flipped the company’s net income to a profit of $833 million, compared to a $295 million loss in 2023. While this windfall was non-recurring, management is targeting operating profitability in 2025, fueled by cost discipline and expanded commercial reach.

Pipeline Progress: Beyond VYVGART

argenx’s growth hinges on its pipeline, which includes:
- Efgartigimod: Expanding into new indications like lupus nephritis (LN), thyroid eye disease (TED), and systemic sclerosis (SSc). Phase 3 trials for these therapies are ongoing, with results expected in 2025–2026.
- Empasiprubart: A complement inhibitor advancing in CIDP and delayed graft function (DGF) in kidney transplants. A Phase 3 trial in CIDP (EMVIGORATE) is set to begin in early 2025.
- ARGX-119: Targeting congenital myasthenic syndromes (CMS) and amyotrophic lateral sclerosis (ALS), with Phase 1b/2a data anticipated in late 2025.

The company’s Vision 2030 goals are ambitious: treat 50,000 patients globally, secure 10 labeled indications, and advance five pipeline candidates to Phase 3 by 2030.

Regulatory Catalysts: Key 2025 Milestones

• VYVGART Pre-Filled Syringe (PFS): Received a positive CHMP recommendation in the EU for gMG, enabling its launch in European markets. The FDA’s PDUFA decision for PFS in gMG and CIDP is set for April 10, 2025, with analysts expecting approval.
• Expanded Commercialization: Plans to roll out PFS in Japan and Canada by late 2025 and an autoinjector formulation by 2027 aim to improve patient accessibility.

Analyst Sentiment: A “Moderate Buy” with Upside

As of January 2025, analysts rated argenx a “Moderate Buy” based on 22 ratings, with an average 12-month price target of $645.61. Notable upgrades include Piper Sandler’s $725 target (January 2025) and Wells Fargo’s $723 target (December 2024), reflecting confidence in pipeline execution and VYVGART’s market potential.

Risks to Consider

• High Operating Costs: 2025 R&D and SG&A expenses are projected at $2.5 billion, requiring strong sales growth to offset.
• Regulatory Uncertainty: While the FDA PDUFA date is a near-term positive, setbacks in other trials or delayed approvals could pressure the stock.
• Market Competition: Rival therapies like Roche’s satralizumab (for neuromyelitis optica spectrum disorder) and Sobi’s efgartigimod (in development) pose threats.

Conclusion: A Growth Play with Catalysts Ahead

argenx is positioned for growth, backed by its blockbuster VYVGART franchise and a pipeline targeting $20 billion+ in addressable markets. The May 8, 2025 earnings call, where Q1 results and strategic updates will be released, is a critical near-term catalyst. Positive catalysts like the FDA PDUFA decision and Phase 3 readouts could push the stock toward analyst targets like $725.

However, investors must weigh the risks: high expenses and execution dependency on clinical trials. For long-term investors willing to tolerate volatility, argenx’s Vision 2030 roadmap and current valuation (trading near its 2025 average price target) make it a compelling buy. But wait for post-earnings clarity before diving in.

Final Take: A Hold until Q1 results are reported, then reevaluate. If milestones are met, argenx could be a top growth stock in 2025.