In the biotechnology industry, the most fascinating stories are often the most fragile.

With only one drug, efgartigimod (trade name Vyvgart), Argenx - an innovative pharmaceutical company founded less than 20 years ago - has placed itself among the top 50 global pharmaceutical companies and the most valuable biotechnology companies in Europe, surpassing most established European pharmaceutical companies at one point.

However, on October 8th, Argenx announced the termination of Phase III clinical UNITY for the treatment of Sjogren's syndrome, causing the company to drop 12% in a single day, hitting the lowest stock price in nearly five months, and its market value falling to $51.2 billion.

On the A-side, it is a legendary rise of a drug that has supported a market value of 60 billion US dollars; B-side is a practical reminder that even a medicine has boundaries. Putting these two sides together, perhaps this is the story that Argenx is truly worth reading for Chinese biotech.

01. The Rise of Self Exemption Bulk Products

On December 17, 2021, after 7 years of research and development, Aijiamod was approved by the FDA for marketing, with its first indication for adult systemic myasthenia gravis. It became Argenx's first approved product, the world's first FcRn blocker, and the first approved therapy aimed at reducing pathogenic IgG.

After the product was approved for market launch, Argenx almost started the double speed mode.

In 2022, the first full year of sales, Agamod grossed $400 million. Sales have been increasing year by year since then: becoming a new "$1 billion numerator" in 2023, reaching $2.2 billion in 2024, jumping to $4.15 billion in 2025 (a year-on-year increase of 90%), and reaching $2.81 billion in the first half of 2026.

The strong sales of Agamod have driven Argenx to achieve its first full year operating profit in 2025, with a net profit of $1.29 billion and an operating profit of $1.05 billion. Over the past five years, Argenx's stock price has skyrocketed and its market value has remained stable at $50-60 billion.

This achievement is supported by the fundamental demand for self immunotherapy and the precise investment of Argenx in commercialization. But what truly determines the long-term growth curve is the drug itself.

Aijiamod, based on the biological mechanism of the FcRn IgG pathway, has the potential to significantly improve the treatment standards for various B-cell mediated autoimmune diseases. Based on this, Argenx has achieved compound interest extension of the "Pipe-in-a-Product" through a development strategy that combines depth and breadth.

Karen Massey, the current CEO of Argenx, positions Aigamimod as the K-drug in the field of autoimmunity. She bluntly stated, 'Vyvgart is an asset that is hard to come by for a generation.'. Similar to Keytruda, it serves as a foundational therapy that allows us to build upon it. Approximately 100 different indications or diseases may be treated with Vyvgart. ”

Along this path, the indications for Agamod have rapidly expanded over the past five years: chronic inflammatory demyelinating polyneuropathy (CIDP) was approved in 2024; In 2026, the scope of application has been expanded to remove restrictions on AChR antibody positivity, covering all gMG patient populations.

In addition to expanding indications, dosage form iteration is also crucial. The subcutaneous injection type will be approved in 2023, and the administration time will be shortened from 1 hour for intravenous injection to 20-30 seconds; Pre filled syringes will be launched in 2025, adding a third administration method that allows patients to self inject, further improving patient compliance and medication accessibility.

In August of this year, Aijiamod achieved positive results in phase III clinical trials on autoimmune myositis, which is also the world's first phase III trial to achieve positive results in immune-mediated necrotizing myopathy (IMNM). Previously, IMNM was drug free and had commercial potential comparable to myasthenia gravis.

At that time, based on this heavyweight clinical result, several securities analysts raised their forecasts for Argenx's performance, and Citizens also raised Argenx's target price from $932 per share to $1200 per share.

In the past, the lifecycle of a new drug often relied on the next generation of products to take over; And Argenx provides another approach - to "fully exploit" a drug around the same mechanism, the wider the indications, the more reusable the clinical and commercial infrastructure built in the early stages, and the higher the efficiency.

02. A side narrative encounters B side reality

However, this narrative also carries a fatal flaw: to some extent, it deeply binds the company's fate to a product, and the ability to resist risks will be compressed to the extreme. Once this product experiences clinical fluctuations, the company will be hit hard.

According to Argenx's plan, the next indications for Aigamimod include ocular myasthenia gravis (oMG), primary immune thrombocytopenia (ITP), autoimmune myositis, Graves' disease (GD), Sjogren's syndrome (SS), systemic sclerosis (SSc), etc., maximizing the value of releasing the FcRn IgG pathway for the treatment of autoimmune diseases.

Among them, the top line results of the UNITY trial for Sjogren's syndrome were originally expected to be read in the second half of 2027, but ineffective analysis led to premature termination.

On October 8th, Argenx announced the termination of Phase III clinical UNITY for adult patients with moderate to severe Sjogren's syndrome treated with subcutaneous injection of mugamod.

This decision was made based on the termination recommendation given by the Independent Data Monitoring Committee (IDMC) after invalid analysis. IDMC believes that UNITY cannot achieve the primary endpoint of the study, and the safety features shown in the study are consistent with the known safety features of Aigamimod, without discovering any new safety signals.

Sjogren's syndrome is a chronic, slowly progressing inflammatory systemic autoimmune disease characterized by immune-mediated destruction of exocrine glands. This disease can cause severe disability and have a negative impact on the quality of life of patients. Common reported symptoms include dry eyes, dry mouth, fatigue, and joint pain. In addition, a considerable number of patients suffer from extraglandular systemic diseases.

We are disappointed with this result, especially for patients with Sjogren's syndrome who are still waiting for treatment methods that can fundamentally change the course of the disease, "said Luc Truyen, Chief Medical Officer of Argenx." Sjogren's syndrome is one of the most heterogeneous and complex diseases in immunology, and revealing the biological mechanisms of complex diseases is at the core of our work. We will analyze this data in depth and share our findings with the Sjogren's syndrome community
After the research is completed and the database is locked, Argenx will conduct a comprehensive analysis of the data to understand the research results and generate insights that may provide information for future research on Sjogren's syndrome.

This is not a safety accident, but a failure to achieve the expected therapeutic effect - for a company that has long relied on the narrative of "single product penetration and unlimited extension of indications", this is undoubtedly an important blow.

Of course, this does not mean that Agamod's base has been overturned.

It has achieved phase III clinical success in indications such as gMG, CIDP, and IMNM, and is expected to achieve annual sales of $6 billion in 2026, making it one of the most commercially successful self administered new drugs in history. Sjogren's syndrome was originally an incremental option, not a fundamental stock currently being sold. But UNITY's failure reminds the market that FcRn is not a universal key.

The mechanisms of different autoimmune indications vary greatly: although the involvement of autoantibodies in disease pathogenesis is relatively clear in many autoimmune indications, there are often other factors involved, such as T cells, B cells, interferon pathways, epithelial damage, etc.

FcRn can solve the "pathogenic antibody" loop by accelerating IgG degradation, but it may not necessarily reverse the entire disease network. The failure of Sjogren's syndrome is a manifestation of this complexity.

Therefore, a 12% decline appears to be a response to the failure of an indication, but deep down it is a market repricing of the narrative risk of "pipeline in a-product".
 

03. Argenx's "trump card" and "backhand"

In fact, Argenx has long been aware of the risks of single product dependence. Massey once stated in an interview that Argenx is still "mainly a 'Vyvgart story'" in the eyes of most people, and this situation is unlikely to change in the short term.

But according to Argenx's grand plan, Aigamimod may not only be used as a monotherapy, but also as a "backbone" drug for combination therapy, combined with multiple therapies - just like Keytruda's application in the field of cancer.

、
On the basis of the Agamod monotherapy, Argenx also emphasizes the systematic construction of the second and third growth curves around the core immunology capabilities, and proposes the "Vision 2030" strategy, which aims to treat 50000 patients worldwide by 2030, obtain 10 approved indications, and advance 5 pipeline candidate drugs to registered clinical development.

In order to advance this goal, Argenx actively promotes self-developed pipelines and also attempts to quickly fill in its capacity gaps through pragmatic mergers and acquisitions.

In July 2026, Argenx announced the acquisition of Nasdaq listed Forte Biosciences for $77 per share, with a total equity value of approximately $2.2 billion. One of the key components of this acquisition is Forte's core pipeline FB102, a pioneering anti-CD122 antibody.

This target regulates the IL-12/IL-15 signaling pathway to inhibit inflammatory responses related to activated T cells, memory T cells, and NK cells, while retaining the supportive effect of the IL-2/CD25 pathway on Treg cells, achieving more precise and safe immune regulation, and has the potential to expand to various autoimmune diseases.

On October 8th, while announcing the termination of Phase III clinical UNITY, Argenx also announced the positive top line results of the Phase II study of FB102 in the treatment of adult celiac disease, which is also the first clinical data readout of FB102 after Argenx's acquisition of Forte Biosciences.

The results showed that patients receiving FB102 treatment exhibited statistically significant and clinically relevant therapeutic effects compared to placebo. The study achieved its primary endpoint, which was that the change in villus height to crypt depth ratio (V/C) on day 78 compared to baseline was statistically significant (p=0.0176) in adult celiac disease patients who received gluten challenge compared to placebo.

In addition, a wide range of efficacy indicators, including intraepithelial lymphocyte (IEL) density, villus height and crypt depth intraepithelial lymphocyte (VCIEL) composite score, and symptoms, are consistent with the primary endpoint, providing additional evidence for efficacy in histological, inflammatory, and clinical indicators.

In terms of security, the observed security features are consistent with previous studies and known security features of FB102, and no new security signals have been found.

These positive phase II results have strengthened our confidence in the potential of FB102, which has the potential to address the huge unmet needs of patients with celiac disease, for which there are currently no approved therapies

Argenx Chief Medical Officer Luc Truyen said, "Combining the consistent safety features observed in various studies, these findings support advancing FB102 to Phase III development and further exploring its broader potential in immune-mediated diseases. ”

This clinical success is the first achievement of Argenx2's $2.2 billion acquisition, and also adds a few more trump cards to Argenx's future pipeline.

- Write at the end -

To summarize the rise story of Argenx, it relies on turning a drug into a platform: one mechanism, multiple indications, continuously iterating dosage forms, and reusable clinical and commercial capabilities. This logic makes it run extremely fast and also highly concentrated in risk.

Unity failure is not the end, but a clear watershed. It reminds all biotechnologies that large products are both leverage and shackles; It is cash flow and valuation anchor; It could be a moat or a single point of failure.

For Argenx, the key next is not whether Agamod can have another indication, but whether it can truly grow second and third growth curves outside of Agamod.

A drug can support a market value of $60 billion or cause a company to drop by 12% in one day. The real test is not how big the story is told when the wind is favorable, but whether it can continue to use clinical data, pipeline combinations, and organizational skills to turn the story into reality when the wind is unfavorable.
This is true for Argenx and also for Chinese Biotech.

Reference: 

1. Argenx Provinces Update on Phase 3 UNITY Study of Efgartigimod SC in Sj ö gren's Disease
2.argenx Announces Positive Topline Results from Phase 2 Study of FB102 in Celiac Disease
3. With a market value of 60 billion yuan supported by a drug, what did this innovative pharmaceutical company do right?