argenx Strikes $2.2B Deal for Forte, Adds Autoimmune Drug FB102

Key Points

• argenx agreed to acquire Forte Biosciences for approximately $2.2 billion in equity value, offering $77 per share in an all-cash tender offer expected to close in the third quarter, subject to customary conditions.
• The acquisition adds FB102, an anti-CD122 antibody designed to target pathogenic T and natural killer cells while preserving regulatory T-cell activity. The drug is being developed for autoimmune diseases including vitiligo, celiac disease, alopecia areata and potentially other indications.
• Early Phase 1b results showed improvements in vitiligo and positive findings in celiac disease; a Phase 2 celiac trial is ongoing, with results expected by year-end. argenx will use upcoming data to determine FB102’s broader development and commercialization strategy.

argenex NASDAQ: ARGX said it has agreed to acquire Forte Biosciences in a transaction valued at approximately $2.2 billion in equity value, adding FB102, an anti-CD122 antibody being developed for autoimmune diseases including vitiligo and celiac disease.

Under the agreement, argenex will commence a cash tender offer for all outstanding Forte shares at $77 per share. The transaction will be funded entirely with cash on hand, is not subject to a financing condition, and has been approved by both companies’ boards of directors. The company expects the acquisition to close during the third quarter, subject to customary closing conditions.

Karen Massey, argenex’s chief executive officer, described the deal as an investment in the company’s next stage of growth and its objective of becoming a broader immunology innovator. She said the acquisition aligns with the company’s Vision 2030 strategy, which includes expanding VYVGART, advancing new pipeline medicines and pursuing differentiated biology through internal research, partnerships, investments and acquisitions.

“Our ambition has never been limited to a single molecule, a single target, or a single therapeutic area,” Massey said. “Our ambition is to become the leading immunology innovator, building a pipeline across multiple targets and multiple dimensions of the immune system.”

FB102 Adds CD122 Biology to Pipeline

FB102 is designed to inhibit IL-2- and IL-15-mediated activation and proliferation of pathogenic T cells and natural killer cells while preserving beneficial IL-2 signaling in regulatory T cells, according to Peter Ulrichts, argenex’s chief scientific officer. The company said the approach is intended to target disease-driving immune activity without relying on broad immune suppression.

Arjen Lemmen, vice president of corporate development and strategy, said the asset complements argenex’s existing portfolio across immune-system pathways. The company’s pipeline includes efgartigimod and ARGENX-121 in antibody-related areas, as well as empasiprubart, which targets complement activation at C2.

Management characterized FB102 as a potential “pipeline-in-a-product” opportunity, with possible development across vitiligo, celiac disease, alopecia areata and other autoimmune conditions. However, the company said it has not yet selected additional indications beyond its current lead programs.

argenex made a strategic investment in Forte in April after following CD122 biology for several years, Massey said. The company’s interest increased following positive Phase 1b data in vitiligo.

Early Clinical Data in Vitiligo and Celiac Disease

In vitiligo, Ulrichts said FB102 showed rapid and sustained benefits in a Phase 1b study, with statistical significance reached by day 64. At week 24, or 12 weeks after the last dose, the treatment produced a mean facial Vitiligo Area Scoring Index improvement of 29.6%, compared with 7.9% for placebo.

Management said vitiligo is a chronic autoimmune disease rather than simply a cosmetic condition. Massey said more than 2 million people in the U.S. live with the condition and that existing therapies do not consistently produce complete or durable repigmentation.

In celiac disease, argenex said FB102 met the primary vCAL endpoint in a Phase 1b study and was associated with fewer gluten-induced gastrointestinal symptoms than placebo. The drug is now being evaluated in a Phase 2 celiac disease trial, with results expected before the end of the year.

Massey said the Phase 2 study is intended to provide information needed to design a potential Phase 3 program, including through its gluten-challenge design and primary and secondary endpoints. She cautioned that the Phase 2 trial remains a learning study and that the company is awaiting the data.

Development and Commercialization Plans

Management said it will use the coming months to evaluate additional indications and determine future development plans for FB102. The company said its selection process will emphasize biological rationale, preclinical or translational support, regulatory and development paths, unmet need and commercial potential.

Ulrichts said early safety findings have not shown an increase in infection risk over approximately three months of exposure. He added that the mechanism does not result in total natural killer cell depletion, though longer-term data will be needed to fully assess the molecule’s risk-benefit profile.

The company also said it sees opportunities to apply lessons from VYVGART’s product-presentation strategy to FB102. Massey cited VYVGART’s progression from intravenous administration to subcutaneous delivery, a prefilled syringe and a planned autoinjector launch next year.

While FB102 would potentially enter larger autoimmune markets than argenex’s prior rare-disease launches, Massey said the company expects to build commercialization capabilities over time, including patient education, evidence generation and payer execution. She added that argenex’s existing conviction in VYVGART and its other pipeline programs remains unchanged following the proposed acquisition.

About argenex (NASDAQ:ARGX)

argenx NASDAQ: ARGX is a biotechnology company focused on the discovery, development and commercialization of antibody-based therapeutics for severe autoimmune and neuromuscular diseases. The company uses its proprietary SIMPLE Antibody platform to generate differentiated antibodies and engineered Fc regions, and it pursues mechanisms that modulate the neonatal Fc receptor (FcRn) to reduce pathogenic IgG levels. Argenx's research and development activities span target identification, preclinical development and late-stage clinical programs aimed at addressing unmet needs in immunology.

The company's lead product, efgartigimod (marketed as Vyvgart), is an FcRn antagonist developed to reduce circulating IgG antibodies and treat IgG-mediated disorders.

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