argenx Eyes More VYVGART Growth as Pipeline Catalysts Near

Executives at argenex NASDAQ: ARGX told investors at a Goldman Sachs healthcare event that they continue to see meaningful growth opportunities for VYVGART across myasthenia gravis and chronic inflammatory demyelinating polyneuropathy, while also pointing to a busy slate of pipeline readouts in the second half of the year.

The discussion was hosted by Rajan Sharma, European pharma and biotech analyst at Goldman Sachs. Arjen Lemmen, head of corporate development and strategy, and Karl Gubitz, chief financial officer, represented the company.

Lemmen said his role covers business development, partnerships, alliances, supplier sourcing and broader corporate strategy. He joined argenx in 2015, when the company had about 30 employees, and said his team helps determine which countries to enter, which indications to prioritize and which molecules to advance.

VYVGART Growth Remains a Central Focus

Gubitz said VYVGART’s myasthenia gravis launch still has “a lot of growth ahead of it,” noting that the company is 17 quarters into the launch and that growth is “not slowing down.” He said biologics account for only about 20% of the total myasthenia gravis market, with the remaining 80% still treated with oral therapies such as Mestinon, steroids and immunosuppressants.

According to Gubitz, VYVGART is the largest product among newer biologic therapies in the category and is helping drive expansion of the biologics segment. He said the company’s broader label, including seronegative generalized myasthenia gravis, supports growth. He described a potential expansion in total addressable patients from about 11,000 to 60,000 when including seronegative patients, earlier-line use and ocular myasthenia gravis, where the company has data but not yet FDA approval.

Gubitz also highlighted the prefilled syringe for self-injection as a growth driver, citing the convenience of a 22-second injection. On seronegative myasthenia gravis, he said the launch dynamic differs from a new indication because payers largely need to remove a testing requirement rather than renegotiate an entirely new indication.

For ocular myasthenia gravis, Gubitz said argenx hopes to change the label from generalized myasthenia gravis to myasthenia gravis. Lemmen added that ocular disease should not be considered less severe simply because symptoms are concentrated in the eye, noting that double vision can interfere with work, driving and mobility.

CIDP Launch Still in Early Stages

In chronic inflammatory demyelinating polyneuropathy, Gubitz said the company is still “early in the launch” and focused on patients not adequately treated with current standards of care. He said 42,000 patients are diagnosed in the U.S., 24,000 are treated and roughly half of treated patients are not adequately addressed with existing options.

Gubitz said expanding use will require continued physician education and patient activation, including direct-to-consumer television campaigns. He said penetration remains relatively low, and that moving to earlier lines is a longer-term goal.

Business Development Strategy Expands With Profitability

Lemmen said partnerships have been part of argenx’s approach from the beginning, referring to “co-creation” with technology and academic partners as a cultural pillar. He said the company consistently uses business development and licensing to build its early-stage pipeline and that “not any program in argenx” begins without some form of partnership.

With the company now profitable, Lemmen said argenx can apply that approach to later-stage assets. He said the company is looking for first-in-class opportunities with novel target biology in neuromuscular and immunology and inflammation areas. He cited assets roughly 12 months before or after an investigational new drug filing, or possibly Phase 2 assets, while adding that the criteria are not rigid.

As an example, Lemmen pointed to argenx’s option to acquire Tensegrity, a Japanese biotech company with an antibody targeting FN14. He said argenx believes the target has potential in multiple muscle-wasting disorders.

Gubitz said revenue growth remains the company’s top priority, but that argenx also has an opportunity to invest in longer-term innovation. He said combined R&D and SG&A expenses are expected to grow about 30% year over year, reaching roughly $3.5 billion for the full year. He also noted that argenx reported $400 million in operating profit in the first quarter, representing a 30% operating margin, while declining to provide formal margin targets.

Pipeline Readouts Expected in the Second Half

Gubitz said a registrational myositis study is expected to read out in the third quarter. The basket study includes dermatomyositis, immune-mediated necrotizing myopathy and polymyositis. He said the FDA and the data will determine whether the company can pursue all three subsets or only some of them.

Gubitz described immune-mediated necrotizing myopathy as a “complete white space,” with about 20,000 patients and no treatment options. He said dermatomyositis represents a larger opportunity of about 40,000 patients, though with more competition.

argenx is also developing empasiprubart, which Lemmen described as a differentiated antibody targeting C2 in the complement system. The company expects data in multifocal motor neuropathy in the fourth quarter. Lemmen said the condition has about 12,500 patients in core markets, including about 6,000 in the U.S., and that patients are among the highest consumers of IVIG.

Gubitz said empasiprubart is important because it could help address investor concerns that argenx is overly dependent on a single asset. Lemmen said empasiprubart is already in two Phase 3 trials, with more indications under evaluation.

Lemmen also discussed next-generation FcRn assets, including ARGX-213, which he said is longer acting and ready for late-stage studies, and ARGX-124, which is in Phase 1 with data expected in the second half of the year. He said the company is evaluating how those assets could extend its FcRn strategy beyond VYVGART.

Other upcoming areas include systemic sclerosis, where Phase 2 data are expected in the second half, and an IgA-targeting “sweeper” molecule. Lemmen said IgA nephropathy is the first indication for that program and that the company will need to demonstrate the benefits of fast and deep IgA reduction in clinical trials.

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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