Argenx stock surged Monday after the Food and Drug Administration approved its drug, Vyvgart Hytrulo, for patients with an autoimmune condition known as CIDP.
CIDP, for chronic inflammatory demyelinating polyneuropathy, occurs when the immune system attacks the myelin sheath around nerve cells. This causes nerve swelling and irritation. CIDP can lead to progressive weakness and impaired sensory function in the arms and legs.
This is the second approval for Vyvgart Hytrulo. Patients with generalized myasthenia gravis can also receive Vyvgart Hytrulo. Wedbush analyst Laura Chico noted that the FDA gave Vyvgart Hytrulo a broad label. That means patients can use it as a first option for CIDP treatment.
Further, Argenx expects to charge $450,000 per patient annually. The company believes there are about 2,000 CIDP patients in the U.S. who aren't benefiting from current treatments, William Blair analyst Myles Minter said in a report. Generally, patients receive intravenous immunoglobulin, or IVIG.
"We expect to see robust patient enthusiasm for Vyvgart in the initial target market, based on its compelling (effectiveness) and safety profile that we believe is differentiated from that of current standard of care agents," Wedbush's Chico said in a report. She said another major differentiator is "its super dosing convenience relative to IVIG."
On today's stock market, Argenx stock popped 11.7%, closing at 440.59.
Argenx Stock: 'Excellent Tolerability'
The approval was based on a study Argenx called Adhere. Chico noted 99% of patients in the Adhere test also enrolled in an open-label extension study. In an open-label extension study, all patients receive the experimental drug. This shows the "excellent tolerability" of Vyvgart Hytrulo, she said.
Bank of America analyst Tazeen Ahmad expects $4.2 billion in peak sales of Argenx's drug in patients with CIDP. That's up from her prior estimate of $3.2 billion.
"We are not surprised by the approval and label given the robust data from the Adhere trial showing clear clinical benefit to CIDP patients regardless of prior therapy," BofA's Tazeen said in a report. "We are highly encouraged by the large commercial opportunity in CIDP."
Tazeen reiterated Argenx stock as one of her top picks for 2024. She rates shares with a buy and has a new price target of 607, up from 535.
Follow Allison Gatlin on X, the platform formerly known as Twitter, at @IBD_AGatlin.
