Argenx stock jumped Friday after the Food and Drug Administration cleared its autoimmune disease drug, Vyvgart Hytrulo, for at-home treatment.
The decision updates the label for Vyvgart Hytrulo, an under-the-skin-treatment for neuromuscular condition generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy, or CIDP. Patients can now use a prefilled syringe to treat themselves at home.
"Importantly, the updated label allows for patient self-administration with the (prefilled syringe), with no explicit clinician monitoring requirements that would explicitly (or practically) preclude MG or CIDP patients from self-administering," Leerink Partners analyst Thomas Smith said in a report.
On today's stock market, Argenx stock jumped 6.4% to 580.94. Shares bounded off their 200-day line after sinking below that key mark on April 4.
'Best-Case Scenario' For Argenx Stock
Smith called the approval a "best-case scenario" for Argenx that should "further enable Vyvgart penetration into earlier lines or therapy and unlock additional patient share."
Wedbush analyst David Nierengarten said the approval was expected.
"We believe the approval should help push Vyvgart into earlier lines of therapy in gMG and help sustain the growing commercial momentum in CIDP," he said in a client note. "Prior to (prefilled syringe) approval, patients were typically required to receive injections from a health care provider followed by monitoring for allergic reactions."
He retained his outperform rating and 715 on Argenx stock.
Notably, the approval came on time despite worries about a stretched-thin FDA following mass firings from U.S. health agencies earlier this month, William Blair analyst Myles Minter said in a client note.
Shorter Administration Time
The prefilled syringe requires 20 to 30 seconds to administer by a patient, caregiver or health care provider, compared to the injection which requires 30 to 90 seconds.
The prefilled syringe will cost $16,732 per vial, before insurance and reimbursements kick in. This is a 4% premium over the under-the-skin injection. Medicare patients who self-administer will shift to Part D coverage from Part B. Typically, plan rebates are higher in Medicare Part D. This will lead to a higher gross-to-net discounting for self-administering patients.
"While the impact has not been quantified, management expects that the net pricing impact will be offset by increased patient volumes driven by the prefilled syringe," he said.
Minter rates Argenx stock an outperform.
Follow Allison Gatlin on X/Twitter at @AGatlin_IBD.
