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Thu, February 26, 2026 astatine 9:59 AM CST 7 min read
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Phase 3 success: The ADAPT OCULUS proceedings successful ocular MG met its superior endpoint (VYVGART high‑titer vs placebo, p=0.012), was good tolerated, and argenx plans to contiguous broader information and record a supplemental BLA; the seronegative MG PDUFA day is May 10.
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Commercial momentum: The prefilled‑syringe (PFS) motorboat helped thrust maturation to astir 19,000 patients globally and >4,700 prescribers (≈1,000 added since PFS), with VYVGART starring biologic starts successful MG and expanding payer sum for CIDP.
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Strong finances: argenx reported FY merchandise nett income of $4.2 billion (90% YoY) and its archetypal yearly operating nett of $1.1 cardinal (profit $1.3 billion) with ~$4.4 cardinal successful cash, and expects gross maturation to outpace operating‑expense maturation implicit time.
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argenx (NASDAQ:ARGX) utilized its fourth-quarter net telephone to item affirmative Phase 3 information successful ocular myasthenia gravis (MG), continued commercialized momentum for VYVGART, and its archetypal twelvemonth of yearly operating profitability.
Chief Medical Officer Luc Truyen said the company’s Phase 3 ADAPT OCULUS proceedings was designed arsenic the archetypal registrational survey successful ocular MG, enrolling patients with MGFA Class I illness who had meaningful, measurable oculus symptoms without grounds of generalized MG and who were connected unchangeable inheritance therapy.
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The proceedings randomized 141 patients 1:1 to VYVGART high-titer oregon placebo. Part A consisted of 4 play injections, followed by Part B with aggregate cycles of VYVGART high-titer. The superior endpoint was alteration from baseline to Day 29 successful the MG-II patient-reported ocular people focused connected diplopia and ptosis.
Truyen said the survey met its superior endpoint, with VYVGART high-titer producing a statistically important betterment versus placebo astatine Week 4 (p=0.012). Patients treated with VYVGART had a mean 4.04-point betterment versus a 1.99-point betterment connected placebo, with “clear improvements” successful diplopia and ptosis. He added that VYVGART was well-tolerated and showed nary caller information signals, accordant with its established information profile. The institution said it plans to contiguous broader information astatine an upcoming aesculapian gathering and intends to record a supplemental BLA (sBLA) with the FDA based connected the results.
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