Argenx ((ARGX)) announced an update on their ongoing clinical study.
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Study Overview: Argenx is conducting a Phase 3 clinical study titled ‘A Phase 3, Single-Arm, Multicenter, Open-label Extension of Study ARGX-113-2007 to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy.’ The study aims to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with active idiopathic inflammatory myopathy (IIM), a condition characterized by muscle inflammation and weakness.
Intervention/Treatment: The intervention being tested is a biological treatment known as EFG PH20 SC. This is a subcutaneous injection of efgartigimod co-formulated with rHuPH20, which acts as a permeation enhancer. The treatment is designed to improve the management of IIM by enhancing drug delivery and efficacy.
Study Design: This is an interventional study with a single-group assignment. There is no random allocation, and the study is open-label, meaning no masking is involved. The primary purpose of the study is treatment-focused, aiming to evaluate the long-term safety and efficacy of the intervention.
Study Timeline: The study began on September 12, 2023. The primary completion date and estimated study completion date are yet to be disclosed. The last update was submitted on July 16, 2025, indicating ongoing progress in the study.
Market Implications: The continuation of this study could positively impact Argenx’s stock performance, as successful results may lead to an expanded market presence in treating idiopathic inflammatory myopathy. Investors should monitor this study’s developments, as positive outcomes could enhance investor sentiment and position Argenx favorably against competitors in the autoimmune treatment market.
The study is ongoing, with further details available on the ClinicalTrials portal.