Celltrion says FDA clears Phase 3 trial plan for Zymfentra in rheumatoid arthritis

Bitget2026/09/23 05:50

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Celltrion secured FDA clearance to start a Phase 3 U.S. trial of subcutaneous infliximab CT-P13 SC (Zymfentra) in rheumatoid arthritis.
Study targets 296 patients, evaluates superiority versus placebo on ACR50 response at week 12, includes 52 weeks of treatment.
FDA filing dated July 24, 2026; authorization confirmed Sept. 23, 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Celltrion Inc. published the original content used to generate this news brief via DART, the regulatory disclosure system operated by the South Korea Financial Supervisory Service (FSS) (Ref. ID: 20260923800359), on September 23, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Celltrion says FDA clears Phase 3 trial plan for Zymfentra in rheumatoid arthritis

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