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Celltrion's EU Clinical Trial Nod for Ulcerative Colitis Drug Lapses

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Celltrion (KRX:068270) said approval for Part 1 of its European Phase 3 clinical trial application for Remsima (CT-P13 SC) in pediatric patients with moderately to severely active ulcerative colitis has lapsed, according to a Friday filing with the Korea Exchange.

The approval lapsed on June 18 after the South Korean biopharmaceutical company opted not to submit Part 2 of the application, citing changes to its clinical development strategy.

Under the European Union Clinical Trials Regulation, approval for Part 1 automatically lapses if Part 2 is not filed within two years.

Celltrion said plans and timelines for the study will be determined following consultations with regulators on the trial design.

Shares of Celltrion fell over 2% in recent trade.

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