Company: RGNX
Filing Date: 2025-08-18
Form Type: 8-K
Source: 0000950170-25-109829
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Company: REGENXBIO Inc.
Filing Date: 2025-08-18
Form: 8-K
Item: Item 8.01
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Item 8.01. Other Events.

On August 18, 2025, REGENXBIO Inc. (the “ Company”) issued a press release announcing that the U. S. Food and Drug Administration (“ FDA”) has extended the Prescription Drug User Fee Act (“ PDUFA”) date for the Company’s Biologics License Application seeking accelerated approval of clemidsogene lanparvovec (RGX-121) for the treatment of Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome. The FDA extended the PDUFA action date from November 9, 2025 to February 8, 2026 to allow for the review of additional data.

A copy of the press release is filed herewith as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.