REGENXBIO Inc. Announces FDA Extension of Review Timeline for RGX-121 BLA to February 2026 for Hunter Syndrome Therapy

Reuters

08/19

REGENXBIO Inc. Announces FDA Extension of Review Timeline for RGX-121 BLA to February 2026 for Hunter Syndrome Therapy

Regenxbio Inc. has announced an extension in the regulatory review timeline for its Biologics License Application $(BLA.AU)$ for clemidsogene lanparvovec (RGX-121), designed to treat Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome. The U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date from November 9, 2025, to February 8, 2026. This extension comes after Regenxbio submitted longer-term clinical data for all patients involved in the pivotal study. The data will be presented at the International Congress of Inborn Errors of Metabolism in September 2025. The RGX-121 treatment aims to be the first one-time commercially-available therapy to directly address the genetic cause of Hunter syndrome, pending approval. Despite the review extension, commercial launch plans remain on track.

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. Regenxbio Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: PH53938) on August 18, 2025, and is solely responsible for the information contained therein.

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Announces FDA Extension of Review Timeline for RGX-121 BLA to February 2026 for Hunter Syndrome Therapy\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time smaller\">2025-08-19 05:00</p>\n</div>\n</a>\n</h4>\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      REGENXBIO Inc. Announces FDA Extension of Review Timeline for RGX-121 BLA to February 2026 for Hunter Syndrome Therapy\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        <a href=\"https://laohu8.com/S/RGNX\">Regenxbio Inc</a>. has announced an extension in the regulatory review timeline for its Biologics License Application <a href=\"https://laohu8.com/S/BLA.AU\">$(BLA.AU)$</a> for clemidsogene lanparvovec (RGX-121), designed to treat Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome. The U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date from November 9, 2025, to February 8, 2026. This extension comes after Regenxbio submitted longer-term clinical data for all patients involved in the pivotal study. The data will be presented at the International Congress of Inborn Errors of Metabolism in September 2025. 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Announces FDA Extension of Review Timeline for RGX-121 BLA to February 2026 for Hunter Syndrome Therapy\n    \n\nRegenxbio Inc. has announced an extension in the regulatory review timeline for its Biologics License Application $(BLA.AU)$ for clemidsogene lanparvovec (RGX-121), designed to treat Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome. The U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date from November 9, 2025, to February 8, 2026. This extension comes after Regenxbio submitted longer-term clinical data for all patients involved in the pivotal study. The data will be presented at the International Congress of Inborn Errors of Metabolism in September 2025. The RGX-121 treatment aims to be the first one-time commercially-available therapy to directly address the genetic cause of Hunter syndrome, pending approval. 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