FDA Halts Regenxbio Gene Therapy Trials After Tumor Case

Reuters01-28

FDA Halts Regenxbio Gene Therapy Trials After Tumor Case

Regenxbio Inc. is facing a regulatory setback after the U.S. Food and Drug Administration (FDA) placed clinical holds on its investigational gene therapies RGX-111 and RGX-121, which target the ultra-rare conditions MPS I (Hurler syndrome) and MPS II (Hunter Syndrome), respectively. The action follows the preliminary discovery of a neoplasm in a participant who received RGX-111, with genetic analysis revealing an AAV vector genome integration linked to proto-oncogene overexpression. While the investigation into the drug's role in this event is ongoing and causality has not been established, the FDA extended the hold to RGX-121 due to similarities in the therapies and patient populations. Regenxbio has not yet received the full clinical hold letter and is awaiting further details from the FDA.

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: PH72936) on January 28, 2026, and is solely responsible for the information contained therein.

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The action follows the preliminary discovery of a neoplasm in a participant who received RGX-111, with genetic analysis revealing an AAV vector genome integration linked to proto-oncogene overexpression. While the investigation into the drug's role in this event is ongoing and causality has not been established, the FDA extended the hold to RGX-121 due to similarities in the therapies and patient populations. Regenxbio has not yet received the full clinical hold letter and is awaiting further details from the FDA.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>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. 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The action follows the preliminary discovery of a neoplasm in a participant who received RGX-111, with genetic analysis revealing an AAV vector genome integration linked to proto-oncogene overexpression. While the investigation into the drug's role in this event is ongoing and causality has not been established, the FDA extended the hold to RGX-121 due to similarities in the therapies and patient populations. Regenxbio has not yet received the full clinical hold letter and is awaiting further details from the FDA.\n      \n\n\nDisclaimer: 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. 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