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Update: Regenxbio Shares Rise After FDA Aligns on Accelerated Approval Path for Hunter Syndrome Gene Therapy

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(Updates with the company's latest stock move in the headline and the first paragraph.)

Regenxbio (RGNX) shares were up 19% in Monday afternoon trading after the company said the US Food and Drug Administration has agreed on the next steps for a potential accelerated approval of Navsunli, its experimental gene therapy for Mucopolysaccharidosis II, following discussions related to its appeal of a complete response letter issued in February.

The company said the US FDA agreed that existing clinical data for Navsunli may support the accelerated approval pathway and that Regenxbio does not need to enroll additional patients or conduct new studies, including a previously requested untreated control arm.

The agency asked the company to request a type A meeting to review longer-term biomarker and clinical data before resubmitting its marketing application, the company said.

Regenxbio said it expects the meeting to occur in July and plans to resubmit the application in Q3.

Price: $9.29, Change: $+1.49, Percent Change: +19.04%

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