REGENXBIO targets Q3 for gene therapy resubmission
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- REGENXBIO reached an agreement with the FDA regarding its application for the NAVSUNLI gene therapy.
- Following the positive regulatory update, the company's shares jumped to 8.53 dollars.
- The company targets a formal resubmission in the third quarter of 2026 without conducting new trials.
REGENXBIO (NASDAQ:RGNX) aligned with the FDA to resubmit its rare disease drug application in Q3 2026.
This collaborative regulatory agreement follows a complete response letter issued by the agency in February 2026.
"We will continue to work closely with the FDA to bring this therapy to boys living with Hunter syndrome," said REGENXBIO President and CEO Curran Simpson.
The agency confirmed that the business requires no additional clinical studies or new patient enrollments for this filing.
Following the announcement, REGENXBIO's share price was up at $8.53.
The underlying treatment targets Mucopolysaccharidosis II, a rare neurodegenerative disease affecting approximately 2,000 patients globally.
The company previously established a partnership with NS Pharma to handle domestic commercialization after potential regulatory approval.
