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RGNX REGENXBIO INC US FDA Inspections 8-K Filing

RGNX

RGNX

REGENXBIO INC

(RGNX)

2026 8-K

Settlement Agreement

Financial Results Announced

FDA Response Letter

FDA Holds Trials

Financial Results Report

FDA Date Extension

Debt-Equity Swaps

Financial Statements

Financial Results

Collaboration Agreement

Collaboration Agreement

Financial Results

Management Grant of Restric...

Earnings Reports

Management Change

Annual Meeting Voting Results

Earnings Reports

Underwriting Agreement

Financial Results Press Rel...

Earnings Reports

Equity Offering

Earnings Reports

Annual Meeting Voting Results

Earnings Reports

Financial Results Press Rel...

Management Changes

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On February 7, 2026, REGENXBIO Inc. announced they received a Complete Response Letter (CRL) from the FDA regarding their Biologics License Application for RGX-121, a gene therapy for Mucopolysaccharidosis type II, indicating further review is needed.

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REGENXBIO INC

2026

8 K

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