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US FDA source recordCRL · Complete Response Letter

FDA-regulated product — FDA Complete Response Letter

Issued to REGENXBIO, Inc.. Application reviewed but not approved; deficiencies must be corrected.

Issued

February 7, 2026

Product

FDA-regulated product

Company

REGENXBIO, Inc.

Stage

Final Decision

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What did FDA decide for FDA-regulated product?

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Source facts

FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Safety and adverse events, Labeling, packaging, and proprietary name, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

Key details in this letter

  • 1Clinical efficacy and substantial evidence: 8 source-text matches.
  • 2Safety and adverse events: 2 source-text matches.
  • 3Labeling, packaging, and proprietary name: 2 source-text matches.
  • 4Statistical analysis: 2 source-text matches.
Clinical efficacy and substantial evidenceSafety and adverse eventsLabeling, packaging, and proprietary nameStatistical analysis

Suggested next step

Review the exact redacted FDA letter and address each stated deficiency before resubmission.

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Built from structured FDA metadata and deterministic source-text signals. Topic matches are navigation aids, not legal or regulatory conclusions. Verify material decisions against the original FDA document.

FDAPDFUpdated Jul 30, 2026

FDA source document

Read the full FDA complete response letter (PDF)

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Common questions about the FDA-regulated product complete response letter

What does this complete response letter mean for FDA-regulated product?

Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to REGENXBIO, Inc. on February 7, 2026.

What happens after an FDA complete response letter?

FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.