Story perspectives

FDA Reverses Rejection, Allows Regenxbio Hunter Gene Therapy Resubmission

6/22/2026

Summary

Story summary

FDA reversed its February 2026 rejection of Regenxbio’s Navsunli gene therapy for Hunter syndrome and will accept a resubmission.
The agency said the data support accelerated approval without control arm.
Regenxbio will seek a Type A meeting in July, file a biologics license application (BLA) in Q3 2026, and expects expedited FDA review.
Shares rose 37% after the reversal, indicating an anticipated $100 million AbbVie milestone for its diabetic retinopathy partnership.

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Story summary

FDA reversed its February 2026 rejection of Regenxbio’s Navsunli gene therapy for Hunter syndrome and will accept a resubmission.
The agency said the data support accelerated approval without control arm.
Regenxbio will seek a Type A meeting in July, file a biologics license application (BLA) in Q3 2026, and expects expedited FDA review.
Shares rose 37% after the reversal, indicating an anticipated $100 million AbbVie milestone for its diabetic retinopathy partnership.