Regenxbio Concludes Pre-biologics License Application Meeting For RGX-121 For Mucopolysaccharidosis Type II, Where It Finalized Details Of Its Application With The FDA, Expects To Initiate Submission Of A Rolling BLA In Q3 Of 2024

6/18/24 7:11:31 AM ET

$RGNX

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Aligned with FDA on content of BLA and plans for submission:
- Submission of a rolling BLA using the accelerated approval pathway expected to start in Q3 2024
- Confirmatory trial expected to begin in H2 2025
- FDA confirmed RGX-121 commercial bulk drug is comparable to clinical material
Positive biomarker, neurocognitive and systemic data will be part of BLA submission

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Regenxbio Concludes Pre-biologics License Application Meeting For RGX-121 For Mucopolysaccharidosis Type II, Where It Finalized Details Of Its Application With The FDA, Expects To Initiate Submission Of A Rolling BLA In Q3 Of 2024

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Director Karabelas Argeris N exercised 10,000 shares at a strike of $3.76 and sold $101,052 worth of shares (10,000 units at $10.11) (SEC Form 4)

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Amendment: SEC Form SC 13G/A filed by REGENXBIO Inc.

Amendment: SEC Form SC 13G/A filed by REGENXBIO Inc.

Amendment: SEC Form SC 13G/A filed by REGENXBIO Inc.

SEC Form 10-Q filed by REGENXBIO Inc.

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