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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Regenxbio has concluded a pre-biologics license application (BLA) meeting with the FDA for its RGX-121 treatment for Mucopolysaccharidosis Type II. The company plans to initiate a rolling BLA submission in Q3 2024, with a confirmatory trial expected to begin in H2 2025. The FDA has confirmed that the commercial bulk drug is comparable to the clinical material.
June 18, 2024 | 11:11 am
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Regenxbio has finalized details with the FDA for its RGX-121 BLA submission, expected to start in Q3 2024. The FDA confirmed the commercial bulk drug is comparable to the clinical material, and positive data will be included in the submission.
The finalization of BLA details and the FDA's confirmation of the drug's comparability to clinical material are positive developments. The planned rolling BLA submission and inclusion of positive data are likely to boost investor confidence in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100