REGENXBIO INITIATES PIVOTAL PHASE OF AFFINITY DUCHENNE® TRIAL OF RGX-202 GENE THERAPY AND REPORTS POSITIVE FUNCTIONAL DATA
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REGENXBIO has initiated the pivotal phase of its AFFINITY DUCHENNE® trial for the RGX-202 gene therapy, showing positive functional data. The trial has FDA alignment for accelerated approval, with a BLA expected in 2026. Early data shows significant functional improvements and a favorable safety profile.
November 18, 2024 | 12:15 pm
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REGENXBIO's pivotal trial for RGX-202 gene therapy shows promising results, with FDA alignment for accelerated approval and a BLA expected in 2026. Early data indicates significant functional improvements and a favorable safety profile.
The initiation of the pivotal phase of the RGX-202 trial and positive early data are significant milestones for REGENXBIO. The alignment with the FDA for accelerated approval and the expectation of a BLA in 2026 are likely to boost investor confidence and positively impact the stock price in the short term.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100