Regenxbio: 'Hold' On RGX-121 CRL MPS II And RGX-202 DMD Results
REGENXBIO has been downgraded from 'Buy' to 'Hold' following regulatory challenges for its drug RGX-121. The company received a Complete Response Letter and faces an uncertain path for RGX-202 despite positive phase 3 results. With cash reserves only lasting until early 2027, financing concerns are growing as pivotal trial data approaches.
- ▪REGENXBIO was downgraded from 'Buy' to 'Hold' due to regulatory setbacks.
- ▪The company received a Complete Response Letter for RGX-121 and faces an uncertain appeals process.
- ▪Positive phase 3 data for RGX-202 showed strong results, but FDA approval remains uncertain.
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