Regenxbio Inc.'s rolling BLA submission of RGX-121 for the treatment of patients with MPS II expected in Q3 of 2024. Additional results from the phase 1/2/3 CAMPSIITE study, using RGX-121 for the ...
Recently, additional findings from the ongoing phase 1/2 AFFINITY DUCHENNE trial (NCT05693142) of RGX-202 (REGENXBIO), an investigational adeno-associated virus (AAV) vector-based gene therapy for ...
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FDA Extends Review for RegenXBio’s RGX-121 Therapy
Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. RegenXBio ( (RGNX)) has issued an ...
REGENXBIO specializes in gene therapies using proven AAV technology. RGX-121, targets Hunter syndrome and is under FDA review, with a PDUFA date set for November 9, 2025. We believe the upcoming FDA ...
The U.S. Food and Drug Administration (FDA) on Monday extended its review timeline for REGENXBIO Inc.’s (NASDAQ:RGNX) Biologics License Application (BLA) for clemidsogene lanparvovec (RGX-121) for ...
Credit: Getty Images. RGX-202 is an investigational one-time gene therapy designed to deliver a transgene for a novel microdystrophin. The Food and Drug Administration (FDA) has granted Fast Track ...
Pivotal data evaluating the safety and efficacy of the subretinal delivery of ABBV-RGX-314 in patients with wet age-related macular degeneration (wet AMD) are expected in 2026 AbbVie and REGENXBIO ...
We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected]. The phase 2 study compared RGX-314 (Regenxbio/AbbVie) ...
RegenXBio will fill its coffers with up to $250 million by monetizing more royalty rights for Novartis-partnered Zolgensma as well as anticipated payments linked to a gene therapy nearing approval and ...
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