Information
Biologics Licensing Application (BLA) for clemidsogene lanparvovec (RGX-121) submitted and on track ...
Original sourceAI Summary
RGN submitted BLA for RGX-121, aiming for FDA approval by 2025. RGX-202 pivotal trial for Duchenne shows rapid progress, BLA filing expected 2026. Partnership with Nippon Shinyaku enhances market access for RGX-121 and RGX-111. AbbVie collaboration advances retinal therapies; pivotal results are anticipated in 2026. Financial results show reduced net loss and significant operational updates.
Sentiment Rationale
The positive developments, including BLA submissions and partnerships, suggest revenue growth.
Trading Thesis
Expected FDA approvals and ongoing trials will likely shape RGN's future financial performance.
Market-Moving
- RGN submitted BLA for RGX-121, aiming for FDA approval by 2025.
- RGX-202 pivotal trial for Duchenne shows rapid progress, BLA filing expected 2026.
- Partnership with Nippon Shinyaku enhances market access for RGX-121 and RGX-111.
Key Facts
- RGN submitted BLA for RGX-121, aiming for FDA approval by 2025.
- RGX-202 pivotal trial for Duchenne shows rapid progress, BLA filing expected 2026.
- Partnership with Nippon Shinyaku enhances market access for RGX-121 and RGX-111.
- AbbVie collaboration advances retinal therapies; pivotal results are anticipated in 2026.
- Financial results show reduced net loss and significant operational updates.
Companies Mentioned
- ABBV (ABBV)
- NVS (NVS)
Corporate Developments
Upcoming drug approvals and partnerships could position RGN for significant revenue streams.