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- **RGX-202 Milestone**: Pivotal trial enrollment complete; BLA submission in mid-2026 with potential accelerated approval. Confirmatory trial enrolling 30 patients to support full approval.
- **MPS II Progress**: FDA inspections cleared; BLA on track for February 2026 PDUFA date. Commercial doses via Nippon Shinyaku expected early 2026.
- **Financial Strength**: $302 million cash balance with runway into 2027, supported by $145 million healthcare royalty monetization and $110 million Nippon Shinyaku payment.
- **Retinal Leadership**: Wet AMD trial largest in gene therapy history; DR program to initiate Phase IIb/III in 2026 with AbbVie collaboration.

**【CEO Summary Section】**
- **RGX-202 Duchenne Program**: Completed enrollment in the pivotal AFFINITY trial, with plans to submit a BLA under accelerated approval in mid-2026. The program features a novel immune suppression regimen, high-purity manufacturing (80% full capsids), and a 2,500 doses/year commercial capacity. Confirmatory trial enrollment is progressing, targeting 30 patients.
- **RGX-121 MPS II Program**: FDA inspections of clinical sites and manufacturing facilities resulted in no observations. The BLA is on track for a February 8, 2026, PDUFA date, with potential commercial doses available early 2026 via partner Nippon Shinyaku.
- **Retinal Franchise**: Wet AMD programs (sura-vec) achieved full enrollment in the largest gene therapy trial (1,200+ patients). Diabetic retinopathy (DR) program expects to initiate Phase IIb/III trials in early 2026, leveraging AbbVie's global infrastructure.

**【CFO Financial Commentary】**
- **Cash Position**: $302 million as of Q3 2025, up from $245 million in Q4 2024, driven by $110 million from Nippon Shinyaku and $145 million from healthcare royalty monetization. Cash runway extends into early 2027, with potential extensions via priority review voucher sales, milestones, and partnerships.
- **Revenue Growth**: Q3 2025 revenue of $30 million (vs. $24 million in Q3 2024) reflects increasing collaboration activity, particularly with AbbVie and Nippon Shinyaku.

**【Q&A Key Highlights】**
- **Regulatory Strategy**: RGX-202 eligible for accelerated approval based on functional benefits exceeding natural history controls. FDA interactions for MPS II were productive, with no additional data requests.
- **Manufacturing Scale**: Rockville facility equipped with a 2,000-liter bioreactor, capable of producing 2,500 RGX-202 doses/year. MPS II uses <5% of total capacity, enabling focus on high-priority programs.
- **Commercial Partnerships**: AbbVie's global ophthalmology expertise accelerates retinal programs, with $2 of every $3 in wet AMD costs covered by AbbVie. Nippon Shinyaku's MPS II partnership includes a $100 million milestone for DR first patient dosing.
- **Risk Considerations**: Duchenne label may require non-ambulatory patient studies post-launch. Medicare coverage for gene therapies is evolving, with AbbVie leading wet AMD reimbursement discussions.

REGENXBIO Inc. (RGNX) Q3 2025 Earnings Call Transcript

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