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Dec 31, 2025
REGENXBIO Q4 2025 Earnings Report
REGENXBIO Q4 2025 Earnings Report
Key Takeaways
REGENXBIO reported a net loss of $67.1 million for Q4 2025, despite a 43% increase in revenue driven by higher license and royalty income. The company faced regulatory setbacks with clinical holds on RGX-111 and RGX-121, but continues to advance its pivotal trials for RGX-202 and sura-vec with a cash runway extending into early 2027.
Revenue increased to $30.3 million in Q4 2025, up from $21.2 million in the prior year period.
The FDA placed clinical holds on RGX-111 and RGX-121 in early 2026, and issued a Complete Response Letter for the RGX-121 BLA.
Pivotal topline data for RGX-202 in Duchenne muscular dystrophy is expected in early Q2 2026.
Cash and securities of $240.9 million are expected to fund operations into early 2027, excluding potential milestone payments.
Revenue by Segment
Forward Guidance
REGENXBIO expects its current cash position to fund operations into early 2027, focusing on pivotal data readouts and regulatory milestones in 2026.
Positive Outlook
- Cash runway extends into early 2027 based on current plans.
- Topline pivotal data for RGX-202 expected in early Q2 2026.
- Anticipated $100 million milestone payment from AbbVie in Q2 2026.
- Pre-BLA meeting for RGX-202 planned for mid-2026.
- Topline pivotal data for subretinal sura-vec expected in Q4 2026.
Challenges Ahead
- Clinical hold currently in place for RGX-111.
- Clinical hold currently in place for RGX-121.
- Complete Response Letter received from FDA for RGX-121 BLA.
- Cash runway guidance excludes potential impact of material payments not yet received.
Historical Earnings Impact
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Avg. Return Before/After Earnings
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