RGNX
REGENXBIO Inc.14.11
+0.28+2.02%
Dec 16, 4:00:00 PM EST
Earnings Call Transcripts
This Quarter (Q4 '25)
No earnings call transcript available yet
Last Quarter (Q3 '25)
No earnings call transcript available
Key Stats
Market Cap
714.29MP/E (TTM)
-Basic EPS (TTM)
-3.46Dividend Yield
0%Recent Filings
8-K
10-Q
8-K
FDA extends RGX-121 review
REGENXBIO announced the FDA extended the PDUFA date for its BLA seeking accelerated approval of RGX-121, a one-time gene therapy for Hunter syndrome, from November 9, 2025, to February 8, 2026, to review additional 12-month data from all 13 pivotal study patients. The extension follows a clean pre-license inspection with no safety concerns raised. Commercial launch plans stay on track. Updated data will be presented at the ICIEM meeting in September 2025.
8-K
AbbVie amends REGENXBIO deal
REGENXBIO and AbbVie amended their collaboration on August 5, 2025, restructuring milestones for the surabgene lomparvovec diabetic retinopathy program and adding a new Phase IIIb ACHIEVE study for wet AMD. AbbVie will pay $100 million upon first patient dosing in the combined Phase IIb/III DR trial and another $100 million for the follow-on Phase III, while covering all ACHIEVE costs; REGENXBIO funds Phase IIb of the DR study. This bolsters late-stage retinal gene therapy efforts, yet trial success hinges on pivotal data expected in 2026.
10-Q
Q2 FY2025 results
REGENXBIO's Q2 FY2025 revenue dipped 4% y/y to $21.4M, driven by a 15% drop in Zolgensma royalties to $18.4M, yet YTD revenue soared 191% to $110.4M on a $70M Nippon Shinyaku license fee. Operating loss widened 13% y/y to $63.3M amid 22% higher R&D spend, while net loss deepened to $70.9M from $11.5M interest expense on new debt. Cash swelled to $363.6M after a $144.5M royalty bond drawdown, supporting runway past 2026. In May 2025, closed a $150M royalty bond (9.75% + SOFR, min 14%, matures 2035) with HCR, securing Zolgensma royalties post-2020 cap and other streams, recognizing no goodwill. Regulatory hurdles could delay pipeline approvals.
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