REGENXBIO Inc.
12.84-0.32 (-2.43%)
Oct 29, 4:00:01 PM EDT · NasdaqGS · RGNX · USD
Key Stats
Market Cap
648.60MP/E (TTM)
-Basic EPS (TTM)
-3.44Dividend Yield
0%Recent Filings
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.
8-K
Annual meeting results approved
REGENXBIO Inc. held its 2025 Annual Meeting on May 30, with 82.4% of shares represented. Shareholders elected Allan Fox, Alexandra Glucksmann, Curran Simpson, and Jennifer Zachary as Class I directors until 2028. They ratified PricewaterhouseCoopers as auditors, approved executive compensation annually, and passed the 2025 Equity Incentive Plan. Strong turnout signals investor confidence in governance.
8-K
REGENXBIO secures $150M royalty financing
REGENXBIO closed a $250 million royalty bond deal with HCRx on May 16, 2025, securing $150 million upfront to fund late-stage gene therapy programs and extend its cash runway into early 2027. The limited-recourse financing monetizes royalties from Zolgensma sales, RGX-121, RGX-111, and NAV platform licensees, with interest at 9.75% plus SOFR (4.25% floor) paid solely from those proceeds; additional $100 million hinges on sales thresholds and mutual option. This non-dilutive capital bolsters preparations for potential approvals in MPS II and Duchenne while retaining PRV and milestone upsides. Yet risks loom if royalty flows falter.
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