REGENXBIO Inc.
NASDAQ•RGNX
CEO: Mr. Curran M. Simpson M.S.
Sector: Healthcare
Industry: Biotechnology
Listing Date: 2015-09-17
REGENXBIO Inc., a clinical-stage biotechnology company, provides gene therapies that deliver functional genes to cells with genetic defects in the United States. Its gene therapy product candidates are based on NAV Technology Platform, a proprietary adeno-associated virus gene delivery platform. The company's products in pipeline includes ABBV-RGX-314 for the treatment of wet age-related macular degeneration, diabetic retinopathy, and other chronic retinal diseases; and RGX-202, which is in Phase I/II clinical trial for the treatment of Duchenne muscular dystrophy. It also develops RGX-121 for the treatment of mucopolysaccharidosis type II that is in Phase III clinical trial; RGX-111 for treating mucopolysaccharidosis type I; RGX-181 for the treatment of late infantile neuronal ceroid lipofuscinosis type II; and RGX-381 to treat the ocular manifestations of CLN2 disease. In addition, the company licenses its NAV Technology Platform to other biotechnology and pharmaceutical companies. Further, it has a collaboration and license agreement with AbbVie Global Enterprises Ltd. to develop ABBV-RGX-314 outside the United States. REGENXBIO Inc. was incorporated in 2008 and is headquartered in Rockville, Maryland.
Contact Information
Market Cap
$463.01M
P/E (TTM)
-2.4
18.1
Dividend Yield
--
52W High
$16.19
52W Low
$6.89
52W Range
Rank61Top 91.5%
2.0
F-Score
Modified Piotroski Analysis
Based on 10-year fundamentals
Weak • 2 / 9 points
Scoring Range (0-9)
8-9: Excellent Value
6-7: Strong Fundamentals
4-5: Average Quality
0-3: Weak Performance
Data Period: 2016-2025
Financial Dashboard
Q4 2025 Data
Revenue
$30.34M+0.00%
4-Quarter Trend
EPS
-$1.30+0.00%
4-Quarter Trend
FCF
-$52.80M+0.00%
4-Quarter Trend
2025 Annual Earnings Highlights
Key Highlights
License Revenue Jumps 90.7% License and royalty revenue reached $156.27M, showing 90.7% growth driven by Nippon Shinyaku upfront recognition.
Net Loss Significantly Narrows Net loss decreased by $33.22M to $193.88M loss for 2025, reflecting improved operational efficiency and partnership revenue.
Strong Cash Position Maintained Ended year with $240.9M in cash, equivalents, and marketable securities, funding operations into early 2027.
Key Collaboration Payments Received Recognized $72.9M upfront revenue from Nippon Shinyaku deal, supporting RGX-121/111 development efforts.
Risk Factors
RGX-121 BLA Suffers CRL FDA issued Complete Response Letter for RGX-121 BLA; path to resubmission and approval remains highly uncertain.
Clinical Holds Impact Programs FDA clinical holds on RGX-111 and RGX-121 programs may delay development, increase costs, or cause termination.
Manufacturing Complexity Risks Novel gene therapy products are complex to manufacture; disruptions limit supply or delay commercialization efforts.
Revenue Concentration Exposure Two customers accounted for 99% of 2025 revenues; loss of major partner severely harms future revenue streams.
Outlook
Sura-vec Pivotal Data Expected Topline data for pivotal wet AMD trials (ATMOSPHERE/ASCENT) expected in the fourth quarter of 2026.
RGX-202 DMD Data Near Pivotal RGX-202 topline data expected early Q2 2026; pre-BLA meeting planned with FDA mid-2026.
Address Regulatory Hurdles Plan Type A meeting with FDA to discuss CRL for RGX-121 and work to lift clinical holds on RGX-111/121.
New DR Trial Initiating Planning Phase IIb/III NAAVIGATE trial for DR suprachoroidal delivery, expecting first patient dosed in Q2 2026.
Peer Comparison
Revenue (TTM)
$170.44M
$85.21M
$81.39M
Gross Margin (Latest Quarter)
99.4%
98.4%
97.7%
Key Metrics
Symbol | Market Cap | P/E (TTM) | ROE (TTM) | Debt to Assets |
|---|---|---|---|---|
| KALV | $1.37B | -8.1 | -444.4% | 84.7% |
| CRVS | $1.28B | -78.5 | -23.3% | 1.3% |
| OLMA | $1.26B | -8.1 | -42.9% | 0.2% |
Long-Term Trends
Last 4 Quarters
Revenue
Net Income
Operating Cash Flow
4Q Revenue CAGR
-30.1%
Growth Under Pressure
4Q Net Income CAGR
N/M
Profitability Shift
Cash Flow Stability
25%
Cash Flow Needs Attention
Deep Research
Next earnings:May 11, 2026
EPS:-$1.36
|Revenue:$25.84M
Financials
Earnings Calls
Reports
News
Income Statement
Balance Sheet
Cash Flow Statement
Ratios
% Chg.
Income Statement | LTM |
|---|
No Data