RegenXBio Inc. (RGNX)
NASDAQ:RGNX
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RegenXBio
(NASDAQ:RGNX)
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Rating:48Neutral
Price Target:
$7.00
▼(-26.24% Downside)
Action:Reiterated
Date:05/18/26
The score is held down primarily by weak financial performance (sharp revenue decline, large ongoing losses, heavy cash burn, and elevated leverage vs equity). Technicals also remain bearish with the stock trading well below key moving averages. These negatives are partly offset by a strong earnings-call update on RGX-202’s pivotal results and pipeline milestones, though regulatory and dataset maturity risks remain.
Positive Factors
NAV AAV platform and licensing model
The NAV AAV platform creates durable, scalable revenue channels via upfront fees, milestones and royalties from partners. A platform licensing model spreads technical risk, leverages partner development/commercialization capabilities, and can produce non-dilutive cash as multiple partners advance products.
Negative Factors
Heavy cash burn and weakened balance sheet
Leverage has risen materially while equity has fallen to a thin cushion. Combined with sustained operating losses, an elevated debt-to-equity ratio raises financing, covenant and dilution risk over the medium term, limiting flexibility for expensive late-stage launches or manufacturing scale-up.
Read all positive and negative factors
Positive Factors
Negative Factors
NAV AAV platform and licensing model
The NAV AAV platform creates durable, scalable revenue channels via upfront fees, milestones and royalties from partners. A platform licensing model spreads technical risk, leverages partner development/commercialization capabilities, and can produce non-dilutive cash as multiple partners advance products.
Read all positive factors
RegenXBio Key Performance Indicators (KPIs)
Any
Revenue by Segment
Analyzes income from different business units, highlighting which segments drive growth and profitability, and indicating potential areas for strategic focus or improvement.
Analyzes income from different business units, highlighting which segments drive growth and profitability, and indicating potential areas for strategic focus or improvement.
Data provided by:
The Fly
The FlyRegenXBio (RGNX) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$362.40M
Dividend YieldN/A
Average Volume (3M)1.53M
Price to Earnings (P/E)―
Beta (1Y)2.38
Revenue Growth-43.96%
EPS Growth-78.31%
CountryUS
Employees353
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-5.60
Shares Outstanding51,697,620
10 Day Avg. Volume3,061,883
30 Day Avg. Volume1,533,591
Financial Highlights & Ratios
PEG Ratio0.21
Price to Book (P/B)7.23
Price to Sales (P/S)4.36
P/FCF Ratio-5.88
Enterprise Value/Market Cap1.15
Enterprise Value/Revenue4.76
Enterprise Value/Gross Profit-3.49K
Enterprise Value/Ebitda-1.78
Forecast
1Y Price Target
$22.78Price Target Upside140.02% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering9
EPS Forecast (FY)-2.85
Revenue Forecast (FY)$234.86M
RegenXBio Business Overview & Revenue Model
Company Description
REGENXBIO Inc., a clinical-stage biotechnology company, provides gene therapy product candidates to deliver genes to cells to address genetic defects or to enable cells in the body to produce therapeutic proteins or antibodies that are intended to...
How the Company Makes Money
REGENXBIO primarily makes money through (1) collaboration and licensing arrangements tied to its AAV-based NAV Technology Platform and (2) revenue recognized from partnered programs (e.g., upfront payments, license fees, and potential milestone pa...
RegenXBio Earnings Call Summary
Earnings Call Date:May 14, 2026
(Q1-2026)
| % Change Since: |
Next Earnings Date:Aug 05, 2026
Earnings Call Sentiment Positive
The call presented a notably positive clinical and programmatic update: RGX-202 met its pivotal primary endpoint with high biomarker expression, demonstrated an unusually strong correlation between microdystrophin and functional benefit (>0.9), and showed encouraging interim safety and functional signals with plans for potential accelerated approval in 2027. Key operational and regulatory risks were acknowledged — chiefly the limited number of mature 12‑month functional datapoints so far, reliance on external controls (and FDA concern about bias), and the possibility that the agency could request randomized trials which would materially delay approval. Remaining uncertainties on long‑term durability and the logistical burden of the prophylaxis regimen were also discussed. Overall the clinical readout and pipeline progress meaningfully outweigh near‑term risks, but regulatory process and more mature datasets remain critical next milestones.Positive Updates
Pivotal Phase III Primary Endpoint Met
AFFINITY DUCHENNE pivotal Phase III met its primary endpoint with high statistical significance: 93% (28 of 30 biopsied patients) exceeded the predefined microdystrophin >10% threshold. Interim safety available for 31 dosed pivotal patients.
Negative Updates
Limited Mature Functional Dataset
Only 9 patients had 12‑month functional data included in the top‑line functional analyses; microdystrophin biopsy data available for 30 of 31 pivotal patients (one patient refused biopsy). Company expects more 12‑month functional readouts (estimated ~15–20 patients by early 2027).
Read all updates
Q1-2026 Updates
Positive
Negative
Pivotal Phase III Primary Endpoint Met
AFFINITY DUCHENNE pivotal Phase III met its primary endpoint with high statistical significance: 93% (28 of 30 biopsied patients) exceeded the predefined microdystrophin >10% threshold. Interim safety available for 31 dosed pivotal patients.
Read all positive updates
Company Guidance
Management’s guidance highlighted program and regulatory milestones and specific metrics: the company has dosed >50 patients across pivotal and confirmatory studies with line-of-sight to 60 patients by mid‑2026; plans to seek potential accelerated approval in 2027 (rolling BLA possible) and expects a safety database of ~50 patients at filing and roughly 15–20 patients with 12‑month functional data by early 1H‑2027; current top‑line dataset includes 30 patients with microdystrophin biomarker data, 31 with interim safety, and 9 with 12‑month functional data (age ≥4); the pivotal met its primary endpoint with 93% (28/30) >10% microdystrophin at Week 12, 80% >40% expression, mean expression 71.1% overall and 41.6% in patients ≥8; there is a >0.9 correlation coefficient between microdystrophin and NSAA/cTAP functional measures; safety to date: 2 treatment‑related SAEs among 31 patients (one subacute myocarditis, one asymptomatic liver injury with GGT peak 123 U/L), both resolved without sequelae, no drug‑related thrombocytopenia/myositis/neurotoxicity, and mean GGT and total bilirubin remained below ULN through 12 months; additional pipeline and corporate milestones include dosing the first Phase IIb diabetic retinopathy patient in Q2‑2026 for a $100M AbbVie milestone, subretinal pivotal readouts in Q4‑2026, RGX‑121 hold lifted and CRL appeal filed, and an expectation of 3 potential approvals over the next couple of years (including 2 blockbuster opportunities).RegenXBio Financial Statement Overview
Summary
Income Statement
24
Negative
Balance Sheet
30
Negative
Cash Flow
22
Negative
| Breakdown | TTM | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 87.82M | 170.44M | 83.33M | 90.24M | 112.72M | 470.35M |
| Gross Profit | -120.00K | 150.14M | 49.76M | 53.03M | 58.18M | 418.51M |
| EBITDA | -235.22M | -145.58M | -198.23M | -239.46M | -244.24M | 169.54M |
| Net Income | -290.01M | -193.88M | -227.10M | -263.49M | -280.32M | 127.84M |
Balance Sheet | ||||||
| Total Assets | 341.89M | 453.03M | 465.99M | 573.97M | 833.27M | 1.11B |
| Cash, Cash Equivalents and Short-Term Investments | 150.49M | 230.07M | 234.69M | 275.26M | 364.64M | 457.44M |
| Total Debt | 71.07M | 260.52M | 82.03M | 89.29M | 94.80M | 86.68M |
| Total Liabilities | 320.81M | 350.30M | 206.34M | 262.23M | 317.07M | 349.61M |
| Stockholders Equity | 21.08M | 102.73M | 259.65M | 311.74M | 516.20M | 764.30M |
Cash Flow | ||||||
| Free Cash Flow | -236.40M | -126.38M | -175.56M | -228.37M | -238.21M | 134.70M |
| Operating Cash Flow | -233.78M | -123.96M | -173.13M | -218.41M | -207.49M | 218.88M |
| Investing Cash Flow | 9.98M | -15.87M | 103.45M | 190.94M | -11.93M | -406.64M |
| Financing Cash Flow | 108.93M | 116.77M | 92.68M | -34.97M | -28.84M | 195.25M |
RegenXBio Technical Analysis
Negative
9.49
Price Trends
8.39
Negative
9.60
Negative
10.48
Negative
Market Momentum
-0.68
Positive
43.03
Neutral
78.50
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For RGNX, the sentiment is Negative. The current price of 9.49 is above the 20-day moving average (MA) of 7.93, above the 50-day MA of 8.39, and below the 200-day MA of 10.48, indicating a bearish trend. The MACD of -0.68 indicates Positive momentum. The RSI at 43.03 is Neutral, neither overbought nor oversold. The STOCH value of 78.50 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for RGNX.
RegenXBio Risk Analysis
RegenXBio disclosed 54 risk factors in its most recent earnings report. RegenXBio reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
RegenXBio Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
55 Neutral | $1.67B | -9.94 | -40.99% | ― | -73.07% | -2335.85% | |
54 Neutral | $1.53B | ― | -563.89% | ― | 550.00% | -107.04% | |
53 Neutral | $435.71M | -37.04 | -12.84% | ― | ― | 40.38% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
49 Neutral | $722.62M | -4.20 | -74.45% | ― | ― | 34.94% | |
48 Neutral | $362.40M | -1.27 | -232.50% | ― | -43.96% | -78.31% |
* Healthcare Sector Average
RGNX
RegenXBio
7.01
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-32.27%
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RegenXBio Corporate Events
Business Operations and StrategyFinancial Disclosures
RegenXBio Advances RGX-202 With Positive Phase III Results
Positive
May 14, 2026
On May 14, 2026, REGENXBIO reported first-quarter 2026 results and unveiled positive topline data from its pivotal Phase III AFFINITY DUCHENNE trial of RGX-202, which met its primary endpoint with high statistical significance and showed a strong ...
Business Operations and StrategyLegal Proceedings
RegenXBio Reaches Settlement with GSK Over License Fees
Neutral
Mar 20, 2026
On March 18, 2026, REGENXBIO Inc. entered into a Settlement and Release Agreement with GlaxoSmithKline LLC to resolve a dispute over the amount of sublicense fees previously paid under a 2009 license arrangement. REGENXBIO agreed to pay $10 millio...
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.