RegenXBio Inc. (RGNX)
NASDAQ:RGNX
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RegenXBio
(NASDAQ:RGNX)
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Rating:51Neutral
Price Target:
$8.00
▼(-15.70% Downside)
Action:Reiterated
Date:06/04/26
The score is held back primarily by weak financial performance (sharp revenue contraction, sustained heavy cash burn, and a highly leveraged/thin equity position) and bearish technicals (below all major moving averages with negative MACD). These are partially offset by a notably positive earnings call driven by strong RGX-202 pivotal biomarker results and clear regulatory/commercial milestones, though regulatory and data-maturity risks remain significant.
Positive Factors
Partnering / licensing revenue model
A business model centered on licensing the NAV AAV platform creates durable, non-dilutive revenue levers: upfronts, R&D funding, milestones and royalties. These streams can fund development and de-risk cash needs over time as partners advance programs using REGENXBIO's core vector tech.
Negative Factors
Sharp revenue decline and heavy cash burn
Material revenue contraction and persistent negative free cash flow create a structural funding need. Over a multi-quarter horizon this increases reliance on partner milestones or financing, raising dilution or covenant risk and limiting the company's ability to self-fund late-stage commercialization.
Read all positive and negative factors
Positive Factors
Negative Factors
Partnering / licensing revenue model
A business model centered on licensing the NAV AAV platform creates durable, non-dilutive revenue levers: upfronts, R&D funding, milestones and royalties. These streams can fund development and de-risk cash needs over time as partners advance programs using REGENXBIO's core vector tech.
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
$403.24M
Dividend YieldN/A
Average Volume (3M)2.08M
Price to Earnings (P/E)―
Beta (1Y)2.49
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. Volume1,869,135
30 Day Avg. Volume2,084,770
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/Revenue5.29
Enterprise Value/Gross Profit-3.87K
Enterprise Value/Ebitda-2.02
Forecast
1Y Price Target
$19.50Price Target Upside105.48% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering8
EPS Forecast (FY)-2.85
Revenue Forecast (FY)$234.86M
RegenXBio Business Overview & Revenue Model
Company Description
REGENXBIO Inc. is a biotechnology company operating in the clinical stage, dedicated to developing gene therapy candidates. These therapies are designed to introduce genes into cells, aiming either to rectify genetic deficiencies or to stimulate t...
How the Company Makes Money
REGENXBIO primarily makes money through (1) collaboration and license revenue tied to its NAV AAV vector technology and (2) potential future product revenue if its wholly owned or co-developed gene therapy candidates receive regulatory approval an...
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 | -229.35M | -133.25M | -198.23M | -239.46M | -244.24M | 177.09M |
| 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
Positive
9.49
Price Trends
7.95
Negative
8.51
Negative
10.34
Negative
Market Momentum
-0.14
Negative
56.89
Neutral
73.00
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For RGNX, the sentiment is Positive. The current price of 9.49 is above the 20-day moving average (MA) of 6.73, above the 50-day MA of 7.95, and below the 200-day MA of 10.34, indicating a neutral trend. The MACD of -0.14 indicates Negative momentum. The RSI at 56.89 is Neutral, neither overbought nor oversold. The STOCH value of 73.00 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive 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 | $1.55B | -9.23 | -40.99% | ― | -73.07% | -2335.85% | |
53 Neutral | $451.99M | -38.43 | -12.84% | ― | ― | 40.38% | |
52 Neutral | $820.09M | -4.77 | -74.45% | ― | ― | 34.94% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
51 Neutral | $403.24M | -1.41 | -232.50% | ― | -43.96% | -78.31% | |
46 Neutral | $1.37B | -11.14 | -563.89% | ― | 550.00% | -107.04% |
* Healthcare Sector Average
RGNX
RegenXBio
7.80
-0.06
-0.76%
SLDB
Solid Biosciences
8.33
3.82
84.70%
MNPR
Monopar Therapeutics Inc
67.47
35.64
111.97%
GLUE
Monte Rosa Therapeutics
18.31
13.67
294.61%
INBX
Inhibrx Biosciences Inc
93.05
78.49
539.08%
RegenXBio Corporate Events
Business Operations and StrategyExecutive/Board ChangesShareholder Meetings
RegenXBio Launches Targeted Employee Stock Option Exchange
Positive
Jun 3, 2026
REGENXBIO Inc., a gene therapy-focused biotechnology company, reported the results of its 2026 Annual Meeting of Stockholders held on May 29, 2026, where shareholders elected three Class II directors to serve until 2029 and ratified Pricewaterhous...
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.