RegenXBio (RGNX)
NASDAQ:RGNX
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RegenXBio
(NASDAQ:RGNX)
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Rating:45Neutral
Price Target:
$10.00
▲(21.07% Upside)
Action:ReiteratedDate:03/06/26
The score is held down primarily by weak financial performance (large ongoing losses and continued cash burn) and bearish technical positioning (below key moving averages with negative MACD). Offsetting factors include constructive earnings-call catalysts and liquidity guidance into early 2027 (with a potential AbbVie milestone), but regulatory setbacks and program risk remain material.
Positive Factors
Platform Partnerships & Milestones
The NAV AAV platform generates non-dilutive cash via large partnership milestones and royalties. A validated collaboration with AbbVie and milestone-triggered payments provide durable funding optionality and third-party validation that supports long-term R&D and commercialization capacity.
Negative Factors
Regulatory Safety Setbacks
A documented AAV integration event linked to a tumor and subsequent CRL/clinical holds create persistent regulatory and safety scrutiny across AAV CNS programs. This can force longer follow-up, additional studies, or altered regulatory expectations that materially extend timelines and development costs for affected indications.
Read all positive and negative factors
Positive Factors
Negative Factors
Platform Partnerships & Milestones
The NAV AAV platform generates non-dilutive cash via large partnership milestones and royalties. A validated collaboration with AbbVie and milestone-triggered payments provide durable funding optionality and third-party validation that supports long-term R&D and commercialization capacity.
Read all positive factors
RegenXBio (RGNX) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$426.32M
Dividend YieldN/A
Average Volume (3M)935.54K
Price to Earnings (P/E)―
Beta (1Y)2.34
Revenue Growth91.30%
EPS Growth30.69%
CountryUS
Employees353
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.30
Shares Outstanding51,612,984
10 Day Avg. Volume945,412
30 Day Avg. Volume935,542
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 Cap1.47
Enterprise Value/Revenue3.68
Enterprise Value/Gross Profit6.95
Enterprise Value/Ebitda-4.30
Forecast
1Y Price Target
$30.60Price Target Upside270.46% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering11
EPS Forecast (FY)-2.15
Revenue Forecast (FY)$243.39M
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 generates revenue primarily through strategic partnerships and collaborations with larger pharmaceutical companies, which often involve upfront payments, milestone payments, and royalties on sales of approved therapies. The company may r...
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 Earnings Call Summary
Earnings Call Date:Mar 05, 2026
(Q4-2025)
| % Change Since: |
Next Earnings Date:May 06, 2026
Earnings Call Sentiment Positive
The call highlighted multiple strong development and commercial catalysts: completed pivotal enrollment in Duchenne with differentiated efficacy and safety signals for RGX-202, substantial progress and promising outcomes in the Cirovec retinal programs (including large reductions in anti-VEGF injections and durable responses), an active AbbVie collaboration with a near-term $100M milestone, and solid revenue/financing transactions that support a runway into early 2027. Offsetting these positives are material regulatory setbacks in the MPS programs (CRL and clinical holds) driven by an AAV integration–associated tumor in one patient and biomarker/assay issues, plus higher R&D spend and reliance on milestone/monetization proceeds. Overall, the company appears to have multiple high-value, late-stage assets and funding pathways, but faces meaningful program-specific safety and regulatory risks that will need to be resolved.Positive Updates
RGX-202 Duchenne Pivotal Program Momentum
Completed dosing in the AFFINITY pivotal trial (enrollment completed Oct 2025); robust enrollment in confirmatory trial. Phase 1/2 18-month NSAA results showed a 7.4-point average improvement versus the CTAP natural-history model. Majority of pivotal patients exceeded expected functional outcomes at 12 months. Safety differentiation to date: no SAEs/AESIs reported in Phase 1/2 and no observed thrombocytopenia or liver injury; proactive immune suppression, novel construct and >80% full capsids at a 2e14 dose.
Negative Updates
CRL and Clinical Holds in MPS Programs
Received a Complete Response Letter (CRL) for RGX-121 and clinical hold letters for both RGX-111 and RGX-121. Company is preparing a CRL response and pursuing a Type A meeting to resubmit, but these regulatory actions materially delay and complicate the MPS program timelines.
Read all updates
Q4-2025 Updates
Positive
Negative
RGX-202 Duchenne Pivotal Program Momentum
Completed dosing in the AFFINITY pivotal trial (enrollment completed Oct 2025); robust enrollment in confirmatory trial. Phase 1/2 18-month NSAA results showed a 7.4-point average improvement versus the CTAP natural-history model. Majority of pivotal patients exceeded expected functional outcomes at 12 months. Safety differentiation to date: no SAEs/AESIs reported in Phase 1/2 and no observed thrombocytopenia or liver injury; proactive immune suppression, novel construct and >80% full capsids at a 2e14 dose.
Read all positive updates
Company Guidance
REGENXBIO said it finished 12/31/2025 with $241M in cash/cash equivalents/marketable securities (vs $245M a year earlier) after a $110M Nippon Shinyaku upfront and $145M net proceeds from a royalty monetization; 2025 R&D was $228M (vs $209M in 2024) and total 2025 revenue was $170M, and management expects this cash to fund operations into early 2027 (excluding a $100M AbbVie NAVIGATE milestone expected on first patient dose next quarter and any additional royalty proceeds, either of which could extend the runway). Key clinical/regulatory timelines: RGX‑202 pivotal enrollment completed Oct‑2025 (pivotal cohort ~30) with topline data expected early Q2‑2026 and the majority of pivotal patients to have 12‑month functional data in 2026; Phase‑1/2 RGX‑202 showed a 7.4‑point NSAA improvement vs CTAP at 18 months, >80% full capsids, no SAEs/AESIs reported, and dosing at 2e14 with the confirmatory study expanding safety exposures (~50 vs ~30). Retina and other program metrics: ATMOSPHERE/ASCENT enrollment complete with subretinal Cirovec wet AMD topline due Q4‑2026; NAVIGATE Phase‑2b/3 will enroll 136 NPDR patients in the Phase‑2b with a primary endpoint of ≥2‑step DRSS improvement at one year and first dosing next quarter (triggers $100M); ALTITUDE DL3 showed >70% reduction in vision‑threatening complications and a 93% reduction in annualized anti‑VEGF injections (60% injection‑free at 12 months). Finally, RGX‑121 received a CRL and RGX‑111/121 are on clinical hold; the company is pursuing a Type A meeting to resubmit.RegenXBio Financial Statement Overview
Summary
Income Statement
34
Negative
Balance Sheet
46
Neutral
Cash Flow
29
Negative
| Breakdown | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 170.44M | 83.33M | 90.24M | 112.72M | 470.35M |
| Gross Profit | 150.14M | 49.76M | 53.03M | 58.18M | 418.51M |
| EBITDA | -145.58M | -198.23M | -239.46M | -244.24M | 169.54M |
| Net Income | -193.88M | -227.10M | -263.49M | -280.32M | 127.84M |
Balance Sheet | |||||
| Total Assets | 453.03M | 465.99M | 573.97M | 833.27M | 1.11B |
| Cash, Cash Equivalents and Short-Term Investments | 230.07M | 234.69M | 275.26M | 364.64M | 457.44M |
| Total Debt | 260.52M | 82.03M | 89.29M | 94.80M | 86.68M |
| Total Liabilities | 350.30M | 206.34M | 262.23M | 317.07M | 349.61M |
| Stockholders Equity | 102.73M | 259.65M | 311.74M | 516.20M | 764.30M |
Cash Flow | |||||
| Free Cash Flow | -126.38M | -175.56M | -228.37M | -238.21M | 134.70M |
| Operating Cash Flow | -123.96M | -173.13M | -218.41M | -207.49M | 218.88M |
| Investing Cash Flow | -15.87M | 103.45M | 190.94M | -11.93M | -406.64M |
| Financing Cash Flow | 116.77M | 92.68M | -34.97M | -28.84M | 195.25M |
RegenXBio Technical Analysis
Negative
8.26
Price Trends
10.02
Negative
11.52
Negative
10.53
Negative
Market Momentum
-0.44
Negative
43.30
Neutral
32.89
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 8.26 is below the 20-day moving average (MA) of 8.79, below the 50-day MA of 10.02, and below the 200-day MA of 10.53, indicating a bearish trend. The MACD of -0.44 indicates Negative momentum. The RSI at 43.30 is Neutral, neither overbought nor oversold. The STOCH value of 32.89 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 53 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 |
|---|---|---|---|---|---|---|---|
57 Neutral | $760.56M | -2.68 | -73.34% | ― | ― | 17.88% | |
54 Neutral | $1.25B | -5.57 | -15.12% | ― | 1112.27% | ― | |
53 Neutral | $364.60M | -42.31 | -25.72% | ― | ― | -73.48% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
45 Neutral | $426.32M | -2.77 | -103.12% | ― | 91.30% | 30.69% | |
42 Neutral | $961.00M | ― | -269.56% | ― | ― | ― |
* Healthcare Sector Average
RGNX
RegenXBio
8.26
0.43
5.49%
SLDB
Solid Biosciences
7.73
3.41
78.94%
MNPR
Monopar Therapeutics Inc
54.56
14.23
35.28%
GLUE
Monte Rosa Therapeutics
15.67
10.57
207.25%
INBX
Inhibrx Biosciences Inc
65.79
51.67
365.93%
RegenXBio Corporate Events
Product-Related AnnouncementsRegulatory Filings and Compliance
REGENXBIO Faces FDA Setback on RGX-121 Gene Therapy
Negative
Feb 10, 2026
On February 9, 2026, REGENXBIO Inc. reported that the U.S. Food and Drug Administration had issued a Complete Response Letter for its Biologics License Application for RGX-121, a one-time gene therapy for the ultra-rare neurodegenerative disorder ...
Business Operations and StrategyLegal Proceedings
FDA Halts RegenXBio MPS Gene Therapy Trials
Negative
Jan 28, 2026
On January 28, 2026, REGENXBIO announced that the U.S. Food and Drug Administration placed clinical holds on its investigational gene therapies RGX-111 for MPS I (Hurler syndrome) and RGX-121 for MPS II (Hunter syndrome). The action followed detec...
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.