tiprankstipranks
Trending News
More News >
RegenXBio (RGNX)
NASDAQ:RGNX

RegenXBio (RGNX) AI Stock Analysis

Compare
1,023 Followers

Top Page

RGNX

RegenXBio

(NASDAQ:RGNX)

Select Model
Select Model
Select Model
Neutral 54 (OpenAI - 5.2)
Rating:54Neutral
Price Target:
$15.50
▲(12.65% Upside)
RegenXBio's overall score is driven by strong technical momentum and positive earnings call sentiment, offset by financial challenges and valuation concerns. The company's strategic advancements in clinical trials and financial stability are promising, but profitability and cash flow issues remain significant risks.
Positive Factors
Pipeline Advancements
The completion of enrollment in the AFFINITY DUCHENNE trial and positive safety data position RegenXBio well for future approvals, enhancing its market position in gene therapy.
Strong Financial Position
A strong cash position ensures operational stability and supports ongoing R&D efforts, providing a buffer against financial uncertainties.
Commercial Manufacturing Capability
In-house manufacturing capabilities enhance RegenXBio's ability to scale production efficiently, supporting long-term growth and competitive advantage.
Negative Factors
Declining Revenue
Significant revenue decline poses a challenge to sustaining operations and funding future growth, impacting long-term financial health.
Regulatory Challenges
Regulatory uncertainties could delay product approvals, affecting market entry timelines and revenue generation.
High Leverage
Increased leverage limits financial flexibility and increases risk, potentially impacting the company's ability to invest in growth opportunities.

RegenXBio (RGNX) vs. SPDR S&P 500 ETF (SPY)

RegenXBio Business Overview & Revenue Model

Company DescriptionREGENXBIO 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 impact disease. Its gene therapy product candidates are based on NAV Technology Platform, a proprietary adeno-associated virus gene delivery platform. The company's lead product candidate is RGX-314, which is in Phase III clinical trial for the treatment of wet age-related macular degeneration. It is also developing RGX-121 that is in Phase I/II clinical trial to treat mucopolysaccharidosis type II;RGX-111, which is in Phase I/II clinical trial for treating mucopolysaccharidosis type I;RGX-181 which is in pre clinic stage for the treatment of late-infantile neuronal ceroid lipofuscinosis type II disease;RGX-202, to treat Duchenne muscular dystrophy which is in phase I/II clinical trial; and RGX-381, to treat the ocular manifestations of CLN2 disease which is in preclinical stage. REGENXBIO Inc. also licenses its NAV Technology Platform to other biotechnology and pharmaceutical companies; and has a collaboration and license agreement with Neurimmune AG to develop novel gene therapies. REGENXBIO Inc. was founded in 2008 and is headquartered in Rockville, Maryland.
How the Company Makes MoneyRegenXBio 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 receive funding through research grants and investments aimed at advancing its gene therapy pipeline. Additionally, potential commercialization of its therapies, once approved, will contribute to revenue through product sales. Collaborations with organizations such as Novartis and other biotech firms are significant sources of income, as they typically include financial support for research and development activities, as well as sharing of technology and expertise.

RegenXBio Key Performance Indicators (KPIs)

Any
Any
Revenue by Segment
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.
Chart InsightsRegenXBio's Zolgensma royalties have shown volatility, with recent declines in 2024, reflecting potential market saturation or competitive pressures. The earnings call highlights strong clinical progress and strategic partnerships, positioning the company for future growth. However, regulatory uncertainties and competitive challenges, particularly in the Duchenne muscular dystrophy space, could impact revenue stability. The company's robust cash position and manufacturing capabilities are positive indicators for sustaining operations and potential expansion.
Data provided by:The Fly

RegenXBio Earnings Call Summary

Earnings Call Date:Nov 06, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Mar 03, 2026
Earnings Call Sentiment Positive
The earnings call highlighted significant progress and achievements in clinical development and financial positioning. However, there are regulatory challenges and uncertainties, particularly concerning international approvals and the use of external controls. Despite these challenges, the overall sentiment leans positive due to strong pipeline advancements and financial stability.
Q3-2025 Updates
Positive Updates
Progress in RGX-202 Program for Duchenne
Enrollment completed ahead of schedule for the AFFINITY DUCHENNE pivotal trial. Strong safety and efficacy profile in Phase I/II with no serious adverse events reported. Top-line data expected in early Q2 2026, with a BLA submission planned for mid-2026.
Advancements in RGX-121 for MPS II
Positive 12-month data delivered to FDA, with no observations during site inspections. The program is on track for potential approval by February 2026.
Strong Financial Position
Cash, cash equivalents, and marketable securities of $302 million as of September 30, 2025. Cash runway expected to fund operations into early 2027, with potential nondilutive financing opportunities available.
Completion of Enrollment in Wet AMD Studies
Over 1,200 patients enrolled across 200 sites in the global Phase III studies for subretinal wet AMD, marking the largest global gene therapy program ever conducted.
Negative Updates
Regulatory and Competitive Challenges
Concerns remain over the use of external controls and potential regulatory hurdles for RGX-202 accelerated approval, especially in the context of FDA's evolving stance on gene therapies.
Uncertainty in European Approval Pathways
For RGX-121, there are indications that a placebo-controlled arm may be required by EMA, adding complexity to the approval process outside the U.S.
Company Guidance
During the REGENXBIO third-quarter 2025 earnings call, the company provided guidance on several key metrics and strategic plans. They announced the completion of enrollment in the AFFINITY DUCHENNE pivotal trial for RGX-202, aiming to share top-line data in early Q2 2026 and submit a BLA for accelerated approval by mid-2026. The company highlighted its capability to produce 2,500 doses of RGX-202 annually, supporting commercial launch preparations anticipated for 2027. For RGX-121, intended for MPS II, REGENXBIO expressed confidence in FDA approval by early 2026, with a PDUFA date set for February 8. Financially, the company reported cash reserves of $302 million as of September 30, 2025, and expects this to fund operations into early 2027. Additional nondilutive financing opportunities, including a priority review voucher sale, could extend the runway further. The company continues to advance its retinal disease franchise in partnership with AbbVie, with significant progress in their global Phase III studies for wet AMD, aiming for data readouts in Q4 2026.

RegenXBio Financial Statement Overview

Summary
RegenXBio faces financial challenges with persistent losses and high leverage. Despite some revenue growth and strong gross profit margins, profitability and cash flow remain significant concerns due to negative net income and high debt-to-equity ratio.
Income Statement
35
Negative
RegenXBio's income statement shows a challenging financial position with negative net profit margins and declining EBIT and EBITDA margins over the years. Despite a slight revenue growth in the TTM period, the company has struggled to maintain profitability, as evidenced by the negative net income and EBIT margins. The gross profit margin remains relatively strong, indicating some efficiency in production, but overall profitability is a concern.
Balance Sheet
45
Neutral
The balance sheet reveals a high debt-to-equity ratio in the TTM period, indicating increased leverage and potential financial risk. The return on equity is negative, reflecting the company's inability to generate profits from shareholders' equity. However, the equity ratio remains stable, suggesting that a significant portion of the company's assets is financed by equity.
Cash Flow
40
Negative
Cash flow analysis indicates negative operating and free cash flows, which have shown some improvement in growth rates but remain concerning. The operating cash flow to net income ratio is negative, highlighting cash flow challenges. The free cash flow to net income ratio is slightly above 1, indicating that free cash flow is somewhat aligned with net income, albeit both are negative.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue161.32M83.33M90.24M112.72M470.35M154.57M
Gross Profit80.62M49.76M53.03M58.18M418.51M118.85M
EBITDA-120.00M-198.23M-239.46M-244.24M169.54M-96.83M
Net Income-177.91M-227.10M-263.49M-280.32M127.84M-111.25M
Balance Sheet
Total Assets525.20M465.99M573.97M833.27M1.11B708.16M
Cash, Cash Equivalents and Short-Term Investments274.20M234.69M275.26M364.64M457.44M475.74M
Total Debt268.14M82.03M89.29M94.80M86.68M72.65M
Total Liabilities363.75M206.34M262.23M317.07M349.61M330.41M
Stockholders Equity161.45M259.65M311.74M516.20M764.30M377.75M
Cash Flow
Free Cash Flow-106.28M-175.56M-228.37M-238.21M134.70M-80.93M
Operating Cash Flow-103.30M-173.13M-218.41M-207.49M218.88M-54.06M
Investing Cash Flow-13.13M103.45M190.94M-11.93M-406.64M122.76M
Financing Cash Flow118.61M92.68M-34.97M-28.84M195.25M200.21M

RegenXBio Technical Analysis

Technical Analysis Sentiment
Neutral
Last Price13.76
Price Trends
50DMA
13.11
Positive
100DMA
11.85
Positive
200DMA
10.14
Positive
Market Momentum
MACD
0.40
Positive
RSI
47.65
Neutral
STOCH
57.80
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For RGNX, the sentiment is Neutral. The current price of 13.76 is below the 20-day moving average (MA) of 14.34, above the 50-day MA of 13.11, and above the 200-day MA of 10.14, indicating a neutral trend. The MACD of 0.40 indicates Positive momentum. The RSI at 47.65 is Neutral, neither overbought nor oversold. The STOCH value of 57.80 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for RGNX.

RegenXBio Risk Analysis

RegenXBio disclosed 49 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

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
75
Outperform
$1.83B78.859.28%1112.27%
54
Neutral
$756.82M-3.94-76.88%91.30%30.69%
53
Neutral
$465.11M-20.09-26.54%-73.48%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
49
Neutral
$1.10B-7.01-144.07%
47
Neutral
$452.66M-2.27-86.83%17.88%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
RGNX
RegenXBio
13.76
6.39
86.70%
SLDB
Solid Biosciences
5.66
2.39
73.09%
MNPR
Monopar Therapeutics Inc
69.07
40.53
142.01%
GLUE
Monte Rosa Therapeutics
24.08
18.42
325.44%
INBX
Inhibrx Biosciences Inc
71.80
58.31
432.25%
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.Date of analysis: Nov 26, 2025