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RegenXBio (RGNX)
NASDAQ:RGNX
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RegenXBio (RGNX) AI Stock Analysis

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RGNX

RegenXBio

(NASDAQ:RGNX)

Rating:54Neutral
Price Target:
$8.50
▼(-6.90%Downside)
RegenXBio's overall score reflects significant financial challenges and valuation concerns, partly offset by positive developments in its clinical pipeline and strategic partnerships. The recent royalty monetization deal adds financial stability, but regulatory uncertainties and competitive pressures remain key risks.
Positive Factors
Regulatory Approval
Interactions with regulatory agency have been positive, with accelerated approval still remaining on the table.
Safety Profile
RGNX has a clean safety profile with no serious adverse events reported in the 13 patients treated thus far.
Trial Enrollment
Enrollment in the pivotal portion of AFFINITY DUCHENNE has surpassed 50%, indicating strong interest in the trial.
Negative Factors
Market Performance
Shares are down over 10% despite functional benefit optically superior to Elevidys, as bears argue small number of patients and optical regression in NSAA make differentiation versus SRPT unclear.
Market Sentiment
Recent events are expected to weigh on sentiment for gene therapy stocks across the S&P 600 Health Care Index.
Regulatory Concerns
There is an expectation that RGNX bears may argue regulators could become more conservative on future DMD gene therapies.

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

RegenXBio Business Overview & Revenue Model

Company DescriptionRegenXBio Inc. is a biotechnology company specializing in the development, commercialization, and licensing of gene therapy products. It operates in the biopharmaceutical sector with a focus on leveraging its proprietary NAV Technology Platform to develop transformative treatments for retinal, neurodegenerative, and metabolic diseases. RegenXBio's core products and services include a pipeline of internally developed gene therapy candidates and partnerships with other biopharmaceutical companies to advance novel therapeutic solutions.
How the Company Makes MoneyRegenXBio makes money through a combination of product development, licensing agreements, and strategic partnerships. A significant portion of the company's revenue is derived from licensing its NAV Technology Platform to other biotech and pharmaceutical companies, allowing them to develop their own gene therapy products. These licensing agreements often include upfront payments, milestone payments based on the achievement of specific development or regulatory goals, and royalties on future sales of licensed products. Additionally, RegenXBio generates revenue through collaborations and partnerships that involve co-development or co-commercialization of therapeutic candidates, sharing both the risks and potential rewards of product development. The company's revenue model is heavily dependent on the success of its gene therapy candidates, both those developed internally and those advanced through partnerships.

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:Main Street Data

RegenXBio Earnings Call Summary

Earnings Call Date:May 12, 2025
(Q1-2025)
|
% Change Since: 14.55%|
Next Earnings Date:Jul 30, 2025
Earnings Call Sentiment Positive
The earnings call revealed a strong start to the fiscal year for REGENXBIO, with significant clinical and financial progress. The company's strategic partnerships and manufacturing capabilities position them well for future commercial success, though regulatory uncertainties and competitive pressures remain challenges.
Q1-2025 Updates
Positive Updates
Strong Clinical Progress
REGENXBIO reported significant advancements in their late-stage clinical programs, including RGX-121 for MPS II and RGX-202 for Duchenne muscular dystrophy, with over 50% enrollment reached in pivotal studies.
Strategic Partnerships
The company established a key strategic partnership with Nippon Shinyaku to commercialize neurodegenerative franchises, including RGX-121 and RGX-111, enhancing their commercial prospects.
Solid Financial Position
The company ended the quarter with $272 million in cash, cash equivalents, and marketable securities, up from $245 million at the end of 2024, thanks to a $110 million upfront payment from Nippon Shinyaku.
Upcoming Data and Approvals
REGENXBIO anticipates FDA approval for RGX-121 in the second half of 2025 and plans to submit a BLA for RGX-202 in mid-2026.
Manufacturing Capabilities
Their Manufacturing Innovation Center in Maryland is set to produce RGX-202 commercial supply beginning in the third quarter of 2025, with the capacity to produce up to 2,500 doses annually.
Positive Phase I/II Data
The Phase I/II data for RGX-202 showed consistent microdystrophin expression and functional improvements in patients, with a favorable safety profile.
Negative Updates
Regulatory Uncertainty
There is some uncertainty around the FDA's acceptance of the BLA for RGX-121, which is expected imminently, and potential changes in regulatory requirements for gene therapies.
Competitive Challenges
The company faces competitive challenges in the Duchenne muscular dystrophy space, particularly from Sarepta Therapeutics, which has experienced regulatory and commercial hurdles.
Company Guidance
In the first quarter of 2025 earnings call, REGENXBIO provided guidance on several key metrics, highlighting robust progress across their gene therapy pipeline. The company anticipates FDA acceptance of the BLA for RGX-121, a potential first gene therapy for MPS II, with an expected approval in the second half of 2025. RGX-202, their candidate for Duchenne muscular dystrophy, has surpassed 50% enrollment in its pivotal study, with a BLA submission planned for mid-2026. The company is preparing for commercial supply production in Q3 2025, capable of producing 2,500 doses annually. Financially, REGENXBIO ended Q1 2025 with $272 million in cash, projecting this to fund operations into the second half of 2026, excluding potential non-dilutive financing. Additionally, the company is progressing on its retinal programs in collaboration with AbbVie, with pivotal trials for ABBV-RGX-314 targeting wet AMD and diabetic retinopathy.

RegenXBio Financial Statement Overview

Summary
RegenXBio faces significant financial challenges with consistent losses and negative cash flows. While there is a strong cash position and slight improvement in free cash flow, overall financial health remains weak.
Income Statement
45
Neutral
RegenXBio has experienced fluctuating revenue with a significant decline from 2021 to 2024, followed by a slight recovery in TTM. The company has consistently reported negative EBIT and net income, indicating ongoing operational challenges. Gross profit margins have remained relatively stable, but the net profit margin is negative, reflecting persistent losses.
Balance Sheet
55
Neutral
The company maintains a moderate debt-to-equity ratio, suggesting manageable leverage. However, stockholders' equity has decreased over time, indicating potential financial strain. The equity ratio has also declined, reflecting reduced financial stability. Despite these challenges, the company has maintained a strong cash position relative to its debt.
Cash Flow
50
Neutral
RegenXBio has faced negative operating and free cash flows, highlighting cash flow challenges. However, there has been a positive trend in free cash flow growth in the TTM period, indicating some improvement. The operating cash flow to net income ratio is unfavorable, reflecting cash flow inefficiencies.
BreakdownDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue83.33M90.24M112.72M470.35M154.57M
Gross Profit49.76M53.03M58.18M418.51M118.85M
EBITDA-198.23M-239.46M-244.24M169.54M-96.83M
Net Income-227.10M-263.49M-280.32M127.84M-111.25M
Balance Sheet
Total Assets465.99M573.97M833.27M1.11B708.16M
Cash, Cash Equivalents and Short-Term Investments234.69M275.26M364.64M457.44M475.74M
Total Debt82.03M89.29M94.80M86.68M72.65M
Total Liabilities206.34M262.23M317.07M349.61M330.41M
Stockholders Equity259.65M311.74M516.20M764.30M377.75M
Cash Flow
Free Cash Flow-175.56M-228.37M-238.21M134.70M-80.93M
Operating Cash Flow-173.13M-218.41M-207.49M218.88M-54.06M
Investing Cash Flow103.45M190.94M-11.93M-406.64M122.76M
Financing Cash Flow92.68M-34.97M-28.84M195.25M200.21M

RegenXBio Technical Analysis

Technical Analysis Sentiment
Positive
Last Price9.13
Price Trends
50DMA
8.97
Positive
100DMA
8.17
Positive
200DMA
8.42
Positive
Market Momentum
MACD
-0.01
Negative
RSI
55.09
Neutral
STOCH
77.06
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 9.13 is above the 20-day moving average (MA) of 8.63, above the 50-day MA of 8.97, and above the 200-day MA of 8.42, indicating a bullish trend. The MACD of -0.01 indicates Negative momentum. The RSI at 55.09 is Neutral, neither overbought nor oversold. The STOCH value of 77.06 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 48 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 (52)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
57
Neutral
$739.87M-83.24%-100.32%-197.69%
54
Neutral
$458.03M-47.44%80.70%46.66%
52
Neutral
$7.61B0.10-63.03%2.08%16.34%0.32%
52
Neutral
$992.16M-34.26%271.44%26.65%
50
Neutral
$677.36M-159.34%-48.97%69.32%
47
Neutral
$451.65M344.74%-47.32%-26.67%
34
Underperform
$484.42M-45.82%10.38%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
RGNX
RegenXBio
9.13
-5.20
-36.29%
IVA
Inventiva
3.39
1.11
48.68%
TSHA
Taysha Gene Therapies
2.59
0.29
12.61%
VERV
Verve Therapeutics
11.13
3.73
50.41%
ERAS
Erasca
1.71
-1.57
-47.87%
AMLX
Amylyx Pharmaceuticals Inc
8.30
6.33
321.32%

RegenXBio Corporate Events

Executive/Board ChangesShareholder Meetings
RegenXBio Holds 2025 Annual Stockholders Meeting
Neutral
Jun 3, 2025

At REGENXBIO Inc.’s 2025 Annual Meeting of Stockholders held on May 30, 2025, several key proposals were voted on. Four individuals were elected as Class I directors to serve until 2028, and PricewaterhouseCoopers LLP was ratified as the independent public accounting firm for the year. Additionally, stockholders approved the executive compensation plan and decided to hold annual advisory votes on this matter. The 2025 Equity Incentive Plan was also approved.

The most recent analyst rating on (RGNX) stock is a Buy with a $39.00 price target. To see the full list of analyst forecasts on RegenXBio stock, see the RGNX Stock Forecast page.

Private Placements and FinancingBusiness Operations and Strategy
RegenXBio Secures $250M Royalty Monetization Deal
Positive
May 19, 2025

On May 16, 2025, REGENXBIO Inc. announced a strategic royalty monetization agreement with HealthCare Royalty Management, LLC, securing up to $250 million in non-dilutive funding through a limited recourse royalty bond. This agreement provides immediate capital of $150 million, extending the company’s cash runway into early 2027 and supporting its late-stage gene therapy programs. The deal allows REGENXBIO to leverage anticipated royalties from products like ZOLGENSMA® and potential future milestones, positioning the company to accelerate commercial preparations and maintain its leadership in gene therapy.

The most recent analyst rating on (RGNX) stock is a Buy with a $39.00 price target. To see the full list of analyst forecasts on RegenXBio stock, see the RGNX Stock Forecast page.

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: Jul 23, 2025