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RegenXBio (RGNX)
NASDAQ:RGNX

RegenXBio (RGNX) AI Stock Analysis

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RegenXBio

(NASDAQ:RGNX)

Rating:66Neutral
Price Target:
$10.50
▲(13.27%Upside)
RegenXBio's overall stock score is driven by strong technical momentum and positive earnings call sentiment, highlighting clinical advancements and strategic partnerships. Financial challenges and valuation concerns weigh down the score, but the recent corporate event provides a positive funding outlook, enhancing the company's financial stability.
Positive Factors
Clinical Trial Progress
RGX-202 improved North Star Ambulatory Assessment (NSAA) and timed function tests, exceeding external natural history control.
Financial Stability
RGNX announced a royalty transaction with Healthcare Royalty, extending cash runway into early-27.
Safety Profile
Safety data is clean with no serious adverse events or adverse events of special interest across 12 dosed patients.
Negative Factors
Revenue Uncertainty
Uncertainty around Zolgensma revenue trajectory and patent duration remains.
Stock 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.

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

RegenXBio Business Overview & Revenue Model

Company DescriptionRegenXBio Inc. (RGNX) is a biotechnology company focused on the development, commercialization, and licensing of gene therapy products. The company leverages its proprietary NAV Technology Platform to develop treatments for a range of retinal, metabolic, and neurodegenerative diseases. RegenXBio's core offerings include gene therapy product candidates designed to address unmet medical needs by delivering therapeutic genes to patients using viral vectors.
How the Company Makes MoneyRegenXBio generates revenue primarily through licensing agreements and collaborations related to its NAV Technology Platform. The company licenses its technology to other pharmaceutical and biotechnology companies, which in turn develop and commercialize gene therapy products. RegenXBio receives upfront payments, milestone payments, and royalties on sales of products developed using its platform. Additionally, the company engages in strategic partnerships and collaborations to co-develop therapies, sharing both the costs and profits. These partnerships often provide funding for research and development, contributing significantly to RegenXBio's earnings.

RegenXBio Earnings Call Summary

Earnings Call Date:May 12, 2025
(Q1-2025)
|
% Change Since: 16.31%|
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 ongoing net losses despite healthy gross profit margins. The balance sheet shows moderate strength with manageable debt levels, but the negative net profit margin and cash flow issues remain concerning. Improvement in free cash flow is a positive sign, yet profitability is needed to leverage equity effectively.
Income Statement
40
Negative
RegenXBio's income statement shows significant challenges with profitability. The company's gross profit margin is healthy at approximately 76.55% TTM, but it is overshadowed by persistent net losses, as indicated by a negative net profit margin of -100.62% TTM. Revenue growth shows volatility, with a recent increase of 88.04% from the previous year, yet this is not translating into profits. EBIT and EBITDA margins are also negative, reflecting ongoing operational losses.
Balance Sheet
50
Neutral
The balance sheet reveals a moderate financial position with a debt-to-equity ratio of 0.29 TTM, indicating a manageable debt level relative to equity. The equity ratio is 55.84% TTM, suggesting a decent proportion of assets financed by equity. However, the company's return on equity remains negative due to sustained net losses, highlighting the need for improved profitability to leverage equity effectively.
Cash Flow
45
Neutral
RegenXBio's cash flow statement presents a mixed picture. Operating cash flow is negative, reflecting cash burn from operations. Despite this, the free cash flow has shown improvement, with a reduction in negative free cash flow by 50.47% from the previous year. The ratio of operating cash flow to net income is above 1, indicating that the company is effective in converting net income (albeit negative) into operating cash flow, yet free cash flow remains a concern.
Breakdown
TTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
156.72M83.33M90.24M112.72M470.35M154.57M
Gross Profit
119.95M49.76M53.03M58.18M418.51M118.85M
EBIT
-157.36M-233.35M-268.13M-262.88M159.98M-119.23M
EBITDA
-128.92M-198.23M-239.46M-244.24M169.54M-96.83M
Net Income Common Stockholders
-157.69M-227.10M-263.49M-280.32M127.84M-111.25M
Balance SheetCash, Cash Equivalents and Short-Term Investments
267.87M234.69M275.26M364.64M457.44M475.74M
Total Assets
490.93M465.99M573.97M833.27M1.11B708.16M
Total Debt
79.85M82.03M89.29M94.80M86.68M72.65M
Net Debt
-50.26M24.51M54.77M-2.15M-258.53M-265.77M
Total Liabilities
216.73M206.34M262.23M317.07M349.61M330.41M
Stockholders Equity
274.20M259.65M311.74M516.20M764.30M377.75M
Cash FlowFree Cash Flow
-86.94M-175.56M-228.37M-238.21M134.70M-80.93M
Operating Cash Flow
-84.04M-173.13M-218.41M-207.49M218.88M-54.06M
Investing Cash Flow
135.01M103.45M190.94M-11.93M-406.64M122.76M
Financing Cash Flow
-33.84M92.68M-34.97M-28.84M195.25M200.21M

RegenXBio Technical Analysis

Technical Analysis Sentiment
Neutral
Last Price9.27
Price Trends
50DMA
8.40
Positive
100DMA
7.89
Positive
200DMA
8.82
Positive
Market Momentum
MACD
0.34
Positive
RSI
50.26
Neutral
STOCH
65.56
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 9.27 is below the 20-day moving average (MA) of 9.54, above the 50-day MA of 8.40, and above the 200-day MA of 8.82, indicating a neutral trend. The MACD of 0.34 indicates Positive momentum. The RSI at 50.26 is Neutral, neither overbought nor oversold. The STOCH value of 65.56 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 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 (54)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
66
Neutral
$511.64M-47.44%80.70%46.66%
58
Neutral
$569.63M-34.26%271.44%26.65%
57
Neutral
$483.14M-83.24%-100.32%-197.69%
54
Neutral
$698.29M-159.34%-48.97%69.32%
54
Neutral
$5.41B3.27-45.10%3.29%16.81%0.02%
IVIVA
51
Neutral
$473.84M344.74%-47.32%-26.67%
34
Underperform
$430.60M-45.82%10.38%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
RGNX
RegenXBio
9.27
-2.37
-20.36%
IVA
Inventiva
3.47
0.80
29.96%
TSHA
Taysha Gene Therapies
2.54
-1.49
-36.97%
VERV
Verve Therapeutics
6.16
0.89
16.89%
ERAS
Erasca
1.48
-0.52
-26.00%
AMLX
Amylyx Pharmaceuticals Inc
5.52
3.87
234.55%

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.