RegenXBio (RGNX) AI Stock Analysis

• Market Cap: $671.26M
• Dividend Yield: N/A
• Average Volume (3M): 567.46K
• Price to Earnings (P/E): ―
• Beta (1Y): 2.17
• Revenue Growth: 91.30%
• EPS Growth: 30.69%
• Country: US
• Employees: 353
• Sector: Healthcare
• Sector Strength: 45
• Industry: Biotechnology
• EPS (TTM): -1.20
• Shares Outstanding: 50,623,085
• 10 Day Avg. Volume: 583,321
• 30 Day Avg. Volume: 567,462
• PEG Ratio: 0.07
• Price to Book (P/B): 1.47
• Price to Sales (P/S): 4.59
• P/FCF Ratio: -2.18
• Enterprise Value/Market Cap: 0.73
• Enterprise Value/Revenue: 3.05
• Enterprise Value/Gross Profit: 6.11
• Enterprise Value/Ebitda: -4.11
• 1Y Price Target: $24.25
• Price Target Upside: 82.88% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 9
• EPS Forecast (FY): -3.1
• Revenue Forecast (FY): $198.55M

• Rating: 54 Neutral
• Price Target: $13.50 ▲(1.81% 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 Business Overview & Revenue Model

Company Description

RegenXBio (RGNX) is a clinical-stage biotechnology company focused on developing gene therapies for the treatment of genetic diseases and disorders. The company leverages its proprietary AAV gene delivery platform to create therapies that address a range of conditions, including rare and chronic diseases. RegenXBio's core products and services revolve around its gene therapy candidates, which are designed to provide lasting therapeutic effects by delivering healthy copies of genes directly to patients' cells.

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 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 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

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

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

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.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	161.32M	83.33M	90.24M	112.72M	470.35M	154.57M
Gross Profit	80.62M	49.76M	53.03M	58.18M	418.51M	118.85M
EBITDA	-120.00M	-198.23M	-239.46M	-244.24M	169.54M	-96.83M
Net Income	-177.91M	-227.10M	-263.49M	-280.32M	127.84M	-111.25M
Balance Sheet
Total Assets	525.20M	465.99M	573.97M	833.27M	1.11B	708.16M
Cash, Cash Equivalents and Short-Term Investments	274.20M	234.69M	275.26M	364.64M	457.44M	475.74M
Total Debt	268.14M	82.03M	89.29M	94.80M	86.68M	72.65M
Total Liabilities	363.75M	206.34M	262.23M	317.07M	349.61M	330.41M
Stockholders Equity	161.45M	259.65M	311.74M	516.20M	764.30M	377.75M
Cash Flow
Free Cash Flow	-106.28M	-175.56M	-228.37M	-238.21M	134.70M	-80.93M
Operating Cash Flow	-103.30M	-173.13M	-218.41M	-207.49M	218.88M	-54.06M
Investing Cash Flow	-13.13M	103.45M	190.94M	-11.93M	-406.64M	122.76M
Financing Cash Flow	118.61M	92.68M	-34.97M	-28.84M	195.25M	200.21M

RegenXBio Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 13.26
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Negative
• RSI: Neutral
• STOCH: Negative

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 13.26 is above the 20-day moving average (MA) of 11.77, above the 50-day MA of 11.38, and above the 200-day MA of 9.03, indicating a bullish trend. The MACD of 0.25 indicates Negative momentum. The RSI at 64.30 is Neutral, neither overbought nor oversold. The STOCH value of 86.94 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for RGNX.

RegenXBio Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
INBX	55 Neutral	$1.22B	―	-144.07%	―	―	―
RGNX	54 Neutral	$671.26M	―	-76.88%	―	91.30%	30.69%
GLUE	52 Neutral	$1.04B	52.36	9.28%	―	1112.27%	―
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
MNPR	48 Neutral	$591.21M	―	-26.54%	―	―	-73.48%
SLDB	44 Neutral	$401.24M	―	-86.83%	―	―	17.88%
OPT	39 Underperform	$477.76M	-3.01	―	―	-80.09%	60.14%

RegenXBio Corporate Events

REGENXBIO Reports Q3 2025 Financial and Operational Progress

REGENXBIO Inc. is a biotechnology company specializing in the development of gene therapies for rare and retinal diseases, leveraging its proprietary AAV gene therapy platform to deliver one-time treatments.

RegenXBio’s RGX-202 Gene Therapy: A Promising Step for Duchenne Muscular Dystrophy

RegenXBio Inc. is conducting a clinical study titled ‘AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD).’ The study aims to evaluate the safety, tolerability, efficacy, pharmacodynamics, and pharmacokinetics of RGX-202 gene therapy in males with DMD. This study is significant as it explores a potential new treatment for DMD, a severe genetic disorder.

RegenXBio’s RGX-202: Promising Long-term Study for Duchenne Muscular Dystrophy

Study Overview: RegenXBio Inc. is conducting a long-term follow-up study titled ‘A Long-term Follow-up Study to Evaluate the Safety and Efficacy of RGX-202 Gene Therapy in Males With Duchenne Muscular Dystrophy (DMD)’. The study aims to assess the prolonged safety and effectiveness of RGX-202, a gene therapy designed to deliver a transgene for a novel microdystrophin, in individuals who participated in a previous study. This research is significant as it seeks to provide insights into the long-term impact of gene therapy on DMD, a severe genetic disorder.

RegenXBio’s New Study: A Step Forward in DMD Research

RegenXBio Inc. is conducting a study titled ‘Anti-AAV8 Antibody Assessment Study of Boys With Duchenne Muscular Dystrophy Aged 0 to <12 Years.' The study aims to evaluate the prevalence of anti-adeno-associated serotype 8 (AAV8) antibodies in boys with Duchenne muscular dystrophy (DMD), a significant step in understanding immune responses in this patient population.

FDA Extends Review for RegenXBio’s RGX-121 Therapy

On August 18, 2025, REGENXBIO announced that the FDA has extended the review timeline for its Biologics License Application for RGX-121, a potential one-time therapy for Mucopolysaccharidosis II (Hunter syndrome), from November 9, 2025, to February 8, 2026. This extension allows for the review of additional clinical data, which the company plans to present at the ICIEM meeting in September 2025. The FDA’s inspection found no safety concerns, and RGX-121 has received several designations from the FDA, indicating its potential impact on addressing the unmet medical needs of patients with Hunter syndrome.

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.

REGENXBIO Reports Q2 2025 Financial Results and Progress

REGENXBIO Inc. is a biotechnology company focused on developing gene therapies for serious diseases, including Duchenne muscular dystrophy, Hunter syndrome, and retinal diseases. The company is advancing a late-stage pipeline of one-time treatments, leveraging its AAV gene therapy platform.

RegenXBio and AbbVie Amend Collaboration Agreement

On August 5, 2025, REGENXBIO Inc. and AbbVie Global Enterprises Ltd. amended their collaboration agreement to modify the development plan for diabetic retinopathy and enhance investment in the wet AMD program. This amendment includes a revised milestone payment structure, with AbbVie committing $100 million upon the first patient dosed in the Phase IIb/III trial and another $100 million for the subsequent Phase III trial. Additionally, AbbVie will lead a new Phase IIIb study for wet AMD, while REGENXBIO will focus on advancing its gene therapy programs, including RGX-202 for Duchenne muscular dystrophy and RGX-121 for Hunter syndrome, with potential FDA approvals and pivotal trial data expected in the coming years.

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.