RegenXBio (RGNX) AI Stock Analysis

• Market Cap: $586.47M
• Dividend Yield: N/A
• Average Volume (3M): 620.02K
• Price to Earnings (P/E): ―
• Beta (1Y): 2.23
• Revenue Growth: 74.95%
• EPS Growth: 34.25%
• Country: US
• Employees: 353
• Sector: Healthcare
• Sector Strength: 45
• Industry: Biotechnology
• EPS (TTM): -1.20
• Shares Outstanding: 50,514,217
• 10 Day Avg. Volume: 520,963
• 30 Day Avg. Volume: 620,023
• 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: 0.00
• Enterprise Value/Revenue: 0.00
• Enterprise Value/Gross Profit: 0.00
• Enterprise Value/Ebitda: 0.00
• 1Y Price Target: $24.25
• Price Target Upside: 117.10% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 9
• EPS Forecast (FY): N/A
• Revenue Forecast (FY): N/A

• Rating: 51 Neutral
• Price Target: $11.00 ▼(-1.52% Downside)

RegenXBio's overall stock score reflects significant financial challenges and mixed technical indicators. While the company shows strong pipeline progress and a solid cash position, ongoing losses and regulatory uncertainties weigh heavily on its valuation and financial performance.

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 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 Money

RegenXBio generates revenue primarily through the development and commercialization of its gene therapy products. The company earns money through several key revenue streams, including upfront payments, milestone payments, and royalties from partnerships and collaborations with larger pharmaceutical companies. Notable partnerships, such as those with Novartis and AbbVie, contribute to the company's earnings by providing funding for research and development, as well as access to additional resources for clinical trials. Additionally, RegenXBio may receive milestone payments tied to the successful development and commercialization of its therapies, further enhancing its revenue potential.

RegenXBio Financial Statement Overview

Summary

RegenXBio faces significant financial challenges, with declining revenues, negative profitability, and increased leverage. The company's operational inefficiencies and cash flow issues pose risks to its financial health. While there are some strengths in gross profit margins, the overall financial position is concerning, requiring strategic improvements to stabilize and grow the business.

Income Statement

RegenXBio's income statement shows significant challenges with declining revenue and negative profit margins. The TTM data indicates a sharp revenue decline of 59.7% compared to the previous year, and the company is operating at a net loss with a net profit margin of -112.7%. The gross profit margin remains relatively high at 79.9%, suggesting some efficiency in managing production costs, but the negative EBIT and EBITDA margins highlight ongoing operational inefficiencies.

Balance Sheet

The balance sheet reflects a high debt-to-equity ratio of 1.27 in the TTM period, indicating increased leverage and potential financial risk. Stockholders' equity has decreased, impacting the equity ratio. Return on equity is negative, reflecting the company's inability to generate profit from shareholders' investments. The company's financial stability is a concern due to rising debt levels and declining equity.

Cash Flow

Cash flow analysis reveals negative operating and free cash flows, with a slight improvement in free cash flow growth. The operating cash flow to net income ratio is negative, indicating cash flow challenges. The free cash flow to net income ratio is slightly above 1, suggesting that the company is managing to convert some of its net income into free cash flow, but overall cash flow health remains weak.

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	136.72M	49.76M	53.03M	58.18M	418.51M	118.85M
EBITDA	-127.52M	-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	76.51M	141.72M	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: 11.17
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Positive
• RSI: Neutral
• STOCH: Positive

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 11.17 is below the 20-day moving average (MA) of 12.25, above the 50-day MA of 10.73, and above the 200-day MA of 8.77, indicating a neutral trend. The MACD of 0.32 indicates Positive momentum. The RSI at 44.81 is Neutral, neither overbought nor oversold. The STOCH value of 8.73 is Positive, 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	$1.19B	-7.46	-113.71%	―	―	―
GLUE	52 Neutral	$760.26M	37.92	9.81%	―	2990.57%	―
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
RGNX	51 Neutral	$586.47M	―	-62.49%	―	74.95%	34.25%
MNPR	48 Neutral	$595.88M	―	-59.38%	―	―	-44.41%
SLDB	44 Neutral	$306.19M	―	-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.