RegenXBio (RGNX) AI Stock Analysis

• Market Cap: $457.63M
• Dividend Yield: N/A
• Average Volume (3M): 1.03M
• Price to Earnings (P/E): ―
• Beta (1Y): 2.35
• 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: 684,138
• 30 Day Avg. Volume: 1,028,832
• 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: 1.48
• Enterprise Value/Revenue: 4.20
• Enterprise Value/Gross Profit: 8.40
• Enterprise Value/Ebitda: -5.64
• 1Y Price Target: $32.89
• Price Target Upside: 263.83% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 10
• EPS Forecast (FY): -2.04
• Revenue Forecast (FY): $254.28M

• Rating: 47 Neutral
• Price Target: $13.00 ▲(43.81% Upside)
• Action: Downgraded Date: 01/29/26
• Date: Action: Downgraded 01/29/26

The score is weighed down primarily by weak financial performance (ongoing losses, negative cash flow, and higher leverage) and a materially negative corporate event (FDA clinical holds). Technicals are mixed with near-term weakness but some longer-term support, while valuation remains challenging due to negative earnings. The earnings call provides a partial offset via strong cash runway and multiple near-term pipeline catalysts, but regulatory risk remains the dominant concern.

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 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

Financial statements point to persistent losses and negative operating/free cash flow. While gross margin and recent revenue growth provide some support, leverage is elevated (high debt-to-equity) and returns on equity remain negative, keeping overall financial quality weak.

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: Negative
• Last Price: 9.04
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• 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 Negative. The current price of 9.04 is below the 20-day moving average (MA) of 9.15, below the 50-day MA of 12.13, and below the 200-day MA of 10.58, indicating a bearish trend. The MACD of -1.09 indicates Negative momentum. The RSI at 41.18 is Neutral, neither overbought nor oversold. The STOCH value of 85.80 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for RGNX.

RegenXBio Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
GLUE	75 Outperform	$1.35B	58.12	9.28%	―	1112.27%	―
MNPR	53 Neutral	$366.24M	-15.94	-26.54%	―	―	-73.48%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
INBX	49 Neutral	$1.08B	-7.24	-144.07%	―	―	―
RGNX	47 Neutral	$457.63M	-2.59	-76.88%	―	91.30%	30.69%
SLDB	47 Neutral	$483.82M	-2.49	-86.83%	―	―	17.88%

RegenXBio Corporate Events

FDA Halts RegenXBio MPS Gene Therapy Trials

On January 28, 2026, REGENXBIO announced that the U.S. Food and Drug Administration placed clinical holds on its investigational gene therapies RGX-111 for MPS I (Hurler syndrome) and RGX-121 for MPS II (Hunter syndrome). The action followed detection of an intraventricular CNS tumor in a five-year-old participant who had received RGX-111 four years earlier; preliminary analysis found an AAV vector genome integration event linked to overexpression of the proto-oncogene PLAG1, though causality has not been established and the child remains asymptomatic with developmental gains. No neoplasms have been seen in nine other RGX-111 recipients or in 32 patients treated with RGX-121, and management publicly questioned the FDA’s decision to halt RGX-121 given its safety record and pivotal-trial efficacy to date. The holds temporarily stall two cornerstone ultra-rare disease programs that target critical unmet neurological needs in MPS I and II, introducing regulatory uncertainty for REGENXBIO’s CNS gene therapy platform while heightening scrutiny of AAV vector integration risks across the gene therapy field.

The most recent analyst rating on (RGNX) stock is a Buy with a $37.00 price target. To see the full list of analyst forecasts on RegenXBio stock, see the RGNX Stock Forecast page.