RegenXBio (RGNX) AI Stock Analysis

• Market Cap: $460.69M
• Dividend Yield: N/A
• Average Volume (3M): 667.50K
• Price to Earnings (P/E): ―
• Beta (1Y): 2.18
• Revenue Growth: 74.95%
• EPS Growth: 34.25%
• Country: US
• Employees: 353
• Sector: Healthcare
• Sector Strength: 49
• Industry: Biotechnology
• EPS (TTM): -1.38
• Shares Outstanding: 50,514,217
• 10 Day Avg. Volume: 619,400
• 30 Day Avg. Volume: 667,496
• PEG Ratio: N/A
• Price to Book (P/B): N/A
• Price to Sales (P/S): N/A
• P/FCF Ratio: N/A
• Enterprise Value/Market Cap: 0.81
• Enterprise Value/Revenue: 2.38
• Enterprise Value/Gross Profit: 2.98
• Enterprise Value/Ebitda: -2.86
• 1Y Price Target: $27.25
• Price Target Upside: 189.28% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 9

• Rating: 59 Neutral
• Price Target: $9.50 ▲(0.85% Upside)

RegenXBio's overall stock score reflects a mix of significant financial challenges and promising strategic developments. The company's strong clinical progress and strategic partnerships are positive factors, but financial instability and valuation concerns weigh heavily. The amended collaboration with AbbVie and solid cash position provide some optimism for future growth.

Positive Factors

Financial Performance

Current cash of $363.6mm is expected to fund operations into early-'27.

Partnerships and Collaborations

RGNX entered a partnership with Nippon Shinyaku to commercialize RGX-121 in the US and Asia in exchange for $110M upfront and $700M in potential milestones.

Regulatory Approvals

RGX-121 has received Orphan Drug, Rare Pediatric Disease, Fast Track, and Regenerative Medicine Advanced Therapy (RMAT) designations from the FDA and advanced therapy medicinal products (ATMP) classification from the European Medicines Agency.

Negative Factors

Market Opportunities

Share impact will likely be muted as commercial opportunity in MPS II is modest and RGNX monetized the majority of its economic interest through strategic partnership with Nippon Shinyaku.

Regulatory Delays

The FDA extended BLA review of clemidsogene lanparvovec (RGX-121) for Mucopolysaccharidosis II, pushing the PDUFA date to February 8, 2026.

Stock Price Target

The price target was lowered to $17 from a previous value.

RegenXBio Business Overview & Revenue Model

Company Description

RegenXBio Inc. is a biotechnology company focused on developing gene therapies for the treatment of various genetic diseases and disorders. The company specializes in its proprietary adeno-associated virus (AAV) gene therapy platform, which is designed to provide long-lasting therapeutic effects by delivering genetic material directly to target cells. RegenXBio's core products include treatments for conditions such as X-linked retinitis pigmentosa, spinal muscular atrophy, and other rare genetic disorders, positioning the company at the forefront of the growing gene therapy market.

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	155.78M	83.33M	90.24M	112.72M	470.35M	154.57M
Gross Profit	124.53M	49.76M	53.03M	58.18M	418.51M	118.85M
EBITDA	-129.93M	-198.23M	-239.46M	-244.24M	169.54M	-96.83M
Net Income	-175.57M	-227.10M	-263.49M	-280.32M	127.84M	-111.25M
Balance Sheet
Total Assets	581.03M	465.99M	573.97M	833.27M	1.11B	708.16M
Cash, Cash Equivalents and Short-Term Investments	323.30M	234.69M	275.26M	364.64M	457.44M	475.74M
Total Debt	271.69M	82.03M	89.29M	94.80M	86.68M	72.65M
Total Liabilities	367.35M	206.34M	262.23M	317.07M	349.61M	330.41M
Stockholders Equity	213.68M	259.65M	311.74M	516.20M	764.30M	377.75M
Cash Flow
Free Cash Flow	-90.71M	-175.56M	-228.37M	-238.21M	134.70M	-80.93M
Operating Cash Flow	-87.89M	-173.13M	-218.41M	-207.49M	218.88M	-54.06M
Investing Cash Flow	-5.16M	103.45M	190.94M	-11.93M	-406.64M	122.76M
Financing Cash Flow	114.84M	92.68M	-34.97M	-28.84M	195.25M	200.21M

RegenXBio Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 9.42
• 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 9.42 is above the 20-day moving average (MA) of 8.67, above the 50-day MA of 8.62, and above the 200-day MA of 8.24, indicating a bullish trend. The MACD of 0.23 indicates Negative momentum. The RSI at 57.81 is Neutral, neither overbought nor oversold. The STOCH value of 84.58 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
RGNX	59 Neutral	$460.69M	―	-62.49%	―	74.95%	34.25%
AMLX	57 Neutral	$889.89M	―	-87.42%	―	-100.08%	-2.45%
IVA	53 Neutral	$729.08M	―	344.74%	―	-47.32%	-26.67%
TSHA	53 Neutral	$796.56M	―	-51.86%	―	-37.09%	58.96%
VERV	52 Neutral		―		―	271.44%	26.65%
Sector *	51 Neutral	$7.91B	-0.36	-41.70%	2.23%	23.45%	-1.86%
ERAS	34 Underperform	$453.87M	―	-31.16%	―	―	50.77%

RegenXBio Corporate Events

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.

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.

RegenXBio Holds 2025 Annual Stockholders Meeting

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.