REGENXBIO (NASDAQ:RGNX) Issues Earnings Results, Misses Expectations By $1.82 EPS

REGENXBIO (NASDAQ:RGNX) posted its quarterly earnings results on Thursday. The biotechnology company reported ($1.72) earnings per share for the quarter, missing analysts’ consensus estimates of $0.10 by ($1.82), FiscalAI reports. REGENXBIO had a negative net margin of 113.75% and a negative return on equity of 103.12%. The business had revenue of $6.39 million during the quarter, compared to the consensus estimate of $25.84 million.

Here are the key takeaways from REGENXBIO’s conference call:

• REGENXBIO said the pivotal phase III portion of the AFFINITY DUCHENNE trial for RGX-202 met its primary endpoint with high statistical significance, and the company is now pointing to a potential accelerated approval path in 2027.
• The therapy showed strong microdystrophin expression, with 93% of patients above the prespecified threshold and 80% above 40%, which management called the highest average expression reported for the older age group across gene therapy programs.
• REGENXBIO highlighted a highly statistically significant correlation between microdystrophin expression and functional improvement, saying this level of biomarker-function linkage has not previously been seen in Duchenne gene therapy.
• Interim 12-month data showed patients performing better than external controls across North Star Ambulatory Assessment and timed function tests, including encouraging results in boys age 8 and older, a group management emphasized as especially difficult to treat.
• The safety profile was described as manageable and in line with earlier studies, though there were two treatment-related serious adverse events—one myocarditis case and one liver injury case—both of which resolved without sequelae.

REGENXBIO Price Performance

Shares of NASDAQ RGNX opened at $6.24 on Friday. The stock’s fifty day moving average price is $8.92 and its two-hundred day moving average price is $11.03. REGENXBIO has a one year low of $6.01 and a one year high of $16.19. The firm has a market cap of $322.11 million, a price-to-earnings ratio of -1.66 and a beta of 1.12.

Wall Street Analysts Forecast Growth

A number of equities research analysts recently weighed in on RGNX shares. Chardan Capital dropped their price target on REGENXBIO from $52.00 to $50.00 and set a “buy” rating on the stock in a research note on Tuesday, February 10th. Morgan Stanley dropped their price target on REGENXBIO from $18.00 to $17.00 and set an “overweight” rating on the stock in a research note on Thursday, March 5th. The Goldman Sachs Group dropped their price target on REGENXBIO from $14.00 to $12.00 and set a “neutral” rating on the stock in a research note on Tuesday, February 10th. HC Wainwright dropped their price target on REGENXBIO from $32.00 to $30.00 and set a “buy” rating on the stock in a research note on Monday, March 9th. Finally, Barclays restated an “overweight” rating and issued a $12.00 price target on shares of REGENXBIO in a research note on Friday. Eight research analysts have rated the stock with a Buy rating, one has assigned a Hold rating and one has given a Sell rating to the company. Based on data from MarketBeat, the stock currently has a consensus rating of “Moderate Buy” and a consensus price target of $25.00.

Insider Buying and Selling

In other REGENXBIO news, insider Steve Pakola sold 15,309 shares of the company’s stock in a transaction on Monday, May 11th. The stock was sold at an average price of $11.02, for a total value of $168,705.18. Following the transaction, the insider directly owned 232,617 shares of the company’s stock, valued at $2,563,439.34. This represents a 6.17% decrease in their position. The sale was disclosed in a filing with the SEC, which is available through this hyperlink. 14.22% of the stock is currently owned by corporate insiders.

Institutional Trading of REGENXBIO

Several large investors have recently modified their holdings of RGNX. AQR Capital Management LLC grew its holdings in shares of REGENXBIO by 2,247.7% during the 1st quarter. AQR Capital Management LLC now owns 620,595 shares of the biotechnology company’s stock worth $4,437,000 after purchasing an additional 594,161 shares in the last quarter. Jane Street Group LLC grew its holdings in shares of REGENXBIO by 151.1% during the 1st quarter. Jane Street Group LLC now owns 414,067 shares of the biotechnology company’s stock worth $2,961,000 after purchasing an additional 249,156 shares in the last quarter. Franklin Resources Inc. acquired a new stake in shares of REGENXBIO during the 2nd quarter worth $239,000. American Century Companies Inc. grew its holdings in shares of REGENXBIO by 8.4% during the 2nd quarter. American Century Companies Inc. now owns 110,066 shares of the biotechnology company’s stock worth $904,000 after purchasing an additional 8,487 shares in the last quarter. Finally, Prudential Financial Inc. acquired a new stake in shares of REGENXBIO during the 2nd quarter worth $87,000. 88.08% of the stock is owned by institutional investors and hedge funds.

REGENXBIO News Summary

Here are the key news stories impacting REGENXBIO this week:

• Positive Sentiment: REGENXBIO reported positive topline results from its pivotal AFFINITY DUCHENNE study of RGX-202, saying the trial met its primary endpoint with high statistical significance and showed a strong correlation between microdystrophin expression and functional improvement, which supports the drug’s regulatory case. Article: REGENXBIO Announces Positive Topline Results from Pivotal Phase III AFFINITY DUCHENNE Study of RGX-202
• Positive Sentiment: Management said RGX-202 is on track toward accelerated approval, and other pipeline catalysts remain ahead, including first dosing in the diabetic retinopathy study and topline wet AMD data expected later this year. Article: REGENXBIO Reports First Quarter 2026 Financial Results and Operational Highlights
• Neutral Sentiment: REGENXBIO also highlighted that the clinical hold on RGX-121 was lifted, removing a development overhang for that program. Article: REGENXBIO Reports First Quarter 2026 Financial Results and Operational Highlights
• Negative Sentiment: The company posted a larger-than-expected Q1 loss of $1.72 per share and revenue of $6.39 million, both well below estimates, reinforcing concerns about weak near-term financial performance. Article: Regenxbio (RGNX) Reports Q1 Loss, Lags Revenue Estimates
• Negative Sentiment: Coverage also pointed to cash-burn concerns and broader balance-sheet pressure, which appear to be outweighing the trial success in trading today. Article: RGNX stock on track for worst day ever as big Q1 loss, cash concerns eclipse Duchenne trial success

REGENXBIO Company Profile

REGENXBIO Inc is a clinical?stage biotechnology company specializing in the development of gene therapies using its proprietary NAV® AAV (adeno?associated virus) platform. The company engineers next?generation AAV vectors designed to deliver functional genes to targeted cells, aiming to address a range of rare genetic diseases and ocular, metabolic and neurologic disorders. REGENXBIO’s pipeline features several product candidates in various stages of preclinical and clinical development, including RGX-314 for wet age?related macular degeneration, RGX-121 for mucopolysaccharidosis II (Hunter syndrome) and RGX-121 for other rare lysosomal storage diseases.

In addition to its internally funded programs, REGENXBIO has established partnerships with major biopharmaceutical companies to advance its NAV technology.