REGENXBIO (NASDAQ:RGNX) Announces Quarterly Earnings Results

REGENXBIO (NASDAQ:RGNX) posted its earnings results on Thursday. The biotechnology company reported ($1.72) earnings per share for the quarter, missing the consensus estimate of ($1.36) by ($0.36), FiscalAI reports. The firm had revenue of $6.39 million during the quarter, compared to analyst estimates of $25.84 million. REGENXBIO had a negative net margin of 330.23% and a negative return on equity of 182.07%.

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 Stock Down 8.3%

RGNX opened at $5.72 on Friday. The firm has a market cap of $295.27 million, a P/E ratio of -1.02 and a beta of 1.12. REGENXBIO has a 52 week low of $5.71 and a 52 week high of $16.19. The business’s fifty day simple moving average is $8.86 and its 200 day simple moving average is $10.99.

Key Stories Impacting REGENXBIO

Here are the key news stories impacting REGENXBIO this week:

• Positive Sentiment: REGENXBIO reported positive topline results from its pivotal Phase III AFFINITY DUCHENNE study of RGX-202, saying it hit the primary endpoint with high statistical significance and showed a strong link between microdystrophin expression and functional improvement. Article: REGENXBIO Announces Positive Topline Results from Pivotal Phase III AFFINITY DUCHENNE Study of RGX-202
• Positive Sentiment: Bank of America lowered its price target to $14 from $25 but kept a buy rating, which still signals meaningful upside from current levels and may help support sentiment. Article: Bank of America price target cut on REGENXBIO
• Neutral Sentiment: Management also highlighted several upcoming catalysts, including progress in wet AMD, diabetic retinopathy, and the lifting of the clinical hold on RGX-121, which could matter later this year. Article: REGENXBIO Reports First Quarter 2026 Financial Results and Operational Highlights
• Negative Sentiment: First-quarter results badly missed expectations, with a larger-than-expected loss and revenue well below forecasts, reinforcing concerns about operating performance. Article: Regenxbio (RGNX) Reports Q1 Loss, Lags Revenue Estimates
• Negative Sentiment: Investors also reacted to cash-burn and balance-sheet worries, with commentary saying those concerns are outweighing the Duchenne trial win for now. Article: RGNX stock on track for worst day ever as big Q1 loss cash concerns eclipse Duchenne trial success
• Negative Sentiment: An insider sale by Steve Pakola added to the cautious tone, as markets often view insider selling as a modest negative signal. Article: Insider Selling: REGENXBIO (NASDAQ:RGNX) Insider Sells 15,309 Shares of Stock

Analyst Upgrades and Downgrades

Several research firms have weighed in on RGNX. Barclays lowered their target price on REGENXBIO from $37.00 to $12.00 and set an “overweight” rating on the stock in a report on Friday. Bank of America lowered their target price on REGENXBIO from $25.00 to $14.00 and set a “buy” rating on the stock in a report on Friday. Chardan Capital decreased their price objective 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 set a $16.00 price objective on REGENXBIO in a research note on Friday. Finally, Wall Street Zen lowered REGENXBIO from a “hold” rating to a “sell” rating in a research note on Saturday, January 31st. Nine 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’s stock. Based on data from MarketBeat, the company currently has an average rating of “Moderate Buy” and an average target price of $23.91.

Insider Activity at REGENXBIO

In related news, insider Steve Pakola sold 15,309 shares of the stock in a transaction on Monday, May 11th. The stock was sold at an average price of $11.02, for a total transaction of $168,705.18. Following the sale, the insider owned 232,617 shares of the company’s stock, valued at $2,563,439.34. This trade represents a 6.17% decrease in their ownership of the stock. The transaction was disclosed in a legal filing with the Securities & Exchange Commission, which is available at the SEC website. 14.22% of the stock is currently owned by insiders.

Institutional Trading of REGENXBIO

Large investors have recently made changes to their positions in the stock. State Street Corp lifted its position in REGENXBIO by 15.2% during the fourth quarter. State Street Corp now owns 2,286,736 shares of the biotechnology company’s stock worth $32,929,000 after buying an additional 301,858 shares during the period. AQR Capital Management LLC lifted its position in REGENXBIO by 5.6% during the fourth quarter. AQR Capital Management LLC now owns 1,361,962 shares of the biotechnology company’s stock worth $19,612,000 after buying an additional 72,307 shares during the period. Integral Health Asset Management LLC lifted its position in REGENXBIO by 9.1% during the fourth quarter. Integral Health Asset Management LLC now owns 1,200,000 shares of the biotechnology company’s stock worth $17,280,000 after buying an additional 100,000 shares during the period. Geode Capital Management LLC lifted its position in REGENXBIO by 1.7% during the fourth quarter. Geode Capital Management LLC now owns 1,145,206 shares of the biotechnology company’s stock worth $16,495,000 after buying an additional 19,658 shares during the period. Finally, Nuveen LLC lifted its position in REGENXBIO by 19.3% during the fourth quarter. Nuveen LLC now owns 658,510 shares of the biotechnology company’s stock worth $9,483,000 after buying an additional 106,363 shares during the period. Institutional investors and hedge funds own 88.08% of the company’s stock.

About REGENXBIO

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.