REGENXBIO (NASDAQ:RGNX) Releases Earnings Results, Misses Estimates By $0.38 EPS

Key Points

• REGENXBIO missed earnings estimates, reporting EPS of -$1.72 versus expectations of -$1.34 and revenue of $6.39 million versus the $25.84 million forecast.
• The company said its phase III AFFINITY DUCHENNE trial for RGX-202 met its primary endpoint, supporting a potential accelerated approval path in 2027.
• Management highlighted strong microdystrophin expression and a statistically significant link to functional improvement, while noting the safety profile was manageable despite two treatment-related serious adverse events that resolved.

REGENXBIO (NASDAQ:RGNX - Get Free Report) announced its earnings results on Thursday. The biotechnology company reported ($1.72) earnings per share (EPS) for the quarter, missing analysts' consensus estimates of ($1.34) by ($0.38), FiscalAI reports. REGENXBIO had a negative return on equity of 103.12% and a negative net margin of 113.75%.The company had revenue of $6.39 million for the quarter, compared to analyst estimates 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 RGNX traded down $3.82 during midday trading on Thursday, reaching $6.22. The stock had a trading volume of 9,086,398 shares, compared to its average volume of 995,799. The company has a market capitalization of $321.21 million, a P/E ratio of -1.65 and a beta of 1.12. REGENXBIO has a 52 week low of $6.02 and a 52 week high of $16.19. The firm's 50 day moving average price is $8.97 and its 200-day moving average price is $11.08.

Insider Activity

In related news, insider Steve Pakola sold 15,309 shares of the firm's stock in a transaction that occurred on Monday, May 11th. The shares were sold at an average price of $11.02, for a total value of $168,705.18. Following the completion of the transaction, the insider owned 232,617 shares of the company's stock, valued at approximately $2,563,439.34. This trade represents a 6.17% decrease in their position. The transaction was disclosed in a document filed with the SEC, which is accessible through this hyperlink. 14.22% of the stock is owned by corporate insiders.

Institutional Investors Weigh In On REGENXBIO

Hedge funds and other institutional investors have recently added to or reduced their stakes in the stock. State Street Corp boosted 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 valued at $32,929,000 after purchasing an additional 301,858 shares during the last quarter. AQR Capital Management LLC lifted its stake in shares of REGENXBIO by 5.6% in the 4th quarter. AQR Capital Management LLC now owns 1,361,962 shares of the biotechnology company's stock valued at $19,612,000 after purchasing an additional 72,307 shares during the last quarter. Integral Health Asset Management LLC raised its holdings 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 valued at $17,280,000 after buying an additional 100,000 shares in the last quarter. Geode Capital Management LLC increased its holdings in shares of REGENXBIO by 1.7% during the 4th quarter. Geode Capital Management LLC now owns 1,145,206 shares of the biotechnology company's stock valued at $16,495,000 after acquiring an additional 19,658 shares during the last quarter. Finally, Nuveen LLC boosted 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 purchasing an additional 106,363 shares during the period. Hedge funds and other institutional investors own 88.08% of the company's stock.

Wall Street Analysts Forecast Growth

RGNX has been the subject of several research analyst reports. Robert W. Baird set a $27.00 target price on REGENXBIO in a research note on Tuesday, February 10th. HC Wainwright dropped their price objective on REGENXBIO from $32.00 to $30.00 and set a "buy" rating on the stock in a research note on Monday, March 9th. Barclays assumed coverage on REGENXBIO in a research report on Tuesday, January 27th. They issued an "overweight" rating and a $37.00 target price on the stock. Chardan Capital reduced their price objective on shares of REGENXBIO from $52.00 to $50.00 and set a "buy" rating on the stock in a research note on Tuesday, February 10th. Finally, Wall Street Zen downgraded shares of REGENXBIO from a "hold" rating to a "sell" rating in a research note on Saturday, January 31st. Eight equities research analysts have rated the stock with a Buy rating, one has assigned a Hold rating and one has assigned a Sell rating to the company's stock. Based on data from MarketBeat, the stock currently has a consensus rating of "Moderate Buy" and an average target price of $27.50.

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.

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