REGENXBIO (NASDAQ:RGNX – Get Free Report) released its quarterly earnings data on Thursday. The biotechnology company reported ($1.72) EPS for the quarter, missing the consensus estimate of ($1.34) by ($0.38), FiscalAI reports. The business had revenue of $6.39 million for the quarter, compared to analysts’ expectations of $25.84 million. REGENXBIO had a negative net margin of 113.75% and a negative return on equity of 103.12%.
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 Trading Down 37.8%
REGENXBIO stock traded down $3.79 during midday trading on Thursday, hitting $6.25. The stock had a trading volume of 9,448,368 shares, compared to its average volume of 999,402. REGENXBIO has a 52-week low of $6.02 and a 52-week high of $16.19. The company has a market capitalization of $322.50 million, a PE ratio of -1.66 and a beta of 1.12. The firm’s fifty day moving average is $8.97 and its two-hundred day moving average is $11.08.
Wall Street Analysts Forecast Growth
View Our Latest Research Report on REGENXBIO
Insider Activity
In other news, insider Steve Pakola sold 15,309 shares of the firm’s stock in a transaction on Monday, May 11th. The shares were sold at an average price of $11.02, for a total transaction of $168,705.18. Following the sale, the insider directly owned 232,617 shares in the company, valued at $2,563,439.34. This trade represents a 6.17% decrease in their position. The sale was disclosed in a document filed with the Securities & Exchange Commission, which is available at this hyperlink. 14.22% of the stock is currently owned by company insiders.
Institutional Inflows and Outflows
A number of large investors have recently added to or reduced their stakes in RGNX. Bridgefront Capital LLC bought a new stake in shares of REGENXBIO in the fourth quarter worth about $159,000. Headlands Technologies LLC purchased a new stake in shares of REGENXBIO during the 4th quarter worth approximately $166,000. CANADA LIFE ASSURANCE Co raised its holdings in shares of REGENXBIO by 33.9% during the 3rd quarter. CANADA LIFE ASSURANCE Co now owns 14,510 shares of the biotechnology company’s stock worth $143,000 after acquiring an additional 3,671 shares in the last quarter. Brevan Howard Capital Management LP bought a new position in shares of REGENXBIO during the 3rd quarter valued at approximately $158,000. Finally, BNP Paribas Financial Markets grew its holdings in shares of REGENXBIO by 18.8% in the third quarter. BNP Paribas Financial Markets now owns 17,724 shares of the biotechnology company’s stock valued at $171,000 after purchasing an additional 2,800 shares in the last quarter. 88.08% of the stock is owned by hedge funds and other institutional investors.
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.
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