REGENXBIO (NASDAQ:RGNX – Get Free Report) released its earnings results on Thursday. The biotechnology company reported $0.43 earnings per share for the quarter, beating analysts’ consensus estimates of $0.08 by $0.35, FiscalAI reports. The company had revenue of $108.02 million during the quarter, compared to analyst estimates of $97.63 million. REGENXBIO had a negative return on equity of 232.50% and a negative net margin of 330.23%.
Here are the key takeaways from REGENXBIO’s conference call:
- REGENXBIO ended the quarter with more than $310 million pro forma, following a $100 million AbbVie milestone and a $108 million follow-on offering. Management expects this to fund operations into Q4 2027, including the anticipated RGX-202 PDUFA date.
- RGX-202 enrollment and dosing in the confirmatory Duchenne muscular dystrophy study were completed ahead of schedule, with more than 60 patients across pivotal and confirmatory studies. The company plans to submit the first BLA module in Q3 2026 and initiate the global AFFINITY RISE trial in the first half of 2027.
- The FDA agreed that RGX-121’s existing data are sufficient for accelerated-approval review and said no additional studies, including a randomized controlled trial, are required for BLA resubmission. REGENXBIO plans to resubmit the application in Q3 2026 with longer-term efficacy, safety, imaging, and neurocognitive data.
- REGENXBIO and AbbVie began the Phase IIb/III NAAVIGATE study of sura-vec in diabetic retinopathy, triggering the $100 million milestone payment. The partners expect fourth-quarter top-line results from the ATMOSPHERE and ASCENT wet AMD studies, while longer-term follow-up showed durable effects and favorable safety through five years in wet AMD and 2.5 years in diabetic retinopathy.
- The company acknowledged that its U.S. patent covering Zolgensma has expired, although royalties will continue in roughly 20 countries outside the United States. Management highlighted Evrysdi coverage and potential future royalties from Itvisma as offsets, but did not provide specific royalty-rate guidance.
REGENXBIO Stock Up 7.4%
Shares of NASDAQ:RGNX traded up $0.78 during midday trading on Thursday, hitting $11.28. 1,766,472 shares of the stock traded hands, compared to its average volume of 1,848,277. The business’s 50 day moving average is $9.94 and its two-hundred day moving average is $9.42. The stock has a market capitalization of $583.18 million, a PE ratio of -2.01 and a beta of 0.94. REGENXBIO has a one year low of $5.45 and a one year high of $16.19.
Wall Street Analyst Weigh In
Check Out Our Latest Research Report on RGNX
Insider Activity
In related news, insider Steve Pakola sold 2,161 shares of the firm’s stock in a transaction dated Thursday, July 2nd. The stock was sold at an average price of $13.64, for a total value of $29,476.04. Following the sale, the insider directly owned 213,009 shares of the company’s stock, valued at $2,905,442.76. This trade represents a 1.00% decrease in their ownership of the stock. The transaction was disclosed in a document filed with the Securities & Exchange Commission, which is available through this link. Insiders sold 73,803 shares of company stock valued at $886,937 over the last quarter. 14.22% of the stock is owned by company insiders.
Institutional Inflows and Outflows
A number of hedge funds and other institutional investors have recently bought and sold shares of the business. Bridgefront Capital LLC purchased a new position in shares of REGENXBIO during the fourth quarter valued at approximately $159,000. Headlands Technologies LLC bought a new position in shares of REGENXBIO during the fourth quarter valued at approximately $166,000. CANADA LIFE ASSURANCE Co lifted its stake in REGENXBIO by 33.9% in the third 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 during the period. Brevan Howard Capital Management LP purchased a new stake in REGENXBIO in the third quarter worth $158,000. Finally, BNP Paribas Financial Markets lifted its stake in REGENXBIO by 18.8% in the third quarter. BNP Paribas Financial Markets now owns 17,724 shares of the biotechnology company’s stock worth $171,000 after acquiring an additional 2,800 shares during the period. Institutional investors own 88.08% of the company’s stock.
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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