REGENXBIO (NASDAQ:RGNX) Issues Earnings Results

REGENXBIO (NASDAQ:RGNX) issued its quarterly earnings results on Thursday. The biotechnology company reported $0.43 earnings per share (EPS) for the quarter, beating analysts’ consensus estimates of $0.08 by $0.35, FiscalAI reports. REGENXBIO had a negative return on equity of 232.50% and a negative net margin of 330.23%.The firm had revenue of $108.02 million during the quarter, compared to analyst estimates of $97.63 million.

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 Performance

Shares of NASDAQ RGNX traded down $0.84 during mid-day trading on Friday, reaching $10.44. The company had a trading volume of 653,066 shares, compared to its average volume of 1,454,971. The company has a market capitalization of $539.75 million, a price-to-earnings ratio of -1.86 and a beta of 0.94. The stock has a fifty day moving average of $9.94 and a two-hundred day moving average of $9.42. REGENXBIO has a 12-month low of $5.45 and a 12-month high of $16.19.

Insider Buying and Selling

In other REGENXBIO news, insider Steve Pakola sold 36,725 shares of the company’s stock in a transaction that occurred on Wednesday, July 1st. The shares were sold at an average price of $12.86, for a total value of $472,283.50. Following the transaction, the insider owned 213,009 shares in the company, valued at approximately $2,739,295.74. This represents a 14.71% decrease in their position. The transaction was disclosed in a filing with the Securities & Exchange Commission, which is available through the SEC website. Insiders have sold 73,803 shares of company stock worth $886,937 over the last quarter. Insiders own 14.22% of the company’s stock.

Institutional Trading of REGENXBIO

Hedge funds and other institutional investors have recently modified their holdings of the company. State Street Corp grew its stake in REGENXBIO by 15.2% in 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 in the last quarter. AQR Capital Management LLC raised its stake in shares of REGENXBIO by 5.6% during the 4th quarter. AQR Capital Management LLC now owns 1,361,962 shares of the biotechnology company’s stock worth $19,612,000 after purchasing an additional 72,307 shares in the last quarter. Integral Health Asset Management LLC lifted its holdings in shares of REGENXBIO by 9.1% during the 4th 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 during the last quarter. Geode Capital Management LLC grew its stake in shares of REGENXBIO by 1.7% in 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 buying an additional 19,658 shares in the last quarter. Finally, Nuveen LLC grew its stake in shares of REGENXBIO by 19.3% in the 4th quarter. Nuveen LLC now owns 658,510 shares of the biotechnology company’s stock valued at $9,483,000 after buying an additional 106,363 shares in the last quarter. 88.08% of the stock is currently owned by hedge funds and other institutional investors.

Key REGENXBIO News

Here are the key news stories impacting REGENXBIO this week:

• Positive Sentiment: Quarterly results exceeded expectations. REGENXBIO reported adjusted earnings of $0.43 per share, compared with the $0.08 consensus estimate, while revenue of $108.0 million surpassed expectations of approximately $97.6 million. Results also improved from a $1.38-per-share loss in the prior-year quarter. REGENXBIO Beats Q2 Earnings and Revenue Estimates
• Positive Sentiment: Key regulatory milestones remain on track. The company expects to begin its RGX-202 biologics license application submission for Duchenne muscular dystrophy in the third quarter of 2026, with potential accelerated approval in the second half of 2027. An RGX-121 resubmission for Hunter syndrome is also targeted for the third quarter. REGENXBIO Second-Quarter Results and Operational Highlights
• Positive Sentiment: REGENXBIO strengthened its financial position. More than $200 million of new capital raised in July increased pro forma cash, cash equivalents and marketable securities to above $310 million and extended the projected cash runway into the fourth quarter of 2027. REGENXBIO Cash Runway and RGX-202 Update
• Positive Sentiment: Additional clinical catalysts are ahead. Topline data from the ATMOSPHERE and ASCENT wet age-related macular degeneration studies are expected in the fourth quarter of 2026, while longer-term ABBV-RGX-314 data continue to support the program’s safety and efficacy profile.
• Neutral Sentiment: Barclays reaffirmed an Equal Weight rating and assigned a $12 price target, implying potential upside from recent trading levels but signaling a balanced view of RGNX’s risk-reward profile. Barclays Rating Update
• Negative Sentiment: The earnings beat does not eliminate ongoing financial risk. REGENXBIO remains deeply unprofitable, with a reported negative net margin and analysts expecting a full-year loss. Investors may also remain cautious because the company’s valuation depends heavily on successful clinical execution, regulatory filings and future trial readouts.

Wall Street Analyst Weigh In

Several brokerages recently weighed in on RGNX. Zacks Research cut REGENXBIO from a “hold” rating to a “strong sell” rating in a research note on Tuesday, July 14th. Bank of America decreased their price target on shares of REGENXBIO from $25.00 to $14.00 and set a “buy” rating on the stock in a research report on Friday, May 15th. Leerink Partners increased their price objective on REGENXBIO from $17.00 to $18.00 and gave the company an “outperform” rating in a research report on Monday, June 22nd. Weiss Ratings restated a “sell (e+)” rating on shares of REGENXBIO in a report on Monday, June 8th. Finally, Morgan Stanley reaffirmed an “overweight” rating and set a $18.00 target price on shares of REGENXBIO in a research report on Friday. Nine research analysts have rated the stock with a Buy rating, two have assigned a Hold rating and two have given a Sell rating to the company’s stock. Based on data from MarketBeat, the company presently has a consensus rating of “Moderate Buy” and an average price target of $24.00.

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.