REGENXBIO (NASDAQ:RGNX) Releases Earnings Results, Beats Estimates By $0.67 EPS

REGENXBIO (NASDAQ:RGNX) announced its quarterly earnings results on Thursday. The biotechnology company reported ($0.62) EPS for the quarter, topping the consensus estimate of ($1.29) by $0.67, FiscalAI reports. REGENXBIO had a negative net margin of 112.58% and a negative return on equity of 220.07%. The firm had revenue of $9.16 million for the quarter, compared to analyst estimates of $10.89 million.

Here are the key takeaways from REGENXBIO’s conference call:

• Sura-vec wet AMD pivotal results are expected this quarter. The two trials enrolled more than 1,300 patients and are testing non-inferiority to anti-VEGF controls; the company and AbbVie expect global regulatory submissions in 2027. Results remain a significant upcoming catalyst.
• RGX-202 is advancing toward a planned Q1 2027 BLA filing under the accelerated approval pathway, with potential U.S. approval in the second half of 2027. Management cited safety data from more than 60 patients and a correlation between microdystrophin levels and functional improvement, but FDA feedback and review remain key uncertainties.
• Sura-vec is also progressing in diabetic retinopathy. The pivotal NAAVIGATE study is enrolling, and management reported that 60% of patients at the same dose in the Phase II ALTITUDE study improved by at least two retinopathy severity steps at three years without additional treatment.
• Regenxbio reported $251 million in cash, equivalents and marketable securities at quarter-end and guided to a runway through late Q4 2027, beyond several stated milestones. The balance benefited from a $100 million AbbVie milestone and $108 million in public offering proceeds; the runway estimate excludes potential additional funding and the $39 million Sarepta settlement payment received in October.

REGENXBIO Stock Performance

REGENXBIO stock traded up $0.24 during midday trading on Friday, hitting $7.62. 1,186,482 shares of the company’s stock were exchanged, compared to its average volume of 1,316,993. REGENXBIO has a 12-month low of $5.45 and a 12-month high of $16.19. The stock has a market cap of $503.00 million, a price-to-earnings ratio of -2.37 and a beta of 1.24. The firm’s 50 day simple moving average is $7.80 and its 200 day simple moving average is $9.06.

Analysts Set New Price Targets

RGNX has been the subject of several research analyst reports. HC Wainwright restated a “buy” rating on shares of REGENXBIO in a research note on Monday, September 28th. Robert W. Baird reduced their target price on REGENXBIO from $32.00 to $29.00 and set an “outperform” rating for the company in a report on Tuesday, August 25th. Weiss Ratings reissued a “sell (e+)” rating on shares of REGENXBIO in a report on Friday, September 4th. Morgan Stanley reissued an “overweight” rating and issued a $18.00 target price on shares of REGENXBIO in a research report on Friday, August 7th. Finally, Zacks Research upgraded REGENXBIO from a “strong sell” rating to a “hold” rating in a research note on Wednesday, August 12th. One analyst has rated the stock with a Strong Buy rating, eight have assigned a Buy rating, three have given a Hold rating and one has issued a Sell rating to the company. According to data from MarketBeat, the company currently has an average rating of “Moderate Buy” and an average target price of $23.18.

About REGENXBIO

REGENXBIO Inc (NASDAQ: RGNX) is a clinical-stage biotechnology company focused on developing gene therapies for serious diseases. The company’s programs use adeno-associated virus (AAV) vectors to deliver genetic material to targeted cells, with the goal of addressing the underlying causes of disease rather than primarily treating symptoms.

REGENXBIO’s technology is built around its NAV AAV Technology Platform, which supports the design and development of gene-delivery vectors. Its pipeline has included investigational therapies for conditions such as Duchenne muscular dystrophy, Hunter syndrome, age-related macular degeneration and other rare diseases.