REGENXBIO (NASDAQ:RGNX) Announces Quarterly Earnings Results

REGENXBIO (NASDAQ:RGNX) released its earnings results on Thursday. The biotechnology company reported ($0.62) EPS for the quarter, beating 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 analysts’ expectations 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 Trading Up 3.3%

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

Wall Street Analyst Weigh In

Several research analysts have commented on RGNX shares. Zacks Research upgraded shares of REGENXBIO from a “strong sell” rating to a “hold” rating in a report on Wednesday, August 12th. HC Wainwright restated a “buy” rating on shares of REGENXBIO in a research report on Monday, September 28th. Wall Street Zen raised shares of REGENXBIO from a “strong sell” rating to a “hold” rating in a research note on Saturday, August 8th. Morgan Stanley reiterated an “overweight” rating and set a $18.00 price objective on shares of REGENXBIO in a research report on Friday, August 7th. Finally, Weiss Ratings reissued a “sell (e+)” rating on shares of REGENXBIO in a research note on Friday, September 4th. One investment analyst has rated the stock with a Strong Buy rating, nine have given a Buy rating, three have issued a Hold rating and one has assigned a Sell rating to the company. Based on data from MarketBeat.com, the stock has an average rating of “Moderate Buy” and a consensus price target of $22.83.

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.