REGENXBIO (NASDAQ:RGNX) Announces Quarterly Earnings Results

Key Points

• REGENXBIO reported quarterly EPS of -$0.62, beating analyst expectations of -$1.29, while revenue of $9.16 million fell short of the $10.89 million consensus.
• Upcoming clinical milestones include pivotal wet AMD trial results expected this quarter and RGX-202’s targeted Q1 2027 BLA filing; regulatory submissions for wet AMD are anticipated in 2027.
• The company ended the quarter with $251 million in cash, equivalents and marketable securities, with management projecting a runway through late Q4 2027.

REGENXBIO (NASDAQ:RGNX - Get Free Report) posted its quarterly earnings data on Thursday. The biotechnology company reported ($0.62) EPS for the quarter, topping analysts' consensus estimates of ($1.29) by $0.67, FiscalAI reports. REGENXBIO had a negative return on equity of 220.07% and a negative net margin of 112.58%. The company 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

NASDAQ RGNX traded up $0.24 during trading hours on Friday, hitting $7.62. 1,186,482 shares of the company traded hands, compared to its average volume of 1,316,993. The business's 50-day moving average is $7.80 and its 200-day moving average is $9.06. The stock has a market capitalization of $503.00 million, a price-to-earnings ratio of -2.37 and a beta of 1.24. REGENXBIO has a twelve month low of $5.45 and a twelve month high of $16.19.

Wall Street Analyst Weigh In

A number of equities research analysts recently weighed in on RGNX shares. Barclays downgraded shares of REGENXBIO from an "overweight" rating to a "hold" rating in a research note on Friday, August 7th. Robert W. Baird dropped their target price on shares of REGENXBIO from $32.00 to $29.00 and set an "outperform" rating for the company in a research report on Tuesday, August 25th. HC Wainwright reissued a "buy" rating on shares of REGENXBIO in a research note on Monday, September 28th. Morgan Stanley restated an "overweight" rating and issued a $18.00 price target on shares of REGENXBIO in a research report on Friday, August 7th. Finally, Mizuho set a $18.00 price objective on REGENXBIO in a research note on Friday. One equities research analyst has rated the stock with a Strong Buy rating, nine have given a Buy rating, three have assigned a Hold rating and one has given a Sell rating to the company's stock. According to MarketBeat.com, REGENXBIO currently has a consensus rating of "Moderate Buy" and a consensus target price 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.

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