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RegenXBio ( (RGNX) ) has issued an announcement.
On August 18, 2025, REGENXBIO announced that the FDA has extended the review timeline for its Biologics License Application for RGX-121, a potential one-time therapy for Mucopolysaccharidosis II (Hunter syndrome), from November 9, 2025, to February 8, 2026. This extension allows for the review of additional clinical data, which the company plans to present at the ICIEM meeting in September 2025. The FDA’s inspection found no safety concerns, and RGX-121 has received several designations from the FDA, indicating its potential impact on addressing the unmet medical needs of patients with Hunter syndrome.
The most recent analyst rating on (RGNX) stock is a Buy with a $39.00 price target. To see the full list of analyst forecasts on RegenXBio stock, see the RGNX Stock Forecast page.
Spark’s Take on RGNX Stock
According to Spark, TipRanks’ AI Analyst, RGNX is a Neutral.
RegenXBio’s overall stock score reflects significant financial challenges, including declining revenues and negative profitability, which are the most impactful factors. While technical indicators and valuation metrics are weak, recent strategic partnerships and corporate events provide some positive outlook. The earnings call suggests potential for future growth, but regulatory and competitive risks remain.
To see Spark’s full report on RGNX stock, click here.
More about RegenXBio
REGENXBIO is a biotechnology company focused on advancing gene therapy treatments for rare and retinal diseases. Founded in 2009, the company has pioneered the field of AAV gene therapy and is developing a late-stage pipeline of one-time treatments, including RGX-202 for Duchenne, RGX-121 for MPS II, RGX-111 for MPS I, and ABBV-RGX-314 for wet AMD and diabetic retinopathy.
Average Trading Volume: 872,977
Technical Sentiment Signal: Sell
Current Market Cap: $445.5M
Learn more about RGNX stock on TipRanks’ Stock Analysis page.