Overview
Stifel has reiterated its Buy recommendation on REGENXBIO Inc. and maintained a $45.00 price target for the shares of the company, even as the U.S. Food and Drug Administration imposed a clinical hold on RGX-111, REGENXBIO’s investigational therapy for Hurler syndrome (MPS I). The $45.00 target implies a 296% upside from the current quoted share price of $11.36 and sits well above the average analyst target of $24.67. According to InvestingPro fair value metrics cited with the company’s data, RGNX appears undervalued versus peer and model-based measures.
Regulatory impact and timeline
Stifel warned that the clinical hold related to RGX-111 is likely to push back the Prescription Drug User Fee Act (PDUFA) date for RGX-121, REGENXBIO’s candidate for Hunter syndrome (MPS II). The PDUFA date for RGX-121 had been scheduled for February 8, 2026, but Stifel indicated delays could occur because FDA reviews generally run two to three months behind schedule and because the agency requires completion of laboratory analyses tied to RGX-111.
Company communications, as relayed by Stifel, state that REGENXBIO has already submitted a draft label for RGX-121, though formal discussions with regulators have not yet taken place. The firm also said the company is prepared to respond to all FDA information requests, including magnetic resonance imaging analyses on RGX-121 patients, and is working to remove the clinical hold as quickly as possible.
Distinguishing manufacturing and program differences
Stifel highlighted a notable manufacturing distinction: RGX-121 is produced using a higher-purity, modernized manufacturing process relative to RGX-111. The analyst firm characterized this difference as potentially material in assessments of the two programs. Stifel also emphasized that the clinical hold on RGX-111 should not affect two other REGENXBIO programs - RGX-202 and RGX-314 - which use different viral vectors and routes of administration and are supported by years of data from a larger patient population.
Clinical developments and market reaction
The clinical holds followed the discovery of a brain tumor in a five-year-old patient who had received RGX-111 four years earlier, leading the FDA to place holds on both RGX-111 and RGX-121. Despite these regulatory actions, Stifel and other firms pointed to encouraging data from the RGX-202 program for Duchenne muscular dystrophy, where trial patients have reportedly outperformed expected disease trajectories.
Market performance has been mixed in the short term. RGNX shares declined 10.7% over the most recent week noted, yet the stock has delivered gains of 52.6% over six months and 76.5% over the prior 12 months. Stifel called out successful facility inspections and identified upcoming 2026 catalysts when reaffirming its valuation and stance.
Analyst stance across the market
Alongside Stifel’s action, other brokerages have maintained positive coverage: H.C. Wainwright reiterated a Buy rating and Baird maintained an Outperform stance, each citing favorable data from the RGX-202 trial. Stifel specifically raised its price target to $45 and described the company’s outlook as supported by both clinical data and operational milestones.
Near-term investor considerations
Investors monitoring REGENXBIO can expect the company to respond to FDA queries and to pursue removal of the clinical hold, while watching for any formal regulator discussions on labeling. The company’s next scheduled earnings report is on March 3, and additional research and analysis resources are available through InvestingPro for those seeking deeper coverage.
Note on available information: Where details are limited in public statements, the article reflects the company and analyst disclosures without extrapolating beyond those facts.