Promising Interim Data and Accelerated Approval Pathway Drive Buy Rating for RegenXBio’s RGX-202

H.C. Wainwright analyst Yi Chen has reiterated their bullish stance on RGNX stock, giving a Buy rating yesterday.

Yi Chen has given his Buy rating due to a combination of factors, primarily driven by the promising interim data from the Phase 1/2 trial of RGX-202 for Duchenne muscular dystrophy (DMD). The data revealed that patients treated with RGX-202 showed significant improvements in functional measures compared to natural history, suggesting that the treatment may delay disease progression and improve patient outcomes.
Moreover, the trial’s pivotal portion has already enrolled a significant number of patients, with topline data expected in the first half of 2026. This positions RegenXBio to potentially submit a Biologics License Application (BLA) under the accelerated approval pathway by mid-2026. The positive impact on disease trajectory and the absence of serious adverse events further support the Buy rating, along with the potential for RGX-202 to meet clinically important benchmarks recognized by the FDA.

Chen covers the Healthcare sector, focusing on stocks such as Vivani Medical, Opko Health, and RegenXBio. According to TipRanks, Chen has an average return of -10.8% and a 35.44% success rate on recommended stocks.

In another report released yesterday, Bank of America Securities also reiterated a Buy rating on the stock with a $22.00 price target.