H.C. Wainwright Reiterates Buy Rating on Regenxbio Inc. (RGNX)

H.C. Wainwright analyst Yi Chen reiterated a Buy rating and $34.00 price target on Regenxbio Inc. (NASDAQ: RGNX).

The analyst commented: "Yesterday, REGENXBIO reported new positive 18-month functional data from patients treated with the pivotal dose of RGX-202 in the Phase 1/2 portion of the AFFINITY DUCHENNE trial in Duchenne muscular dystrophy (DMD). Notably, all patients (n=4) exceeded disease trajectory on the North Star Ambulatory Assessment (NSAA) using the established cTAP disease progression model. Patients had an average improvement of 7.4 points compared to cTAP. Of note, these same patients had an average improvement of 6.6 points compared to cTAP at 12 months post treatment. Therefore, RGX-202 has demonstrated durable treatment effect for at least 18 months, in our view. The company plans to share additional safety, biomarker, and functional data at the MDA Clinical and Scientific Conference in March 2026. As a reminder, the AFFINITY DUCHENNE pivotal trial in DMD has completed enrollment of 30 participants (aged 1 and above). The primary pivotal endpoint is the proportion of participants whose RGX-202 microdystrophin expression is ≥10% at Week 12. Management expects the pivotal trial to report topline data in 2Q26, which may allow the company to submit a BLA under the accelerated approval pathway in mid-2026. REGENXBIO continues to enroll in the confirmatory trial, and the majority of this trial could be enrolled at the time of BLA filing. Regulatory interactions with the FDA and European Medical Association (EMA) are being planned for 1H26. We reiterate our Buy rating and $34 price target."

For an analyst ratings summary and ratings history on Regenxbio Inc. click here. For more ratings news on Regenxbio Inc. click here.

Shares of Regenxbio Inc. closed at $14.59 yesterday.

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