Analyst Yi Chen from H.C. Wainwright reiterated a Buy rating on RegenXBio and keeping the price target at $34.00.
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Yi Chen’s rating is based on the promising 12-month data from the Phase 1/2/3 CAMPSIITE trial for RGX-121, which demonstrated a significant reduction in cerebrospinal fluid levels of heparan sulfate, a key indicator for Mucopolysaccharidosis II treatment. This data supports the use of CSF HS D2S6 as a surrogate endpoint, potentially predicting clinical benefits and aiding in the accelerated approval pathway. Additionally, the FDA’s pre-license inspections for the RGX-121 BLA were completed without any observations, suggesting a smooth regulatory process.
Moreover, RGX-121 has received multiple designations from the FDA, including Orphan Drug and Fast Track, which could expedite its approval and commercialization. If approved, it would be the first gene therapy addressing the genetic cause of Hunter syndrome, with commercial launch plans already in place. The potential for significant royalties and milestone payments further strengthens the financial outlook for RegenXBio, justifying the Buy rating.
In another report released on September 5, Raymond James also reiterated a Buy rating on the stock with a $29.00 price target.