Regenxbio's (RGNX) RGX-202 investigational therapy for Duchenne muscular dystrophy appears "approvable," with safety and function comparable with that of the FDA-approved rival drug from Sarepta Therapeutics (SRPT), RBC Capital Markets said in a Thursday note.
The company continues to target biologics license application submission to the US FDA in Q1 2027, with a potential approval in H2 of the same year, RBC said. Regenxbio also designed a randomized trial to back RGX-202's global submissions, the investment firm added.
In retinal disease, Regenxbio and partner AbbVie (ABBV) are set to release topline data from two trials of surabgene lomparvovec in wet age-related macular degeneration within this quarter, the brokerage said. Regulatory submissions for the product candidate are planned for 2027, RBC noted.
RBC has an outperform rating on Regenxbio, with a $19 price target.
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