Regenxbio provides corporate update on candidate development programs

Regenxbio (RGNX) provided a year-end 2018 corporate update. Highlights include: further positive interim update from RGX-314 Phase I trial for wet AMD, in which 50% of subjects treated in Cohort 3 continue to remain free of anti-VEGF injections at nine months and mean RGX-314 intraocular protein expression in recently dosed Cohort 4 was higher than in previously reported Cohort 3 at one month; received FDA clearance to expand RGX-314 Phase I protocol immediately into a Phase IIa clinical trial, and on track to initiate Phase IIb trial in late 2019; plans to expand RGX-314 into additional retinal conditions, with the first such IND submission anticipated in 2H19; RGX-121 was well-tolerated in first patient dosed at initial eight-week safety assessment; additional recruitment and site activation continues; interim trial updates for RGX-121, RGX-111 and RGX-501 anticipated in 2H19; first anticipated FDA regulatory action for a proprietary NAV Technology-based treatment, Novartis’ (NVS) Zolgensma for the treatment of SMA Type I, expected in May; the company had over $470M in cash, cash equivalents and marketable securities as of December 31, 2018, and expects to end 2019 with over $330M in cash, cash equivalents and marketable securities, excluding any projected commercial revenue from Zolgensma.
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