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REGENXBIO Inc. (RGNX) RBC Capital Markets Global Healthcare Conference 2026 May 20, 2026 9:30 AM EDT
Company Participants
Curran Simpson - President, CEO & Director
Conference Call Participants
Luca Issi - RBC Capital Markets, Research Division
Presentation
Luca Issi
RBC Capital Markets, Research Division
Let's maybe go back to last week. Again, data was a landmark as you described it. However, there's a lot of debate among the investment community around kind of regulatory and why waiting. You guys have been pretty clear that you'd like to wait to submit that data set until the new leadership team at the FDA is in place. However, there's maybe a counterargument to be made that like kind of control the control of world in life, and that's something you can't control.
Question-and-Answer Session
Luca Issi
RBC Capital Markets, Research Division
So like just maybe walk us through what are the primary advantages of actually waiting to submit this data set?
Curran Simpson
President, CEO & Director
Yes. I actually would probably want to clarify, the waiting aspect of that is further discussions with FDA. So what we're looking to do is see FDA stabilize in terms of new leadership, additional changes last week, as everybody saw. And I think we look at all the changes as really, really positive in the sense of -- particularly in rare disease where the patient advocacy groups and patients are in great need for alternative therapies to come to market. So as it relates to the Duchenne data, we think the top line data checks every box that you need for accelerated approval. Our plan is to begin initiate filing the BLA in Q3 this year, and that rolling BLA process will complete in Q1 of '27. So that gives us plenty of time in '27 to secure an approval. So I think that part got co-mingled with when would we meet
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