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What will be the FDA's decision on RGX-202 by end of 2025?
2
Resolution / Starting Odds
Accelerated Approval • 25%
Full Approval • 25%
Conditional Approval • 25%
No Approval • 25%
FDA's official announcements or press releases
Story
Regenxbio's RGX-202 Gene Therapy Shows Positive Results, FDA Approval Pathway Available
Nov 18, 2024, 12:34 PM
Regenxbio has reported promising results from its experimental gene therapy, RGX-202, for treating boys with Duchenne muscular dystrophy. The company presented clinical evidence showing improved muscle function in patients following the treatment. Regenxbio's CEO, Curran Simpson, indicated in an interview with STAT on Sunday that the FDA has communicated that the accelerated approval pathway remains available for this therapy. The positive data from a small trial is expected to support Regenxbio's pursuit of regulatory approval.
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Approval • 33%
Rejection • 33%
Request for more data • 34%
Approved without conditions • 25%
Approved with conditions • 25%
Approval delayed • 25%
Not approved • 25%
Full Approval • 25%
Accelerated Approval • 25%
Conditional Approval • 25%
Rejection • 25%
Approved for all indications • 25%
Approved for some indications • 25%
Not approved • 25%
Approval delayed • 25%
Yes • 50%
No • 50%
Approved at 20 mg dose • 25%
Approved at higher dose • 25%
Approved at multiple doses • 25%
Not approved • 25%
Complete Response (CR) • 25%
Partial Response (PR) • 25%
Stable Disease (SD) • 25%
Progressive Disease (PD) • 25%
Yes • 50%
No • 50%
