RGX-202 Phase 3 trial meets primary endpoint in Duchenne Muscular Dystrophy (REGENXBIO)

Nasdaq: RGNX−38.15% 24h move
Price before$10.04May 13, 2026, 4:00 PM ET
First trade after$9.90May 14, 2026, 7:40 AM ET
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Complete Announced during: Premarket · announced Thu 7:15a ET (premarket); before = Wed close; first trade Thu 7:40a ET; time = SEC 8-K acceptance

REGENXBIO (Nasdaq: RGNX) reported topline results from a Phase 3 trial of RGX-202 on May 14, 2026. The company said the trial met its primary endpoint (p<0.0001).

Trial details

Drug
RGX-202Brand DUCHENNE
Phase
Phase 3
Result
Met endpointThe trial met its primary endpoint with high statistical significance (p<0.0001), with 93% of participants reaching at least 10% microdystrophin expression at Week 12 (n=30).p-value p<0.0001Figures as reported by the sponsor or registry; not calculated by DrugTrials.org.
Safety
“It’s encouraging to see robust microdystrophin expression, correlation with functional outcomes, and a manageable safety profile.
Sponsor
REGENXBIO Nasdaq: RGNX
Dates
Announced May 14, 2026, 7:15 AM ET (SEC 8-K filing time)

About this trial

This Phase 3 trial tested RGX-202 (DUCHENNE) in Duchenne Muscular Dystrophy. REGENXBIO reported that the trial met its primary endpoint (p-value: p<0.0001).

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