CAPRICOR THERAPEUTICS, INC. 8K

Capricor Therapeutics reported that The Lancet published positive Phase 3 HOPE-3 trial results for Deramiocel in Duchenne muscular dystrophy, reinforcing the evidence base for its BLA currently under FDA review with an August 22, 2026 PDUFA date.

On July 29, 2026, Capricor Therapeutics, Inc. announced that The Lancet has published the pivotal Phase 3 HOPE-3 trial results for Deramiocel (CAP-1002), its investigational allogeneic cardiac-derived cell therapy for Duchenne muscular dystrophy, confirming via independent expert peer review that the randomized, double-blind, placebo-controlled study (n=106) met its primary endpoint by slowing upper limb function decline by 54% versus placebo (PUL 2.0, p=0.03) and demonstrating clinically meaningful cardiac benefits; the company emphasized that this body of evidence underpins its pending Biologics License Application, which remains under active FDA review with a PDUFA target action date of August 22, 2026, and highlighted multiple regulatory designations that may support eventual approval and commercialization.

Filing Facts

CIK

1133869

Ticker

CAPR

Form

8K

Source Type

fda

Accession

0001104659-26-087891

Alert Tier

7