Capricor To Present 24-Month HOPE-3 Data At WMS 2026
(RTTNews) - Capricor Therapeutics (CAPR) will present new data from its Phase 3 HOPE-3 study and open-label extension (OLE) of deramiocel at the 2026 World Muscle Society Congress, taking place between September 29 and October 3, 2026, in Hiroshima, Japan.
The presentations will provide updated findings on skeletal muscle and cardiac outcomes through 24 months in patients with Duchenne muscular dystrophy (DMD), a severe X-linked genetic disorder marked by progressive degeneration of skeletal, respiratory and cardiac muscles.
The upcoming data build on the 12-month HOPE-3 results and the 24-month OLE data submitted by Capricor to the FDA as part of a Biologics License Application (BLA) amendment in August. The FDA accepted the amendment for review and extended the PDUFA target action date to November 22, 2026.
HOPE-3 is a randomized, double-blind, placebo-controlled Phase 3 trial that enrolled 106 patients with DMD. Participants received intravenous deramiocel or placebo every three months for 12 months, after which eligible patients could continue in an OLE. Of the 106 patients, 82 reached the 24-month time point, including 40 originally assigned to deramiocel and 42 to placebo.
HOPE-3 met its primary endpoint, with deramiocel slowing the decline in upper-limb function by 54 percentage versus placebo, as measured by the Performance of the Upper Limb (PUL) 2.0 scale.
At WMS 2026, the late-breaking poster is titled "Deramiocel slows upper limb decline in the HOPE-3 OLE: cross-phase delayed-start analysis and 2-year comparison with natural history." An oral presentation, "HOPE-3, a phase 3 study of deramiocel, an allogeneic cell therapy, in advanced Duchenne muscular dystrophy: evidence to support both musculoskeletal and cardiac efficacy," is scheduled for October 3.
Capricor reported approximately $237.93 million in cash, cash equivalents and marketable securities as of June 30, 2026.
CAPR is trading up 10.41% at $9.45.
