Capricor Therapeutics Inc. (NASDAQ: CAPR) shares jumped 13.54% to $9.73 in Wednesday pre-market trading amid the opening of the World Muscle Society’s 2026 congress, where Capricor’s late-breaking HOPE-3 open-label-extension poster on Deramiocel was available to registered delegates on the virtual platform.
The rally extended a sharp move that began after Tuesday’s regular session. CAPR closed at $8.57, down 1.61%, before rising to $10.28 in after-hours trading.
WMS opened its virtual congress platform to registered delegates on Sept. 29, and its programme lists late-breaking poster presentations as available online. Capricor’s poster covers a cross-phase delayed-start analysis and a two-year comparison with natural history. WMS’s press policy keeps late-breaking abstracts under embargo until the final day of the congress even when related content is accessible beforehand.
HOPE-3 Extension Poster Covers Delayed-Start, Natural-History Analyses
Capricor previously said 82 of the 106 patients randomized in HOPE-3 reached the 24-month time point, including 40 originally assigned to Deramiocel and 42 initially assigned to placebo. The company said its WMS presentations would report skeletal-muscle and cardiac outcomes through 24 months.
The longer-term analyses build on 12-month HOPE-3 efficacy data that Capricor and FDA reviewers have evaluated using different statistical approaches.
The published 12-month HOPE-3 analysis reported a 54% slowing in upper-limb decline with Deramiocel versus placebo on the Performance of the Upper Limb 2.0 measure (p = 0.029). Mean percentage change from baseline was -3.86% with Deramiocel and -8.41% with placebo.
FDA reviewers reached a different statistical result using an agency analysis based on SAP 1.1, calculating a 0.66-point between-group difference in PUL 2.0 total score at 12 months with a p-value of 0.24. The FDA characterized Capricor’s SAP 3.0-based BLA analysis as post hoc. Capricor disputes that characterization, saying SAP 3.0 was finalized before unblinding and SAP 1.1 was an unsigned, incomplete internal draft.
FDA Already Has the 24-Month HOPE-3 Analyses
Capricor had already said it submitted the delayed-start and natural-history analyses to the FDA as part of a major amendment to the Deramiocel Biologics License Application.
The August amendment also asked the FDA to consider a refined proposed indication focused on upper-limb function. The FDA classified the submission as a major amendment and moved the PDUFA target action date from Aug. 22 to Nov. 22, 2026.
The amendment followed a July 29 FDA advisory committee meeting in which the panel voted 3 in favor and 9 against on whether the available evidence supported Deramiocel’s effectiveness for cardiomyopathy in DMD. The committee’s voting question did not cover the HOPE-3 upper-limb primary endpoint or Deramiocel’s overall benefit-risk profile.
Capricor also has a separate HOPE-3 oral presentation scheduled for Oct. 3 at WMS covering evidence related to musculoskeletal and cardiac efficacy. That session had not taken place during Wednesday’s pre-market move.
Separately, Capricor Therapeutics Tokenized Stock (Ondo), or CAPRon, was trading at $8.57, up 3.2% over the previous 24 hours, according to CoinMarketCap; it is a separate tokenized market product from Nasdaq-listed CAPR.