StealthX vaccine

May 12, 2026 — Capricor Therapeutics (NASDAQ: CAPR) reported Q1 2026 financial results and provided a corporate update focused on deramiocel (CAP-1002), its cell therapy candidate for Duchenne muscular dystrophy (DMD). The company said its Biologics License Application is under active FDA review following acceptance of a Class 2 resubmission, with a PDUFA target action date of August 22, 2026 and labeling discussions expected to begin soon.

Capricor highlighted HOPE-3 Phase 3 results: the trial met its primary endpoint (PUL v2.0 upper limb function) and all Type I error-controlled secondary endpoints. Additional analyses presented in 2026 included cardiac MRI showing significantly reduced myocardial fibrosis (LGE) vs placebo and statistically significant improvement vs placebo on the Duchenne Video Assessment “eat 10 bites” measure.

Operationally, its San Diego GMP facility completed an FDA pre-license inspection (Form 483 observations addressed); expansion aims to support ~2,000–2,500 patients/year by 1H 2027. Capricor filed suit against Nippon Shinyaku/NS Pharma to rescind a U.S. distribution agreement, citing pricing/access barriers; it said FDA review is unaffected.

Financials: cash, equivalents and marketable securities were $278.6M (Mar 31, 2026); operating expenses $36.8M; net loss $33.9M ($0.59/share). Cash runway expected into Q4 2027; approval could yield a transferable Rare Pediatric Disease Priority Review Voucher.