• Capricor Therapeutics highlighted a pending FDA decision for deramiocel in Duchenne muscular dystrophy, with a PDUFA target action date of Aug. 22, 2026.
• The company said the HOPE-3 Phase 3 trial in DMD (n=106) met its primary endpoint on PUL v2.0 (p=0.03) with a key cardiac secondary endpoint on LVEF (p=0.04).
• A U.S. commercial launch is being prepared, supported by an operational San Diego GMP facility with a second-floor expansion underway.
• Capricor reported a cash balance of $279 million based on Q1 10-Q financials, citing runway through 2027 excluding potential product revenue or monetization of a priority review voucher.
• The presentation also outlined the StealthX exosome platform, including a Phase 1 exosome-based vaccine study run in collaboration with the NIH.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Capricor Therapeutics Inc. published the original content used to generate this news brief on May 21, 2026, and is solely responsible for the information contained therein.