Standing up sends pain through Trevor Wiberg’s back, and lifting a box is enough to throw his arm out of joint. Yet, many who meet him, including medical professionals, take one look at him and assume he’s a drug addict. His medical condition is so painful he relies on narcotics...
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-Company remains on track for PDUFA target action date of August 31, 2025- -Advisory committee meeting to be held in advance of target action date- SAN DIEGO, Calif. — Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced...
SAN DIEGO, Calif. — Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the U.S. Food and Drug Administration (“FDA”) has accepted for review its Biologics License Application (“BLA”) seeking full approval for deramiocel, an investigational cell therapy,...
SAN DIEGO, Calif. — Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced positive topline results from its pivotal Phase 3 HOPE-3 trial evaluating Deramiocel, the Company’s investigational cell therapy for the treatment of Duchenne muscular dystrophy (DMD). “HOPE-3...
SAN DIEGO, Calif. — Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, announced today that the Company has been granted an in-person Type-B meeting with the U.S. Food & Drug Administration (FDA) scheduled for late March. In the...
San Diego — Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, announced that the Company presented the 18-month results from its HOPE-2 open-label extension (OLE) study with lead asset, CAP-1002,...
SAN DIEGO, Calif. — Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, announced today that the Company will present the positive 24-month results from its HOPE-2 open-label extension (OLE) study with lead asset, CAP-1002, for the treatment of...
SAN DIEGO, Calif. — Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced a regulatory update for its Biologics License Application (BLA) for Deramiocel, the Company’s investigational cell therapy for the treatment of Duchenne muscular dystrophy (DMD). This update follows a recent...
THOUSAND OAKS, Calif. — Capsida Biotherapeutics today announced new preclinical data supporting the potential of Capsida’s gene therapy candidate, CAP-002, to achieve levels of gene supplementation necessary to correct neurological phenotypes associated with genetic epilepsy due to syntaxin-binding protein 1 (STXBP1) mutations. Gene therapy for genetic epilepsy due to STXBP1...
Capsida previously received FDA Orphan Drug Designation and IND clearance to initiate the SYNRGY Phase 1/2a clinical trial for CAP-002 THOUSAND OAKS, Calif. — Capsida Biotherapeutics (“Capsida”) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its CAP-002 program. CAP-002 is the company’s investigational...