FDA pushes back decision on Capricor’s Duchenne cell therapy, GSK clears hepatitis B drug in Japan

The U.S. Food and Drug Administration has extended its review of Capricor Therapeutics' experimental Duchenne muscular dystrophy cell therapy, deramiocel. The agency moved its decision deadline from August 22 to November 22 after the company submitted a major amendment with new data supporting a refined indication focused on upper‑limb function.

The amendment shifts the therapy's target from a heart‑related complication to upper‑limb function. An advisory panel that previously voted against the cardiomyopathy indication expressed greater support for the updated findings.

The three‑month delay gives Capricor additional time to gather evidence while investors watch for the agency's verdict.

Separately, GSK secured its first regulatory clearance in Japan for Hibsago, an antisense oligonucleotide therapy for hepatitis B, a product the company hopes will become a blockbuster.