Research · Aug 25, 2026
Cardiac Cell Therapy Receives First Reimbursed Price in Japan
Japan's conditional approval pathway set a ¥53.2 million reimbursed price for ReHeart, making MHLW the first regulator to price cardiac cell therapy.
BCDA
BioCardia, Inc.
NASDAQ · Healthcare · Biotechnology · US
$1.08
−0.92%Research · Aug 25, 2026
Rare-Disease Gene Therapy Shifts From Sham-Surgery Control to Delivery Hardware and Endpoint Instruments
The FDA told uniQure a sham-surgery control is no longer required, moving the cost of rare-disease gene therapy onto delivery hardware and endpoint instruments.
Research · Aug 25, 2026
Rare CNS Gene Therapy Moves Past Sham-Surgery Control
uniQure, ClearPoint and BioCardia disclosed the FDA no longer requires a sham-surgery control in rare CNS gene therapy, moving the gate to delivery hardware.