Pharmaceutical Technology

Affinia receives FDA fast track designation for AFTX-201

Affinia Therapeutics has received the US FDA fast track designation for AFTX-201, a genetic medicine under investigation for ...

Affinia Therapeutics Granted FDA Fast Track Designation for AFTX-201 as a Treatment for People Living with BAG3-Associated Dilated Cardiomyopathy (DCM)

AFTX-201 is designed using Affinia's proprietary capsid engineered for efficient cardiac transduction at doses that are 5-10-fold lower than doses of gene therapies using conventional capsids WALTHAM, ...
MPR

Gene Therapy Fast Tracked for BAG3-Associated Dilated Cardiomyopathy

AFTX-201 uses a proprietary capsid to deliver a human BAG3 transgene, aiming to restore cardiac function with lower doses than conventional gene therapies.
CURE

PLT012 Receives FDA Fast Track Designation for Liver Cancer Treatment

PLT012 received FDA fast track status for liver cancer, with an ongoing trial evaluating safety and early activity of the CD36-targeting immunotherapy.
Seeking Alpha

Werewolf Therapeutics Receives Fast Track Designation from the U.S. FDA for WTX-124, an Investigational Therapy for the Treatment of Cancer

WATERTOWN, Mass., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (HOWL), pioneering the development of therapeutics engineered to stimulate the body’s immune system for the treatment of ...