A gene therapy for heart failure being developed by Bayer’s AskBio unit has been granted fast-track status by the FDA, shortly after it showed preliminary signs of efficacy in a phase 1 trial.
The designation is for AB-1002 (also known as NAN-101) as a one-shot therapy for adults with non-ischemic cardiomyopathy and New York Heart Association (NYHA) class III heart failure symptoms, which is being put to the test in the phase 2 GenePHIT trial.
