Liafensine

Denovo Biopharma's DB104 (liafensine) receives FDA fast track designation for treatment-resistant depression (TRD). Liafensine, a triple reuptake inhibitor, shows potential via a novel pharmacogenomic biomarker, DGM4, in phase 2b ENLIGHTEN trial. This marks a significant advance in TRD treatment and precision medicine for psychiatric diseases.

FDA Fast Track designation granted to liafensine (DB104) for treatment-resistant depression (TRD), based on phase 2b ENLIGHTEN trial data showing significant improvement in DGM4-positive patients. Liafensine, a serotonin, norepinephrine, and dopamine reuptake inhibitor, demonstrated safety without adverse effects.

FDA grants Fast Track designation to Denovo Biopharma's DB104 (liafensine) for treatment-resistant depression (TRD), recognizing its potential to address an unmet medical need. Liafensine, a first-in-class triple reuptake inhibitor, demonstrated efficacy and favorable safety profile in the ENLIGHTEN clinical trial, guided by Denovo's novel pharmacogenomic biomarker, DGM4™.

FDA Fast Track designation granted to Denovo Biopharma's DB104 (liafensine) for treatment-resistant depression (TRD), leveraging novel biomarker DGM4. Liafensine, a triple reuptake inhibitor, showed significant efficacy and safety in phase 2b ENLIGHTEN trial, marking a breakthrough in precision medicine for CNS diseases.