DENOVO BIOPHARMA LLC

FDA grants Fast Track designation to Denovo Biopharma's DB104 (liafensine) for treatment-resistant depression (TRD), leveraging a novel pharmacogenomic biomarker, DGM4™, to potentially expedite review.

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.

The global cancer biomarkers market size was USD 31.90 billion in 2023 and is projected to reach USD 107.33 billion by 2033, growing at a CAGR of 12.9%. Key drivers include rising technical developments, individualized treatment approaches, and increasing prevalence of cancer globally. The breast cancer segment led the market in 2023, while the genetic biomarkers segment dominated in terms of revenue. North America held the largest market share in 2023, with the U.S. leading due to high prevalence of renal cancer and strong pipeline. Technological innovations and advancements in personalized medicine are expected to further fuel market growth.