German pharmaceutical and life sciences company Bayer AG (ETR:BAYN) (OTC:BAYRY) announced on Thursday that it is expanding the clinical development program for NUBEQA (darolutamide) in prostate cancer.
NUBEQA is an androgen receptor inhibitor (ARi) that competitively inhibits androgen binding, AR nuclear translocation and AR-mediated transcription.
A new Phase III clinical study will investigate the efficacy of NUBEQA plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline. BCR is defined as rising prostate-specific antigen (PSA) levels with a doubling time of
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Frontage expands early phase clinical research capabilities across US and China
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
InSysBio agrees new collaborative project with BeOne Medicines
Physiomics secures new modelling contract with Numab Therapeutics
Mabwell reports first patient dosed with 7MW4911 in US trial
Atossa Therapeutics' founder and CEO named one of The Top 50 Healthcare Technology CEOs of 2025
Avacta secures FDA clearance for second pre|CISION oncology programme
Guardant Health and Merck enter multi-year oncology diagnostics collaboration
Akeso secures NMPA review acceptance for gumokimab in ankylosing spondylitis