Venus Medtech Completes Enrollment in PREVAILS TAVR Trial for Venus-PowerX
Venus Medtech completes enrollment in PREVAILS TAVR trial for Venus-PowerX, a retrievable aortic valve targeting CE marking and NMPA...
LB Pharmaceuticals Accelerates NOVA-2 Schizophrenia Trial Readout
LB Pharmaceuticals accelerates readout from NOVA-2 schizophrenia trial of LB-102, signaling confidence in the Phase 3 data package ahead...
FDA Accepts BridgeBio’s Encaleret NDA for Autosomal Dominant Hypocalcemia Type 1
FDA accepts BridgeBio's Encaleret NDA for autosomal dominant hypocalcemia type 1, with PDUFA review set for May 2027.
Armata Submits Phase 3 Protocol for AP-SA02 Bacteriophage in S. aureus Bacteremia
Armata Pharmaceuticals submits Phase 3 protocol for AP-SA02 bacteriophage targeting S. aureus bacteremia, with trial launch planned for late...
Healx Doses First Patient in HLX-4310 Trial for Metastatic Osteosarcoma
Healx doses first patient in HLX-4310 trial for metastatic osteosarcoma, targeting micro-metastatic dormancy in relapsed and refractory cases.
Agios Discontinues Tebapivat Development in Sickle Cell Disease
Agios discontinues tebapivat development in sickle cell disease after Phase 2 showed no meaningful separation from placebo.
IMUNON’s IMNN-001 Shows Lower Residual Disease in Phase 2 Ovarian Cancer Study
IMNN-001 demonstrated lower residual disease rates versus control in Phase 2 ovarian cancer study, with 44% showing disease at...
Mabwell’s Bulumtatug Fuvedotin Shows Promise in Topo I-Pretreated TNBC
Mabwell's bulumtatug fuvedotin shows clinical promise in triple-negative breast cancer patients with prior topoisomerase I inhibitor exposure.
OMEICOS’ OMT-28 Advances to Phase 3 Trial in Mitochondrial Disease
OMT-28 Phase 3 trial advances for mitochondrial disease after FDA end-of-phase 2 meeting, with composite functional endpoints and adaptive...
4D Molecular Therapeutics Reports 2-Year Durability Data for 4D-150 in Wet AMD
4D-150 shows sustained efficacy in wet AMD patients at two years post-injection, supporting the Phase 3 program's durability foundation...