UroGen’s UGN-103 Shows 94.5% Six-Month Response in NMIBC Trial
UroGen's UGN-103 demonstrates 94.5% six-month response in bladder cancer trial, offering simplified manufacturing over existing ZUSDURI therapy.
Roche’s giredestrant shows 30% reduction in breast cancer recurrence at ASCO 2026
Roche's giredestrant demonstrates 30% reduction in breast cancer recurrence or death in the lidERA trial, with FDA filing implications...
Regeneron’s Fianlimab Misses Primary Endpoint in Phase 3 Melanoma Trial
Regeneron's fianlimab misses primary endpoint in Phase 3 melanoma trial, posting p-value of 0.0627 despite 5.1-month PFS improvement over...
Senti Bio Advances SENTI-202 to Pivotal Trial With Donor X Selection Strategy
Senti Bio advances SENTI-202 pivotal trial with Donor X selection strategy, achieving 50% complete remission in heavily pretreated R/R...
Alumis Reports 68% PASI 90 Response for Envudeucitinib in Psoriasis Trial
Alumis reports 68% PASI 90 response for envudeucitinib in psoriasis trial ONWARD1, matching deucravacitinib efficacy with early scalp clearance...
Cardiff Oncology Advances Onvansertib Phase 3 for RAS-Mutated Metastatic Colorectal Cancer
Cardiff Oncology advances onvansertib Phase 3 for RAS-mutated metastatic colorectal cancer with 72.2% response rate in Phase 2 data.
NBTXR3 Shows 57% Complete Response Rate in Stage III Lung Cancer Study
NBTXR3 achieves 57% complete response rate in stage III lung cancer study, compared to under 5% with current standard...
UroGen’s UGN-103 Shows 94.5% Response Rate in Phase 3 NMIBC Trial
UroGen's UGN-103 demonstrated 94.5% six-month response rate in Phase 3 NMIBC trial, edging prior standard ZUSDURI's efficacy benchmark.
Regeneron’s Fianlimab Misses Statistical Significance in Melanoma Trial
Regeneron's fianlimab melanoma trial missed statistical significance for progression-free survival, though the high-dose combination showed a 5.1-month numeric
BioXcel Awaits FDA Decision on IGALMI At-Home Label Expansion
BioXcel awaits FDA decision on IGALMI at-home label expansion with November 14 PDUFA date. Approval would enable first outpatient...