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...
Alumis’ Envudeucitinib Hits 68% PASI 90 in Phase 3 Psoriasis Trial
Alumis' envudeucitinib achieved 68% PASI 90 in Phase 3 psoriasis trial, exceeding typical oral TYK2 inhibitor benchmarks of 50–55%.
Cardiff Oncology Advances Onvansertib to Phase 3 in RAS-Mutated Colorectal Cancer
Cardiff Oncology advances onvansertib to Phase 3 in RAS-mutated colorectal cancer after Phase 2 showed 72.2% response rate versus...
UroGen’s UGN-103 Shows 94.5% Six-Month Response Rate in NMIBC Trial
UroGen's UGN-103 demonstrated a 94.5% six-month response rate in non-muscle invasive bladder cancer, tracking closely with the approved ZUSDURI...
Regeneron’s Fianlimab Misses Statistical Significance in Melanoma Trial
Regeneron's fianlimab misses statistical significance in melanoma trial despite a 5.1-month PFS improvement in high-dose combination therapy.
Senti Bio’s SENTI-202 Shows 50% Complete Remission Rate in Donor X Cohort
SENTI-202 achieved 50% complete remission in Donor X cohort of relapsed/refractory AML patients, with all responders MRD-negative and responses...
BioXcel Reports Q1 2026 Loss; IGALMI Approval Decision Due November
BioXcel's IGALMI Approval Decision due November 14, 2026, for at-home agitation treatment in bipolar disorder and schizophrenia.
Alumis’ envudeucitinib hits 68% PASI 90 in Phase 3 psoriasis trials
Envudeucitinib Phase 3 trials show 68% PASI 90 response by Week 24, with early itch relief and scalp psoriasis...
Cardiff Oncology Advances Onvansertib Phase 3 for RAS-Mutated Colorectal Cancer
Cardiff Oncology advances onvansertib Phase 3 for RAS-mutated colorectal cancer with 72.2% response rate in Phase 2 trial data.
UroGen’s UGN-103 Achieves 94.5% Six-Month Response Rate in NMIBC Trial
UroGen's UGN-103 demonstrates 94.5% six-month response rate in NMIBC trial, supporting FDA filing planned for Q3 2026.