Development
Envudeucitinib misses Phase IIb lupus endpoints, subgroup signal keeps program alive
The Phase IIb LUMUS trial of envudeucitinib in systemic lupus erythematosus (SLE) failed to meet its primary and secondary endpoints in the overall patient...
Novartis's remibrutinib beats teriflunomide across Phase III relapsing MS trials
Novartis's remibrutinib has met the primary endpoint in both replicate Phase III trials in relapsing multiple sclerosis (RMS), demonstrating superiority...
BioNTech halts personalized mRNA cancer vaccine trial in CRC after survival imbalance
BioNTech SE (Nasdaq: BNTX) has terminated the Phase II BNT122-01 trial of autogene cevumeran in resected colorectal cancer after an independent data safety...
Savolitinib plus Tagrisso hits first-line PFS goal in MET-overexpressing EGFR-mutated lung cancer
The SANOVO Phase III trial has moved savolitinib (Orpathys) plus osimertinib into the first-line EGFR-mutated lung cancer setting, showing a statistically...
Acoramidis shows signs of cardiac remodeling reversal in ATTR-CM CMR analysis
Serial cardiac magnetic resonance imaging (CMR) data from the Phase III ATTRibute-CM trial and its open-label extension (OLE) now show that acoramidis...
Vutrisiran shows consistent HELIOS-B benefit regardless of tafamidis use
New subgroup data from the HELIOS-B Phase III trial show that vutrisiran (Amvuttra) maintained consistent reductions in all-cause mortality and recurrent...
Five-year Camzyos data show sustained oHCM benefit as aficamten competition emerges
Five-year data from the EXPLORER-LTE cohort of the MAVA-LTE study, presented at the European Society of Cardiology (ESC) Congress 2026 in Munich, show that...
Bayer’s evuzamitide posts 94% sensitivity in Phase III cardiac amyloidosis study
Detailed results from the Phase III REVEAL study evaluating Bayer's iodine 124 evuzamitide as a PET diagnostic for cardiac amyloidosis met both primary...
Kazia touts 100% clinical benefit rate for paxalisib in early-stage TNBC study
A 100% clinical benefit rate across six evaluable patients with Stage IV triple-negative breast cancer (TNBC) has emerged from an ongoing Phase Ib study of...
Amgen/AZ's Tezspire extends TSLP platform to eosinophilic esophagitis with Phase III win
Tezepelumab has met both co-primary and all key secondary endpoints in eosinophilic esophagitis, Amgen (Nasdaq: AMGN) and AstraZeneca reported on August 27,...
Graviton/Beijing Tide’s GV101 posts 86% response rate in Phase Ib cGvHD study
Phase Ib/II data from New York-based Graviton BioScience Corporation's selective ROCK2 inhibitor GV101, published in Signal Transduction and Targeted...
TRexBio’s TNFR2 agonist shows human proof-of-mechanism in Phase I
South San Francisco-based TRex Bio, Inc. (TRexBio) has reported positive Phase Ia results for TRB-061, a selective tumor necrosis factor receptor 2 (TNFR2)...
Shanghai Minwei launches first human trial of ActRIIA/B antibody for obesity
Shanghai Minwei Biotechnology Co., Ltd. has registered a Phase I first-in-human clinical trial of MWN110, a monoclonal antibody the company said targets...
AZ, Daiichi Sankyo take Datroway-rilvegostomig combo into Phase III bladder cancer trial
The first Phase III adjuvant trial of rilvegostomig, AstraZeneca's anti-PD-1/TIGIT bispecific antibody, in urothelial cancer has enrolled its first patient...
Spyre’s TL1A antibody hits RA endpoint but falls short in Phase II
SPY072, Spyre Therapeutics' (Nasdaq: SYRE) extended half-life anti-TL1A antibody, produced statistically significant reductions in disease activity in...
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