Development
Stoke, Biogen report four-year durability for Dravet therapy zorevunersen
Four-year open-label extension data for zorevunersen, the antisense oligonucleotide being developed by Massachusetts-based Stoke Therapeutics (Nasdaq: STOK)...
Innovent takes once-weekly oral GLP-1 into Phase I
Innovent Biologics (HKEX: 01801) has registered a Phase I study of IBI3042, an oral small-molecule glucagon-like peptide-1 receptor (GLP-1R) agonist...
Soufflé joins DUX4 race in FSHD with muscle-targeted siRNA conjugate
Massachusetts-based Soufflé Therapeutics, Inc. has registered a Phase I/II clinical trial of SFL-0821, an antibody-siRNA conjugate designed to silence DUX4...
AbbVie’s monthly BCMAxCD3 bispecific clears Phase III hurdle
AbbVie (NYSE: ABBV) has reported that etentamig, its investigational BCMA × CD3 bispecific T-cell engager (TCE), met both dual primary endpoints in the...
France clears Sensorion's gene therapy SENS-601 into human testing for GJB2 hearing loss
France's drug regulator has cleared Sensorion to begin human testing of SENS-601, its adeno-associated virus (AAV)-based gene therapy for GJB2-related...
NEJM publishes daraxonrasib NSCLC data supporting Phase III program
Revolution Medicines (Nasdaq: RVMD) has published updated Phase I/II data in the New England Journal of Medicine showing antitumor activity for daraxonrasib...
Akeso's ivonescimab beats Keytruda on overall survival in advanced NSCLC
Akeso's ivonescimab has now demonstrated a statistically significant overall survival benefit versus Merck's Keytruda (pembrolizumab) monotherapy in...
Ultragenyx’s Angelman setback puts UBE3A strategy under scrutiny
The Phase III Aspire study of apazunersen (GTX-102) in Angelman syndrome failed to meet its primary endpoint, leaving the condition without an approved...
Adicet preps off-the-shelf gamma delta CAR-T for first-in-human prostate cancer study
Redwood City-based Adicet Bio (Nasdaq: ACET) has registered a Phase I/II trial of ADI-212, an allogeneic gamma delta chimeric antigen receptor (CAR) T cell...
Norroy advances first domestically developed PSMA-targeted therapy into pivotal China trial
China-based Norroy Bioscience Co., Ltd. has initiated a pivotal Phase III trial of 177Lu-NYM032, a prostate-specific membrane antigen (PSMA)-targeted...
GSK advances dual-antigen mRNA flu vaccine to Phase III after positive Phase II
Positive Phase II data for GSK's mRNA seasonal influenza vaccine candidate FLUm3HA.b-3NA have cleared the bar for a Phase III efficacy trial, with the UK...
Teva's anti-IL-15 antibody cuts gluten-induced intestinal damage in Phase IIa celiac disease trial
A single subcutaneous dose of TEV-'408, Teva Pharmaceutical Industries' (NYSE: TEVA) investigational anti-interleukin-15 monoclonal antibody, significantly...
Raziel's RZL-012 meets Phase III endpoints for submental fat reduction, paving China NDA path
A pivotal 480-patient Phase III trial of utenpanium chloride (RZL-012) has met all primary and secondary efficacy and safety endpoints in submental fat (fat...
BigHat's AI-designed CDH17 antibody enters human testing for gastric cancer
San Mateo, California-based BigHat Biosciences has dosed its first patient with BHB810, a cadherin-17 (CDH17)-directed antibody-drug conjugate (ADC) for...
Ocugen launches Phase III trial of one-time gene therapy for geographic atrophy
Ocugen (Nasdaq: OCGN) has dosed the first patient in ArMaDa3, a global Phase III registrational trial of OCU410, an AAV5-based modifier gene therapy for...
The AllSci Brief
Free, systematic R&D and deal news. Daily.