Development
Sanofi's Nexviazyme clears path to replace Myozyme in infantile-onset Pompe disease
Sanofi (Nasdaq: SNY) reported that avalglucosidase alfa (Nexviazyme) met all primary and secondary endpoints in the Baby-COMET Phase III study in...
Grünenthal advances NOP agonist into efficacy testing after clear Phase I
Germany-based Grünenthal Group has reported the successful completion of a Phase I trial for its proprietary nociceptin receptor (NOP) agonist, an...
Genmab's epcoritamab beats chemotherapy in earlier relapsed DLBCL, opening chemo-free path
Denmark-based Genmab A/S (Nasdaq: GMAB) reported that the Phase III EPCORE DLBCL-4 trial met its primary endpoint, with epcoritamab (Epkinly) plus...
Neurogene's gene therapy shows sustained milestone gains in Rett syndrome through 30 months
New York-based Neurogene (Nasdaq: NGNE) reported updated Phase I/II data for NGN-401, an AAV9 gene therapy delivering a full-length human MECP2 transgene,...
Evommune to focus on dermatology after MRGPRX2 antagonist stumbles in Phase IIb CSU trial
Palo Alto-based Evommune, Inc. (NYSE: EVMN) reported that its oral MRGPRX2 antagonist EVO756 failed to meet its primary endpoint in a Phase IIb trial in...
Arcus enters immunology with first-in-human MRGPRX2 antagonist for atopic disease
Arcus Biosciences (NYSE: RCUS) has registered a first-in-human trial of AB102, an oral small-molecule antagonist of MRGPRX2 (Mas-related G-protein-coupled...
Arrowhead launches mysterious RNAi candidate ARO-033 with undisclosed target and mechanism
Arrowhead Pharmaceuticals (Nasdaq: ARWR) has registered a first-in-human trial for ARO-033, an investigational subcutaneous agent that appears to be derived...
Otsuka reports positive Phase IIIb anxiety data as centanafadine nears July FDA decision
Otsuka has reported positive Phase IIIb results for centanafadine sustained-release in adults with ADHD and comorbid anxiety, a readout that matters because...
Epitopea's mRNA vaccine targets ovarian cancer's treatment-resistant majority with first-in-human trial
Epitopea's mRNA cancer vaccine CryptiVax-1001 enters first-in-human testing in ovarian cancer's hardest-to-treat subgroup
HUTCHMED's fanregratinib posts pivotal Phase II data as China NDA enters priority review
HUTCHMED's fanregratinib demonstrated a 42.5% objective response rate in pretreated patients with FGFR2 fusion-positive intrahepatic cholangiocarcinoma,...
Mwyngil reports one of the first public in vivo datasets for GPR75 obesity program
Boston-based Mwyngil Therapeutics reported preclinical proof-of-concept data for its GPR75 inverse agonist obesity program, with lead oral compounds...
Immunomic's self-amplifying RNA vaccine enters human testing in TNBC
Immunomic Therapeutics Initiates First-in-Human saRNA Cancer Vaccine Trial in Triple-Negative Breast Cancer
Viking's dual amylin-calcitonin agonist enters clinic to advance combo obesity strategy
San Diego-based Viking Therapeutics (Nasdaq: VKTX) has initiated a Phase I single ascending dose trial of VK3019, an internally developed dual amylin and...
Definium's LSD formulation becomes first psychedelic to beat placebo in Phase III depression trial
New York-based Definium Therapeutics (Nasdaq: DFTX) reported positive topline results from the Emerge Phase III trial of DT120 (lysergide) orally...
Trace Neuroscience launches first-in-class UNC13A restoration therapy into human ALS trials
South San Francisco-based Trace Neuroscience has dosed the first patients with TRCN-1023, an antisense oligonucleotide (ASO) targeting UNC13A protein...
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