Development
Mezzion Pharma secures financing to advance udenafil Phase III trial in Fontan circulation
Mezzion Pharmaceuticals has announced the completion of an institutional financing round to support continued execution of the FUEL-2 trial, its global...
Biogen to contine with tau-targeted diranersen despite missed endpoint in early Alzheimer's Phase II
Biogen (Nasdaq: BIIB) reported topline Phase II results for diranersen (BIIB080) in early Alzheimer's disease on May 14, marking the first randomized Phase...
Novo Nordisk's oral semaglutide achieves 21.6% weight loss in early responders in Phase III obesity trial
New sub-analyses from the phase III OASIS 4 trial show that oral semaglutide 25 mg (Wegovy pill) produced 21.6% weight loss in early responders by week 64,...
Pfizer terminates Phase I trial of anti-CD25 ADC PF-08046032 in oncology
Pfizer's Phase I program for PF-08046032, an anti-CD25 antibody-drug conjugate designed to deplete immunosuppressive regulatory T cells within the tumor...
Restore Vision's optogenetic gene therapy restores light perception in end-stage retinitis pigmentosa patients
Interim data from a GPCR-based optogenetic gene therapy add early human evidence to a mutation-agnostic approach for end-stage retinitis pigmentosa, a...
Inhibrx's OX40 agonist doubles response rates in head and neck cancer trial
Interim INBRX-106 Phase 2 data show a near doubling of confirmed response rates over pembrolizumab alone in a high-PD-L1 head and neck cancer population,...
Fractyl's AAV gene therapy for type 2 diabetes enters first-in-human testing with endoscopic pancreatic delivery
The first adeno-associated virus (AAV)-based gene therapy candidate for type 2 diabetes has cleared regulatory review for human testing, as Fractyl Health...
Hengrui, Braveheart's cardiac myosin inhibitor produces positive Phase II data in non-obstructive HCM
Phase 2 data for HRS/BHB-1893 in non-obstructive hypertrophic cardiomyopathy show reductions in cardiac biomarkers and structural remodeling markers, with a...
Longeveron's stem-cell therapy laromestrocel clears safety review in Phase IIb hypoplastic left heart syndrome trial
An independent Data Monitoring Committee (DMC) has cleared the ELPIS II trial of laromestrocel (Lomecel-B) to proceed to completion without modification,...
Anixa's FSHR-directed CAR-T shows extended survival in recurrent ovarian cancer
Survival data from a follicle-stimulating hormone receptor-targeted CAR-T therapy in recurrent ovarian cancer are adding to a limited evidence base for cell...
Ranok Therapeutics' KRAS G12D inhibitor shows 58% response rate in non-small cell lung cancer
Phase Ia data for RNK08954, an oral KRAS G12D inhibitor developed by Ranok Therapeutics, show an overall objective response rate of 28% and a disease...
Lysoway's TRPML1 agonist enters clinic aiming to validate autophagy pathway in neurodegeneration
HARD CONSTRAINT NOTICE: This article must be between 420 and 500 words. The writing guidelines requesting 850+ words conflict with the hard constraint. The...
enGene reports 54% CR in NMIBC pivotal cohort, but 12-month durability remains limited at 25%
enGene Therapeutics (Nasdaq: ENGN) reported updated interim data from the pivotal cohort of its LEGEND trial showing detalimogene voraplasmid achieved a 54%...
Entrada Therapeutics' ENTR-601-44 meets primary safety goals in Duchenne muscular dystrophy trial
Entrada Therapeutics reported topline results from Cohort 1 of the Phase I/II ELEVATE-44-201 study evaluating ENTR-601-44 in ambulatory pediatric patients...
Ukko doses first participant in mRNA-LNP peanut allergy trial redirecting IgE to protective IgG response
Ukko, Inc., a Boston-based biotechnology company, has dosed the first participant in a Phase 1/2a clinical study evaluating UKK-0018 for peanut allergy,...
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