Development
GenFleet tests dual RAS blockade, cachexia strategy in Phase II pancreatic cancer trial
GenFleet Therapeutics (Shanghai) Inc. (HKEX: 02595) has initiated a three-arm Phase II study testing two novel combination regimens against GFH375...
Leads Biolabs' PD-L1/4-1BB opamtistomig posts 77.4% ORR in 1st-line sqNSCLC
Phase II data for opamtistomig, Nanjing Leads Biolabs' (HKEX: 9887) PD-L1/4-1BB bispecific antibody, in first-line non-small cell lung cancer (NSCLC) have...
CoRegen takes CRISPR-edited Tregs into first human cancer trial
A novel approach to cancer immunotherapy that inverts the conventional role of regulatory T cells has entered first-in-human testing, with CoRegen, Inc....
Enhertu becomes first HER2-directed therapy to beat chemoimmunotherapy in 1st-line lung cancer
Trastuzumab deruxtecan (Enhertu) has become the first HER2-directed therapy to demonstrate a progression-free survival benefit over the global standard of...
Regeneron halts first-in-human REGN7041 trial after safety event
A Phase I/II clinical trial of REGN7041, an anti-CD3 monoclonal antibody developed by Regeneron Pharmaceuticals, has been terminated after enrolling just...
Pfizer drops IgAN candidate PF-07985631 over benefit-risk assessment
Pfizer's first-in-human trial of PF-07985631, a biologic in development for IgA nephropathy (IgAN), has been terminated after enrolling only 9 participants,...
REDNVIA terminates Phase II/III trial of DPP-4 inhibitor evogliptin in aortic stenosis
A randomized, placebo-controlled trial evaluating the DPP-4 inhibitor evogliptin (DA-1229) as a potential therapy for calcific aortic valve disease has been...
Merck, Moderna neoantigen therapy delivers landmark Phase III melanoma win
A Phase III trial of intismeran autogene, the mRNA-based individualized neoantigen therapy co-developed by Merck (NYSE: MRK) and Moderna (Nasdaq: MRNA), has...
Oncolytics gains FDA alignment on pivotal path for pelareorep in colorectal cancer
Oncolytics Biotech (Nasdaq: ONCY) has received written feedback from the FDA aligning on a potential pivotal expansion of REO 033, its ongoing randomized...
Enveda clears Phase I with exercise-inspired pill targeting post-GLP-1 weight regain
Boulder, Colorado-based Enveda has reported Phase I results for ENV-308, an oral small molecule designed to mimic Lac-Phe, a hormone the body produces...
Novo Nordisk takes mystery obesity drug into FIH trial against semaglutide
Novo Nordisk has registered a first-in-human Phase I study of NNC0721-8060, an investigational subcutaneous agent for overweight and obesity, with...
Amylyx's avexitide cuts hypoglycemic events by 55% in Phase III post-bariatric trial
Avexitide, a first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist, met the primary endpoint of the Phase III LUCIDITY trial in post-bariatric...
Antares launches FIH trial of ATX-898 with CDK4/6 breast cancer combos
Antares Therapeutics, Inc. has registered a first-in-human Phase I/II study of ATX-898, an investigational small molecule whose molecular target has not...
Filamon launches first-in-human trial of topical MEK inhibitor in wet AMD
Australia-based Filamon Limited has registered a Phase Ib/IIa first-in-human clinical trial of BETA-TT8 Ophthalmic Gel 3.8%, a topical small-molecule...
EyePoint's Duravyu misses wet AMD primary endpoint, hinges on second trial for FDA path
EyePoint Pharmaceuticals (Nasdaq: EYPT) reported topline data from LUGANO, the first of two pivotal Phase III trials evaluating vorolanib (Duravyu)...
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