Development
Bezisterim meets motor and non-motor endpoints in phase II early Parkinson's trial.
BioVie (Nasdaq: BIVI) reported that bezisterim, its investigational oral anti-inflammatory compound, met prespecified endpoints in a Phase II trial in early...
Luye clears US bridging milestone for first dual-mechanism TD therapy
Luye Pharma Group (HKEX: 02186) announced on August 5 the successful completion of a US pharmacokinetic (PK) bridging study of LY03015, its investigational...
Hengrui, Braveheart's cardiac myosin inhibitor shows strong early efficacy against cardiomyopathy
Hengrui Pharma and Braveheart Bio reported Phase 2 results for HRS-1893 (BHB-1893), a selective small-molecule cardiac myosin inhibitor, in patients with...
Summit expands ivonescimab's challenge to Keytruda into bladder cancer
Summit Therapeutics (Nasdaq: SMMT) announced the initiation of HARMONi-GU1, a Phase II/III trial testing ivonescimab plus Astellas/Pfizer's Padcev...
Forlong moves SC IL-15 superagonist into Phase I in Australia
China-based Forlong Biotechnology has announced approval to initiate a Phase I clinical trial of FL115, an IL-15/IL-15Rα-Fbody fusion protein, administered...
Moderna advances Bundibugyo Ebola mRNA vaccine into Phase I
Moderna (Nasdaq: MRNA) has dosed the first participants in a Phase I trial of mRNA-1469, its investigational mRNA vaccine against Bundibugyo ebolavirus...
Leads Biolabs' NewCo Oblenio advances CD19×BCMA×CD3 trispecific into clinic
Oblenio Bio has dosed the first patients in a Phase Ia first-in-human trial of LBL-051, a CD19×BCMA×CD3 tri-specific T-cell engager being evaluated in...
Otsuka's sibeprenlimab stabilizes kidney function decline to near-baseline rate in IgAN Phase III
Otsuka reported two-year kidney function data from the Phase III VISIONARY trial of sibeprenlimab (Voyxact) in IgA nephropathy (IgAN) that complete the...
Novo's ziltivekimab misses cardiovascular endpoint despite biomarker success
Novo Nordisk's ZEUS trial has delivered a clean failure for ziltivekimab, the company's anti-IL-6 monoclonal antibody, dealing a setback to the hypothesis...
CREATE clears Australian ethics review for first-in-human in vivo CAR-T study
Cambridge, Massachusetts-based CREATE Medicines, Inc. has received Human Research Ethics Committee (HREC) approval in Australia to begin a first-in-human...
Pfizer's Litfulo succeeds in Phase III vitiligo trials, setting up rivalry with Rinvoq
Pfizer (NYSE: PFE) reported positive topline Phase III results for ritlecitinib (Litfulo) in nonsegmental vitiligo (NSV), positioning the drug to become the...
Candid's trispecific CND319 enters first-in-human testing under UCB
San Diego-based Candid Therapeutics has initiated a first-in-human Phase I clinical trial of CND319, a dual-targeting T-cell engager (TCE) designed to...
Verdiva advances oral amylin strategy with first-in-human study of VRB-103
London and San Francisco-based Verdiva Bio Limited has dosed the first patient in a Phase I single ascending dose study of VRB-103, a once-weekly oral...
FDA clears Iksuda's CA242-targeted ADC for Phase I study in GI cancers
UK-based Iksuda Therapeutics has received US FDA clearance of its investigational new drug application for IKS04, a CA242-directed antibody-drug conjugate...
GSK/Hansoh's B7-H3 ADC set for China filing after hitting Phase III endpoint in osteosarcoma
China-based Hansoh Pharmaceutical Group (HKEX: 03692) announced that HS-20093, its proprietary B7-H3-directed antibody-drug conjugate, met the primary...
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