AI-driven clinical trial design company Opyl Ltd. formed a partnership with L39 Capital Pty Ltd. to establish a $100 million biotech fund that will showcase the predictive power of Opyl’s Trialkey software in selecting successful biotech and pharmaceutical stocks. Melbourne, Australia-based Opyl leverages AI to elevate clinical trial design and forecast outcomes, empowering clinical researchers, biopharma companies and investors to enhance trial design, drug development and market delivery.
Kazia Therapeutics Ltd.'s stock shot up 248% on July 10 after the Sydney-based company reported that paxalisib showed a 3.8-month improvement in overall survival, a 33% improvement, for newly diagnosed unmethylated patients with glioblastoma (GBM) compared to the concurrent standard-of-care arm in the pivotal GBM-Agile phase II/III study.
Nonalcoholic steatohepatitis was renamed, for the first time in 34 years, to metabolic dysfunction associated steatohepatitis (MASH), but a name change is far from being the biggest development in the field, according to experts at Bioplus Interphex (BIX) Korea 2024.
Nanjing, China-based Iaso Biotherapeutics Co. Ltd. has bought out global rights to human anti-B cell maturation antigen CAR T Fucaso (equecabtagene autoleucel) from partner Innovent Biologics Inc.
Biocity Biopharmaceutics Co. Ltd.’s selective endothelin receptor type A antagonist, SC-0062, met the primary endpoint of reducing proteinuria in a phase II chronic kidney disease trial. The candidate showed a clinically meaningful and statistically significant reduction in proteinuria, with a clear dose-response relationship and good safety profile.
Tracon Pharmaceuticals Inc. is shuttering all development of its subcutaneous PD-L1 antibody, envafolimab, after the pivotal trial failed to meet the primary endpoint in soft tissue sarcoma.
In May 2024, BioWorld covered 298 updates across phase I-III clinical trials, surpassing March (261), February (236) and January (252), though falling short of April’s high of 323. Additionally, at the end of May BioWorld revised its reporting criteria for clinical trial updates, focusing mainly on data readouts and excluding trial initiations, enrollment changes and initial patient dosing, thereby impacting the update count relative to prior months.
Takeda Pharmaceutical Co. Ltd. is progressing mezagitamab to phase III trials after the CD38 monoclonal antibody showed rapid and sustained increases in platelet counts in patients with persistent or chronic primary immune thrombocytopenia (ITP) in a phase IIb trial.
Preliminary data show Biotron Ltd.’s lead compound BIT-225 met the primary objectives of the phase II BIT225-011 trial, a longitudinal, open-label trial designed to characterize the effect of the compound added to ongoing, suppressive antiretroviral therapy in HIV-1-infected, treatment-experienced patients who achieved only partial immune reconstitution.
China’s National Medical Products Administration (NMPA) approved Dizal Pharmaceutical Co. Ltd.’s golidocitinib for treating adults with relapsed or refractory peripheral T-cell lymphoma whose disease has progressed or was refractory to at least one prior systemic therapy.
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