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Drug & Device Pipeline News
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
Exegenesis Bio | EXG102-031 | Neovascular age-related macular degeneration | IND for a phase 1 trial approved by the FDA |
Cyrano Therapeutics | CYR-064 | Post-viral smell loss | IND for a phase 2 trial approved by the FDA |
Orthogen | Orthogen device | Knee osteoarthritis stages II through IV | IDE for a phase 3 trial approved by the FDA |
Trials Initiated | |||
Ceruvia Lifesciences | NYPRG-101 (BOL-148) | Neurological and psychiatric disorders, including cluster headaches | Initiation of a phase 1 trial |
Trefoil Therapeutics | TTHX1114 | Corneal epithelial defects | Initiation of a phase 1 trial |
Asher Biotherapeutics | AB248 and AB248 plus Keytruda | Locally advanced/metastatic solid tumors, including melanoma, renal cell carcinoma, non-small cell lung cancer and squamous cell carcinoma of the head and neck | Initiation of a phase 1a/1b trial |
Biomea Fusion | BMF-219 | KRAS-mutated unresectable, locally advanced or metastatic non-small cell lung cancer, colorectal cancer and pancreatic ductal adenocarcinoma | Initiation of a phase 1/1b trial |
Cardiol Therapeutics | CardiolRx | Recurrent pericarditis | Initiation of a phase 2 trial |
ORYZON Therapeutics | Iadademstat | Relapsed/refractory high-grade neuroendocrine carcinomas | Initiation of a phase 2 trial |
Apex Labs | APEX-52 (synthetic psilocybin) | Post-traumatic stress disorder | Initiation of a phase 2b trial |
Palatin Technologies | Bremelanotide | Type 2 diabetic kidney disease | Initiation of a phase 2b trial |
Plus Therapeutics | Rhenium (186Re) obisbemeda | Recurrent glioblastoma | Initiation of a phase 2b trial |
Theriva Biologics | VCN-01 plus chemotherapy | Newly diagnosed metastatic pancreatic ductal adenocarcinoma | Initiation of a phase 2b trial |
Versanis Bio | Bimagrumab and bimagrumab plus Rybelsus (semaglutide) | Obesity | Initiation of a phase 2b trial |
Stemedica Cell Technologies | Allogeneic mesenchymal stem cells | Ischemic stroke | Initiation of a phase 2b/3 trial |
Life Molecular Imaging | PI-2620 imaging agent | Alzheimer’s disease | Initiation of a phase 3 trial |
Approvals | |||
Luye Pharma | Rykindo (risperidone) for extended-release injectable suspension | Schizophrenia and bipolar 1 disorder in adults | Approved by the FDA for new formulation |
Novo Nordisk | Rybelsus (semaglutide) | First-line treatment for type 2 diabetes in adults | Approved by the FDA for expanded indication |
Abbott | Navitor transcatheter aortic valve implantation system | Severe aortic stenosis in patients at high or extreme risk for open heart surgery | Approved by the FDA |
Shanghai Henlius Biotech | Hansizhuang (serplulimab) injection in combination with carboplatin and etoposide | Extensive-stage small cell lung cancer | Approved in China |

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