Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
| Trials Authorized | |||
| Aravax | PVX108 | Peanut allergy | IND approved by the FDA |
| Inventiva | Lanifibranor plus empagliflozin | Type 2 diabetes and noncirrhotic nonalcoholic steatohepatitis (NASH) | IND approved by the FDA |
| Insightec | Exablate Neuro ultrasound system | Nonsmall-cell lung cancer and brain cancer | IDE approved by the FDA |
| Akeso | Cadonilimab plus docetaxel | Nonsmall-cell lung cancer | IND approved by China’s regulatory authority |
| Antengene | ATG-101 | Solid tumors and B-cell nonHodgkin’s lymphoma | IND approved by China’s regulatory authority |
| CARsgen Therapeutics | CLDN18.2 | Gastric and pancreatic cancer | Approval for a phase 2 trial granted by China’s regulatory authority |
| Biomind Labs | N, N-dimethyltryptamine (DMT) | Treatment-resistant depression | Approval for a phase 2 trial granted by Brazil’s regulatory authority |
| Altamira Therapeutics | Bentrio preventive nasal spray | COVID-19 | Approval for a clinical trial granted by Bulgaria’s regulatory authority |
| Trials Initiated | |||
| Pionyr Immunotherapeutics | PY314 | Solid tumors | Initiation of phase 1b trial |
| Confo Therapeutics | CFTX-1554 | Neuropathic pain | Initiation of phase 1 trial |
| Digestome Therapeutics | DGX-001 | Schizophrenia and Parkinson’s disease | Initiation of phase 1 trial |
| MiNK Therapeutics | AgenT-797 | Solid tumors | Initiation of phase 1 trial |
| Eucure Biopharma | YH002 plus YH001 | Solid tumors | Initiation of phase 1 trial in Australia and China |
| Denali Therapeutics | DNL593 | Frontotemporal dementia-granulin | Initiation of phase 1/2 trial |
| Freeline Therapeutics | FLT180a | Hemophilia B | Initiation of phase 1/2 trial |
| Palleon Pharmaceuticals | E-602 | Advanced cancers | Initiation of phase 1/2 trial |
| Aldeyra Therapeutics | ADX-2191 | Retinitis pigmentosa | Initiation of phase 2 trial |
| Pfizer | Paxlovid | COVID-19 | Initiation of phase 2/3 pediatric trial |
| Equillium | Itolizumab | Acute graft-versus-host disease | Initiation of phase 3 trial |
| KalVista Pharmaceuticals | KVD900 | Hereditary angioedema | Initiation of phase 3 trial |
| Approvals | |||
| Bristol Myers Squibb | Opdivo (nivolumab) | Nonsmall-cell lung cancer in the neoadjuvant setting | Approved by the FDA for expanded indication |
| Antengene | Xpovio (selinexor) | Relapsed and/or refractory multiple myeloma and triple-class refractory multiple myeloma | Approved in Australia |
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