Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Acticor Biotech | Glenzocimab | Acute ischemic stroke | IND approved by the FDA for phase 2/3 trial |
| Neurona Therapeutics | NRTX-1001 | Drug-resistant mesial temporal-lobe epilepsy | IND approved by the FDA for phase 1/2 trial |
| Pharmaxis | PXS-5505 | Hepatocellular carcinoma | IND approved by the FDA |
| Prelude Therapeutics | PRT2527 | Selected solid tumors | IND approved by the FDA |
| Inovio | INO-4800 | COVID-19 vaccine | Approval of phase 3 trial granted by the FDA |
| Ascletis Pharma | ASC22 (envafolimab) | Immune restoration/functional cure of patients with HIV-1 infection | Approval for a phase 2 trial granted by China’s regulatory authority |
| Promore Pharma | Ensereptide | Skin scarring prevention | Approval for a phase 2 trial granted by Sweden’s regulatory authority |
| Trials Initiated | |||
| Nodthera | NT-0796 | Chronic inflammation | Initiation of phase 1 trial |
| Epizyme | EZM0414 | Relapsed or refractory diffuse large B-cell lymphoma | Initiation of phase 1/1b trial |
| Affimed NKGen Biotech |
AFM24 plus SNK01 | Nonsmall-cell lung cancer, squamous-cell carcinoma of the head and neck and colorectal cancer | Initiation of phase 1/2 trial |
| Bicycle Therapeutics | BT7480 | Advanced solid tumors associated with Nectin-4 expression | Initiation of phase 1/2 trial |
| Cyclacel Pharma | Oral fadraciclib | Leukemias or myelodysplastic syndromes | Initiation of phase 1/2 trial |
| Iterion Therapeutics | Tegavivint | Pediatric cancers | Initiation of phase 1/2 trial |
| Pieris Servier |
PRS-344/S095012 | Advanced solid tumors | Initiation of phase 1/2 trial |
| Taiga Biotechnologies | TBX-2400 | Acute myeloid leukemia and myelofibrosis patients undergoing hematopoietic stem-cell transplant | Initiation of phase 1/2 trial in Croatia |
| Alnylam | Zilebesiran | Hypertension | Initiation of phase 2 trial |
| Ambrx | ARX788 | HER2-positive metastatic breast cancer | Initiation of phase 2 trial |
| Hookipa Pharma | HB-201 | HPV-16 squamous-cell head and neck cancers | Initiation of phase 2 trial |
| NeoImmuneTech | NT-I7 (efineptakin alfa) | First-line treatment for PD-L1-expressing, locally advanced or metastatic nonsmall-cell lung cancer | Initiation of phase 2 trial |
| Noxopharm | DAART immunotherapy | Cancer | Initiation of phase 2 trial |
| Horizon Therapeutics | HZN-825 | Diffuse cutaneous systemic sclerosis | Initiation of phase 2b trial |
| Eyenovia | MicroLine proprietary pilocarpine formulation | Presbyopia | Initiation of phase 3 trial |
| Zymeworks BeiGene |
Zanidatamab with or without BeiGene’s tislelizumab | HER2-positive gastroesophageal adenocarcinoma | Initiation of phase 3 trial |
| Approvals | |||
| Azurity Pharmaceuticals | Eprontia (topiramate) oral solution | Partial-onset or primary generalized tonic-clonic seizures | Approved by the FDA |
| Tris Pharma | Dyanavel XR extended-release once-daily tablets | ADHD in patients 6 years and older | Approved by the FDA |
| Insightec | Exablate neuro device | Parkinson’s disease | Approved by the FDA |
| GenBody | COVID-19 antigen test kit | Detection of SARS-CoV-2 antigen | Emergency Use Authorization granted by the FDA |
| Merck Ridgeback Biotherapeutics |
Molnupiravir (Lagevrio) | Treatment of mild-to-moderate COVID-19 in adults who have at least one risk factor for developing severe illness | Approved by the UK’s regulatory authority |
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