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Pipeline
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Angion Biomedica | ANG-3070 | primary proteinuric kidney diseases | IND approved by the FDA for a phase 2 trial |
| Avidity Bioscience | AOC 1001 | adults with myotonic dystrophy type 1 | IND approved by the FDA |
| Excel Diagnostics | 225Ac-PSMA I&T targeted alpha therapy | metastatic castrate-resistant prostate cancer | IND approved by the FDA |
| I-Mab | Protollin | Alzheimer's disease | IND approved by the FDA |
| Monopar Therapeutics | camsirubicin plus growth-factor support (pegfilgrastim) | advanced soft tissue sarcoma | IND approved by the FDA |
| Sorrento Therapeutics | allogeneic anti-CD38 dimeric antigen receptor (DAR) T-cell therapy | relapsed or refractory multiple myeloma | IND approved by the FDA |
| Vaxart | S-only oral tablet | SARS-CoV-2 vaccine | IND approved by the FDA |
| ABL Bio | ABL501 | solid tumors | IND approved by South Korea's Ministry of Food and Drug Safety |
| Arcturus Therapeutics | ARCT-810 | ornithine transcarbamylase (OTC) deficiency | approval received from the UK Health Research Authority for a phase 2 trial |
| Arcturus Therapeutics | ARCT-154 and ARCT-165 STARR mRNA vaccines | SARS-CoV-2 alpha, beta, gamma and delta variants | approval received from the Singapore Health Sciences Authority for a phase 1/2 trial |
| Cytodyn | leronlimab (PRO 140) | patients with severe COVID-19 requiring supplemental oxygen | clinical trial authorized by Brazil’s ANVISA (Agência Nacional de Vigilância Sanitária) |
| Eledon Pharmaceuticals | AT-1501 | replacement for tacrolimus as an immunosuppressive regimen component in patients undergoing kidney transplantation | clinical trial authorized by Health Canada |
| Everest Medicines | Xerava (eravacycline) | community-acquired bacterial pneumonia | phase 3 clinical trial authorized by China’s National Medical Products Administration |
| Hummingbird Bioscience | HMBD-001 | advanced cancers | clinical trial authorized by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) |
| PanTher Therapeutics | PTM-101 | pancreatic cancer | approval from the Human Research Ethics Committee of Australia for a phase 1 trial |
| Revolo Biotherapeutics | ‘1104 | moderate-to-severe grass pollen allergy | clinical trial authorized by the UK MHRA |
| Shenzhen Kangtai Biological Products | inactivated COVID-19 vaccine (Vero cells) | COVID-19 vaccine | approval granted by the Philippine Food and Drug Administration for a phase 3 trial |
| Noema Pharma | NOE-105 | Tourette syndrome | initiation of phase 2a trial |
| Prometheus Biosciences | PRA023 | moderate-to-severe Crohn’s disease | initiation of phase 2a trial |
| Stemedica Cell Technologies | intravenous allogeneic mesenchymal stem cells | patients with moderate-to-severe acute respiratory distress syndrome due to COVID-19 | initiation of phase 2 trial |
| Cytokinetics | reldesemtiv | amyotrophic lateral sclerosis | initiation of phase 3 trial |
| Eli Lilly | baricitinib with or without remdesivir | treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen | Emergency Use Authorization expanded by the FDA |
| Allergan | Botox (onabotulinumtoxinA) | upper-limb spasticity in adults | approved by the FDA for expanded indication |
| AstraZeneca | Saphnelo (anifrolumab-fnia) | moderate-to-severe systemic lupus erythematosus | approved by the FDA |
| GlaxoSmithKline | Nucala (mepolizumab) | chronic rhinosinusitis with nasal polyps | approved by the FDA for new indication |
| Janssen | Uptravi (selexipag) intravenous injection | pulmonary arterial hypertension | new formulation approved by the FDA |
| Pillar Bioscience | OncoReveal Dx lung and colon cancer assay | qualitative detection of somatic mutations in DNA derived from nonsmall-cell lung cancer and colorectal cancer tumors | approved by the FDA |
| Amicus Therapeutics | Galafold (migalastat) | Fabry disease in children age 12 years and older | approved by the European Commission for expanded indication |
| Bristol Myers Squibb | Opdivo (nivolumab) | adjuvant treatment of adults with esophageal or gastroesophageal junction with residual pathologic disease following chemoradiotherapy | approved by the European Commission |
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