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Pipeline
October 5, 2020
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| Covistat/Ensysce Biosciences | oral nafamostat | acute respiratory failure due to COVID-19 | initiation of phase 1 trial |
| Covaxx | UB-612 | COVID-19 vaccine | first patient dosed in phase 1 trial |
| Stemedica Cell Technologies | intravenous allogeneic mesenchymal stem cells | patients with moderate to severe lung injury due to COVID-19 | IND approved by the FDA for phase 2 trial |
| Windtree Therapeutics | lyo lucinactant | COVID-19 associated lung injury and acute respiratory distress syndrome | IND approved by the FDA for phase 2 trial |
| FSD Pharma | FSD201 (ultramicronized palmitoylethanolamide) | hospitalized patients with COVID-19 | initiation of phase 2 trial |
| Novavax | NVX-CoV2373 (COVID-19 vaccine) | COVID-19 | initiation of phase 3 trial |
| Organicell Regenerative Medicine | Zofin acellular therapy | patients with SARS-CoV-2 who have mild to moderate COVID-19, or who are judged by a healthcare provider to be at high risk of progression to moderate disease | expanded access protocol granted by the FDA |
| ADial Pharmaceuticals | Assure/FaStep COVID-19 IgG/IgM Rapid Test Device | antibody point-of-care test for COVID-19 | Emergency Use Authorization (EUA) granted by the FDA |
| Cepheid | Xpert Xpress SARS-CoV-2/Flu/RSV molecular diagnostic test | qualitative detection of the viruses causing COVID-19, Flu A, Flu B, and RSV infections from a single patient sample | EUA granted by the FDA |
| Hologic | Panther Fusion SARS-CoV-2 assay | testing of individuals without symptoms or other reasons to suspect COVID-19 infection | EUA granted by the FDA |
| Quotient | MosaiQ COVID-19 antibody test | detection of COVID-19 antibodies | EUA granted by the FDA |
| Other Trials and Actions | |||
| Aerie Pharmaceuticals | AR-15512 (TRPM8 agonist) eye drop | dry eye disease | IND approved by the FDA |
| IRLAB | mesdopetam (IRL790) | levodopa-induced dyskinesias in Parkinson's disease | IND approved by the FDA |
| Inversago Pharma | INV-101 | Prader-Willi syndrome and non-alcoholic steatohepatitis | initiation of phase 1 trial |
| Kuur Therapeutics | KUR-502 | relapsed/refractory CD19-positive malignancies | first patients dosed in phase 1 trial |
| Prelude Therapeutics | PRT1419 | relapsed/refractory hematologic malignancies | first patients dosed in phase 1 trial |
| Zucara Therapeutics | ZT-01 | type 1 diabetes | first patient dosed in phase 1 trial |
| BioMarin | BMN 307 | phenylketonuria | first patient dosed in phase 1/2 trial |
| Codiak Biosciences | exoSTING | advanced metastatic or recurrent, injectable solid tumors | first patients dosed in phase 1/2 trial |
| Aptinyx | NYX-2925 | fibromyalgia | patient recruitment recommenced in phase 2 trial |
| Calithera Biosciences | telaglenastat (CB-839) | nonsmall-cell lung cancer | first patient dosed in phase 2 trial |
| Concert Pharmaceuticals | CTP-692 | schizophrenia | patient enrollment complete in phase 2 trial |
| Ocular Therapeutics | OTX-CSI (cyclosporine intracanalicular insert) | dry eye disease | first patients dosed in phase 2 trial |
| Aurinia | voclosporin ophthalmic solution | dry eye syndrome | last patient study visit in phase 2/3 trial |
| CiVi Biopharma/Eicos Sciences | CIVI030 (intravenous iloprost) | systemic sclerosis | patient recruitment resumed in phase 3 trial |
| Eisai | lorcaserin | Dravet syndrome | initiation of phase 3 trial |
| Harbour BioMed | batoclimab (HBM 9161) | myasthenia gravis (MG) and adult immune thrombocytopenia | first patient dosed in phase 3 trials |
| Infinity | eganelisib (IPI-549) in combination with a checkpoint inhibitor and chemotherapy | patients with inoperable locally advanced or metastatic triple-negative breast cancer, in the first-line setting | Fast-Track designation granted by the FDA |
| AbbVie | elezanumab (ABT-555) | spinal cord injury | Orphan Drug and Fast-Track designations granted by the FDA |
| Neurophth Therapeutics | NR082 (rAAV2-ND4, NFS-0) | Leber's Hereditary Optic Neuropathy associated with ND4 mutation | Orphan Drug designation granted by the FDA |
| CSL Behring | Haegarda (C1 Esterase Inhibitor Subcutaneous [human] | routine prophylaxis to prevent hereditary angioedema attacks in patients 6 years of age and older | approved by the FDA for expanded indication |
| Eton Pharmaceuticals | Alkindi Sprinkle (hydrocortisone) oral granules | replacement therapy for adrenocortical insufficiency in children under 17 years of age | approved by the FDA |
| GlaxoSmithKline | Nucala (mepolizumab) | hypereosinophilic syndrome (HES) without an identifiable non-blood-related cause of the disease in adults and children 12 years of age and older | approved by the FDA for expanded indication |
| Janssen | Simponi Aria (golimumab) | active polyarticular juvenile idiopathic arthritis and active psoriatic arthritis in patients 2 years of age and older | approved by the FDA |
| Masimo | Rad-G Pulse Oximeter | pulse oximetry and respiration rate monitoring | approved by the FDA |
| Pfizer | Xeljanz (tofacitinib) | children and adolescents 2 years and older with active polyarticular-course juvenile idiopathic arthritis | approved by the FDA for expanded indication |
| Shionogi | Fetroja (cefiderocol) | hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia | approved by the FDA for expanded indication |
| Vertex Pharmaceuticals | Kalydeco (ivacaftor) | children with cystic fibrosis ages four months to less than six months old who have at least one mutation in their CFTR gene | approved by the FDA for expanded indication |
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