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Pipeline
September 30, 2019
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| BioLineRx Ltd. | AGI-134 | solid tumors | Phase 1/2a trial initiated enrolling subjects at 15 sites in the U.S., U.K. and Israel |
| Neuralstem Inc. | NSI-566 | chronic ischemic stroke | Phase 2 trial initiated enrolling 22 subjects with sustained chronic motor deficits due to an ischemic stroke |
| Oragenics, Inc. | AG013 | severe oral mucositis | Phase 2 trial initiated enrolling 200 subjects at 59 sites in the U.S. and Europe |
| ImaginAB, Inc. | 89Zr-Df-IAB22M2C | cancer | Phase 2 trial initiated enrolling subjects with advanced and metastatic cancer at the O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham |
| Oncopeptides AB | melflufen in combination with dexamethasone | relapsed/refractory multiple myeloma (RRMM) | Phase 2 trial initiated enrolling 150 subjects |
| Rigel Pharmaceuticals, Inc. Kissei Pharmaceuticals Co., Ltd. |
fostamatinib disodium hexahydrate | chronic immune thrombocytopenia (ITP) | Phase 3 study initiated enrolling adult subjects with ITP |
| Protalix BioTherapeutics, Inc. Chiesi Farmaceutici S.p.A. |
PRX 102 (pegunigalsidase alfa) | Fabry disease with impaired renal function | Phase 3 trial initiated enrolling subjects previously treated with an enzyme replacement therapy: agalsidase alfa or agalsidase beta |
| Ocular Therapeutix, Inc. | DEXTENZA | allergic conjunctivitis (AC) | Phase 3 trial initiated enrolling 80 subjects |
| Annexon Biosciences | ANX005 | Guillain-Barré Syndrome (GBS) | Fast Track approval granted by the FDA |
| Merck & Company | PIFELTRO (in combination with other antiretroviral agents) | HIV-1 in adult subjects who are virologically suppressed | sNDA approval granted by the FDA |
| Merck & Company | DELSTRIGO | HIV-1 in adult subjects who are virologically suppressed | sNDA approval granted by the FDA |
| Abiomed | Impella 5.5 with SmartAssist minimally invasive forward flow heart pump | residual myocardial function | PMA approval granted by the FDA |
| Novo Nordisk | Rybelsus (semaglutide) oral tablets | type 2 diabetes | Approval granted by the FDA |
| Exact Sciences Corp. | Cologuard | noninvasive colorectal cancer screening test for subjects ages 45 and older | Approval granted by the FDA |
| Bavarian Nordic A/S | Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating | smallpox and monkeypox disease in adults 18 years of age and older | Approval granted by the FDA |
