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Pipeline
June 4, 2018
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| NeoImmune Tech, Inc. | HyLeukin-7 | brain cancer | Phase I trial initiated enrolling up to 75 subjects |
| Atox Bio | Reltecimod | Abdominal sepsis and Stage 2/3 Acute Kidney Injury (AKI) | Phase II trial initiated enrolling 120 subjects at approximately 50 level 1 trauma centers in the U.S. |
| Atox Bio | Reltecimod | Necrotizing Soft Tissue Infections (NSTI) | Phase III trial initiated enrolling 290 subjects at approximately 70 level 1 trauma sites in the U.S. |
| Synedgen | Catasyn Advanced Technology Wound Hydrogel | wound care | 510(k) clearance granted by the FDA |
| Novartis | Promacta (eltrombopag) | Severe aplastic anemia (SAA) | sNDA approval granted by the FDA |
| Nektar Therapeutics | NKTR-181 | chronic lower back pain | NDA approval granted by the FDA |
| Sage Therapeutics | brexanolone (SAGE-547) | postpartum depression (PPD) | NDA approval granted by the FDA |
| MicroVention, Inc. | Low profile Visualized Intraluminal Support (LVIS) and LVIS Jr. neuro stent devices | wide-necked saccular intracranial aneurysms | PMA granted by the FDA |
| Dova Pharmaceuticals | Doptelet (avatrombopag) | thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure | Approval granted by the FDA |
| TherapeuticsMD | Imvexxy (TX-004HR) | moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), symptom of vulvar and vaginal atrophy (VVA) | Approval granted by the FDA |
| BioMarin Pharmaceutical | Palynziq (pegvaliase-pqpz) | Henylketonuria (PKU) | Approval granted by the FDA |
| Zeto, Inc. | zEEG | dry electrode electroencephalography (EEG) headset | Approval granted by the FDA |
| Astellas Pharma Inc. | gilteritinib | Relapsed or refractory Acute Myeloid Leukemia (AML) with a FLT3 mutation | Priority Review granted by the FDA |
| Pfizer | Xalkori (crizotinib) | Metastatic non-small cell lung cancer (NSCLC) with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy | Breakthrough Therapy Designation granted by the FDA |
| Pfizer | tafamidis | Transthyretin cardiomyopathy | Breakthrough Therapy Designation granted by the FDA |
| Yamo Pharmaceuticals, LLC | L1-79 | autism spectrum disorder (ASD) | Fast Track Designation granted by the FDA |
| Genea Biocells | GBC0905 | Facioscapulohumeral muscular dystrophy (FSHD) | Orphan Drug Designation granted by the FDA |
