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Pipeline
April 8, 2019
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Tizona Therapeutics, Inc. | TTX-030 | cancer | Phase I/Ib trial initiated |
| Amylyx Pharmaceuticals, Inc. | AMX0035 | Alzheimer’s Disease | Phase II trial initiated enrolling 100 subjects |
| Odonate Therapeutics, Inc. | tesetaxel | locally advanced or metastatic breast cancer (MBC) | Phase II trial initiated |
| Poxel SA | PXL770 | non-alcoholic steatohepatitis (NASH) | Phase IIa trial initiated enrolling 100 subjects with nonalcoholic fatty liver disease (NAFLD) who likely have NASH at sites in the U.S. |
| Biohaven Pharmaceutical Holding Company, Ltd. | BHV-3500 | migraine | Phase II/III trial initiated |
| Hutchison China MediTech Limited | surufatinib (HMPL-012 or sulfatinib) with capecitabine | advanced biliary tract cancer (BTC) | Phase IIb/III trial initiated |
| PellePharm, Inc. | Patidegib Topical Gel, 2% | Gorlin Syndrome | Phase III trial initiated enrolling 150 subjects |
| Aldeyra Therapeutics, Inc. | topical ocular reproxalap | dry eye disease | Phase III trial initiated enrolling 400 subjects with moderate-to-severe dry eye disease |
| ACell, Inc. | Gentrix Surgical Matrix | gastroenterological or plastic and reconstructive surgery | 510(k) clearance granted by the FDA |
| ACell, Inc. | Gentrix Surgical Matrix Thin | urological, gastroenterological or plastic and reconstructive surgery | 510(k) clearance granted by the FDA |
| ACell, Inc. | Gentrix Surgical Matrix Plus | gastroenterological or plastic and reconstructive surgery | 510(k) clearance granted by the FDA |
| AstraZeneca and Merck | selumetinib | NF1 plexiform neurofibromas | Breakthrough Therapy designation granted by the FDA |
| CSA Medical, Inc. | RejuvenAir System | moderate to severe chronic obstructive pulmonary disease (COPD) with chronic bronchitis (CB) | Breakthrough Device designation granted by the FDA |
| Fera Pharmaceuticals | Avaclyr (acyclovir ophthalmic ointment) | herpetic keratitis | NDA approval granted by the FDA |
| Intellirod Spine | LOADPRO | kyphotic correction surgery | De Novo approval granted by the FDA |
| Immunocore Limited | tebentafusp (IMCgp100) | metastatic uveal melanoma (mUM) | Fast Track approval granted by the FDA |
| Clarus Therapeutics | Jatenzo (testosterone undecanoate) | hypogonadism | Approval granted by the FDA |
| EMD Serono | Mavenclad (cladribine) | relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive disease (SPMS) | Approval granted by the FDA |
