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Pipeline
September 17, 2018
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Amryt | AP101 | Epidermolysis Bullosa, a genetic disorder that causes skin and lining of internal organs to blister and tear | Granted Investigational New Drug clearance by FDA to open U.S. sites as part of EASE Phase III clinical trial |
| Fibrocell Science, Inc. | FCX-013 | Moderate to severe localized scleroderma | Granted Fast Track designation by the FDA |
| Loxo Oncology, Inc. | LOXO-292 | Metastatic RET-fusion-positive non-small cell lung cancer; RET-mutant medullary thyroid cancer | Granted Breakthrough Therapy designation by the FDA |
| Genesys Spine | AIS-C Stand-Alone System a first of its kind, non-screw based, zero-profile, direct-anterior interbody system | Cervical spine surgery | Granted FDA clearance |
| Perrigo Company plc | OTC equivalent of Imodium® Multi-Symptom Relief (loperamide hydrochloride and simethicone tablets, 2 mg/125 mg) | Diarrhea plus bloating, pressure and cramps | Granted approval by the FDA |
| Concentric Analgesics, Inc. | CA-008, a non-opioid therapeutic | Post-surgical pain | Granted Breakthrough Therapy designation by the FDA |
| physIQ | AFib detection analytics engine | Atrial Fibrillation | Granted FDA 510(k) clearance |
| Foamix Pharmaceuticals, Ltd. | FMX101, tpical minocycline foam | Moderate to severe acne | Met endpoints in Phase III trial |
| Merck KGaA and Pfizer | Combination of Bavencio (avelumab) and Inlyta (axitinib) | Advanced renal cell carcinoma | Therapy significantly improved progression-free survival in Phase III trial |
| Vital Therapies | VT-308 | Severe alcoholic hepatitis | Failed Phase III clinical trial |
| Gilead Sciences and Galapagos NV | Filgotinib | Moderate to severe active rheumatoid arthritis | FINCH 2 Phase III trial successfully met primary endpoints |
| Bristol-Myers Squibb | BMS-986165 | Moderate to severe plaque psoriasis | Hit efficacy endpoints in Phase II clinical trial |
| Amygdala Neurosciences | ANS-6637 | Alcohol use disorder | Initiated Phase II clinical trial with NIAAA |
| Abeona Therapeutics, Inc. | Gene therapy product ABO-101 (AAV-NAGLU) | MPS IIIB (Sanfilippo syndrome type B) | Initiated Phase I/II clinical trial in Spain |
| EpicGenetics, Inc. | Tuberculosis vaccine, BCG | Fibromyalgia | Launching Phase II clinical trial with Mass General Hospital |
| Checkpoint Therapeutics, Inc. | CK-101 (also known as RX518), a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (TKI) | Non-small cell lung cancer | Positive preliminary safety and efficacy data announced from an ongoing Phase I/II clinical trial |
