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

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