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Pipeline

New Pipeline Updates from RDD Pharma, Pulmatrix and IntraBio

February 18, 2019

Company Drug/Device Medical Condition Status
ADC Therapeutics ADCT-402 (loncastuximab tesirine) plus AstraZeneca’s IMFINZI (durvalumab) advanced diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) or follicular lymphoma (FL) Phase I trial initiated enrolling 75 subjects
Exelixis, Inc. XL092 cancer Phase I trial initiated
ReGenTree, LLC and Ora, Inc. RGN-259 dry eye syndrome Phase III trial initiated enrolling 700 subjects
LASEROPTEK Co., Ltd. PicoLO picosecond Nd:YAG laser dermatology and general and plastic surgery 510(k) clearance granted by the FDA
Grifols, S.A. Procleix Babesia assay blood screening 510(k) clearance granted by the FDA
Finch Therapeutics Group, Inc. CP101 recurrent Clostridium difficile (C. difficile) infection Breakthrough Therapy designation granted by the FDA
RDD Pharma, Inc. RDD-0315 fecal incontinence in spinal cord injury Fast Track designation granted by the FDA
Neurotech Pharmaceuticals, Inc. NT-501 (Renexus) macular telangiectasia type 2 (MacTel) Fast Track designation granted by the FDA
IntraBio, Inc. IB1001 GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease) IND approval granted by the FDA
Pulmatrix, Inc. Pulmazole (PUR1900) allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma IND approval granted by the FDA
Precigen, Inc. PRGN-3005 advanced-stage platinum-resistant ovarian cancer IND approval granted by the FDA
Janssen Pharmaceutical Companies of Johnson & Johnson Darzalex (daratumumab) split-dosing regimen multiple myeloma BLA approval granted by the FDA
Sanofi Cablivi (caplacizumab-yhdp) in combination with plasma exchange and immunosuppression acquired thrombotic thrombocytopenic purpura (aTTP) in adults BLA approval granted by the FDA
Medtronic expanded indication for Pipeline Flex embolization device brain aneurysm Approval granted by the FDA
Orthofix Medical, Inc. M6-C artificial cervical disc cervical disc degeneration Approval granted by the FDA