Pipeline

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