Pipeline

June 11, 2018

Company	Drug/Device	Medical Condition	Status
Peloton Therapeutics, Inc.	PT2977 (oral HIF-2α inhibitor)	Treatment of von Hippel-Linau (VHL) disease-associated kidney cancer	Phase II trial initiated enrolling 50 subjects in the U.S.
Viking Therapeutics, Inc.	VK2809	Primary hypercholesterolemia and non-alcoholic fatty liver desease (NAFLD)	Phase II trial initiated
Tricida, Inc.	TRCA-301	chronic kidney disease patients with metabolic acidosis	Phase III trial initiated enrolling 217 subjects in the U.S. and Europe
Janssen (part of Johnson & Johnson)	esketamine nasal spray	adults with treatment-resistant depression	Phase III trial initiated
Camber Spine Technologies	ENZA (Titanium Anterior Lumbar Interbody Fusion (ALIF) system	autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1	510(k) clearance granted by the FDA
Royal Philips	Ingenia Elition 3.0T MR solution	increased diagnostic performance	510(k) clearance granted by the FDA
Partner Therapeutics, Inc.	Leukine	adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrom of Acute Radiation Syndrome)	Approval granted by the FDA
Mylan	Fulphila (pegfilgrastim-jmbd)	febrile neutropenia	Approval granted by the FDA
Eli Lilly and Incyte Corporation	OLUMIANT (baricitnib)	adults with moderately-to-severely active Rheumatoid Arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies	Approval granted by the FDA
Micronics, Inc.	PanNAT STEC Test	Shiga toxin-producing E. Coli (STEC)	Clearance granted by the FDA
Chugai Pharmaceutical Co., Ltd.	HEMLIBRA (U.S. generic name: emicizumab-kxwh)	adults and children with hemophilia A without factor VIII inhibitors	Priority Review Designation granted by the FDA
Pfizer	Talazoparib	germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC)	Priority Review Designation granted by the FDA
Pfizer	Xalkori (crizotinib)	relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive	Breakthrough Therapy Designation granted by the FDA
AutoGenomics, Inc.	INFINITI Neutral Response Panel	opioid dependency	Breakthrough Device Designation granted by the FDA
Curis, Inc.	fimepinostat (CUDC-907)	relapsed or fractory (R/R) diffuse large B-cell lymphoma (DLBCL)	Fast Track Designation granted by the FDA
Alnylam Pharmaceuticals, Inc.	ALN-TTRsc02	Transthyretin-mediated amyloidosis	Orphan Drug Designation granted by the FDA