Pipeline

July 2, 2018

Company	Drug/Device	Medical Condition	Status
Oramed Pharmaceuticals Inc.	ORMD-0801	type 1 diabetes	Phase I trial initiated
Erimos Pharmaceuticals, LLC	terameprocol (EM-1421)	High Grade Glioma (Grade III or IV)	Phase I trial initiated
BioGend Therapeutics	one-step autologous knee cartilage repair/regeneration	repair treatment for knee chondral or osteochondral defects	Phase I trial initiated enrolling 92 subjects
Rigel Pharmaceuticals, Inc.	R835 (IRAK1/4 inhibitor)	autoimmune and inflammatory diseases	Phase I trial initiated enrolling 91 subjects
Navitor Pharmaceuticals, Inc.	NV-5138	treatment-resistant depression (TRD)	Phase I trial initiated enrolling 88 subjects
Axonics Modulation Technologies, Inc.	rechargeable Sacral Neuromodulation (r-SNM) System	urinary and bowel disfunction	Phase I trial initiated enrolling 120 subjects
BioAtla, LLC	BA3021 (CAB-ROR2-ADC therapeutic)	advanced solid tumors including non-small cell lung cancer (NSCLC), triple negative breast cancer and soft tissue sarcoma	Phase I/II trial initiated
Roche and Genentech	TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and etoposide)	Extensive-stage small cell lung cancer (ES-SCLC)	Phase III trial initiated enrolling 403 subjects in the U.S.
Beckman Coulter Diagnostics	Access hsTnl (high-sensitivity troponin assay)	myocardial infarction	510(k) Clearance granted by the FDA
Renovis Surgical Technologies, Inc.	Tesera SA Hyperlordotic ALIF Interbody Spinal Fusion System	spinal fusion	510(k) Clearance granted by the FDA
Genentech	Baloxavir marboxil	single-dose oral flu treatment for people 12 years and older	Priority Review and NDA approval granted by the FDA
Merck & Company	KEYTRUDA (pembrolizumab)	adjuvant therapy in advanced melanoma	sBLA accepted by the FDA
Glaukos Corporation	iStent inject Trabecular Micro-Bypass System	reduction of intraocular pressure (IOP) in adult mild-to-moderate primary open-angle glaucoma (POAG) patients undergoing concomitant cataract surgery	Approval granted by the FDA
Ferring Pharmaceuticals Inc.	NOCDURNA (desmopressin acetate)	treatment of nocturne due to nocturnal polyuria in adults who awaken at least two times per night to void	Approval granted by the FDA
Achaogen	Zemdri (plazomicin)	complicated urinary tract infection	Approval granted by the FDA
Array BioPharma, Inc.	Braftovi + Mektovi	BRAF-mutant metastatic melanoma	Approval granted by the FDA
Processa Pharmaceuticals, Inc.	PCS499	Necrobiosis Lipoidica (NL)	Orphan Drug Designation granted by the FDA