Pipeline

October 21, 2019

Company	Drug/Device	Medical Condition	Status
NeuClone	NeuLara	plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis	Phase 1 trial initiated enrolling 200 healthy subjects
Alder BioPharmaceuticals, Inc.	ALD1910	Migraine	Phase 1 trial initiated enrolling 100 healthy subjects between the ages of 18 and 55
Amphivena Therapeutics, Inc.	AMV564	Tumors	Phase 1 trial initiated enrolling subjects in San Antonio, TX, MD Anderson Cancer Center and Peninsula Cancer Institute in Newport News, VA
Nektar Therapeutics	NKTR-255	relapsed or refractory non-Hodgkin lymphoma (NHL) or multiple myeloma (MM)	Phase 1 trial initiated enrolling 40 subjects
DiaMedica Therapeutics Inc.	DM199	Chronic kidney disease	Phase 2 trial initiated enrolling 60 African American subjects with CKD caused by IgA nephropathy (IgAN) and hypertensive with CKD at 10 sites in the U.S.
PhaseBio Pharmaceuticals	PB2452 with low-dose aspirin	blood thinning	Phase 2b trial initiated enrolling 200 elderly subjects aged 50-80
Diamyd Medical	Diamyd	Latent Autoimmune Diabetes in Adults (LADA)	Phase 2 trial initiated enrolling 15 subjects newly diagnosed with LADA not yet on insulin therapy at the Norwegian University of Science and Technology in Trondheim
Can-Fite BioPharma Ltd.	Namodenoson	Nonalcoholic steatohepatitis (NASH)/nonalcoholic fatty liver disease (NAFLD)	Phase 2 trial initiated enrolling 60 subjects with NAFLD with or without NASH
Denovo Bipharma LLC	DB102	glioblastoma (GBM) in combination with radiation and temozolomide	Phase 2b trial initiated enrolling 200 patients with newly-diagnosed GBM
Boehringer Ingelheim	BI 1265162	cystic fibrosis	Phase 2 trial initiated enrolling subjects with relapsed or refractory lymphoma at sites in the U.S. and Europe
Hope Biosciences	HB-adMSCs	Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy	Phase 1/2 trial initiated enrolling 24 subjects
Imbrium Therapeutics	IMB-115	insomnia associated with alcohol cessation (IAAC)	Phase 2 trial initiated enrolling adults with moderate or severe alcohol use disorder (AUD) experiencing IAAC
Diffusion Pharmaceuticals	TSC	stroke	Phase 2 trial initiated enrolling 160 subjects at 23 hospitals in the Virginia and Los Angeles County
Amygdala Neurosciences	ANS-6637	alcohol use disorder AUD)	Phase 2 trial initiated enrolling 81 treatment seeking subjects with at least moderate alcohol use disorder at three sites
Novavax Inc.	NanoFlu	Influenza	Phase 3 trial initiated enrolling 2,650 adult subjects aged 65 and over at 19 sites in the U.S.
Axsome Therapeutics, Inc.	AXS-05	major depressive disorder (MDD)	Phase 3 trial initiated enrolling 300 subjects with moderate to severe MDD
SurgiMab	SGM-101	colorectal cancer	Phase 3 trial initiated enrolling 300 subjects with colorectal cancer in ten clinical centers in Europe and the U.S.
AstraZeneca	DS-8201	breast cancer	Priority review granted by the FDA
Akorn, Inc.	betamethasone dipropionate lotion USP (augmented)	inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses	ANDA approval granted by the FDA
Subtle Medical	SubtleMR	image processing to improve medical imaging	510 (k) clearance granted by the FDA
Cleveland Diagnostics, Inc.	IsoPSA	prostate cancer diagnostic test	Breakthrough device designation granted by the FDA
Genentech, Inc.	Xofluza	influenza complications	Approval granted by the FDA
Noven Pharmaceuticals, Inc.	SECUADO transdermal drug delivery system	schizophrenia	Approval granted by the FDA
Janssen Pharmaceuticals	XARELTO (rivaroxaban)	blood clots	Approval granted by the FDA
Eli Lilly	Reyvow	migraines	Approval granted by the FDA