Pipeline

July 29, 2019

Company	Drug/Device	Medical Condition	Status
Ascentage Pharma	APG-2575	hematologic malignancies	Phase 1 trial initiated enrolling subjects with acute myelogenous leukemia (AML) and non-Hodgkin's lymphoma (NHL) in China
Halozyme Therapeutics	efgartigimod (ARGX-113)	severe autoimmune diseases	Phase 1 trial initiated
AC Immune SA	ACI-3024	neurodegenerative diseases that are characterized by the presence of pathological Tau aggregates	Phase 1 trial initiated enrolling healthy volunteers
NuCana plc	NUC-7738	cancer	Phase 1 trial initiated
CStone Pharmaceuticals	ivosidenib (TIBSOVO)	relapsed or refractory acute myeloid leukemia (R/R AML) with an IDH1 mutation	Phase 1 trial initiated
Prescient Therapeutics Limited	PTX-100	cancer	Phase 1b trial initiated enrolling subjects in Australia
Axial Biotherapeutics	AB-2004	gastrointestinal dysfunction and associated behavioral symptoms of Autism Spectrum Disorder (ASD)	Phase 1b/2a trial initiated enrolling 25 male subjects with ASD
ImaginAb Inc.	CD8 tracer 89Zr-Df-IAB22M2C	cancer	Phase 2 trial initiated enrolling subjects at Dana-Farber Cancer Institute in Boston
DelMar Pharmaceuticals, Inc.	VAL-083	MGMT-unmethylated glioblastoma multiforme (GBM)	Phase 2 trial initiated enrolling 24 newly-diagnosed subjects who have undergone surgery and chemoradiation with temozolomide (TMZ) at the University of Texas MD Anderson Cancer Center (MDACC)
EIP Pharma, Inc.	neflamapimod	cognitive dysfunction associated with dementia with Lewy bodies (DLB)	Phase 2 trial initiated enrolling 80 subjects at several sites in the U.S. and Netherlands
Oyster Point Pharma, Inc.	OC-01 Nasal Spray	dry eye disease	Phase 3 trial initiated enrolling 750 subjects at 20 centers in the U.S.
LifeMax Laboratories, Inc.	LM-030	Netherton Syndrome	Rare Pediatric Disease designation granted by the FDA
Merck and Eisai	KEYTRUDA in combination with LENVIMA	subjects with advanced unresectable hepatocellular carcinoma (HCC) not amenable to locoregional treatment	Breakthrough Therapy designation granted by the FDA
LivaNova PLC	LifeSPARC Advanced Circulatory Support (ACS) system	cardiac and respiratory failure	510(k) clearance granted by the FDA
Aridis Pharmaceuticals, Inc.	AR-501	cystic fibrosis	Orphan Drug designation granted by the FDA
Arrowhead Pharmaceuticals, Inc.	ARO-ANG3	homozygous familial hypercholesterolemia (HoFH)	Orphan Drug designation granted by the FDA
Apic Bio, Inc.	APB-102	genetic SOD1 amyotrophic lateral sclerosis (ALS)	Orphan Drug designation granted by the FDA
Teva Pharmaceuticals Industries Ltd.	AirDuo Digihaler (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder	asthma	Approval granted by the FDA
Novadoz Pharmaceuticals	Abiraterone Acetate 250mg tablet	prostate cancer when used with a steroid medication (prednisone or methylprednisolone)	Approval granted by the FDA
Bayer	Gadavist (gadobutrol) injection	coronary artery disease (CAD)	Approval granted by the FDA
Abbott	MitraClip heart valve repair device	mitral regurgitation	Approval granted by the FDA
Merck	RECARBRIO (imipenem, cilastatin and relebactam) for injection (1.25 grams)	adults with complicated urinary tract and complicated intra-abdominal bacterial infections where limited or no alternative treatment options are available	Approval granted by the FDA
Celgene	OTEZLA (apremilast)	adult with oral ulcers associated with Behçet’s Disease	Approval granted by the FDA
Baxter	Myxredlin	ready-to-use insulin for IV infusion	Approval granted by the FDA
Pfizer, Inc.	RUXIENCE (rituximab-pvvr)	adult subjects with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL) and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)	Approval granted by the FDA
Samsung Bioepis Co., Ltd.	HADLIMA (adalimumab-bwwd)	heumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis	Approval granted by the FDA
Eli Lilly and Company	Baqsimi (glucagon) nasal powder 3 mg	severe hypoglycemia	Approval granted by the FDA