Pipeline

February 4, 2019

Company	Drug/Device	Medical Condition	Status
Dicerna Pharmaceuticals, Inc.	DCR-HBVS	chronic hepatitis B virus (HBV)	Phase I trial initiated enrolling healthy volunteers and subjects with non-cirrhotic chronic HBV
Navitor Pharmaceuticals, Inc.	NV-5138	Treatment-Resistant Depression (TRD)	Phase Ib trial initiated enrolling up to 88 subjects, including healthy volunteers and those diagnosed with TRD
Theravance Biopharma, Inc.	ampreloxetine (TD-9855)	symptomatic neurogenic orthostatic hypotension (nOH)	Phase III trial initiated enrolling 188 subjects with symptomatic nOH caused by primary autonomic failure associated with multiple system atrophy (MSA), Parkinson's disease (PD) and pure autonomic failure (PAF)
Qualigen, Inc.	FastPack IP Sex Hormone Binding Globulin (SHBG) Immunoassay	diagnosis and treatment of men's health	510(k) clearance granted by the FDA
Merck	V114	prevention of invasive pneumococcal disease (IPD) caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age	Breakthrough Therapy Designation granted by the FDA
C2N Diagnostics	brain amyloidosis blood test	screening for brain amyloid pathology in individuals being assessed for an Alzheimer’s Disease diagnosis	Breakthrough Device Designation granted by the FDA
BioInvent International AB	BI-1206	mantle cell lymphoma (MCL)	Orphan Drug Designation granted by the FDA
Eureka Therapeutics, Inc.	ET140202 ARTEMIS T-cell therapy	AFP-positive patients with advanced hepatocellular carcinoma (HCC)	IND approval granted by the FDA
MGB Biopharma	MGB-BP-3	Clostridium difficile-associated diarrhea (CDAD)	IND approval granted by the FDA
CorMatrix Cardiovascular, Inc.	Cor TRICUSPID ECM cardiac valve	adults with endocarditis and for pediatric patients with congenital heart valve disease	IDE approval granted by the FDA
Amerigen Pharmaceuticals, Limited	generic version of Shire's Adderall XR (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate, extended-release capsules)	attention deficit hyperactivity disorder (ADHD)	ANDA approval granted by the FDA
AbbVie and Promius Pharma, LLC	TOSYMRA (previously known as DFN-02)	acute treatment of migraine with or without aura in adults	NDA approval granted by the FDA
Dr. Reddy’s Laboratories Ltd. and Janssen Pharmaceutical Companies of Johnson & Johnson	IMBRUVICA (ibrutinib) in combination with Roche’s obinutuzumab (GAZYVA)	adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)	NDA approval granted by the FDA