Pipeline

May 6, 2019

Company	Drug/Device	Medical Condition	Status
Forbius	AVID200	myelofibrosis (MF)	Phase I trial initiated
Tetra Discovery Partners	BPN14770	early Alzheimer’s disease (AD)	Phase II trial initiated enrolling 255 subjects ages 55-85 in 60 sites across the U.S.
Axovant Gene Therapies, Ltd.	AXO-Lenti-PD	Parkinson’s disease	Phase II trial initiated enrolling 60 subjects
3-V Biosciences, Inc.	TVB-2640	non-alcoholic steatohepatitis (NASH)	Phase II trial initiated enrolling 90 subjects in the U.S. and 25-30 subjects in China
OMEICOS Therapeutics	OMT-28	persistent atrial fibrillation (AF)	Phase II trial initiated enrolling 120 subjects at sites in four European countries
Exelixis	cabozantinib (CABOMETYX) in combination with nivolumab (Opdivo) and ipilimumab (Yervoy) versus nivolumab and ipilimumab	previously untreated advanced renal cell carcinoma (RCC)	Phase III trial initiated enrolling 676 subjects at 150 sites globally
I-Mab Biopharma and MorphoSys AG	TJ202/MOR202	relapsed or refractory multiple myeloma	Phase III trial initiated enrolling 291 subjects at sites in China and Taiwan
ACADIA Pharmaceuticals, Inc.	pimavanserin	major depressive disorder (MDD)	Phase III trial initiated enrolling 280 subjects at sites in the U.S.
CoapTech, LLC	PUMA-G System	gastrostomy	510(k) clearance granted by the FDA
Purdue Pharma, L.P.	nalmefene hydrochloride (HCl) injection	emergency treatment of known or suspected opioid overdose	Competitive Generic Therapy (CGT) designation granted by the FDA
Belite Bio	LBS-008 (BPN-14967)	atrophic age-related macular degeneration and Stargardt disease	IND approval granted by the FDA
AVROBIO, Inc.	AVR-RD-01	Fabry disease	IND approval granted by the FDA
Finch Therapeutics Group, Inc.	Full-Spectrum Microbiota (FSM)	pediatric Autism Spectrum Disorder (ASD)	Fast Track designation granted by the FDA
Bayer	darolutamide	non-metastatic castration-resistant prostate cancer (nmCRPC)	Priority Review designation granted by the FDA
GlaxoSmithKline	Benlysta (belimumab) intravenous (IV) infusion	pediatric systemic lupus erythematosus (SLE)	Priority Review designation granted by the FDA
United Therapeutics Corporation and XVIVO Perfusion, Inc.	XPS and STEEN Solution	ex-vivo lung perfusion (EVLP)	PMA approval granted by the FDA
Samsung Bioepis Co., Ltd.	ETICOVO (etanercept-ykro)	rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis	Approval granted by the FDA
Regeneron Pharmaceuticals, Inc. and Sanofi	Praluent (alirocumab)	reduce the risk of heart attack, stroke and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease	Approval granted by the FDA
Bausch Health Companies, Inc.	DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%	plaque psoriasis in adults	Approval granted by the FDA