Pipeline

February 5, 2018

Company	Drug/Device	Medical Condition	Status
Immuron	IMM-529	Clostridium Difficile Infection	Phase I/II trials initiated enrolling 60 subjects
SillaJen	pexastimogene devacirepvec (Pexa-Vec)	metastatic colon cancer	Phase I/II trials initiated
Mapi Pharma	GA Depot	primary progressive multiple sclerosis	Phase II trials initiated enrolling 12-24 subjects
Merus	MCLA-128	metastatic breast cancer	Phase II trials initiated enrolling 120 subjects in the U.S. and Europe
Novan	SB206	molluscum contagiosum	Phase II trials initiated enrolling 192 children and adolescents
Aldeyra Therapeutics	topical ocular reproxalap	dry eye disease	Phase IIb trials initiated enrolling 300 subjects
Dermira	lebrikizumab	moderate to severe atopic dermatitis	Phase IIb trials initiated enrolling 350 subjects in the U.S.
BeiGene	tislelizumab	advanced unresectable or metastatic esophageal squamous cell carcinoma	Phase III trials initiated enrolling 350 subjects globally
Cara Therapeutics	Korsuva (CR845/difelikefalin)	hemodialysis patients suffering from moderate to severe chronic kidney disease-associated pruritus	Phase III trials initiated enrolling 350 subjects in the U.S.
Diffusion Pharmaceuticals	trans sodium crocetinate	newly-diagnosed inoperable glioblastoma multiforme	Phase III trials initiated enrolling 264 subjects
Aquestive Therapeutics	Riluzole Oral Soluble Film	amyotrophic lateral sclerosis	Orphan Drug designation granted by the FDA
Dauntless Pharmaceuticals	DP1038	acromegaly	Orphan Drug designation granted by the FDA
Ensysce Biosciences	PF614	moderate to severe chronic pain	Fast Track designation granted by the FDA
Faron Pharmaceuticals	Traumakine	acute respiratory distress syndrome	Fast Track designation granted by the FDA
Protalix Biotherapeutics	PRX-102	Fabry disease	Fast Track designation granted by the FDA
Synthon	[vic-]trastuzumab duocarmazine (SYD985)	HER2-positive metastatic breast cancer	Fast Track designation granted by the FDA
Takeda Pharmaceutical	TAK-426	Zika virus vaccine	Fast Track designation granted by the FDA
LimFlow	LimFlow Percutaneous Deep Vein Arterialization System	end-stage critical limb ischemia	Breakthrough Device designation granted by the FDA
Roche	balovaptan	autism spectrum disorder	Breakthrough Therapy Designation granted by the FDA
AngioDynamics	NanoKnife System	stage III pancreatic cancer	Expedited Access Pathway designation granted by the FDA
Abeona Therapeutics	EB-101	recessive dystrophic epidermolysis bullosa	Regenerative Medicine Advanced Therapy designation granted by the FDA
CutisPharma	CutisPharma Firvanq (vancomycin hydrochloride)	Clostridium difficile associated diarrhea and enterocolitis caused by Staphylococcus aureus	FDA approved
Synergy Pharmaceuticals	Trulance (plecanatide)	irritable bowel syndrome with constipation	FDA approved