Pipeline

April 8, 2019

Company	Drug/Device	Medical Condition	Status
Tizona Therapeutics, Inc.	TTX-030	cancer	Phase I/Ib trial initiated
Amylyx Pharmaceuticals, Inc.	AMX0035	Alzheimer’s Disease	Phase II trial initiated enrolling 100 subjects
Odonate Therapeutics, Inc.	tesetaxel	locally advanced or metastatic breast cancer (MBC)	Phase II trial initiated
Poxel SA	PXL770	non-alcoholic steatohepatitis (NASH)	Phase IIa trial initiated enrolling 100 subjects with nonalcoholic fatty liver disease (NAFLD) who likely have NASH at sites in the U.S.
Biohaven Pharmaceutical Holding Company, Ltd.	BHV-3500	migraine	Phase II/III trial initiated
Hutchison China MediTech Limited	surufatinib (HMPL-012 or sulfatinib) with capecitabine	advanced biliary tract cancer (BTC)	Phase IIb/III trial initiated
PellePharm, Inc.	Patidegib Topical Gel, 2%	Gorlin Syndrome	Phase III trial initiated enrolling 150 subjects
Aldeyra Therapeutics, Inc.	topical ocular reproxalap	dry eye disease	Phase III trial initiated enrolling 400 subjects with moderate-to-severe dry eye disease
ACell, Inc.	Gentrix Surgical Matrix	gastroenterological or plastic and reconstructive surgery	510(k) clearance granted by the FDA
ACell, Inc.	Gentrix Surgical Matrix Thin	urological, gastroenterological or plastic and reconstructive surgery	510(k) clearance granted by the FDA
ACell, Inc.	Gentrix Surgical Matrix Plus	gastroenterological or plastic and reconstructive surgery	510(k) clearance granted by the FDA
AstraZeneca and Merck	selumetinib	NF1 plexiform neurofibromas	Breakthrough Therapy designation granted by the FDA
CSA Medical, Inc.	RejuvenAir System	moderate to severe chronic obstructive pulmonary disease (COPD) with chronic bronchitis (CB)	Breakthrough Device designation granted by the FDA
Fera Pharmaceuticals	Avaclyr (acyclovir ophthalmic ointment)	herpetic keratitis	NDA approval granted by the FDA
Intellirod Spine	LOADPRO	kyphotic correction surgery	De Novo approval granted by the FDA
Immunocore Limited	tebentafusp (IMCgp100)	metastatic uveal melanoma (mUM)	Fast Track approval granted by the FDA
Clarus Therapeutics	Jatenzo (testosterone undecanoate)	hypogonadism	Approval granted by the FDA
EMD Serono	Mavenclad (cladribine)	relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive disease (SPMS)	Approval granted by the FDA