Pipeline

October 28, 2019

Company	Drug/Device	Medical Condition	Status
Cyclo Therapeutics, Inc.	Trappsol Cyclo	Niemann-Pick Disease Type C (NPC)	Phase 1 trial initiated enrolling 12 subjects with NPC age 18 years and older at UCSF Benioff Children’s Hospital in Oakland, CA
Adverum Biotechnologies, Inc.	ADVM-022	wet age-related macular degeneration (wet AMD)	Phase 1 trial initiated enrolling subjects with wet AMD who are responsive to anti-vascular endothelial growth factor (VEGF) treatment at eight sites across the U.S.
Cerevel Therapeutics	CVL-231	schizophrenia	Phase 1b trial initiated enrolling 100 subjects age 18 to 50
Axsome Therapeutics, Inc.	AXS-12	narcolepsy	Phase 2 trial initiated enrolling 20 subjects at multiple sites
ADC Therapeutics SA	ADCT-301 (camidanlumab tesirine)	relapsed or refractory Hodgkin lymphoma (HL)	Phase 2 trial initiated enrolling 100 subjects at multiple sites
Aristea Therapeutics	RIST4721	palmoplantar pustulosis (PPP)	Phase 2a trial initiated
HighTide Therapeutics, Inc.	HTD1801	nonalcoholic steatohepatitis (NASH) and type 2 diabetes mellitus (T2DM)	Phase 2a trial initiated enrolling 100 subjects with NASH and T2DM at 17 sites in the U.S.
MacroGenics, Inc.	margetuximab	HER2-positive gastric cancer (GC) or gastroesophageal junction (GEJ) cancer	Phase 2/3 trial initiated enrolling subjects with HER2-positive and PD-L1-positive tumors at global sites
Myovant Sciences	relugolix combination therapy	endometriosis-associated pain	Phase 3 trial initiated enrolling 600 female subjects ages 18 to 50 at sites in the U.S.
Urovant Sciences, Inc.	Vibergron	overactive bladder (OAB)	Phase 3 (part 2) trial initiated enrolling 1,000 male subjects with OAB and benign prostatic hyperplasia (BPH)
Odontate Therapeutics, Inc.	tesetaxel	metastatic breast cancer	Phase 3 trial initiated enrolling 600 subjects with HER2 negative, hormone receptor positive metastatic breast cancer
FibroGen, Inc.	pamrevlumab	unresectable locally advanced pancreatic cancer (LAPC)	Phase 3 trial initiated enrolling 260 subjects
Canon Medical Systems USA, Inc.	Advanced Intelligent Clear-IQ Engine (AiCE)	image reconstruction	510 (k) clearance granted by the FDA
Garwood Medical Devices	BioPrax	knee replacement	Breakthrough Device designation granted by the FDA
CorFlow Therapeutics AG	CoFI (CorFlow Controlled Flow Infusion) System	coronary microcirculation after standard stent implantation	Breakthrough Device designation granted by the FDA
BerGenBio AS	bemcentinib	acute myeloid leukemia	Fast track designation granted by the FDA
Heron Therapeutics, Inc.	CINVANTI (aprepitant) injectable emulsion for intravenous (IV)	prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) following both highly emetogenic cancer chemotherapy (HEC) and MEC	sNDA approval granted by the FDA
Vertex Pharamceuticals Inc.	Trikafta	cystic fibrosis	Approval granted by the FDA
Novartis	Beovu (brolucizumab)	wet age-related macular degeneration	Approval granted by the FDA
AstraZeneca	Farxiga (dapagliflozin)	type 2 diabetes	Approval granted by the FDA
Alexion Pharmaceuticals, Inc.	ULTOMIRIS (ravulizumab-cwvz)	atypical hemolytic uremic syndrome (aHUS)	Approval granted by the FDA
Janssen	Stelara (ustekinumab)	moderately to severely active ulcerative colitis	Approval granted by the FDA
Foamix Pharamceuticals, Ltd.	AMZEEQ (minocycline) topical foam, 4%	moderate to severe acne vulgaris	Approval granted by the FDA
Eton Pharmaceuticals, Inc.	Biorphen (phenylephrine)	hypotension during anesthesia	Approval granted by the FDA