Pipeline

October 1, 2018

Company	Drug/Device	Medical Condition	Status
Verastem	Copiktra	Leukemia	Granted approval by the FDA
MT.DERM GmbH	Exceed, microneedling device	Facial wrinkles	Granted clearance by the FDA
Cook Medical	5 mm diameter version of Zilver® PTX®	Peripheral artery disease (PAD)	Granted clearance by the FDA
Avita Medical	RECELL® Autologous Cell Harvesting Device (RECELL® System)	Severe thermal burns in patients 18 and older	Granted clearance by the FDA
Cardurion Pharmaceuticals	CRD-733, a Phosphodiesterase-9 (PDE-9) inhibitor	Heart failure	FDA has accepted Investigational New Drug Application (IND)
OBI Pharma, Inc.	OBI-3424	Acute Lymphoblastic Leukemia (ALL)	Granted Orphan Drug Designation by FDA
Alnylam Pharmaceuticals	Givosiran	Acute hepatic porphyrias (AHPs)	Successful early Phase III clinical trial results announced
AstraZeneca	Imfinzi (durvalumab)	Non-small cell lung cancer (NSCLC)	Phase III PACIFIC clinical trial found cut deaths by a third
Genentech	Tecentriq plus chemotherapy	Extensive-stage small cell lung cancer (ES-SCLC)	Phase III trial showed treatment helped patients live significantly longer than chemo alone
Daiichi Sankyo Company, Ltd	Trastuzumab deruxtecan (DS-8201)	Previously-treated HER2 positive unresectable and/or metastatic breast cancer	Initiated two Phase III trials
Aurinia Pharmaceuticals, Inc.	Voclosporin added to background therapy of mycophenolate mofetil (MMF)/CellCept®	Lupus nephritis (LN)	Completed enrollment in AURORA Phase III clinical trial
Catabasis Pharmaceuticals, Inc.	Edasalonexent	Duchenne muscular dystrophy (DMD)	Initiated Polaris DMD Phase III clinical trial
AstraZeneca	Farxiga (dapagliflozin)	Cardiovascular disease	Positive Phase III clinical trial results announced
Alexion Pharmaceuticals, Inc.	Soliris® (eculizumab)	Anti-aquaporin-4 (AQP4) auto antibody-positive neuromyelitis optica spectrum disorder (NMOSD)	Positive topline results from the Phase III PREVENT announced