Pipeline

October 22, 2018

Company	Drug/Device	Medical Condition	Status
Viseon, Inc.	Voyant System, featuring proprietary HD imaging sensor and illumination technology	Minimally invasive spine surgery	Granted 510(k) clearance by the FDA
Centric Medical	SATURN External Fixation System which consists of rings, struts, threaded rods, pins, wires and connectors	To stabilize the foot, ankle and long bone segments	Granted 510(k) clearance by the FDA
Pfizer	PARP inhibitor, Talzenna (talazoparib)	BRCA-mutated (gBRCAm), HER2-negative breast cancer	Granted approval by the FDA
Abireo Pharma, Inc.	A4250	Progressive familial intrahepatic cholestasis (PFIC)	Granted Fast Track designation by the FDA
Immusoft Corp.	Iduronicrin genleukocel-T	Mucopolysaccharidosis type I (MPS I)	Granted Rare Pediatric Disease designation (RPDD) by the FDA
Cellenkos, Inc.	CK0801	Treatment-resistant Guillain-Barré Syndrome (GBS)	FDA has cleared its Investigational New Drug (IND) application to proceed with a Phase I clinical trial
Allergan, plc and Medicines360	LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg	Prevention of pregnancy for up to five years	FDA approved Supplemental New Drug Application (sNDA) to extend the duration of use
AstraZeneca and Merck	LYNPARZA	Pancreatic cancer	Granted Orphan Drug designation (ODD) by the FDA
X4 Pharmaceuticals	X4P-001-RD	WHIM syndrome, a primary immunodeficiency disease	Granted Orphan Drug designation by the FDA
AcelRx Pharmaceuticals, Inc.	DSUVIA™	Moderate-to-severe acute pain in medically supervised settings for adult patients	FDA Anesthetic and Analgesic Drug Products Advisory Committee voted in favor of recommending approval
Sutro Biopharma, Inc.	STRO-001	multiple myeloma	Granted Orphan Drug designation by the FDA
Grifols	ID CORE XT molecular diagnostic test	Molecular red blood cell typing	Granted approval by the FDA for use in the U.S.
UCB	CIMZIA® (certolizumab pegol)	Axial spondyloarthritis (axSpA) spectrum	In Phase III trial, showed clinically relevant, statistically significant improvements in patients with active disease and signs of inflammation, as measured by major improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS-MI)