Pipeline

September 30, 2019

Company	Drug/Device	Medical Condition	Status
BioLineRx Ltd.	AGI-134	solid tumors	Phase 1/2a trial initiated enrolling subjects at 15 sites in the U.S., U.K. and Israel
Neuralstem Inc.	NSI-566	chronic ischemic stroke	Phase 2 trial initiated enrolling 22 subjects with sustained chronic motor deficits due to an ischemic stroke
Oragenics, Inc.	AG013	severe oral mucositis	Phase 2 trial initiated enrolling 200 subjects at 59 sites in the U.S. and Europe
ImaginAB, Inc.	89Zr-Df-IAB22M2C	cancer	Phase 2 trial initiated enrolling subjects with advanced and metastatic cancer at the O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham
Oncopeptides AB	melflufen in combination with dexamethasone	relapsed/refractory multiple myeloma (RRMM)	Phase 2 trial initiated enrolling 150 subjects
Rigel Pharmaceuticals, Inc. Kissei Pharmaceuticals Co., Ltd.	fostamatinib disodium hexahydrate	chronic immune thrombocytopenia (ITP)	Phase 3 study initiated enrolling adult subjects with ITP
Protalix BioTherapeutics, Inc. Chiesi Farmaceutici S.p.A.	PRX 102 (pegunigalsidase alfa)	Fabry disease with impaired renal function	Phase 3 trial initiated enrolling subjects previously treated with an enzyme replacement therapy: agalsidase alfa or agalsidase beta
Ocular Therapeutix, Inc.	DEXTENZA	allergic conjunctivitis (AC)	Phase 3 trial initiated enrolling 80 subjects
Annexon Biosciences	ANX005	Guillain-Barré Syndrome (GBS)	Fast Track approval granted by the FDA
Merck & Company	PIFELTRO (in combination with other antiretroviral agents)	HIV-1 in adult subjects who are virologically suppressed	sNDA approval granted by the FDA
Merck & Company	DELSTRIGO	HIV-1 in adult subjects who are virologically suppressed	sNDA approval granted by the FDA
Abiomed	Impella 5.5 with SmartAssist minimally invasive forward flow heart pump	residual myocardial function	PMA approval granted by the FDA
Novo Nordisk	Rybelsus (semaglutide) oral tablets	type 2 diabetes	Approval granted by the FDA
Exact Sciences Corp.	Cologuard	noninvasive colorectal cancer screening test for subjects ages 45 and older	Approval granted by the FDA
Bavarian Nordic A/S	Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating	smallpox and monkeypox disease in adults 18 years of age and older	Approval granted by the FDA