Pipeline

April 20, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials
Pluristem Therapeutics	PLX cell therapy	COVID-19 complications	first patient treated under Coronavirus Treatment Acceleration Program
Can-Fite Biopharma	Piclidenoson	moderate-to-severe symptoms in COVID-19 infected patients	initiation of pilot study
Hope Biosciences	allogeneic, adipose-derived mesenchymal stem cells (HB-adMSCs)	immune support against COVID-19	IND approved by the FDA for second phase 2 trial
Riovant Sciences	gimsilumab	COVID-19 patients with lung injury or acute respiratory distress syndrome	first patient dosed in pivotal BREATHE Study
Athersys	MultiStem therapy	moderate to severe acute respiratory distress syndrome (ARDS) induced by COVID-19	initiation of phase 2/3 study approved by the FDA
Vanda Pharmaceuticals	tradipitant	neurogenic inflammation of the lung secondary to SARS-CoV-2 (COVID-19) infection	first patent enrolled in phase 3 trial
Spectral Medical	Spectral PMX cartridge	COVID-19 patients with septic shock	supplemental Investigational Device Exemption approved by the FDA
Rutgers University	saliva test	COVID-19	Emergency Use Authorization (EUA) granted by the FDA
Ortho Clinical Diagnostics	total antibody assay for COVID-19	COVID-19	EUA granted by the FDA
Cytosorbents	Cytosorb blood purification technology	cytokine storm and inflammation in patients with COVID-19	EUA granted by the FDA
Ortho Clinical Diagnostics	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators	COVID-19 antibody test	EUA granted by the FDA
Synapse Biomedical	TransAeris DPS	aid in weaning patients determined to be at high risk of weaning failure off of ventilators in healthcare settings during the COVID-19 pandemic for no more than 30 days	EUA granted by the FDA
Other Trials
Antengene	ATG-019 (KPT-9274)	advanced solid tumors or non-Hodgkin's lymphoma	dosing of first patient in phase 1 trial
Arcturus Therapeutics	ARCT-810 (LUNAR-OTC)	ornithine transcarbamylase (OTC) deficiency	IND approved by the FDA; CTA approved by the New Zealand Medicines and Medical Devices Safety Authority
Athersys	MultiStem	early treatment of traumatic injuries and the subsequent complications that result following severe trauma	IND approved by FDA
Grid Therapeutics	GT103	solid tumors	IND approved by the FDA
Harbour BioMed	HBM9161	adult immune thrombocytopenia	IND approved by National Medical Products Administration (NMPA) in China
Alnylam Therapeutics	vutrisiran	polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults	Fast-track designation granted by the FDA
LifeMax Laboratories, Inc.	LM-030	Netherton Syndrome	Fast-track designation granted by the FDA
Ascendis Pharma	TransCon hGH (lonapegsomatropin)	growth hormone deficiency	Orphan Drug designation granted by the FDA
Epirium Bio Inc.	EB 002 ((+)-epicatechin)	Duchenne and Becker muscular dystrophy	Orphan Drug designation granted by the FDA
Forma Therapeutics	FT-4202	sickle cell disease	Orphan Drug designation granted by the FDA
Astrazeneca Merck	Koselugo (selumetinib)	pediatric patients, 2 years of age and older with neurofibromatosis type 1	approved by the FDA
Centinel Spine	prodisc L Lumbar Total Disc Replacement (TDR) system	two-level disc replacement	approved by the FDA
Intact Vascular	Tack Endovascular System (4F)	precision dissection repair in the mid/distal popliteal, tibial and/or peroneal arteries	approved by the FDA
Urogen Pharma	Jelmyto (mitomycin gel)	low-grade upper tract urothelial cancer	approved by the FDA