Pipeline

July 26, 2021

Company	Drug/Device	Medical Condition	Status
Organicell Regenerative Medicine	Zofin	COVID-19 long-haulers	IND approved by the FDA for phase 1/2 trial
Viracta Therapeutics	nanatinostat and valganciclovir	EBV+ recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) and other EBV+ solid tumors.	IND approved by the FDA for a phase 1b/2 trial
YishengBio	PIKA recombinant COVID-19 vaccine	COVID-19 prevention	IND approved by the United Arab Emirates Ministry of Health & Prevention
KeifeRx	Nilotinib BE	dementia due to Alzheimer's disease	IND approved by the FDA for phase 3 trial
Antengene	ATG-101	metastatic/advanced solid tumors and B-cell nonHodgkin's lymphoma	phase 1 trial authorized by the Bellberry Human Research Ethics Committee in Australia
Ascletis Pharma	ASC40 combined with bevacizumab	recurrent glioblastoma	phase 3 trial authorized by China’s National Medical Products Administration
InDex Pharmaceuticals	cobitolimod	moderate-to-severe left-sided ulcerative colitis	phase 3 trial authorized by the Swedish Medical Products Agency
Advaxis	ADXS-504	patients with biochemically recurrent prostate cancer	initiation of phase 1 trial
Synlogic	SYNB1934	phenylketonuria	initiation of phase 1 trial
Eureka Therapeutics	ECT204	hepatocellular carcinoma	initiation of phase 1/2 trial
Prometheus Biosciences	PRA023	moderate-to-severe ulcerative colitis	initiation of phase 2 trial
Vertex Pharmaceuticals	VX-548	acute pain following abdominoplasty surgery	initiation of phase 2 trial
Vir Biotechnology	VIR-2218 and VIR-3434	chronic hepatitis B virus	initiation of phase 2 trial
Rain Therapeutics	milademetan (RAIN-32)	de-differentiated liposarcoma	initiation of phase 3 trial
Albireo Pharma	Bylvay (odevixibat)	progressive familial intrahepatic cholestasis	approved by the FDA
Astellas	Prograf (tacrolimus)	prevention of organ rejection in adult and pediatric lung transplant recipients	approved by the FDA for expanded indication
Kadmon Holdings	Rezurock (belumosudil)	patients 12 years and older with chronic graft-vs.-host disease	approved by the FDA
Merck	Vaxneuvance (pneumococcal 15-valent conjugate vaccine)	active immunization against invasive pneumococcal disease in adults caused by 15 serotypes	approved by the FDA
Merck Eisal	Keytruda (pembrolizumab) plus Lenvima (lenvatinib)	advanced endometrial carcinoma	approved by the FDA
Octapharma USA	Octagam 10 percent intravenous immunoglobulin	adult dermatomyositis	approved by the FDA
Nevro	Senza system	chronic pain associated with painful diabetic neuropathy	approved by the FDA
bluebird bio	Skysona (elivaldogene autotemcel, Lenti-D gene therapy)	treatment of patients under age 18 who have early cerebral adrenoleukodystrophy without matched sibling donor	approved by the European Commission
Astra Zeneca Merck	Koselugo (selumetinib)	symptomatic, inoperable plexiform neurofibromas in children under age three with neurofibromatosis type 1	approved by the European Commission
Myovant Sciences	Ryeqo (relugolix 40 mg, estradiol 1.0 mg and norethindrone acetate 0.5 mg)	uterine fibroids	approved by the European Commission
Regeneron Pharmaceuticals	Ronapreve (casirivimab and imdevimab)	mild-to-moderate COVID-19	approved in Japan