Pipeline

July 19, 2021

Company	Drug/Device	Medical Condition	Status
Artax Biopharma	AX-158	T-cell-mediated diseases	phase 1 trial authorized by the UK’s Medicines and Healthcare Products Regulatory Agency
iSTAR Medical	MINIject	primary open-angle glaucoma	Investigational Device Exemption (IDE) granted by the FDA
Advaxis	ADXS-504	early prostate cancer	phase 1 trial initiated
ENA Respiratory	INNA-051 nasal spray	activation of innate immunity to virus entering through the nose	phase 1 trial initiated
Synlogic Therapeutics	SYNB-1934	phenylketonuria	phase 1 trial initiated
Ryvu Therapeutics	RVU120	acute myeloid leukemia and myelodysplastic syndrome	partial clinical hold on phase 1/b trial removed by the FDA
Akeso Biopharma	AK117 in combination with azacitidine	acute myeloid leukemia	phase 1b/2 trial authorized by the National Medical Products Administration of China
Enveric Biosciences	EV101	recurrent or progressive glioblastoma	phase 1/2 trial authorized by the Israeli Ministry of Health
Micron Biomedical	microneedle-based measles-rubella vaccine	measles and rubella	phase 1/2 trial initiated in children and adults in Gambia
Sigilon	SIG-001	severe or moderately severe hemophilia A	phase 1/2 trial placed on clinical hold by the FDA
ImmunityBio	T-Cell COVID-19 vaccine	boost vaccine in people already vaccinated with a spike-only antibody-based vaccine	phase 1/2/3 trial authorized by the South Africa Health Products Regulatory Authority
BriaCell Therapeutics	BRIA-IMT in combination with Incyte’s retifanlimab and epacadostat	advanced breast cancer	phase 1/2a trial initiated
CytoDyn	leronlimab	metastatic triple-negative breast cancer	advanced from phase 1b to phase 2 trial
Kintor Pharmaceutical	pyrilutamide	androgenetic alopecia	phase 2 trial authorized by the FDA
Vir Biotechnology	VIR-2218 with VIR-3434	chronic hepatitis B virus	phase 2 trial initiated
Oryzon	vafidemstat	schizophrenia	phase 2b trial authorized by the Spanish Drug Agency
AiCuris	pritelivir	acyclovir-resistant mucocutaneous herpes simplex virus (HSV) infection	phase 3 trial initiated
Ortho Clinical Diagnostics	VITROS anti-SARS-CoV-2 IgG quantitative test	COVID-19 diagnosis	Emergency Use Authorization granted by the FDA
Astellas	Padcev (enfortumab vedotin-ejfv)	locally advanced or metastatic urothelial cancer	approved by the FDA for expanded indication
Bayer	Kerendia (finerenone)	patients with chronic kidney disease associated with type 2 diabetes	approved by the FDA
Janssen Biotech	Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone	previously treated multiple myeloma	approved by the FDA for expanded indication
Stryker	InSpace balloon implant	arthroscopic treatment of massive irreparable rotator cuff tears	approved by the FDA
Cue Health	Cue COVID-19 test	COVID-19 diagnosis	approved by the Central Drugs Standard Control Organization of India