Pipeline

January 11, 2021

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Arcturus Therapeutics	ARCT-021, COVID-19 vaccine	COVID-19	IND approved by the FDA for a phase 2 trial
Windtree Therapeutics	lucinactant	acute lung injury in adults with COVID-19-associated lung injury and acute respiratory distress syndrome	first patient dosed in phase 2 trial
Nirmidas Biotech	MidaSpot COVID-19 Antibody Combo Detection Kit	COVID-19 rapid antibody IgG/IgM test	Emergency Use Authorization granted by the FDA
Moderna	COVID-19 Vaccine	COVID-19	approved by the European Commission
Other Trials and Actions
BlueRock Therapeutics	pluripotent stem cell-derived dopaminergic neurons	Parkinson's disease	IND approved by the FDA
CURE Pharma	CUREfilm Blue, an oral soluble film of sildenafil citrate	erectile dysfunction	IND approved by the FDA
Forge Biologics	FBX-101	Krabbe disease	IND approved by the FDA
Inozyme	INZ-701	adults with ENPP1 deficiency	IND approved by the FDA
Precigen	PRGN-2012	recurrent respiratory papillomatosis	IND approved by the FDA
Union Therapeutics	oral orismilast	plaque psoriasis in adults	IND approved by the FDA
VISEN Pharmaceuticals	TransCon C-Type Natriuretic Peptide	achondroplasia	IND approved by the National Medical Products Administration (NMPA) of the People's Republic of China for a phase 2 trial
Everest Medicines	sacituzumab govitecan-hziy	metastatic urothelial cancer	Phase 3 trial authorized by the NMPA of the People's Republic of China
F-star Therapeutics	FS222	advanced malignancies	first patient dosed in phase 1 trial
IDEAYA Biosciences	IDE196 and crizotinib	metastatic uveal melanoma	first patient dosed in phase 1 trial
Replimune Group	RP3 alone and in combination with anti-PD-1 therapy	advanced solid tumors	first patient dosed in phase 1 trial
Vir Biotechnology	VIR-1111; HIV T-cell vaccine	HIV	initiation of phase 1 trial
AsclepiX Therapeutics	AXT107	diabetic macular edema	first patient dosed in phase 1/2a trial
Harpoon Therapeutics	HPN328	Small-cell lung cancer and other tumors associated with DLL3 expression	first patient dosed in phase 1/2 trial
Metacrine	MET409 (50 mg) in combination with empagliflozin (Jardiance)	patients with both type 2 diabetes mellitus and nonalcoholic steatohepatitis	first patient dosed in phase 2a trial
Aptinyx	NYX-2925	painful diabetic peripheral neuropathy	patient enrollment recommenced in phase 2 trial
Immutep	eftilagimod alpha in combination with Keytruda (pembrolizumab)	head and neck cancer	patient enrollment complete in phase 2 trial
Lexicon Pharma	LX9211	post-herpetic neuralgia	first patients dosed in phase 2 trial
Graybug Vision	GB-102	wet age-related macular degeneration	completion of patient dosing in phase 2b trial
Axsome Therapeutics	AXS-05	Alzheimer’s disease agitation	initiation of phase 3 trial
Biohaven Pharma	troriluzole	obsessive-compulsive disorder	initiation of phase 3 trial
InflaRx	vilobelimab (IFX-1)	antineutrophil cytoplasmic antibody-associated vasculitis	patient enrollment complete in phase 3 trial
Kedrion Pharma	10% intravenous immunoglobulin	primary immunodeficiency disease	patient enrollment complete in phase 3 trial
Ocuphire Pharma	Nyxol	night-vision disturbances	initiation of phase 3 trial
Ocuphire Pharma	Nyxol	reversal of pharmacologically induced mydriasis	patient enrollment complete in phase 3 trial
PharmaEssentia	ropeginterferon alfa-2b (P1101)	essential thrombocythemia	initiation of phase 3 trial
TLC	TLC599	osteoarthritis knee pain	patient enrollment complete in phase 3 trial
Inversago Pharma	INV-101	Prader-Willi syndrome	Rare Pediatric Disease designation granted by the FDA
Genentech	tiragolumab in combination with Tecentriq (atezolizumab)	first-line treatment of patients with metastatic nonsmall-cell lung cancer with high PD-L1 expression with no EGFR or ALK genomic tumor aberrations	Breakthrough Therapy designation granted by the FDA
Ascentage Pharma	APG-2575	acute myeloid leukemia	Orphan Drug designation granted by the FDA
Bioserenity	Neuronaute EEG System and IceCap EEG wearable device	remote monitoring of electrical brain activity in patients with epilepsy	approved by the FDA