Pipeline

March 29, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Genentech	intravenous Actemra (tocilizumab) plus standard of care	hospitalized adult patients with severe COVID-19 pneumonia	initiation of phase 3 trial
Abbott	RealTime SARS-CoV-2 EUA molecular tests	SARS-CoV-2	approved by the FDA
Cepheid	Xpert Xpress SARS-CoV-2 molecular diagnostic test	SARS-CoV-2	approved by the FDA
Mesa Biotech	Accula SARS-CoV-2 Test	SARS-CoV-2	Emergency Use Authorization approved by the FDA
Bellerophon Therapeutics	inhaled nitric oxide (iNO) delivery system, INOpulse	SARS-CoV-2	emergency expanded access approved by the FDA
PerkinElmer	Coronavirus RT-PCR test	SARS-CoV-2	Emergency Use Authorization approved by the FDA
Quidel Corporation	Lyra SARS-CoV-2 Assay	SARS-CoV-2	Emergency Use Authorization approved by the FDA
Other Trials
Pliant Therapeutics	PLN-1474	nonalcoholic steatohepatitis (NASH) with liver fibrosis	dosing of first cohort in phase 1 trial
EOC Pharma	eftilagimod alpha (IMP321)	metastatic breast cancer	completed patient enrollment in phase 1 trial
Allakos	subcutaneous antolimab (AK002)	healthy subjects	initiation of phase 1 trial
Inflazome	Inzomelid	Cryopyrin-Associated Periodic Syndrome	completion of phase 1 study
Ascentage Pharma	APG-2575 in combination with rituximab or acalabrutinib	relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma	dosing of first subject in phase 1b/2 trial
Allakos	antolimab (AK002)	active, biopsy-confirmed eosinophilic esophagitis	initiation of phase 2/3 trial
Allakos	antolimab (AK002)	active, biopsy confirmed eosinophilic gastritis and/or eosinophilic duodenitis	initiation of phase 3 trial
Avadel Pharmaceuticals	FT218 (once-nightly sodium oxybate)	excessive daytime sleepiness and cataplexy in patients with narcolepsy	completion of phase 3 trial
AgNovos Healthcare	AGN1 Local Osteo-enhancement Procedure (LOEP) Small Volume (SV) Kit	stable vertebral compression fractures	Breakthrough Device designation granted by the FDA
Prevail Therapeutics	PR006	to slow the progression of frontotemporal dementia with a GRN mutation (FTD-GRN)	Fast-Track designation granted by the FDA
AEGEA Medical	Mara Water Vapor Ablation System	heavy menstrual bleeding	approved by the FDA
Pfizer	Eucrisa (crisaborole) ointment, 2%	children 3 months of age and older with mild-to-moderate atopic dermatitis	sNDA approved by the FDA