Pipeline

June 8, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Opko Health	RAYALDEE	mild to moderate COVID-19	initiation of phase 2 trial granted by the FDA
Orpheris	OP-101	patients with severe COVID-19	initiation of phase 2 trial
ViralClear	merimepodib oral solution	adults with COVID-19 who are hospitalized and either require supplemental oxygen or are on noninvasive ventilation or high-flow oxygen devices	initiation of phase 2 trial
Moderna	mRNA-1273 vaccine candidate	coronavirus (SARS-CoV-2)	first patients in each age cohort dosed in phase 2 trial
Relief Therapeutics NeuroRx	RLF-100	Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients on mechanical ventilation	first patients treated in phase 2b/3 trial
CTI BioPharma	pacritinib	hospitalized patients with severe COVID-19	enrollment of first patient in phase 3 trial
Cerecor	CERC-002	COVID-19 cytokine storm-induced ARDS	IND approved by the FDA
Atyu Biosciences	COVID-19 IgG/IgM Rapid Test Cassette	detection of SARS-CoV-2 antibodies	Emergency Use Authorization (EUA) granted by the FDA
Confirm BioSciences	COVID-19 IgG/IgM Rapid Test kits	detection of SARS-CoV-2 antibodies	EUA granted by the FDA
Siemens Healthineers	Siemens Healthineers Total Antibody COV2T assay	detection of SARS-CoV-2 antibodies	EUA granted by the FDA
Other Trials and Actions
Histogen	HST 001	androgenic alopecia in men	enrollment of first patient in phase 1b/2a trial
Adverum Biotechnologies	ADVM-022	patients with diabetic macular edema	initiation of phase 2 trial
MimiVax	SurVaxM (MimiVax) and Keytruda (pembrolizumab)	patients with recurrence of glioblastoma who have failed prior chemotherapy and radiation	initiation of phase 2 trial
Neurotrope, National Institutes of Health	Bryostatin-1	Alzheimer’s disease	initiation of phase 2 trial
Complexa	CXA-10	primary focal segmental glomerulosclerosis	completion of patient enrollment in phase 2 trial
Allakos	Ak002	eosinophilic esophagitis	initiation of phase 2/3 trial
Allakos	AK002	eosinophilic gastritis and/or eosinophilic duodenitis	initiation of phase 3 trial
Aprea Therapeutics	eprenetapopt with azacitidine	front-line TP53 mutant myelodysplastic syndromes	completion of patient enrollment in phase 3 trial
Satsuma Pharma	STS101 (dihydroergotamine (DHE) nasal powder)	acute treatment of migraine	completion of patient enrollment in phase 3 trial
Immune-Onc Therapeutics	IO-202	acute myeloid leukemia	IND approved by the FDA
Compugen	COM701 in combination with Opdivo (nivolumab) and BMS-986207	advanced solid tumors	IND approved by the FDA
NKMax America	SNK01 in combination with trastuzumab (Herceptin) or cetuximab (Erbitux)	advanced/metastatic HER2- or EGFR- expressing cancers	IND approved by the FDA
Cardiff Oncology	onvansertib	second-line treatment of patients with KRAS-mutated metastatic colorectal cancer	Fast-Track designation granted by the FDA
Clarity Pharmaceutical	67Cu-SARTATE	neuroblastoma	Rare Pediatric Disease designation granted by the FDA
Theraly Fibrosis	TLY012	systemic sclerosis	Orphan Drug designation granted by the FDA
AbbVie Neurocrine Biosciences	ORIAHN (elagolix, estradiol, and norethindrone acetate capsules)	heavy menstrual bleeding associated with uterine fibroids in premenopausal women	approved by the FDA
AstraZeneca	BRILINTA (ticagrelor)	reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease	approved by the FDA for expanded indication
Eli Lilly	Tauvid	imaging in Alzheimer’s patients	approved by the FDA
Eli Lilly	Cyramza (ramucirumab) in combination with erlotinib	metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 (L858R) mutations	approved by the FDA
Eli Lilly	Taltz (ixekizumab)	active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation	approved by the FDA for expanded indication
Genentech	Tecentriq (atezolizumab) in combination with Avastin (bevacizumab)	patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy	approved by the FDA
Menlo Therapeutics	ZILXI (minocycline) topical foam	inflammatory lesions of rosacea in adults	approved by the FDA