Pipeline

May 18, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Enlivex Therapeutics	Allocetra	COVID-19	initiation of phase 2 trial
Bellerophon Therapeutics	INOpulse inhaled nitric oxide	COVID-19	IND approved by the FDA
Moderna Therapeutics	mRNA-1273	COVID-19 vaccine	IND approved by the FDA; Fast Track designation granted by the FDA
Pluristem	PLX cells	severe COVID-19 cases complicated by Acute Respiratory Distress Syndrome (ARDS)	IND approved by the FDA
Redhill Biosciences	opaganib (Yeliva, ABC294640)	moderate-to-severe SARS-CoV-2 infection	IND approved by the FDA
Abbott	SARS-CoV-2 IgG lab-based serology blood test	COVID-19 antibody detection test	Emergency Use Authorization (EUA) granted by the FDA
Applied DNA Sciences	Linea COVID-19 RT-PCR test	SARS-CoV-2 detection	EUA granted by the FDA
Quidel	the Sofia 2 SARS Antigen FIA	rapid detection of SARS-Cov-2 antigens	EUA granted by the FDA
Rutgers Clinical Genomics Laboratory	Spectrum Solutions LLC SDNA-1000 Saliva Collection Device	COVID-19 antibody detection test	EUA granted by the FDA
Sherlock Biosciences	Sherlock CRISPR SARS-CoV-2 kit	rapid detection of SARS-Cov-2 antigens	EUA granted by the FDA
Zymo Research	Quick SARS-CoV-2 rRT-PCR Kit	rapid detection of SARS-Cov-2 antigens	EUA granted by the FDA
Other Trials and Actions
Ocular Therapeutix	OTX-CSI (cyclosporine intracanalicular insert)	dry eye disease	dosing of first patient in phase 1 trial
I-Mab Biopharma	TJ004309	advanced solid tumors	dosing of first patients in phase 1/2 trial
Rubius Therapeutics	RTX-240	relapsed/refractory or locally advanced solid tumors	dosing of first patients in phase 1/2 trial
Strongbridge Biopharma	Recorlev (levoketoconazole)	endogenous Cushing’s syndrome	completion of patient enrollment in phase 3 trial
AgenTus Therapeutics	agenT-797	cancer	IND approved by the FDA
Histogen	HST 001	androgenic alopecia in men	IND approved by the FDA
SciMount Pharmatech	SMP-100	Irritable Bowel Syndrome with diarrhea	IND approved by the FDA
Amgen Cytokinetics	omecamtiv mecarbil	chronic heart failure with reduced ejection fraction	Fast Track designation granted by the FDA
AstraZeneca Daichi Sankyo	Enhertu (fam-trastuzumab deruxtecan-nxki)	patients with HER2 positive unresectable or metastatic gastric cancer who have received two or more prior regimens including trastuzumab	Breakthrough Therapy designation granted by the FDA
CRISPR Therapeutics Vertex Pharmaceuticals	CTX001	severe sickle cell disease and transfusion-dependent beta thalassemia	Regenerative Medicine Advanced Therapy designation granted by the FDA
Eli Lilly	Retevmo (selpercatinib)	adults with metastatic RET fusion-positive non-small cell lung cancer and adult and pediatric patients <12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer or advanced or metastatic RET fusion-positive thyroid cancer	approved by the FDA
AstraZeneca Merck	Lynparza (olaparib) in combination with bevacizumab	first-line maintenance treatment for HRD-positive advanced ovarian cancer	approved by the FDA