Pipeline

July 27, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Heron Therapeutics	Cinvanti (aprepitant) injectable emulsion	early hospitalized patients with COVID-19	initiation of phase 2 trial
Inotrem	nangibotide	critically ill COVID-19 patients with features of systemic inflammation	clearance to initiate a phase 2a trial granted by the FDA
PhaseBio	PB1046	hospitalized COVID-19 patients who are at high risk for rapid clinical deterioration and acute respiratory distress syndrome	dosing of first patient in phase 2 trial
Sorrento Therapeutics	abivertinib	patients with COVID-19 who have moderate to severe pulmonary symptoms	clearance to initiate a phase 2 trial granted by the FDA
Sinopharm CNBG and G42 Healthcare	inactivated COVID-19 vaccine	COVID-19	initiation of phase 3 trial
Access Genetics dba OralDNA Lab	OraRisk COVID-19 RT-PCR test	SARS-CoV-2	Emergency Use Authorization (EUA) granted by the FDA
Luminex	xMAP SARS-CoV-2 Multi-Antigen IgG Assay	SARS-CoV-2	EUA granted by the FDA
Other Trials and Actions
Larimar Therapeutics	CTI-1601	Friedreich’s ataxia	dosing of first patients in third cohort of phase 1 trial
Aravive	AVB-500	platinum-resistant ovarian cancer	completion of patient dosing in phase 1b trial
Ascentage Pharma	APG-115 as a single agent or in combinations	Chinese patients with relapsed/refractory acute myeloid leukemia or relapsed/progressed high/very high-risk myelodysplastic syndrome	dosing of first patient in Phase 1b trial
Regulus Therapeutics	RGLS4326	autosomal dominant polycystic kidney disease	completion of patient dosing in phase 1 trial
9 Meters Biopharma	NM-002	adults with short bowel syndrome	dosing of first patients in Phase 1b/2a trial
BerGenBio	bemcentinib	recurrent glioblastoma	dosing of first patient in phase 1/2 trial
ADC Therapeutics	loncastuximab tesirine (Lonca, formerly ADCT-402) in combination with ibrutinib	patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma	dosing of first patient in phase 2 portion of phase 1/2 trial
Dragonfly Therapeutics	DF6002	advanced solid tumors	dosing of first patient in phase 1/2 trial
XyloCor Therapeutics	XC001	refractory angina	dosing of first patients in phase 1/2 trial
AnHeart Therapeutics	taletrectinib	non-small-cell lung cancer with ROS1 fusion	dosing of first patient in phase 2 trial
NovoCure	tumor treating fields	recurrent glioblastoma	enrollment of first patient in phase 2 trial
Terns Pharmaceuticals	TERN-101	nonalcoholic steatohepatitis	dosing of first patient in phase 2 trial
AzurRX BioPharma	MS1819	cystic fibrosis patients with exocrine pancreatic insufficiency	initiation of phase 2b trial
AxoGen	avance nerve graft	digital nerve injuries	patient enrollment complete in phase 3 trial
Blue Earth Diagnostics	rhPSMA-7.3 (18F), an investigational prostate-specific membrane antigen-targeted radiohybrid PET imaging agent	men with suspected prostate cancer recurrence based on elevated PSA following prior therapy	dosing of first patients in phase 3 trial
Biohaven Pharma	verdiperstat	multiple system atrophy	patient enrollment complete in phase 3 trial
Springworks Therapeutics	nirogacestat	adult patients with progressing desmoid tumors	patient enrollment complete in phase 3 trial
Talaris Therapeutics	FCR001	induction or restoration of immune tolerance in living donor kidney transplant recipients	dosing of first patient in phase 3 trial
Denovo Biopahrma	DB102 (enzastaurin)	newly diagnosed glioblastoma	Fast Track designation granted by the FDA
Kiniksa Pharmaceutical	rilonacept	pericarditis	Orphan Drug designation granted by the FDA
Orchard Therapeutics	OTL-203	mucopolysaccharidosis type I (MPS-I)	Orphan Drug designation and Rare Pediatric Disease designations granted by the FDA
Ambu A/S	ambu ascope duodeno	endoscopic retrograde cholangio-pancreatography procedure	approved by the FDA
Channel Medsystems	cerene cryotherapy device	heavy menstrual bleeding	approved by the FDA
Jazz Pharmaceuticals	Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution	cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy	approved by the FDA
KeraNetics	KeraStat cream	radiation dermatitis	approved by the FDA
MC2 Therapeutics	Wynzora cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%)	plaque psoriasis in adults	approved by the FDA
Orthofix Medical	Juniortho plating system	advanced deformity and trauma reconstruction of the lower extremities in pediatrics	approved by the FDA