Pipeline

February 8, 2021

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Selva Therapeutics	SLV213	nonhospitalized COVID-19 patients	completion of phase 1 trial
Valneva	VLA2001	COVID-19 vaccine	patient enrollment complete in phase 1/2 trial
Arch Biopartners	LSALT peptide (Metablok)	acute lung injury and acute kidney injury caused by inflammation in patients with severe cases of COVID-19	approval from ethics committee in Turkey to dose 20 additional patients in phase 2 trial
Atea Pharmaceuticals	AT-527	mild or moderate COVID-19 patients	first patient dosed in phase 2 trial
Biophytis	Sarconeos (BIO101)	acute respiratory failure associated with COVID-19	initiation of patient recruitment in the U.S. and Brazil in part 2 of phase 2/3 trial
NeuroRx	inhaled Zyesami (aviptadil)	severe COVID-19	initiation of phase 2/3 trial
Corvus Pharma	CPI-006	hospitalized patients with COVID-19	initiation of phase 3 trial
Humanigen	lenzilumab	hospitalized and hypoxic patients with COVID-19 pneumonia	patient enrollment complete in phase 3 trial
Other Trials and Actions
KemPharm	KP879	stimulant use disorder	IND approved by the FDA
Tetra Bio-Pharma	QIXLEEF	cancer patients with breakthrough pain	IND approved by the FDA
Vertex Pharmaceuticals	VX-880	type 1 diabetes	IND approved by the FDA
Crinetics Pharmaceuticals	CRN04894	Cushing’s disease and congenital adrenal hyperplasia	initiation of phase 1 trial
Daiichi Sankyo	DS-6000	patients with advanced renal cell carcinoma or ovarian cancer with disease progression following standard treatment	first patient dosed in phase 1 trial
Dynavax Serum Institute of India	tetanus, diphtheria and acellular pertussis (Tdap) booster vaccine adjuvanted with CpG 1018	prevention of tetanus, diphtheria and acellular pertussis	first patient dosed in phase 1 trial
Kira Pharmaceuticals	P014	complement-mediated diseases	first patient dosed in phase 1 trial
LB Pharmaceuticals	LB-102	acute schizophrenia	first patient dosed in phase 1b trial
BridgeBio Pharma Venthera	BBP-68/ VT30 topical gel	patients with venous, lymphatic and venolymphatic malformations	first patient dosed in phase 1/2 trial
Exonate Johnson & Johnson	EXN 407	center-involved diabetic macular edema	first patient dosed in phase 1b/2 trial
ImCyse	IMCY-0098	recent onset type 1 diabetes	first patients dosed in phase 1b/2a trial
Sio Gene Therapies	AXO-AAV-GM2	GM2 gangliosidosis	first patient dosed in phase 1/2 trial
Spark Therapeutics	SPK-3006	late-onset Pompe disease	first patient dosed in phase 1/2 trial
Chemomab	CM-101	primary sclerosing cholangitis	first patient enrolled in phase 2a trial
Gemini Therapeutics	GEM103	patients with wet AMD who have, or may be at risk for, macular atrophy but require ongoing anti-VEGF treatment	initiation of phase 2a trial
ADC Therapeutics	camidanlumab tesirine (ADCT-301)	relapsed or refractory Hodgkin lymphoma	completion of patient enrollment in phase 2 trial
Curis	CA-4948	anemia in patients with very low-, low- or intermediate-risk myelodysplastic syndromes	initiation of phase 2 trial
Daiichi Sankyo	patritumab deruxtecan	patients with EGFR-mutated metastatic or locally advanced nonsmall-cell lung cancer previously treated with a TKI and platinum-based chemotherapy	initiation of phase 2 trial
I-Mab	TJ107 (efineptakin alpha)	glioblastoma multiforme	first patients dosed in phase 2 trial in China
Surface Ophthalmics	SURF-200 (betamethasone in Klarity vehicle)	acute dry eye	first patients dosed in phase 2 trial
Viacyte	VC01-103, encapsulated cell therapy	type 1 diabetes	first patients dosed in phase 2 trial
Arena Pharmaceuticals	etrasimod	moderately to severely active ulcerative colitis	patient enrollment complete in phase 3 trial
Novan	SB206	molluscum contagiosum	patient enrollment complete in phase 3 trial
VectivBio	apraglutide	short bowel syndrome	first patient dosed in phase 3 trial
Chinook Therapeutics	CHK-336	primary hyperoxaluria	Rare Pediatric Disease designation granted by the FDA
Cerecor	CERC-803	leukocyte adhesion deficiency type II	Fast-Track designation granted by the FDA
Gan & Lee Pharmaceuticals	GLR2007	glioblastoma	Fast-Track designation granted by the FDA
Theratechnologies	TH1902	sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy	Fast-Track designation granted by the FDA
Adamas Pharmaceuticals	Gocovri (amantadine) extended-release capsules	adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes	approved by the FDA for expanded indication
Biocryst Pharma	Rapivab (peramivir injection)	acute uncomplicated influenza in patients six months and older who have been symptomatic for no more than two days	approved by the FDA for expanded indication
Biogen	Plegridy (peginterferon beta-1a)	relapsing forms of multiple sclerosis	approved by the FDA for new intramuscular injection route of administration
DURECT	Posimir (bupivacaine solution)	postsurgical pain for up to 72 hours following arthroscopic subacromial decompression	approved by the FDA
Galderma	Restylane Defyne	chin augmentation	approved by the FDA
Johnson & Johnson	TECNIS Eyhance and TECNIS Eyhance Toric II intraocular lens	cataract patients with or without astigmatism	approved by the FDA
Medtronic	DiamondTemp Ablation (DTA) system	patients with recurrent, symptomatic paroxysmal atrial fibrillation and who have been unresponsive to drug therapy	approved by the FDA
Merck KGaA	Tepmetko (tepotinib)	adults with metastatic nonsmall-cell lung cancer who have a MET exon 14 skipping alteration	approved by the FDA
Soliton	Rapid Acoustic Pulse technology	short-term improvement in the appearance of cellulite	approved by the FDA
Astellas	Xospata (gilteritinib)	relapsed or refractory acute myeloid leukemia with a FLT3 mutation	approved in China
Innovent Eli Lilly	Tyvyt (sintilimab injection) in combination with pemetrexed and platinum chemotherapy	first-line therapy for nonsquamous nonsmall-cell lung cancer	approved in China for new indication