Pipeline

April 12, 2021

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
OSE Immunotherapeutics	CoVepiT	COVID-19 vaccine	approval received from the Belgian Federal Agency for Medicines and Health Products for phase 1 trial
AzurRx Biopharma	micronized niclosamide (FW-1022)	COVID-19-related gastrointestinal infections	initiation of phase 2 trial
The Cancer Research Institute RevImmune	interleukin-7 (IL-7)	cancer patients with COVID-19	first patients dosed in phase 2 trial
Novavax	NVX-CoV2373	COVID-19 vaccine	initiation of phase 2b and 3 trials
Abbott	BinaxNOW COVID-19 Ag Self Test	detection of COVID-19 infection	Emergency Use Authorization (EUA) granted by the FDA
Baebies	FINDER 1.5 Instrument and FINDER SARS-CoV-2 Test – RT-PCR	detection of COVID-19 infection	EUA granted by the FDA
Quidel	QuickVue At-Home OTC COVID-19 Test	detection of COVID-19 infection	EUA granted by the FDA
Other Trials and Actions
Arcellx	ACLX-001	multiple myeloma	IND approved by the FDA
BioInvent International	BI-1808	ovarian cancer, nonsmall-cell lung cancer and cutaneous T-cell lymphoma	IND approved by the FDA
Landos Biopharma	omilancor (BT-11)	eosinophilic esophagitis	IND approved by the FDA
Tarus Therapeutics	TT-10	advanced solid tumors	IND approved by the FDA
Antengene Corporation	ATG-019 (monotherapy or combined with niacin ER)	advanced solid tumors or nonHodgkin lymphoma	IND approved by the China National Medical Products Administration
BlueRock Therapeutics	MSK-DA01 Cell Therapy	advanced Parkinson's disease	approval received from Health Canada for a phase 1 trial
Azafaros	AZ-3102	GM1 and GM2 gangliosidoses	first cohort dosed in phase 1 trial
Celon Pharma	CPL’280	diabetes and diabetic neuropathy	completion of phase 1 trial
I-Mab ABL Biotechnologies	TJ-L14B/ABL503	locally advanced or metastatic solid tumors	first patient dosed in phase 1 trial
Nascent Biotech	pritumumab	brain cancer, including malignant primary brain tumors and adult brain metastases	initiation of phase 1 trial
TeneoBio Janssen	JNJ-75348780	B-cell lymphoid malignancies	first patients dosed in phase 1 trial
Pinteon Therapeutics	PNT001	acute traumatic brain injury	first patient dosed in phase 1b trial
SpringWorks Therapeutics	nirogacestat	nirogacestat in combination with teclistamab	first patient dosed in phase 1b trial
Daiichi Sankyo	DS-1594	relapsed/refractory acute myeloid leukemia and acute lymphoblastic leukemia	initiation of phase 1/2 trial
Gracell Biotechnologies	GC007g	B-cell acute lymphoblastic leukemia	first patient enrolled in phase 1/2 trial
Molecular Partners	ensovibep	patients with symptomatic COVID-19	first patient dosed in phase 2a trial
Recognify Life Sciences/atai Life Sciences	RL-007	cognitive impairment associated with schizophrenia	initiation of phase 2a trial
AEON Biopharma	ABP-450 (prabotulinumtoxinA) injection	cervical dystonia	first patients dosed in phase 2 trial
Aptinyx	NYX-458	patients with mild cognitive impairment and mild dementia associated with Parkinson’s disease and dementia with Lewy bodies	restarted patient screening in phase 2 trial
Chinook Therapeutics	atrasentan	patients with proteinuric glomerular disease who are at risk of progressive loss of renal function	first patient dosed in phase 2 trial
Daiichi Sankyo AstraZeneca	Enhertu (trastuzumab deruxtecan)	HER2 overexpressing locally advanced, unresectable or metastatic colorectal cancer with progression following treatment with standard-of-care chemotherapy	first patient dosed in phase 2 trial
Enzychem Lifesciences	EC-18	chemoradiation induced oral mucositis	patient enrollment complete in stage 2 of phase 2 trial
Kadmon	belumosudil	diffuse cutaneous systemic sclerosis	first patient dosed in phase 2 trial
Ocuphire Pharma	APX3330	nonproliferative diabetic retinopathy and mild proliferative diabetic retinopathy	initiation of phase 2 trial
Ionis Pharmaceuticals	ION363	amyotrophic lateral sclerosis with mutations in the fused-in sarcoma gene	initiation of phase 3 trial
Relmada Therapeutics	REL-1017	adjunctive treatment for major depressive disorder	initiation of phase 3 trial
Da Volterra	DAV132	prevention of clostridioides difficile infection in high-risk patients	Fast-Track designation granted by the FDA
Passage Bio	PBKR03	Krabbe disease	Orphan Drug designation granted by the European Commission
Taiho Oncology	futibatinib (TAS-120)	treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements, including gene fusions	Breakthrough Therapy designation granted by the FDA
Sanofi	Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone	treatment of patients with relapsed refractory multiple myeloma who have received one to three prior lines of therapy	approved by the FDA for expanded indication
Supernus Pharmaceuticals	Qelbree (viloxazine extended-release capsules)	attention deficit hyperactivity disorder in pediatric patients 6 to 17 years of age	approved by the FDA
United Therapeutics	Tyvaso (treprostinil) Inhalation Solution	pulmonary hypertension associated with interstitial lung disease	approved by the FDA
Bausch and Lomb	ClearVisc dispersive ophthalmic viscosurgical device	ophthalmic surgery	approved by the FDA
Chemence Medical	Exofin fusion skin closure system	topical adhesive to close and seal incisions	approved by the FDA
NuVasive	NuVasive Simplify Cervical Artificial Disc	two-level cervical total disc replacement	approved by the FDA
Respinova	Pulsehaler	inhaler for patients with respiratory diseases	approved by the FDA
Vysioneer	VBrain, AI-powered tumor autocontouring solution	radiotherapy treatment	approved by the FDA