Pipeline

August 9, 2021

Company	Drug/Device	Medical Condition	Status
Angion Biomedica	ANG-3070	primary proteinuric kidney diseases	IND approved by the FDA for a phase 2 trial
Avidity Bioscience	AOC 1001	adults with myotonic dystrophy type 1	IND approved by the FDA
Excel Diagnostics	225Ac-PSMA I&T targeted alpha therapy	metastatic castrate-resistant prostate cancer	IND approved by the FDA
I-Mab	Protollin	Alzheimer's disease	IND approved by the FDA
Monopar Therapeutics	camsirubicin plus growth-factor support (pegfilgrastim)	advanced soft tissue sarcoma	IND approved by the FDA
Sorrento Therapeutics	allogeneic anti-CD38 dimeric antigen receptor (DAR) T-cell therapy	relapsed or refractory multiple myeloma	IND approved by the FDA
Vaxart	S-only oral tablet	SARS-CoV-2 vaccine	IND approved by the FDA
ABL Bio	ABL501	solid tumors	IND approved by South Korea's Ministry of Food and Drug Safety
Arcturus Therapeutics	ARCT-810	ornithine transcarbamylase (OTC) deficiency	approval received from the UK Health Research Authority for a phase 2 trial
Arcturus Therapeutics	ARCT-154 and ARCT-165 STARR mRNA vaccines	SARS-CoV-2 alpha, beta, gamma and delta variants	approval received from the Singapore Health Sciences Authority for a phase 1/2 trial
Cytodyn	leronlimab (PRO 140)	patients with severe COVID-19 requiring supplemental oxygen	clinical trial authorized by Brazil’s ANVISA (Agência Nacional de Vigilância Sanitária)
Eledon Pharmaceuticals	AT-1501	replacement for tacrolimus as an immunosuppressive regimen component in patients undergoing kidney transplantation	clinical trial authorized by Health Canada
Everest Medicines	Xerava (eravacycline)	community-acquired bacterial pneumonia	phase 3 clinical trial authorized by China’s National Medical Products Administration
Hummingbird Bioscience	HMBD-001	advanced cancers	clinical trial authorized by the UK Medicines and Healthcare Products Regulatory Agency (MHRA)
PanTher Therapeutics	PTM-101	pancreatic cancer	approval from the Human Research Ethics Committee of Australia for a phase 1 trial
Revolo Biotherapeutics	‘1104	moderate-to-severe grass pollen allergy	clinical trial authorized by the UK MHRA
Shenzhen Kangtai Biological Products	inactivated COVID-19 vaccine (Vero cells)	COVID-19 vaccine	approval granted by the Philippine Food and Drug Administration for a phase 3 trial
Noema Pharma	NOE-105	Tourette syndrome	initiation of phase 2a trial
Prometheus Biosciences	PRA023	moderate-to-severe Crohn’s disease	initiation of phase 2a trial
Stemedica Cell Technologies	intravenous allogeneic mesenchymal stem cells	patients with moderate-to-severe acute respiratory distress syndrome due to COVID-19	initiation of phase 2 trial
Cytokinetics	reldesemtiv	amyotrophic lateral sclerosis	initiation of phase 3 trial
Eli Lilly	baricitinib with or without remdesivir	treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen	Emergency Use Authorization expanded by the FDA
Allergan	Botox (onabotulinumtoxinA)	upper-limb spasticity in adults	approved by the FDA for expanded indication
AstraZeneca	Saphnelo (anifrolumab-fnia)	moderate-to-severe systemic lupus erythematosus	approved by the FDA
GlaxoSmithKline	Nucala (mepolizumab)	chronic rhinosinusitis with nasal polyps	approved by the FDA for new indication
Janssen	Uptravi (selexipag) intravenous injection	pulmonary arterial hypertension	new formulation approved by the FDA
Pillar Bioscience	OncoReveal Dx lung and colon cancer assay	qualitative detection of somatic mutations in DNA derived from nonsmall-cell lung cancer and colorectal cancer tumors	approved by the FDA
Amicus Therapeutics	Galafold (migalastat)	Fabry disease in children age 12 years and older	approved by the European Commission for expanded indication
Bristol Myers Squibb	Opdivo (nivolumab)	adjuvant treatment of adults with esophageal or gastroesophageal junction with residual pathologic disease following chemoradiotherapy	approved by the European Commission