Company Product Description Indication Status
Aprea Therapeutics Inc., of Boston APR-548 Apoptosis p53 stimulating protein stimulator Myelodysplastic syndrome FDA accepted IND application for phase I trial
Arca Biopharma Inc., of Westminster, Colo. AB-201 (rNAPc2) Tissue factor inhibitor COVID-19 infection FDA accepted IND application for phase IIb/III sequential Aspen-COVID-19 trial in about 100 people hospitalized with infection, expected to begin in fourth quarter of 2020
Arch Biopartners Inc., of Toronto Metablok LSALT peptide Moderate to severe COVID-19 infection Turkey Ministry of Health cleared site activation in phase II trial targeting acute lung and acute kidney injury in infected individuals
Biomarin Pharmaceutical Inc., of San Rafael, Calif. Palynziq (pegvaliase-pqpz) Phenylalanine hydroxylase stimulator Phenylketonuria FDA approved sBLA to increase maximum allowable dose to 60 mg to treat adults
Eli Lilly and Co., of Indianapolis LY-CoV555 COVID-19 Spike glycoprotein modulator Mild to moderate COVID-19 infection Initial request for emergency use authorization submitted to FDA to use as monotherapy in higher-risk people recently diagnosed with infection
Eton Pharmaceuticals Inc., of Deer Park, Ill. ET-101 (topiramate oral solution) GABA receptor agonist; NMDA receptor antagonist Seizure disorder; migraine NDA submitted to FDA as monotherapy to treat partial-onset or primary general tonic-clonic seizures in people 2 and older, as adjunctive therapy to treat partial-onset seizures in those 2 and older and as preventative treatment of migraine in those 12 and older
OWP Pharmaceuticals Inc., of Naperville, Ill. Quetiapine fumarate (liquid/oral suspension) 5-HT 2 receptor antagonist; dopamine D2 receptor antagonist Schizophrenia; bipolar disorder FDA approved IND application for formulation advancing on 505(b)(2) pathway
Pluristem Therapeutics Inc., of Haifa, Israel PLXPAD Stem cell therapy COVID-19 Received approval from Israel Ministry of Health to expand enrollment in phase II trial to Israel
Polarean Imaging plc, of Durham, N.C. Hyperpolarized 129 Xenon Drug-device diagnostic Lung disease NDA submitted to FDA, requesting priority review, for use to evaluate pulmonary function and visualize lung using MRI
Taiwan Liposome Co. Ltd. (TLC), of Taipei, Taiwan TLC-19 Hydroxychloroquine liposome inhalation suspension COVID-19 infection Australian Human Research Ethics Committee and Taiwan FDA cleared initiation of phase I trial in healthy volunteers
Y-Mabs Therapeutics Inc., of New York Nivatrotamab (huGD2-BsAb) Humanized bispecific anti-GD2 antibody Neuroblastoma FDA granted orphan drug and rare pediatric disease designations

Notes

For more information about individual companies and/or products, see Cortellis.