Company Product Description Indication Status
Alkermes plc., of Dublin ALKS-3831 (olanzapine/samidorphan) Atypical antipsychotic Schizophrenia and bipolar I disorder FDA received the resubmission of the NDA and classified it as a class 2 response of the complete response letter issued in November 2020; new PDUFA target action date is 6/1/21
Ampio Pharmaceuticals Inc., of Englewood, Colo. Ampion  Stem cell antigen-1 inhibitor Osteoarthritis of the knee FDA provided feedback on proposed modifications to the AP-013 study, which was suspended due to COVID-19 pandemic
Arcturus Therapeutics Holdings Inc., of San Diego ARCT-021 Self-replicating mRNA-based vaccine COVID-19 prophylaxis Singapore Health Sciences Authority gave permission to proceed with a phase II study
Capricor Therapeutics Inc., of Los Angeles CAP-1002 Allogeneic cell therapy Severe COVID-19 Independent data and safety monitoring board recommended the Inspire study continue as designed; data expected in the first half of 2021
Celltrion Inc., of Incheon, Korea CT-P59 Monoclonal antibody targeting SARS-CoV-2 Mild-to-moderate COVID-19 Submitted an application for conditional marketing authorization to the Korean Ministry of Food and Drug Safety
Clovis Oncology Inc., of Boulder, Colo. FAP-2286 Peptide-radionuclide conjugate targeting fibroblast activation protein Multiple tumor types Submitted two INDs to the FDA, one for lutetium-177 labeled FAP-2286 as a therapeutic and one for gallium-68 labeled FAP-2286 as a diagnostic to detect fibroblast activation protein-positive tumors
Hutchison China Meditech Ltd., of Hong Kong Surufatinib  Vascular endothelial growth factor receptor and fibroblast growth factor receptor tyrosine kinase inhibitor Pancreatic and non-pancreatic neuroendocrine tumors Started rolling submission of the NDA to the FDA; plans to complete the submission in the first half of 2021
Moleculin Biotech Inc., of Houston Annamycin  Next-generation anthracycline Soft tissue sarcomas FDA granted orphan drug designation
Novo Nordisk A/S, of Bagsværd, Denmark Ozempic (semaglutide) Glucagon-like peptide-1 analogue Type 2 diabetes Submitted a label extension application to the EMA for the 2-mg dose
Pfizer Inc., of New York Lorbrena (lorlatinib) Anaplastic lymphoma kinase inhibitor Anaplastic lymphoma kinase-positive metastatic non-small-cell lung cancer FDA accepted the supplemental NDA for a priority review; PDUFA target action date is in April 2021

Notes

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