Company Product Description Indication Status
Abbvie Inc., of North Chicago Rinvoq (upadacitinib) JAK inhibitor Psoriatic arthritis European Commission approved the drug
Astrazeneca plc, of Cambridge, U.K. Symbicort Turbuhaler (budesonide/formoterol) Inhaled corticosteroid/long-acting beta2-agonist Asthma China's National Medical Products Administration approved the drug
Biontech SE, of Mainz, Germany, and Shanghai Fosun Pharmaceutical Group Co., of Shanghai Comirnaty mRNA-based vaccine COVID-19 prophylaxis Food and Health Bureau of the Hong Kong Special Administrative Region of the PRC authorized the vaccine for emergency use
Cardiff Oncology Inc., of San Diego Onvansertib  KRAS inhibitor Metastatic pancreatic ductal adenocarcinoma Received a study may proceed letter from the FDA for the 40-patient phase II trial; primary endpoint will be overall response rate; secondary and exploratory endpoints include duration of response, median overall survival, ORR in patients receiving greater than 2 treatment cycles, disease control rate and KRAS allelic burden in liquid biopsies
Edesa Biotech Inc., of Toronto EB-05 TLR4 antagonist Acute respiratory distress syndrome in patients with COVID-19  Received clearance from the FDA and Health Canada to add a substudy of up to 100 ICU patients with severe COVID-19 symptoms to the ongoing phase II/III study
Faron Pharmaceuticals Oy, of Turku, Finland Traumakine (intravenous interferon beta-1a) CD73 agonist; interferon-beta ligand COVID-19 infection FDA approved the phase II/III Hibiscus study protocol for the treatment of hospitalized patients 
Immunicum AB, of Stockholm Ilixadencel Cell-based, off-the-shelf immune primer Soft tissue sarcoma FDA granted orphan drug designation
Meiragtx Holdings plc, of London AAV-CNGA3 Gene therapy treatment designed to restore cone function, delivered to the cone receptors at the back of the eye via subretinal injection Achromatopsia caused by mutations in the CNGA3 gene FDA granted fast track designation 
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab) Anti-PD-1 antibody Metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer European Commission approved it as a first-line treatment in adult patients  
Mundipharma International Ltd., of Cambridge, U.K., and Cidara Therapeutics Inc., of San Diego Rezafungin Echinocandin antifungal Invasive candidiasis Received orphan drug designation in the EU
Nanoscope Therapeutics Inc., of Bedford, Texas VMCO-010 Gene therapy Stargardt disease FDA granted orphan drug designation 
OS Therapies LLC, of Cambridge, Md. AOST-2121/OST31-164-01 (now OST-HER2) Attenuated Listeria monocytogenes expressing a tLLO-chimeric HER2 fusion protein Recurred, resected osteosarcoma Received trial approval from Children's Oncology Group for the OST-HER2 phase IIb study 
Recordati SpA, of Milan, Italy Carbaglu tablets 200 mg Carglumic acid Acute hyperammonemia due to propionic acidemia or methylmalonic acidemia  FDA approved it
Veralox Therapeutics Inc., of Frederick, Md. VLX-1005 Small-molecule inhibitor of 12-lipoxygenase Heparin-induced thrombocytopenia FDA granted orphan drug designation
Vertex Pharmaceuticals Inc., of Boston Trikafta (elexacaftor + tezacaftor + ivacaftor) CFTR modulator/stimulator Cystic fibrosis FDA accepted the sNDA seeking use in children ages 6-11 with certain mutations

Notes

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