Company Product Description Indication Status
Algo Therapeutix SAS, of Suresnes, France ATX-01 Topical amitriptyline Chemotherapy-induced peripheral neuropathy Received regulatory approval in the Czech Republic to initiate phase I development 
Athenex Inc., of Buffalo, N.Y. Klisyri Tirbanibulin Actinic keratosis on the face or scalp  FDA approved it 
Astrazeneca plc, of Wilmington, Del. Imfinzi (durvalumab) Antibody targeting PD-L1  Locally advanced, unresectable non-small-cell lung cancer in adults whose tumors express PD-L1 on at least 1% of tumor cells  Recommended for marketing authorization by the EMA's Committee for Medicinal Products for Human Use for a less-frequent, fixed-dose use 
Can-Fite Biopharma Ltd., of Petach Tikva Cannabinoid fractions At nanomolar concentrations binding with the A3 adenosine receptor Cancer, inflammatory diseases and metabolic diseases associated with fat accumulation Received approval from the Medical Cannabis Unit of Israel’s Ministry of Health to conduct preclinical studies 
Cyxone AB, of Stockholm Rabeximod Anti-rheumatic compound COVID-19 and other indications, such as rheumatoid arthritis Filed an IND following positive feedback from a pre-IND meeting with the FDA 
Fortress Biotech Inc., of New York CUTX-101 Restores copper levels Menkes disease FDA granted breakthrough therapy designation
Genentech, of South San Francisco, a member of the Roche Group Ocrevus (ocrelizumab) Monoclonal antibody targeting CD20-positive B cells Relapsing and primary progressive multiple sclerosis FDA approved a shorter 2-hour infusion time, dosed twice-yearly
IO Biotech, of Copenhagen IO-102 and IO-103 Indoleamine 2,3-dioxygenase derived peptide and PD-L1-derived peptide Unresectable/metastatic melanoma FDA granted breakthrough therapy designation in combination with anti-PD-1 monoclonal antibody
Nascent Biotech Inc., of San Diego Pritumumab Vimentin modulator Brain cancer FDA removed a partial clinical hold, allowing it to begin phase I trials
Prometheus Biosciences Inc., of San Diego PRA-023 Humanized IgG1 monoclonal antibody that blocks tumor necrosis factor-like ligand 1A  Ulcerative colitis and Crohn's disease FDA accepted the IND application, and the company commenced dosing in phase Ia study
Rafael Pharmaceuticals Inc., of Cranbury, N.J. CPI-613 (devimistat) Targets mitochondrial tricarboxylic acid cycle Acute myeloid leukemia  FDA granted fast track designation
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan TAK-721 (budesonide oral suspension) Glucocorticoid receptor agonist Eosinophilic esophagitis FDA accepted the NDA and granted priority review 
Xentria Inc., of Chicago XTMAB-16  Intravenous TNF-alpha inhibitor Sarcoidosis FDA granted orphan drug designation 

Notes

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