Company Product Description Indication Status
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia NP-120 (ifenprodil)  N-methyl-D-aspartate receptor glutamate receptor antagonist Idiopathic pulmonary fibrosis and chronic cough Submitted for ethics approval in Australia for its planned phase II study
Arvelle Therapeutics GmbH, of Zug, Switzerland Cenobamate Voltage-gated sodium channel blocker Focal-onset seizures EMA accepted marketing authorization application for use as adjunctive treatment in adults with epilepsy
Astrazeneca plc, of Cambridge, U.K. Imfinzi (durvalumab) PD-L1-inhibiting antibody Small-cell lung cancer FDA approved use as first-line treatment for adults with extensive-stage disease in combination with standard-of-care chemotherapies etoposide and either carboplatin or cisplatin
Beyondspring Inc., of New York Plinabulin Immune and stem cell modulator Chemotherapy-induced neutropenia  Initiated rolling submission of NDA to China’s NMPA
Biocryst Pharmaceuticals Inc., of Research Triangle Park, N.C. Berotralstat (BCX-7353) Oral, once-daily inhibitor of kallikrein in plasma Prevention of hereditary angioedema attacks EMA validated the marketing authorization application
Daiichi Sankyo Co. Ltd., of Tokyo Axicabtagene ciloleucel CAR T-cell therapy Relapsed/refractory diffuse large B-cell lymphoma and related lymphomas Submitted NDA to Japan’s Ministry of Health, Labour and Welfare
Eli Lilly and Co., of Indianapolis Taltz (ixekizumab) Humanized IgG4 monoclonal antibody Moderate to severe plaque psoriasis FDA approved supplemental BLA for treating pediatric patients, ages 6 to under 18, who are candidates for systemic therapy or phototherapy
Humanigen Inc., of Burlingame, Calif. Lenzilumab Humaneered anti-human GM-CSF monoclonal antibody COVID-19 Submitted initial protocol synopsis to FDA to support plans for a phase III study for the prevention of acute respiratory distress syndrome and/or death in hospitalized patients with pneumonia associated with SARS-CoV-2 infection
I-Mab Biopharma Co. Ltd., of Rockville, Md., and Shanghai TJM-2 Neutralizing antibody against human GM-CSF Cytokine storm Submitted IND to South Korea’s Ministry of Food and Drug Safety to evaluate drug in severe and critically ill patients with COVID-19
Junshi Biosciences Ltd., of Shanghai Toripalimab Monoclonal antibody targeting PD-1 Mucosal melanoma FDA granted orphan designation for use in combination with axitinib (Pfizer Inc.)
Orion Corp., of Espoo, Finland Nubeqa (darolutamide) Oral androgen receptor inhibitor Non-metastatic castration-resistant prostate cancer European Commission granted marketing authorization
Rhythm Pharmaceuticals Inc., of Boston Setmelanotide Melanocortin-4 receptor agonist Pro-opiomelanotonin deficiency obesity and leptin receptor deficiency obesity Completed rolling NDA to FDA
Ryvu Therapeutics SA, of Krakow, Poland SEL-120 Oral, selective inhibitor of CDK8 kinase Acute myeloid leukemia FDA granted orphan designation

Notes

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

No Comments