Company Product Description Indication Status
Affimed NV, of Heidelberg, Germany AFM-13 CD30- and CD16A-binding innate cell engager T-cell lymphoma FDA granted orphan drug designation
Applied Therapeutics Inc., of New York AT-001 Aldose reductase inhibitor COVID-19 IND opened with FDA for multiple investigator-initiated studies
Celularity Inc., of Warren, N.J. CYNK-001 Placenta-derived natural killer cell therapy COVID-19 FDA cleared the IND for a phase I/II trial
Fera Pharmaceuticals LLC, of New York, and Nicox SA, of Sophia Antipolis, France Naproxcinod Cyclooxygenase-inhibiting, nitric oxide-donating naproxen Sickle cell disease Applied for orphan drug designation with the FDA
Pfizer Inc., of New York Ruxience (rituximab) Biosimilar to Mabthera Non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris Approved by the European Commission
Pharmamar SA, of Madrid Aplidin (plitidepsin) Cyclodepsipeptide COVID-19 pneumonia Submitted trial protocol for the Aplicov study to the Spanish Medicines and Healthcare Products Agency
Seattle Genetics Inc., of Bothell, Wash. Padcev (enfortumab vedotin-ejfv) Antibody-drug conjugate targeting Nectin-4 Unresectable locally advanced or metastatic urothelial cancer FDA said data from cohort K of the EV-103/Keynote-869 study could serve as a pivotal study testing drug in patients unable to receive cisplatin-based chemotherapy in the first-line setting


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