Regulatory actions for April 2, 2020

April 2, 2020

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

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