Company Product Description Indication Status
Alkermes plc, of Dublin Nemvaleukin alfa (ALKS-4230) IL-2 receptor agonist Mucosal melanoma FDA granted orphan drug designation
Astellas Pharma Inc., of Tokyo Enfortumab vedotin Nectin-4-directed antibody-drug conjugate Urothelial cancer NDA submitted to Japan's MHLW to treat locally advanced/metastatic disease that progressed after cancer medication
Aveo Oncology (formerly Aveo Pharmaceuticals Inc.), of Boston Fotivda (tivozanib) VEGF tyrosine kinase inhibitor Renal cell carcinoma FDA approved to treat adults with relapsed/refractory advanced disease who received 2 or more prior systemic therapies
Biocryst Pharmaceuticals Inc., of Research Triangle Park, N.C. Berotralstat Kallikrein inhibitor Hereditary angioedema French National Agency for Medicines and Health Products Safety granted temporary authorization for use in appropriate patients 12 and older
Biohaven Pharmaceutical Holding Co. Ltd., of New Haven, Conn., and Genpharm Services FZ-LLC, of Dubai, United Arab Emirates  Nurtec ODT (rimegepant) CGRP receptor antagonist in fast-acting orally disintegrating tablet Acute migraine Approved by United Arab Emirates Ministry of Health and Prevention for use in treating migraine, with and without aura, in adults
Bioxcel Therapeutics Inc., of New York BXCL-501 Orally dissolving thin film formulation of dexmedetomidine Agitation associated with schizophrenia and bipolar disorders I and II Completed rolling submission of NDA to FDA seeking approval for acute treatment
Denali Therapeutics Inc., of South San Francisco ETV:IDS (DNL-310) Brain-penetrant enzyme replacement therapy Hunter syndrome FDA granted fast track designation
Eli Lilly and Co., of Indianapolis Bamlanivimab and etesevimab Therapeutic antibody; COVID-19 spike glycoprotein modulator; COVID-19 spike glycoprotein inhibitor COVID-19 EMA’s Committee for Medicinal Products for Human Use started a rolling review of data for both monotherapy bamlanivimab and combination treatment
Johnson & Johnson, of New Brunswick, N.J. Single-dose COVID-19 vaccine  Vaccine COVID-19 EMA’s Committee for Medicinal Products for Human Use issued a positive opinion to recommend conditional marketing authorization for use in people 18 and older
Kadmon Holdings Inc., of New York Belumosudil Selective oral inhibitor of Rho-associated coiled-coil kinase 2 Chronic graft-vs.-host disease FDA extended the review period for the NDA to allow time to review additional information submitted by Kadmon in response to the agency’s request; PDUFA date now set for Aug. 30, 2021
Longeveron Inc., of Miami Lomecel-B Allogeneic, bone marrow-derived medicinal signaling cell product  Hypoplastic left heart syndrome FDA granted expanded access for administration to child with HLHS
Marius Pharmaceuticals Inc., of Raleigh, N.C. Kyzatrex Oral testosterone undecanoate softgel Primary and secondary male hypogonadism FDA assigned a PDUFA date of Oct. 31, 2021, for review of NDA
Nouscom AG, of Basel, Switzerland NOUS-PEV Personalized cancer immunotherapy Locally advanced melanoma or non-small-cell lung cancer Received approval from the Spanish National Agency of Medicines and Medical Devices to start a phase Ib trial in first-line disease
Nuvation Bio Inc., of New York NUV-422 CDK 2/4/6 inhibitor Malignant gliomas FDA granted orphan designation
Russian Direct Investment Fund, of Moscow Sputnik V COVID-19 spike glycoprotein modulator COVID-19 Registered under emergency use authorization by the Ministry of Health and Social Services of Namibia 
Spectrum Pharmaceuticals Inc., of Henderson, Nev. Poziotinib EGFR tyrosine kinase inhibitor Non-small-cell lung cancer FDA granted fast track designation for use in previously treated patients with HER2 exon 20 mutations

Notes

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