Company Product Description Indication Status
Blueprint Medicines Corp., of Cambridge, Mass. Ayvakyt (avapritinib)  D816V mutant KIT inhibitor Mastocytosis  EMA validated type II variation MAA to treat advanced systemic disease
Dialectic Therapeutics Inc., of Dallas DT-2216 Bcl-xL Bcl-2 associated death promotor inhibitor Metastatic solid tumors FDA cleared IND application for phase I trial, expected to begin in first half of 2021
Exicure Inc., of Chicago Cavrotolimod (AST-008) TLR9 agonist Merkel cell carcinoma FDA granted orphan drug designation
Exithera Pharmaceuticals Inc., of Westborough, Mass. EP-7041 Factor XIa inhibitor Thrombosis FDA cleared IND application for phase II trial to prevent blood clot formation in people critically ill with COVID-19
Idorsia Ltd., of Allschwil, Switzerland Daridorexant Dual orexin receptor antagonist Insomnia MAA submitted to EMA for treatment of adults
Kempharm Inc., of Celebration, Fla. Azstarys (serdexmethylphenidate and dexmethylphenidate, formerly KP-415) Alpha 2 adrenoceptor agonist Attention deficit hyperactivity disorder FDA approved to treat people 6 and older
Oblato Inc., of Princeton, N.J., subsidiary of Gtreebnt Co. Ltd., of Seongnam, South Korea OKN-007 (disufenton sodium) Sulfatase inhibitor Diffuse intrinsic pontine glioma FDA granted fast track designation
On Target Laboratories Inc., of West Lafayette, Ind. Pafolacianine Folate receptor modulator Ovarian cancer FDA accepted NDA and granted priority review as adjunct to identify cancer during surgery
Russian Direct Investment Fund (RDIF), of Moscow Sputnik V COVID-19 spike glycoprotein modulator COVID-19 infection Vaccine approved by regulatory authorities of Republic of Angola, Republic of the Congo and Republic of Djibouti
Shanghai Junshi Biosciences Co. Ltd., of Shanghai Toripalimab Anti-PD-1 monoclonal antibody Nasopharyngeal carcinoma Initiated rolling BLA submission to FDA to treat recurrent or metastatic disease
Saniona AB, of Copenhagen, Denmark  Tesomet (tesofensine + metoprolol) Beta 1 adrenoceptor antagonist Prader-Willi syndrome FDA granted orphan drug designation
Sorrento Therapeutics Inc., of San Diego STI-2099 (intranasal COVIDROPS) Gene-encoded anti-SARS-CoV-2 antibodies  COVID-19 infection FDA cleared IND for phase I study in healthy volunteers and people with mild infection
Wellmarker Bio Co. Ltd., of Seoul, South Korea WM-S1-030 Tyrosine kinase receptor inhibitor Colorectal and progressive cancer Australian Therapeutic Goods Administration cleared phase Ia/Ib trial to enroll 100 people with advanced disease
Xentria Inc., of Chicago XTMAB-16 TNF-alpha inhibitor Sarcoidosis IND for phase I trial submitted to FDA

Notes

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