|Aurinia Pharmaceuticals Inc., of Victoria, British Columbia||Voclosporin||Next-generation calcineurin inhibitor||Lupus nephritis||Initiated rolling NDA to FDA; expects to complete submission by end of the second quarter of 2020|
|Cytodyn Inc., of Vancouver, Wash.||Leronlimab (PRO-140)||CCR5 antagonist||COVID-19||Filed modified IND and protocol for phase II trial for patients who experience respiratory complications as result of contracting COVID-19|
|Eli Lilly and Co., of Indianapolis||Baricitinib||Oral JAK inhibitor||Alopecia areata||FDA granted breakthrough therapy designation|
|Kadmon Holdings Inc., of New York||KD-025||ROCK2 inhibitor||Chronic graft-vs.-host disease||Held pre-NDA meeting with FDA and anticipates receiving final minutes within next 30 days; remains on track to complete NDA submission in fourth quarter of 2020|
|Tracon Pharmaceuticals Inc., of San Diego||Envafolimab||Single-domain antibody against PD-L1||Sarcoma||Submitted request for a type B meeting with FDA to discuss the trial design for a potential pivotal study|
|Zai Lab Ltd., of Shanghai||Zejula (niraparib)||PARP inhibitor||Epithelial ovarian, fallopian tube or primary peritoneal cancer||China’s NMPA accepted the supplemental NDA for use as maintenance treatment of adults with advanced disease who are in complete or partial response to first-line platinum-based chemotherapy|
For more information about individual companies and/or products, see Cortellis.