Company Product Description Indication Status
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

Notes

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

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