|Cytodyn Inc., of Vancouver, Wash.||Leronlimab||CCR5 chemokine antagonist||Metastatic triple-negative breast cancer||Company requested meeting with FDA to discuss potential filing for breakthrough therapy designation|
|Gracell Biotechnologies Co. Ltd., of Shanghai||GC-007g||B-lymphocyte antigen CD19 modulator||B-cell acute lymphoblastic leukemia||China's NMPA accepted IND application to initiate phase I study in individuals with CD19-positive relapsed/refractory disease, expected to begin in second quarter of 2020|
|I-Mab Biopharma Co. Ltd., of Shanghai||TJM-2||GM-CSF ligand inhibitor||COVID-19 infection||FDA cleared IND application for phase I study assessing treatment of cytokine release syndrome associated with severe infection; Western Institutional Review Board also provided approval; 3-arm study evaluating effect on reducing severity of complications and levels of multiple cytokines|
|Iveric Bio Inc., of New York||Zimura (avacincaptad pegol)||Complement C5 inhibitor||Geographic atrophy||FDA granted fast track designation to treat GA secondary to dry age-related macular degeneration|
|Novan Inc., of Morrisville, N.C.||SB-206 (berdazimer sodium)||Nitric oxide-releasing macromolecule||Molluscum contagiosum infection||During type C meeting, FDA said it will consider 1 additional pivotal trial (B-Simple4) as confirmatory study of B-Simple2 and provided guidance on trial design and expectations for potential NDA submission|
|Revive Therapeutics Ltd., of Toronto||Bucillamine||Xanthine oxidase inhibitor||COVID-19 infection||Filed pre-IND meeting request with FDA seeking permission to proceed to phase II study in indication|
For more information about individual companies and/or products, see Cortellis.