Company Product Description Indication Status
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

Notes

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

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