|Agios Pharmaceuticals Inc., of Cambridge, Mass.||Mitapivat||Pyruvate kinase stimulator||Thalassemia||FDA granted orphan drug designation|
|Global Blood Therapeutics Inc., of South San Francisco||Oxbryta (voxelotor)||Hemoglobin alpha subunit modulator||Sickle cell disease||Following type B meeting with FDA, company plans to submit NDA for age-appropriate formulation to treat 4- to 11-year-olds under accelerated approval pathway|
|Immune Therapeutics Inc., of Winter Park, Fla.||CYTO-201 (metenkefalin)||Immunotherapy||COVID-19 infection||Partner and former subsidiary Cytocom Inc. submitted IND application to FDA for open-label phase II study to assess CYTO-201 as adjunct to standard of care to mitigate disease progression|
|Immunic Inc., of New York||IMU-838 (vidofludimus)||Dihydroorotate dehydrogenase inhibitor||COVID-19 infection||FDA authorized initiation of phase II Calvid-1 trial at U.S. sites|
|Immuron Ltd., of Melbourne, Australia||Undisclosed||Undisclosed||Acute infectious diarrhea||Research collaborator U.S. DoD Naval Medical Research Center requested pre-IND meeting with FDA on phase II development of oral therapeutic targeting Campylobacter and E. coli-based infections; IND application expected later this year, with 2 studies to commence during first half of 2021|
|Revive Therapeutics Ltd., of Toronto||Bucillamine||Cysteine derivative||COVID-19||Pre-CTA meeting with Health Canada provided guidance for proposed clinical study design and information required for CTA submission; company aims to file IND with FDA in June 2020, followed by CTA in Canada for phase III study|
|Saniona AB, of Copenhagen||Tesomet (tesofensine + metoprolol)||Beta 1 adrenoceptor antagonist||Prader-Willi syndrome||During pre-IND meeting, FDA endorsed proposed filing via 505(b)2 pathway and indicated agreement on proposed design, doses and duration of potential phase IIb trial|
For more information about individual companies and/or products, see Cortellis.