|Adamis Pharmaceuticals Inc., of San Diego||Tempol||Superoxide dismutase modulator||COVID-19||In response to pre-IND filing, FDA provided detailed comments regarding prospective use of Tempol in randomized, placebo-controlled trial; Adamis can proceed to next step of formally submitting IND|
|Kempharm Inc., of Celebration, Fla.||KP-415||Serdexmethylphenidate co-formulated with d-methylphenidate||Attention deficit hyperactivity disorder||At midcycle communication meeting, FDA raised no substantive issues and indicated no major safety concerns noted; PDUFA date of March 2, 2021, was reaffirmed|
|Mesoblast Ltd., of New York||Ryoncil (remestemcel-L)||Culture-expanded mesenchymal stem cells derived from bone marrow of an unrelated donor||Acute graft-vs.-host disease||FDA’s Oncologic Drugs Advisory Committee voted 9-1 that data support efficacy of Ryoncil in pediatric patients with steroid-refractory aGVHD; FDA expected to make decision by Sept. 30, 2020, PDUFA date|
|TLC Biopharmaceuticals Inc., of South San Francisco||TLC-19||Hydroxychloroquine liposome inhalation suspension||COVID-19||Submitted IND to Taiwan FDA|
|Verona Pharma plc, of London||Ensifentrine||CFTR stimulator; PDE 4 inhibitor; PDE 3 inhibitor||COVID-19||Disclosed in second-quarter earnings that FDA cleared IND to proceed with randomized, double-blind, placebo-controlled pilot study to evaluate ensifentrine delivered via pressurized metered-dose inhaler formulation in patients hospitalized with COVID-19|
For more information about individual companies and/or products, see Cortellis.