Company Product Description Indication Status
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

Notes

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

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