Company Product Description Indication Status
Algo Therapeutix SAS, of Suresnes, France ATX-01 Topical amitriptyline Erythromelalgia  FDA granted orphan designation
Arch Biopartners Inc., of Toronto Metablok  LSALT peptide Acute organ inflammation and injury in patients with COVID-19 Submitted an IND for a phase II study to the FDA
CASI Pharmaceuticals Inc., of Rockville, Md. CID-103 Monoclonal antibody targeting CD38 Multiple myeloma Submitted a CTA for a phase I study to the U.K.'s Medicines and Healthcare Products Regulatory Agency
Cytodyn Inc., of Vancouver, Wash. Leronlimab (PRO-140) CCR5 antagonist Highly treatment-experienced HIV patients Company expects to receive a PDUFA action date from the FDA on July 10
Enochian Biosciences Inc., of Los Angeles ENOB-HV-01 Genetically modified autologous stem cell HIV infection Company had an initial targeted engagement for regulatory advice meeting with the FDA
Heat Biologics Inc., of Durham, N.C. PTX-35 Agonist antibody targeting TNFRSF25 Solid tumors FDA cleared the IND for a phase I study
Helsinn Healthcare SA, of Lugano, Switzerland, and Taiho Pharmaceutical Co. Ltd., of Tokyo TAS-0953/HM-06 RET inhibitor Advanced solid tumors with RET gene abnormalities FDA cleared the IND for a phase I/II study; plans to start study in the third quarter of 2020
Insmed Inc., of Bridgewater, N.J. Brensocatib (INS-1007) Dipeptidyl peptidase 1 inhibitor Non-cystic fibrosis bronchiectasis FDA granted breakthrough therapy designation
Kiniksa Pharmaceuticals Ltd., of Hamilton, Bermuda Mavrilimumab Monoclonal antibody targeting granulocyte macrophage colony-stimulating factor receptor alpha Severe COVID-19 pneumonia and hyperinflammation FDA approved the IND for the phase II/III study
Lupin Ltd., of Zug Switzerland Mexiletine Antimyotonic agent Myotonic disorders FDA granted orphan drug designation
Sound Pharmaceuticals Inc., of Seattle SPI-1005 (ebselen) Glutathione peroxidase stimulator  Meniere's disease FDA approved the IND for the pivotal phase III STOPMD-3 study


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

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