Company Product Description Indication Status
Abivax SA, of Paris ABX-464 Small-molecule antiviral COVID-19 Received clearance from National Agency for the Safety of Medicines (ANSM) and French Ethics Committee to initiate phase IIb/III trial to prevent severe inflammation that leads to acute respiratory distress syndrome in 1,034 COVID-19 elderly or high-risk patients (miR-AGE trial)
Aim Immunotech Inc., of Ocala, Fla. Ampligen (rintatolimod) Immunomodulatory drug Cancer patients with COVID-19 FDA authorized phase I/IIb trial assessing combination with interferon alfa-2b
Cellphire Inc., of Rockville, Md. Thrombosomes Platelet-based freeze-dried hemostatic Acute radiation syndrome FDA granted orphan designation
Enzychem Lifesciences Inc., of Englewood, N.J. EC-18 Small molecule Preventing acute respiratory distress syndrome due to COVID-19 pneumonia Korea’s Ministry of Food and Drug Safety accepted the IND for a phase II study
Immunic Inc., of New York IMU-838 Oral DHODH inhibitor COVID-19 Germany’s BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) cleared firm to initiate phase II trial, expected to enroll 230 patients with moderate COVID-19; top-line data expected later this year
Nordic Nanovector ASA, of Oslo, Norway Betalutin (177Lu lilotomab satetraxetan) Antibody-radionuclide conjugate Marginal zone lymphoma Received positive opinion from EMA on orphan designation
Pharmazz Inc., of Willowbrook, Ill. Lyfaquin (centhaquine) Hypotensive drug Hypovolemic shock Indian regulators granted marketing authorization
Restem LLC, of Corona, Calif. Umbilical cord mesenchymal stem cells Umbilical cord mesenchymal stem cells COVID-19 FDA cleared start of 60-patient phase I/IIa study in patients with severe cases
Sanofi SA, of Paris Sutimlimab Monoclonal antibody designed to inhibit complement C1s Cold agglutinin disease FDA granted priority review of BLA; target action date of Nov. 13, 2020
Scimount Pharmatech Co. Ltd., of Chengdu, China SMP-100 Selective serotonin receptor-3 partial agonist Irritable bowel syndrome with diarrhea FDA approved IND for a phase I trial in healthy volunteers
Seattle Genetics Inc., of Bothell, Wash., and Takeda Pharmaceutical Co. Ltd., of Osaka, Japan Adcetris (brentuximab vedotin) Antibody-drug conjugate directed to CD30 Systemic anaplastic large-cell lymphoma European Commission extended conditional marketing authorization to include treatment of adults with previously untreated disease, in combination with CHP (cyclophosphamide, doxorubicin, prednisone)
Verona Pharma plc, of London Nebulized ensifentrine PDE3/4 inhibitor Chronic obstructive pulmonary disease Received written comments from FDA in response to end-of-phase II briefing package for drug as maintenance treatment, which supports company’s plan for phase III program, expected to start later in 2020
Zealand Pharma A/S, of Copenhagen Dasiglucagon Hypopal rescue pen Peptide analogue of human glucagon Severe hypoglycemia Filed NDA with FDA

Notes

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

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