Company Product Description Indication Status
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia NP-120 (ifenprodil) NMDA receptor antagonist COVID-19 Received positive feedback from FDA regarding plans to conduct a phase II trial; plans to submit IND to study drug in patients who experience respiratory complications as a result of contracting COVID-19
Arch Therapeutics Inc., of Framingham, Mass. AC5 Topical Hemostat Contains synthetic peptide that self-assembles into a contiguous physical-mechanical seal on tissue Skin wounds FDA granted CE mark authorization for use as a dressing and to control bleeding in skin wounds in both out- and in-patient settings
Arcturus Therapeutics Inc., of San Diego ARCT-810 (Lunar-OTC) mRNA therapeutic Ornithine transcarbamylase deficiency FDA cleared IND for a phase Ib study in OTC patients; New Zealand Medicines and Medical Devices Safety Authority cleared CTA for phase I study in healthy volunteers
Ascletis Inc., of Hangzhou, China ASC-09F Fixed-dose combo of HIV protease inhibitor and ritonavir HIV Received IND approval from China’s NMPA 
Astrazeneca plc, of Cambridge, U.K., and Merck & Co. Inc., of Kenilworth, N.J. Koselugo (selumetinib) MEK1/2 inhibitor Neurofibromatosis type 1 FDA approved for use in pediatric patients, 2 and older, who have symptomatic, inoperable plexiform neurofibromas
Athersys Inc., of Cleveland Multistem Cell therapy COVID-19 FDA authorized start of phase II/III study to assess safety and efficacy in subjects with moderate to severe acute respiratory distress syndrome induced by COVID-19
Beigene Co. Ltd., of Beijing, and Cambridge, Mass. Tislelizumab Anti-PD-1 antibody Urothelial carcinoma China’s NMPA approved for use in patients with locally advanced or metastatic disease with PD-L1 high expression, whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
Can-Fite Biopharma Ltd., of Petach Tikva, Israel Piclidenoson A3 adenosine receptor agonist COVID-19 Received approval at Rabin Medical Center to start pilot study in treatment of moderate to severe symptoms in COVID-19-infected patients
Fennec Pharmaceuticals Inc., of Research Triangle Park, N.C. Pedmark Formulation of sodium thiosulfate Ototoxicity induced by cisplatin chemotherapy FDA accepted for filing and granted priority review to NDA seeking approval for use in preventing ototoxicity in patients 1 month to under 18 years with localized, nonmetastatic solid tumors
Hope Biosciences Inc., of Houston HB-adMSCs Allogeneic, adipose-derived mesenchymal stem cells COVID-19 FDA approved phase II trial to test safety and efficacy in providing immune support against COVID-19
Predictive Biotech, of Salt Lake City, a subsidiary of Predictive Technology Group MSCs Mesenchymal stem cells derived from umbilical cord tissue COVID-19 Submitted emergency use authorization application to FDA for immediate use of MSCs for treating acute respiratory distress syndrome secondary to SARS-CoV-2 disease
Proteostasis Therapeutics Inc., of Boston Dirocaftor, posenacaftor and nesolicaftor  Triple-combination CF therapy Cystic fibrosis Received scientific advice from Dutch Medicines Evaluation Board for Choices personalized medicine-based study in CF
Ridgeback Biotherapeutics LP, of Miami EIDD-2801 Oral direct-acting antiviral nucleoside analogue  COVID-19 U.K.’s Medicines and Healthcare products Regulatory Agency cleared for phase I testing

Notes

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

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