Company Product Description Indication Status
Abbvie Inc., of North Chicago Elezanumab (ABT-555) Monoclonal antibody targeting repulsive guidance molecule A Spinal cord injury FDA granted orphan drug designation
Aligos Therapeutics Inc., South San Francisco ALG-000184-201 Class II capsid assembly modulator Hepatitis B virus infection Received approval of a CTA for a phase Ia/Ib study in healthy volunteers and patients
Apollomics Inc., of Foster City, Calif. APL-106 (uproleselan) Inhibitor of E-selectin Relapsed/refractory acute myeloid leukemia Received IND approval from the China National Medical Products Administration for a phase I pharmacokinetics and tolerability study, which includes acceptance of a phase III bridging study of APL-106
Aquestive Therapeutics Inc., of Warren, N.J. Libervant (diazepam) Bucal formulation of the benzodiazepine, diazepam Seizure clusters FDA issued a CRL for the NDA due to certain weight groups having a lower drug exposure level than desired and issues with protocol deviations in blood draws in 1 of the studies
Avrobio Inc., of Cambridge, Mass. AVR-RD-02 Autologous hematopoietic stem cells, genetically modified to express glucocerebrosidase Gaucher disease European Commission granted orphan drug designation
Cipla Ltd., of Mumbai, India Dimethyl fumarate DR Generic of Tecfidera (Biogen Inc.) Multiple sclerosis FDA granted final approval of the abbreviated NDA
CSL Behring, of King of Prussia, Pa. Haegarda C1 esterase inhibitor  Hereditary angioedema prophylaxis  FDA approved the expanded indication for the prevention of hereditary angioedema
FSD Pharma Inc., of Toronto FSD-201 (ultramicronized palmitoylethanolamide) Cannabinoid CB2 modulator COVID-19 infection FDA authorized phase II study, expected to begin in October 2020, in 352 people hospitalized with documented infection
Gilead Sciences Inc., of Foster City, Calif. Jyseleca (filgotinib) JAK1 inhibitor Rheumatoid arthritis Japanese Ministry of Health, Labour and Welfare approved the drug
Glaxosmithkline plc, of London Nucala (mepolizumab) Monoclonal antibody targeting IL-5 Hypereosinophilic syndrome FDA approved the drug
Heron Therapeutics Inc., of San Diego Zynrelef (HTX-011) Anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam Somatic postoperative pain from small- to medium-sized surgical wounds European Commission granted marketing authorization to the drug
Huya Bioscience International LLC, of San Diego HBI-8000 Targets class I histone deacetylase Relapsed or refractory adult T-cell leukemia-lymphoma Japanese Ministry of Health, Labour and Welfare granted orphan drug designation
Inceptua AB, of Luxembourg Jetrea (ocriplasmin) Proteolytic enzyme Symptomatic vitreomacular adhesion or vitreomacular traction European Commission approved the transfer of the marketing authorization form Oxurion NV to Inceptua
Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa. INO-4800 DNA-based vaccine COVID-19 prophylaxis FDA issued a partial clinical hold for the planned phase II/III study
Khondrion BV, of Nijmegen, the Netherlands Sonlicromanol (KH-176) Redox modulator with anti-inflammatory properties  MELAS syndrome FDA issued rare pediatric disease designation
Orchard Therapeutics Inc., of Boston and London OTL-203 Ex vivo autologous hematopoietic stem cell gene therapy  Mucopolysaccharidosis type I EMA granted priority medicines (PRIME) designation
Shionogi & Co. Ltd., of Osaka, Japan Fetroja (cefiderocol) Cephalosporin antibiotic Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia FDA approved the supplemental NDA
Stemedica Cell Technologies Inc., of San Diego itMSC Intravenous allogeneic mesenchymal stem cells Moderate to severe lung injury due to COVID-19 FDA approved the IND for a phase II study
Xcures Inc., of San Francisco, and Biomed Valley Discoveries Inc., of Kansas City, Mo. Ulixertinib (BVD-523) ERK inhibitor Cancer FDA granted IND for intermediate expanded access program open to adolescent and adult cancer patients who cannot access an open clinical trial

Notes

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