Company Product Description Indication Status
Arix Bioscience plc., of London Reltecimod Peptide targeting CD28 Necrotizing soft tissue infection FDA accepted the NDA with a PDUFA target action date of 9/30/2021
Biogen, of Cambridge, Mass., and Eisai Co., Ltd., of Tokyo, Japan Aducanumab Monoclonal antibody targeting amyloid beta Alzheimer’s disease Submitted a Japanese NDA to the Ministry of Health, Labor and Welfare
Bristol Myers Squibb Co., of New York Inrebic (fedratinib) Wild type and mutationally activated janus associated kinase 2 and FMS-like tyrosine kinase 3 inhibitor Primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis Committee for Medicinal Products for Human Use of the EMA recommended approving the drug for patients who are Janus Associated Kinase inhibitor naïve or have been treated with ruxolitinib
Daiichi Sankyo Co. Ltd., of Tokyo Trastuzumab deruxtecan Antibody-drug conjugate targeting HER2 Unresectable or metastatic HER2 positive breast cancer Committee for Medicinal Products for Human Use of the EMA recommended conditional approval the drug for patients who have received two or more prior anti-HER2 based regimens
Dynavax Technologies Corporation, of Emeryville, Calif. Heplisav-B Hepatitis B vaccine Hepatitis B virus infection prophylaxis Committee for Medicinal Products for Human Use of the EMA adopted a positive opinion on the MAA
Excellthera Inc., of Montreal ECT-001 Stem cell product Allogeneic hematopoietic stem cell transplants EMA granted priority medicines designation
Gilead Sciences Inc., of Foster City, Calif. Trodelvy (sacituzumab govitecan-hziy) Trop-2-directed antibody/topoisomerase inhibitor conjugate Breast cancer Based on data from phase III Ascent trial, sBLA submitted to FDA for full approval to treat adults with metastatic triple negative disease who received at least 2 prior therapies
Janssen Pharmaceutical Co., a unit of New Brunswick, N.J.-based Johnson & Johnson Spravato (esketamine)  N-methyl-D-aspartate glutamate receptor antagonist Major depressive disorder Committee for Medicinal Products for Human Use of the EMA recommended expanding use of the drug for psychiatric emergencies
Lexicon Pharmaceuticals Inc., of The Woodlands, Texas LX-9211 Adapter-associated kinase 1 inhibitor Diabetic peripheral neuropathic pain FDA granted fast track designation
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab) Monoclonal antibody targeting PD-1 First line metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer Committee for Medicinal Products for Human Use of the EMA adopted a positive opinion on the expanded indication
Passage Bio Inc., of Philadelphia PBGM-01 Gene therapy delivering the GLB1 gene GM1 gangliosidosis U.K.'s Medicines Healthcare Products Regulatory Agency approved the CTA for the phase I/II Imagine-1; global study expected to start in second quarter of 2021
Sanofi SA, of Paris Plavix (clopidogrel) Inhibits ADP-induced platelet aggregation High-risk transient ischemic attack or minor ischemic stroke Committee for Medicinal Products for Human Use of the EMA adopted a positive opinion on the expanded indication
Seagen Inc., of Bothell, Wash. Tukysa (tucatinib) HER2 tyrosine kinase inhibitor HER2-positive locally advanced or metastatic breast cancer Committee for Medicinal Products for Human Use of the EMA adopted a positive opinion recommending approval of the drug for patients who have received at least 2 prior anti-HER2 treatment regimens
Soleno Therapeutics Inc., of Redwood City, Calif. DCCR Diazoxide choline controlled release Prader-Willi Syndrome Minutes from a type C meeting with the FDA confirmed that data from completed and ongoing studies, together with external, natural history studies can support an NDA filing scheduled for the second half of 2021
Viiv Healthcare, of London Rukobia (fostemsavir) Attachment inhibitor HIV-1 infection Committee for Medicinal Products for Human Use of the EMA adopted a positive opinion recommending approval of the drug 
V2act Therapeutics LLC, of San Diego V2ACT Oncolytic immunotherapy and a vaccine-enhanced adoptive cell therapy Newly diagnosed surgically-resectable pancreatic cancer FDA cleared an IND for a phase I/IIa study
Xeris Pharmaceuticals Inc., of Chicago Ogluo (glucagon) Peptide hormone Severe hypoglycemia in diabetes mellitus Committee for Medicinal Products for Human Use of the EMA adopted a positive opinion recommending approval of the drug 

Notes

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