Company Product Description Indication Status
Amryt Pharma plc, of Dublin Filsuvez (AP-101/Oleogel-S10)  Keratinocyte modulator  Junctional and dystrophic epidermolysis bullosa EMA validated the MAA
Antibe Therapeutics Inc., of Toronto Otenaproxesul Anti-inflammatory Osteoarthritis pain FDA cleared the IND for a phase III program
Bristol Myers Squibb Co., of New York Opdivo (nivolumab) Monoclonal antibody targeting PD-1 High-risk muscle-invasive urothelial carcinoma EMA validated the type II variation application for use of Opdivo as an adjuvant to surgical resection
Bristol Myers Squibb Co., of New York, and Bluebird Bio Inc., of Cambridge, Mass. Abecma (idecabtagene vicleucel) CAR T targeting B-cell maturation antigen Relapsed or refractory multiple myeloma  FDA approved the therapy for use in patients after 4 or more prior lines of therapy
Celltrion Group, of Incheon, Korea CT-P59 (regdanvimab) Monoclonal antibody targeting SARS-CoV-2 COVID-19 EMA’s Committee for Medicinal Products for Human Use issued a  positive scientific opinion for use of the drug in patients at high risk of progressing to severe COVID-19
Mezzion Pharma Co. Ltd., of Seoul, South Korea Udenafil  PDE5 inhibitor Single ventricle heart disease after a Fontan operation Resubmitted the NDA to the FDA with a request for a priority review
Mirum Pharmaceuticals Inc., of Foster City, Calif. Maralixibat Apical sodium dependent bile acid transporter Alagille syndrome FDA accepted the NDA and granted a priority review; PDUFA target action date is Sept. 29, 2021
Myovant Sciences Ltd., of Basel, Switzerland, and Pfizer Inc., of New York Relugolix  Gonadotropin-releasing hormone receptor antagonist Advanced prostate cancer EMA validated the MAA
Nymox Pharmaceutical Corp., of Hasbrouck, Heights, N.J. Fexapotide triflutate Pro-apoptotic protein Benign prostatic hyperplasia Plans to file for approval during the summer of 2021; will provide a firm date for the filing within the next 6 weeks
Paion AG, of Aachen, Germany Byfavo (remimazolam) Ultra-short-acting, reversible intravenous benzodiazepine Procedural sedation European Commission approved the drug
Rocket Pharmaceuticals Inc., of Cranbury, N.J. RP-L201 Gene therapy expressing ITGB2 Leukocyte adhesion deficiency-I  EMA granted priority medicines designation
Samsung Bioepis Co. Ltd., of Incheon, Korea, and Merck & Co. Inc., of Kenilworth, N.J. Hadlima (adalimumab) Biosimilar of Humira Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, ulcerative colitis, hidradenitis suppurativa and plaque psoriasis Launched the drug in Australia, following approval
Shanghai Henlius Biotech Inc., of Shanghai HLX10  Monoclonal antibody targeting PD-1 Unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumors Plans to file an NDA with the National Drug Products Administration in China based on positive phase II data
TG Therapeutics Inc., of New York Ublituximab Glycoengineered anti-CD20 monoclonal antibody Chronic lymphocytic leukemia Completed the rolling submission of a BLA to the FDA for ublituximab plus Ukoniq (umbralisib)
Union Therapeutics A/S, of Hellerup, Denmark UNI-91103 Nasal spray of the antihelminthic niclosamide  COVID-19 National Institute for Health Research in the U.K. granted urgent public health prioritization to the Protect-B study
Xenetic Biosciences Inc., of Framingham, Mass. Xcart CAR T targeting neoantigens Non-Hodgkin lymphoma Received approval to start an exploratory patient biopsy study in Eastern Europe

Notes

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