|4D Pharma plc, of Leeds, U.K.||MRx-4DP0004||Live biotherapeutic||COVID-19||Received expedited acceptance from the UK Medicines and Healthcare products Regulatory Agency to start a phase II study|
|Futura Medical plc, of Guilford, U.K.||MED-3000||Volatile solvent||Erectile dysfunction||Filed for a presubmission meeting with the FDA|
|Genentech Inc., of South San Francisco, a unit of Roche Holding AG, of Basel, Switzerland||Ocrevus (ocrelizumab)||Monoclonal antibody targeting CD20||Relapsing or primary progressive multiple sclerosis||FDA accepted the supplemental BLA and the EMA validated the application for a 2-hour infusion, dosed twice yearly|
|Mustang Bio Inc., of New York||MB-107||Lentiviral gene therapy||X-linked severe combined immunodeficiency||EMA granted advanced therapy medicinal product classification|
|Precigen Inc., of Germantown, Md.||PRGN-2009||HPV antigen||Recurrent or metastatic HPV-associated cancers||FDA cleared the IND for a phase I/II study|
For more information about individual companies and/or products, see Cortellis.