Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apogee, Astria, Axsome, Beyondspring, Cassava, Invivyd, Matinas, Syros.

The U.S. FDA granted emergency use authorization (EUA) on March 22 for Waltham, Mass.-based Invivyd Inc.’s half-life extended monoclonal antibody (MAb) VYD-222 – making it available to prevent COVID-19 in immunocompromised adults and adolescents – but its use comes with a boxed warning for anaphylaxis.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boehringer Ingelheim, Cocrystal, Cosmo, CSL Vifor, Deverra, Forge, Hasten, Lib, Orchard, PTC, Revive.

Hyundai Bioscience Corp. is set to become the largest shareholder of ADM Korea Inc., a Seoul, South Korea-based contract research organization (CRO) firm, by purchasing 5.02 million shares for ₩20.4 billion (US$15.5 million) – a 23% stake.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzprotect, Astrocyte, Bavarian Nordic, Clearmind, Cybin, Imunon, Innocare, Pacira, Pepgen, Pfizer, Prilenia, Psyence, Puretech.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akero, Atai, Audion, Avidity, Berlin, Biocardia, Neurogene, Novartis, Nrx, Solascure, Ultimovacs, Vaxcyte, Vivoryon.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akston, CG Oncology, Curadev, Healis, Imunon, Janux, Recce, Tonix, Viking.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aleta, Bioxytran, Cardiol, Enlivex, Immunitybio, Kazia, Lutris, Mabwell, Neurosense, Northsea, Polpharma, Realta, Recode, Rejuvenate, Rhythm, Simcere, Viiv.