Shares of Veru Inc. hit a 52-week low March 3 after the U.S. FDA declined to grant an emergency use authorization (EUA) for sabizabulin for use in hospitalized adults with moderate to severe COVID-19 who are at high risk for acute respiratory distress syndrome. The decision comes as little surprise, given the negative advisory panel vote in November, but the agency’s wording might suggest potential use for the microtubule disruptor in the future.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Alvotech, Astrazeneca, Checkpoint, Genenta, Intellia, Santhera, Serda, Valneva.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amniotics, Biovie, BMS, Brim, Inovio, Janssen, Organogenesis, Poolbeg, Sanofi, Sobi.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bigfoot Biomedical, Boomerang Medical, Convatec, Cordx, Neuro20.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: 23andme, AB, Ambrx, Atom, Cidara, CSL, Deciphera, Emalex, Imcyse, Iveric, Kancera, Karolinska, Lumos, Merck & Co., Moleculin, PDS, Tachyon.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amo, Asklepios, Biophytis, Glaukos, Orchard, PDS, Priothera, Replimune, Springworks.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Astrazeneca, Beigene, Chiesi, Daiichi Sankyo, Incyte, Janssen, Merck, Protalix, Regeneron, Ridgeback, Servier, Sobi, Timber.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aslan, Astria, Atea, Biocryst, Codexis, Fulcrum, Innocare, Keymed, Merck, Nektar, Nestlé, Orchard, Oscotec, Prilenia, Regenxbio, Tvardi, Werewolf.

Global Health Drug Discovery Institute (GHDDI) has presented 3C-like proteinase (3CLpro) (SARS-CoV-2) inhibitors reported to be useful for the treatment of Middle East respiratory syndrome coronavirus (MERS-CoV), severe acute respiratory syndrome coronavirus (SARS-CoV) and SARS-CoV-2 infections (COVID-19).

Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D Molecular, Accutar, Amicus, Astellas, Cantargia, Denali, Forge, Horizon, Janssen, Pharmaessentia, Regenxbio, Sangamo, Skye, Theratechnologies, Viiv.