Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcellera, Adicet, Annexon, Amylyx, Anebulo, Azurrx, Baymedica, Bioarctic, BMS, First Wave, Fujifilm, GT Biopharma, Inmed, Kinnate, Max, MD Anderson, Navrogen, Neuexcell, Polypid, Provention, Provention, Radius, Satellos, Siga, Snipr, SQZ, Telix, Tempest, Tetragenetics, Twist.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diacarta.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Strata Oncology, T2 Biosystems.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alvotech, Apellis, Astrazeneca, Azurx, Cartargia, Cassiopea, Cytodyn, Mersana, Rezolute, Scpharmaceuticals, Senhwa, Sunovion.

Initial efforts at Humanigen Inc. to win an FDA emergency use authorization (EUA) for treating hospitalized COVID-19 patients with its monoclonal antibody, lenzilumab, have failed to gain the regulator's buy-in, sending company shares (NASDAQ:HGEN) down 47.3% to $7.97 on Sept. 9 after touching a 52-week low during the session, a reaction part of a volatile arc that has seen shares climb as high as $29.20 during the same time span.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aim Immunotech, Albireo, Ascendis, Azurrx, Benitec, Biocryst, Boehringer, Clover, Decibel, Eli Lilly, Eloxx, Freeline, GNT, Hibercell, Humanigen, Inflarx, Myovant, Nabriva, Pfizer, Phathom, Sigilon, Sinovac, Sinovant, Soin, Soligenix, Tearclear, Viewpoint, Vor.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affinia, Agentix, Arctic Vision, Benitec, Biocentriq, BMS, Boehringer, Calcimedica, CG Oncology, Clearside, Flamingo, Herantis, Iecure, Ionis, Mindset, Moderna, Nabriva, Nanoform, Neumentum, Precision, Prevail Infoworks, Rhythm, Sen Jam, Telix, Tevogen, Twist, Venturis.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Adlai Nortye, Amgen, Applied Therapeutics, Astrazeneca, Avillion, Azurrx, Biohaven, Calypso, Cardiff, Centessa, Clene, Connect, Cortexyme, Cstone, Denali, Dermavant, Edigene, Ensysce, Erasca, Excalibur, Eyegate, Galera, Gannex, Gensight, Hoth, IGC, Innovent, Inventiva, Isa, Ixaka, Jasper, Kintor, Longboard, Longeveron, Macrogenics, Meiragtx, Metacrine, Novavax, PDS, Resverlogix, Seven and Eight, Sio Gene, Soleno, Stuart, Syros, Telix, Terns, Teva, Wave Life, Xwpharma, Zambon, Zynerba.