Just a few weeks after reporting positive data with izicopan (INF-904) in hidradenitis suppurativa and chronic spontaneous urticaria, Inflarx NV is putting most of its chips on the oral complement C5a receptor inhibitor going forward.

The U.S. FDA signaled during a Type B meeting that existing data could support a BLA filing for Moonlake Immunotherapeutics AG’s sonelokimab to treat the skin disease hidradenitis suppurativa (HS), despite one of two pivotal phase III trials missing the mark.

Debate over Vanda Pharmaceuticals Inc.’s Hetlioz (tasimelteon) for use in jet lag disorder looks to continue after the U.S. FDA rejected the latest supplemental NDA submission, with the agency’s Center for Drug Evaluation and Research concluding the application cannot be approved in its current form.

Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Akeso, Arrowhead, Curadel, GSK, Vivavision.

Biopharma happenings, including deals and partnerships, and other news in brief: Basilea, Cidara, Cytora, Daiichi, Evogene, Fibrogen, Genesis, Made Scientific, Merck, Ono, Oramed, Prokaryotics, Relation, Salarius, Scenic Biotech, Scilex Holding, Sidewinder, Synaffix, Unravel, Ventus, Zeo Scientifix.

Clinical updates, including data readouts and publications: Bridgebio, Genfit, Gilgamesh, GSK, Hutchmed, Jazz, JJP Biologics, Monte Rosa, Pulmocide, Rezolute.

Biopharmas raising money in public or private financings, including: Crinetics, Curis, Mediar, Nocion, Oxeia, Palisade, Poplar, Praxis, Rakuten, Soley.

New hires and promotions in the biopharma industry, including: 3T, Archeus, Aspen, Astronautx, Cancervax, Egle, Enliven, Lift, Nuevocor, Oncolytics, Palvella, Realta, Sab, Vaxxas, Viking, Volastra.

Hutchmed Ltd. plans to file a second NDA in China for sovleplenib, a novel spleen tyrosine kinase inhibitor, based on positive phase II/III findings in warm antibody autoimmune hemolytic anemia.