Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Argenx, Bridgebio, Camurus, Eton, Halozyme, Innorna, Innovent, Italfarmaco, Jazz , Junshi, PTC, Purespring, Regeneron, Telix, Valneva.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ante, Galmed, Ferrer, Formosa, Laboratorios Saval, Medicus, Octagon, Prilenia, Spruce.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akeso, Alterity, Boehringer, CG Oncology, Chemomab, Immunitybio, J&J, Levicept, Merck, Oncoinvent, Pfizer, Revolution, Senti, Urogen, Yoltech.

Biopharmas raising money in public or private financings, including: Biohaven, Oramed, Rezolute, Vakona, Verastem.

New hires and promotions in the biopharma industry, including: Aavantgarde, Adagene, Crescent Biopharma, Hervolution, Montai, Nocion, Scholar Rock, Secarna.

Orum Therapeutics Inc. on April 26 pulled the plug on a U.S.-based phase I study of ORM-5029, its lead oncology degrader antibody conjugate (DAC) asset, a decision that came months after the company first reported a patient death in November 2024.

Off-the-shelf cancer vaccine specialist Nouscom AG announced positive final results for its lead product, Nous-209, showing there was a “highly potent” and durable immune response in carriers of Lynch syndrome, a common hereditary condition that can increase the lifetime risk of cancer by as much as 80%. The data, presented at the annual American Association for Cancer Research meeting on April 29, indicate Nous-209 elicits a cancer-preventing effect.

Ono Pharmaceutical Co. Ltd. terminated development of CTX-177 (ONO-7018), its ex-oncology candidate in-licensed from Chordia Therapeutics Inc. in December 2020 for up to ¥52.9 billion (US$370.37 million).

Stealth Biotherapeutics Inc., and, more importantly, patients with Barth syndrome, faced another disappointing delay April 29 when the U.S. FDA kicked its approval decision down the road for Stealth’s elamipretide.