Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Amgen, Astrazeneca, Cogent, Glaukos, Novo Nordisk, Replimune, Salvat, Sanofi, Silver Creek, Xbrane.
Radiopharm Theranostics Ltd. completed a AU$35 million (US$22.77 million) placement to advance six of its radiopharmaceutical candidates for both diagnostic and therapeutic uses. The funds raised will go toward clinical trials, drug manufacturing and working capital to extend Radiopharm’s funding runway into 2027.
Antibody-drug conjugates (ADCs) are a mature technology. The first ADC, Mylotarg, was initially approved in 2000, and there are now 14 approved agents in both leukemias and solid tumors. According to Clarivate’s Cortellis Drug Discovery & Intelligence, those drugs collectively accounted for $13.55 billion in sales in 2024 – a figure that Cortellis projects will rise to $16 billion in 2025.
Detailed Viktoria-1 results of Celcuity Inc.’s gedatolisib positions the pan-PI3K/mTORC1/2 inhibitor as a top contender for second-line treatment of HR+/HER2- PIK3CA wild-type advanced breast cancer – a multibillion-dollar indication in need of new treatments.
Neuphoria Therapeutics Inc.’s phase III study of social anxiety disorder has missed its primary and secondary endpoints, prompting the company to stop the program’s development and hold a full strategic review of its operations and portfolio. It’s the second stumble for lead candidate BNC-210, a negative allosteric modulator of alpha7 nicotinic acetylcholine receptor, in the indication.
Samsung Bioepis Co. Ltd. announced Oct. 21 the signing of a license deal to codevelop, manufacture and commercialize two of Phrontline Biopharma Suzhou Co. Ltd.’s novel bispecific dual-payload antibody-drug conjugate (ADC) candidates.
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