Delta-Fly Pharma Inc. is pressing ahead with discussions with the FDA for its lead acute myeloid leukemia (AML) candidate, radgocitabine (DFP-10917), despite a phase III miss on its primary endpoint, instead leaning on earlier-stage efficacy signals and emerging combination data to support a potential path toward conditional approval.

The U.S. FDA has accepted and granted priority review to Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s BLA of ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate (ADC) to treat patients with advanced extensive-stage small-cell lung cancer.

Xuanzhu Biopharmaceutical Co. Ltd. reported positive data from a local phase III study of dirozalkib (Xuan Fei Ning), an ALK inhibitor approved in China to treat patients with advanced non-small-cell lung cancer.

Following its 2022 debut on Shanghai’s STAR Market, Mabwell (Shanghai) Bioscience Co. Ltd. is aiming to raise up to HK$1.44 billion (US$184.78 million) in an IPO on the Hong Kong Stock Exchange to advance its Nectin4-targeting antibody-drug conjugate (ADC) 9MW-2821 (bulumtatug fuvedotin).

A pricing standoff between Pfizer Inc. and the Australian government has left women with advanced breast cancer facing tens of thousands of dollars in out-of-pocket costs, underscoring a growing global trend in which access to life-extending drugs is increasingly being shaped by pricing negotiations rather than clinical merit.

“Single drugs targeting single biological pathways are insufficient for complex diseases,” Remedy Cell Ltd. CEO Ayelet Dilion Mashiah told BioWorld. Remedy is taking a secretome-based approach to treat lung disorders, having moved its lead asset, RC-0315, into a first-in-human clinical trial for idiopathic pulmonary fibrosis (IPF) in January.