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.
Shanghai Junshi Biosciences Co. Ltd reported early clinical signals across its next-generation immuno-oncology pipeline, including response rates of up to 71% in metastatic colorectal cancer and 45.5% in hepatocellular carcinoma, at the American Association for Cancer Research meeting in San Diego.
Biogen Inc. has consolidated full global rights to felzartamab through an $850 million deal with TJ Biopharma Co. Ltd. April 20, closing the chapter on a complex 10-year license saga.
Mayo Foundation for Medical Education Research (MFMER) and the University of Minnesota have disclosed new bromodomain-containing protein 4 (BRD4; HUNK1) inhibitors potentially useful for the treatment of cancer, inflammatory and cardiovascular disorders.
Selective inhibition of Werner syndrome helicase (WRN) has been shown to trigger extensive DNA damage and cell death specifically in microsatellite instability-high (MSI-H) cancers, highlighting WRN as a tumor-selective target with potential for precision oncology approaches beyond immunotherapy. Researchers from Eikon Therapeutics Inc. presented the preclinical profile of EIK-1005, a WRN inhibitor.
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