The news that Vinay Prasad has stepped down as CBER director at the U.S. FDA had some biotech stocks literally jumping in joy as the market opened July 30. Meanwhile, Prasad’s decisions regarding vaccine development, as well as actions by Makary and HHS Secretary Robert Kennedy, are coming under fire.
Radiopharma Clarity Pharmaceuticals Ltd. raised AU$203 million (US$132.22 million) in an institutional placement on Australia’s Securities Exchange to advance its late-stage pipeline of copper-based radiopharmaceuticals.
Chinese financings are picking up, with Everest Medicines Ltd. raising US$200 million and Nanjing-based Leads Bioloabs Co. Ltd. listing on the main board of the Hong Kong Stock Exchange in a $189 million IPO.
Hengrui Pharmaceuticals Co. Ltd. is out-licensing to GSK plc its potential best-in-class phase I phosphodiesterase 3 and 4 inhibitor (HRS-9821) for treating chronic obstructive pulmonary disease along with 11 additional programs in development for $500 million up front and up to $12 billion in potential milestones.
With more-than-satisfying phase III data in hand, Minneapolis-based Celcuity Inc. is eyeing an NDA submission in the fourth quarter of this year for gedatolisib (geda) in breast cancer. Shares of the company (NASDAQ:CELC) closed July 28 at $36.79, up $23.02, or 167%, after Wall Street learned of stellar top-line results from the PIK3CA wild-type cohort of the phase III Viktoria-1 trial.
Researchers at the Fred Hutchinson Cancer Research Center found that autoantibodies targeting the exoproteome reshaped checkpoint inhibitor responses and opened new avenues to enhance immunotherapy. In the study published in the July 23, 2025, issue of Nature, the authors set out to address a long-standing question in cancer immunotherapy: why patients with the same type of cancer, treated with the same immunotherapy, can experience such drastically different outcomes.
Current treatments for Alzheimer’s disease have limited effects. While they can slow cognitive decline or alleviate symptoms, they do not reverse this complex neurodegenerative condition caused by multiple factors. Researchers from the Gladstone Institutes and the University of California, San Francisco (UCSF) have screened FDA-approved drugs in search of agents that could potentially modify the disease.
Amplia Therapeutics Ltd. is raising AU$27.5 million (US$18.12 million) to advance lead compound narmafotinib (AMP-945), a focal adhesion kinase (FAK) inhibitor, into new indications beyond pancreatic cancer.
Dispatch Biotherapeutics Inc. is taking aim at solid tumors with a new viral vector/antigen technology backed by major industry names such as Arch Venture Partners and Bristol Myers Squibb Co. With offices in Philadelphia and San Francisco, Dispatch has raised $216 million since its founding in 2022. The firm’s platform delivers a cell-specific viral vector carrying a novel, universal antigen called Flare that tags solid, epithelial-derived tumor cells. Acting as a beacon, the Flare antigen directs the immune system to find and clear the cancer cells without harming healthy tissue.
There are a raft of problems the U.S. FDA wants resolved before Replimune Group Inc.’s BLA for RP-1 (vusolimogene oderparepvec) with nivolumab to treat advanced melanoma goes any further, all of which the company said are a surprise.
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