As Celcuity Inc. awaits a U.S. FDA approval decision for gedatolisib in HER-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, the company already is setting its sights on a supplemental NDA filing, based on a top-line readout of the multi-target PAM inhibitor in a PIK3CA-mutant breast cancer cohort.
A month ahead of its June 5 PDUFA date, Arvinas Inc.’s vepdegestrant gained U.S. FDA approval for use in a specific type of advanced or metastatic breast cancer, becoming the first proteolysis targeting chimera, or PROTAC, drug to reach the market.
Sonire Therapeutics Inc. initiated a U.S.-based Sunrise II study of Suizenji, its novel ultrasound-guided high-intensity focused ultrasound (HIFU) system designed to ablate pancreatic tumors, after closing an $18 million series A financing round April 15.
Wall Street pundits were divided about the likely fate of ivonescimab, Summit Therapeutics Inc.’s bispecific antibody partnered with Akeso Pharmaceuticals Inc., of Hong Kong, and undergoing phase III testing in first-line squamous non-small-cell lung cancer (NSCLC).
Hypervision Surgical Ltd. raised £17 million (US$23 million) in a series A financing round for its platform technology which combines spectral sensing with cloud-enabled AI analytics, to give surgeons real-time insights into tissue physiology during surgery that were previously impossible to see.
After a standout 2025, the BioWorld Cancer Index (BCI) started 2026 on more measured footing. Early volatility this year saw the BCI drop 11.51% by the end of January before recovering to post a modest 1.39% gain for the first quarter (Q1).
Beone Medicines Ltd. gained an exclusive option to develop cancer immunotherapy HH-160 worldwide in a deal potentially worth more than $2 billion for Huahui Health Ltd., the developer of the trispecific antibody.
Following a discussion that focused more on a new personalized trial strategy rather than the proposed therapy, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3-6 April 30 that Astrazeneca plc’s camizestrant demonstrated a clinically meaningful benefit in treating patients with HR+/HER2- metastatic breast cancer.
Caredx Inc. has agreed to acquire Naveris Inc., a precision oncology diagnostics company, for up to $260 million, as part of its strategy to accelerate growth. The acquisition comes as Caredx, an organ transplant diagnostic firm, reshapes its portfolio, expanding its oncology profile while recently divesting its lab products business.
Innervation by the sympathetic nervous system is typically a boon to tumors. But researchers from Weill Cornell Medicine and colleagues have shown that in some cases, the relationship between tumors and the nervous system is more complex. Depending on context, innervation can either assist or obstruct tumor growth. “The nervous system typically has been considered as a driver of cancer growth, but here we’ve found that it can be a brake on cancer growth in some contexts,” said David Simon, an assistant professor of biochemistry and biophysics at Weill Cornell Medicine.
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