Topline phase 3 VIKTORIA-1 results showed gedatolisib combinations improved progression-free survival versus alpelisib plus fulvestrant in PIK3CA-mutant HR-positive/HER2-negative advanced breast cancer. Celcuity plans a supplemental FDA filing based on the data.
Novartis will acquire Pikavation Therapeutics for up to $3 billion to gain its PI3Kα inhibitor programs, led by SNV4818 for metastatic breast cancer. The deal includes $2 billion upfront and up to $1 billion in milestones, with completion expected in first half 2026. SNV4818 is designed to selectively target mutated PI3Kα while sparing healthy cells.
Whole genome sequencing, comprehensive genomic profiling, and spatial multiomics are transforming precision medicine from research tools to clinical applications in oncology, rare diseases, and neonatal care, enabling faster diagnoses and personalized treatments.
MoonLake Immunotherapeutics says FDA feedback indicates sufficient data to support a U.S. BLA for hidradenitis suppurativa without additional efficacy trials, while Relay Therapeutics received FDA Breakthrough Therapy designation for zovegalisib in combination with fulvestrant for PIK3CA-mutant breast cancer.
An international research team has conducted the first comprehensive genetic study of cancer in domestic cats, identifying genetic changes that closely resemble those in human cancers and opening new perspectives for targeted therapies.
The FDA has accepted Celcuity's New Drug Application for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer, granting Priority Review with a PDUFA goal date of July 17, 2026.
