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.
Cogent Biosciences is preparing parallel FDA submissions for bezuclastinib across three indications following positive pivotal trial results, with potential launches beginning in late 2026 and full commercialization expected by early 2027.
Genmab is moving GEN1106, a SLITRK6-targeting ADC acquired through its $1.8bn ProfoundBio takeover, into phase 1 trials despite several recent discontinuations and the 2017 failure of the only other similar project.
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.
