Jul. 31 at 2:28 PM
$CELC
FDA approval (July 14, 2026) covered HR+/HER2- locally advanced or metastatic breast cancer without a PIK3CA mutation, used with fulvestrant ± palbociclib after progression on endocrine therapy. It is the first dual class I PI3K + mTORC1/mTORC2 inhibitor approved in this setting. 
• NCCN Category 1 preferred status is high-signal. NCCN guidelines heavily influence oncologist prescribing, hospital formularies, and payer coverage. Getting listed as preferred Category 1 for second-line (and subsequent) therapy in the PIK3CA wild-type population should accelerate uptake once the drug is commercially available.
• Launch is expected in late Q3 2026, with an expanded access program already in place. Celcuity also plans an sNDA in Q3 for the PIK3CA-mutant population based on the VIKTORIA-1 mutant cohort. 
