- Celcuity Inc (NASDAQ:CELC) concluded two formal meetings with the FDA to obtain their feedback on the gedatolisib Phase 3 trial in the breast cancer setting.
- The study dubbed VIKTORIA-1 will evaluate gedatolisib combined with fulvestrant with or without palbociclib in HR+/HER2- advanced breast cancer.
- The trial will include adult patients whose disease has progressed after prior CDK4/6 therapy combined with an aromatase inhibitor.
- The clinical trial will enroll subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Up to 351 subjects who are PIK3CA WT and Up to 300 subjects who are PIK3CA MT will be enrolled.
- The primary endpoints for this pivotal study are progression-free survival (PFS). The primary PFS endpoints will be evaluated separately in PI3KCA WT and PI3KCA MT subjects.
- Celcuity expects to initiate the clinical trial in 1H of 2022.
- At the end of 2021, Celcuity held cash and cash equivalents of $84.3 million.
- Price Action: CELC shares closed 1.83% lower at $8.04 on Wednesday.
