Celcuity (CELC) Jefferies Global Healthcare Conference 2026 summary

Company overview and recent developments

• Focused on developing therapies targeting the PI3K/AKT/mTOR pathway, with lead candidate gedatolisib acquired from Pfizer after initial platform research.

• Two phase III readouts in second-line breast cancer and ongoing phase III studies in frontline advanced breast cancer and early phase prostate cancer.

Clinical trial results and efficacy insights

• Recent 3-arm trial showed both doublet and triplet regimens with gedatolisib achieved over 11 months median PFS, doubling progression-free survival likelihood versus control.

• Hazard ratios for efficacy were around 0.5, outperforming internal and external expectations.

• Objective response rates were higher with the triplet (50%) versus doublet (36%), with strong duration of response.

• Baseline differences, such as prior CDK4/6 exposure and higher tumor burden, influenced results compared to earlier phase studies.

Regulatory and commercialization plans

• Priority review ongoing with PDUFA date set for July 17; breakthrough designation enabled proactive FDA engagement and risk mitigation.

• Commercial team fully built out, sales force trained and profiling physicians ahead of launch.

• Initial 90-day launch milestones include payer dossier submissions, NCCN engagement, and physician outreach targets.