2025-06-05-Jefferies-塞尔库蒂（CELC）_CELC在Jefferies医疗会议第二天——2线转移性乳腺癌3期数据提前至2025年第三季度_9页_131kb

Celcuity (CELC) Equity Research Summary

• Rating: BUY with a $33 price target, representing a 175% upside.

• Market Cap: $515.8M.

• Analyst Certifications: All analysts certify personal views align with reported recommendations.

• Key Research Highlights:

  • VIKTORIA-1 Phase III Trial: On track for a 2L PIK3CAwt HR+ HER2- mBC readout in Q3 2025. Primary endpoints include mPFS and HR for two-pair analyses. OS results are immature.
  • Safety: No protocol modifications or feedback from interim analyses.
  • Regulatory: NDA planned by year-end, with RTOR or priority review targeting mid-2026 approval.
  • Control Arm: VERITAC-2 data suggests a potential control arm PFS upper-bound around 3.6 months, with management expecting performance south of 3 months due to heterogeneity in patient populations.
  • Outlook: At least one active arm is likely outperforming expectations, due timing adjustments and control arm performance.
  • Market Dynamics: Oral SERDs may underperform in the ESR1wt population; injectables might be preferred if efficacy substantially exceeds SOC.

• Additional Data: Prostate cancer data expected by end of Q2 2025.

• Analyst Distribution: 60.53% of ratings are "Buy".