Candel berencana mengajukan BLA untuk CAN-2409 pada kanker prostat di Q4 2026

Perusahaan mengumumkan akan mengajukan BLA untuk CAN-2409 pada kanker prostat lokal berisiko menengah hingga tinggi di Q4 2026. Pengajuan ini akan didukung oleh data uji coba fase 3 yang positif yang menunjukkan peningkatan signifikan secara statistik pada DFS spesifik kanker prostat (HR 0.62, p=0.0046) serta aktivitas persiapan CMC dan regulasi yang sedang berlangsung.

Fakta utama

Diajukan: 13 Nov 2025, 13.15
Peristiwa: Permohonan diajukan
Arah: Positif
Perusahaan: CADLCandel Therapeutics
Aset: CAN-2409
Sumber: SEC 8-K
Keyakinan: Bersumber
HR: 0.62
nilai p: 0.0046

Kutipan sumber

EX-99.1 2 cadl-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Candel Therapeutics Reports Third Quarter 2025 Financial Results and Recent Corporate Highlights • Presented new subgroup analyses from phase 3 clinical trial of CAN-2409 in localized prostate cancer at the American Society for Radiation Oncology (ASTRO) 2025 meeting, demonstrating improved prostate cancer-specific disease-free survival (DFS), independent of radiation therapy modality utilized • Company plans to initiate pivotal phase 3 clinical trial of CAN-2409 in patients with metastatic, non-squamous, non-small cell lung cancer (NSCLC) and progressive disease, despite immune checkpoint inhibitor (ICI) treatment, in Q2 2026 • Announced encouraging updated survival data for patients enrolled in its phase 1b clinical trial of CA

SEC 8-K