Record mula sa primary source
MateryalNaisumite ang aplikasyon
Plano ng Candel na magsumite ng BLA sa Q4 2026 para sa aglatimagene sa kanser sa prostate
Inihayag ng kumpanya na isinusulong nito ang mga aktibidad sa paghahanda bago ang BLA, kasama ang CMC process validation, at plano nitong magsumite ng BLA para sa aglatimagene besadenovec sa localized, intermediate- to high-risk prostate cancer sa Q4 2026. Ang timeline ng pagsusumite ay sinusuportahan ng naunang publikasyon ng pivotal Phase 3 data sa The Lancet Oncology at extended follow-up data na ipinakita sa AUA 2026.
Mahahalagang fact
- Na-file
- Ago 13, 2026, 12:15 PM
- Kaganapan
- Naisumite ang aplikasyon
- Direksyon
- Positibo
- Kumpanya
CADLCandel Therapeutics- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
Sipi mula sa source
EX-99.1 2 cadl-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Candel Therapeutics Reports Second Quarter 2026 Financial Results and Recent Corporate Highlights • Planning to submit a Biologics License Application (BLA) for aglatimagene besadenovec (aglatimagene) in localized, intermediate- to high-risk prostate cancer in Q4 2026 • Pivotal phase 3 clinical data published in The Lancet Oncology demonstrated a statistically significant improvement in disease-free survival with aglatimagene plus standard-of-care radiotherapy compared with radiotherapy alone in patients with localized, intermediate- to high-risk prostate cancer • Presented supportive clinical data from extended follow-up of the phase 3 clinical trial of aglatimagene in patients with localized, intermediate- to high-risk prostate
Higit pa tungkol sa asset na ito
Decision-grade
Hun 2, 2026
12:05 PM
CADLCandel Therapeutics