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ArriVent BioPharma Initiates Phase 3 ALPACCA Trial for Firmonertinib
AVBP
New Projects/Investments
Product Launch
- Arrivent BioPharma (NASDAQ: AVBP) has initiated the global pivotal Phase 3 ALPACCA trial evaluating firmonertinib for the first-line treatment of EGFR PACC mutant non-small cell lung cancer.
- The oral, once-daily therapy previously demonstrated a 16-month median progression-free survival and a 68% confirmed objective response rate in the FURTHER trial.
- The ALPACCA study is designed to support potential global registration, targeting an estimated annual incidence of approximately 42,000 NSCLC patients with EGFR PACC mutations outside of China and 6,200 patients in the US.
4 hours ago
ArriVent BioPharma Provides Updates on Clinical Trials, Financial Position, and New Appointments
AVBP
New Projects/Investments
Guidance Update
Management Change
- ArriVent BioPharma presented final Phase 1b data at the 2025 World Conference on Lung Cancer, demonstrating clinically meaningful outcomes for firmonertinib in EGFR PACC mutant non-small cell lung cancer.
- The company is advancing two global Phase 3 pivotal studies for firmonertinib, with enrollment for the ALPACCA study expected in Q4 2025 and topline data for the FURVENT study projected in early 2026.
- ArriVent reported $305.4 million in cash and investments as of September 30, 2025, supporting operations into mid-2027, and received FDA IND clearance for ARR-217 for gastrointestinal cancers.
Dec 16, 2025, 6:17 PM
ArriVent BioPharma Reports Third Quarter 2025 Financial Results and Pipeline Progress
AVBP
Earnings
New Projects/Investments
Management Change
- ArriVent BioPharma reported a net loss of $34.978 million for the third quarter ended September 30, 2025, and a net loss of $130.764 million for the nine months ended September 30, 2025.
- As of September 30, 2025, the company had $305.4 million in cash and investments, which is anticipated to fund operations into mid-2027.
- The company advanced its pipeline with the presentation of final Phase 1b results for firmonertinib in EGFR PACC mutant NSCLC and received FDA IND clearance for ARR-217, a CDH-17 targeted ADC.
- Upcoming milestones include the expected enrollment of the first patient in the global pivotal Phase 3 trial for PACC mutant NSCLC in Q4 2025 and projected topline data from the global Phase 3 trial in exon 20 insertion mutant NSCLC in early 2026.
- Brent S. Rice was appointed as Chief Commercial Officer in September 2025.
Nov 10, 2025, 1:00 PM
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