Lead Drug Firmonertinib Misses Primary Endpoint in Phase 3 FURVENT Trial
AVBP sits 69% above its 52-week low of $17.
Summary
ArriVent's lead drug candidate firmonertinib failed its pivotal Phase 3 FURVENT trial in first-line EGFR exon 20 insertion mutant NSCLC, missing the primary endpoint of progression-free survival. The company is evaluating next steps for the asset. ArriVent shares plunged 54% to $13, on pace for its largest single-day decline on record.
Updated with a Dow Jones Newswires report · What changed
Updates
· Dow Jones Newswires — ArriVent shares plunged 54% to $13, on pace for its largest single-day decline on record.
- A lower dose of firmonertinib resulted in median progression-free survival of 8.4 months.
Key Events · Product Development and Regulatory · AVBP
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New · · Dow Jones Newswires
ArriVent Shares Plunge 54%
ArriVent shares plunged 54% to $13, on pace for its largest single-day decline on record.
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Updated · · Dow Jones Newswires
Phase 3 FURVENT Trial Misses Primary Endpoint
Firmonertinib 240mg showed median PFS of 11.0 months vs 9.5 months for chemotherapy by BICR (HR 0.75, 95% CI 0.55-1.02, p=0.0654), failing to reach statistical significance. A lower dose of firmonertinib resulted in median progression-free survival of 8.4 months.
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Secondary Endpoints Show Mixed Results
Confirmed ORR by BICR was 60% for 240mg vs 33% for control, and investigator-assessed PFS favored firmonertinib (11.1 vs 7.1 months, HR 0.61), but these did not rescue the primary endpoint miss.
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Development Path Under Review
CEO Bing Yao stated the company is evaluating the full FURVENT dataset to determine the most appropriate development path for firmonertinib, creating uncertainty about the lead asset's future.
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Safety Profile Consistent with Prior Studies
No new safety signals identified; Grade ≥3 treatment-related adverse events were 26% (240mg) and 22% (160mg) vs 40% for control.
Analysis · AVBP · Life Sciences
The Phase 3 FURVENT trial of firmonertinib, ArriVent's lead development candidate, failed to meet its primary endpoint of progression-free survival by blinded independent central review in first-line EGFR exon 20 insertion mutant NSCLC. The 240mg dose showed a median PFS of 11.0 months versus 9.5 months for chemotherapy (HR 0.75, p=0.0654), which did not reach statistical significance. A lower dose of firmonertinib resulted in median progression-free survival of 8.4 months. This is a thesis-altering event for a clinical-stage company whose valuation is largely tied to firmonertinib's prospects. The company is now evaluating the full dataset to determine the development path forward, creating significant uncertainty about the asset's future. The failure comes despite firmonertinib's prior FDA Breakthrough Therapy Designation and approval in China for other EGFR mutations. ArriVent shares plunged 54% to $13, on pace for its largest single-day decline on record.
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In the 30 days to Oct 22, 2026, 46.1% of the 284 measured filings Wiseek scored 9 moved their stock by 5% or more by the next session's close. The median move was -0.53%. These are measured outcomes after filings of this importance, not a forecast for this one.
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At the time of this filing, AVBP was trading at $28.70 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.4B. The 52-week trading range was $17.00 to $35.83. This filing was assessed with negative market sentiment and an importance score of 9 out of 10.