• Firmonertinib shows potential in EGFR PACC mutant NSCLC in Phase 1b update.
• Phase 3 ALPACCA study expected to enroll first patient in 2H 2025.
• First patient dosed in Phase 1 Study for ARR-217 (MRG007) in gastrointestinal tumors.
• Top-line firmonertinib data from FURVENT Phase 3 study projected in early 2026.
• Cash and investments of $254.5 million as of June 30, 2025.
• Additional $81.1 million raised in public offering in July 2025.
• Expected to fund operating plan to mid-2027.
ArriVent BioPharma, Inc. (Nasdaq: AVBP) announced significant progress in its clinical pipeline, particularly for its lead candidate, firmonertinib, in treating EGFR PACC mutant NSCLC. The company reported positive interim Phase 1b results for firmonertinib monotherapy in NSCLC patients with EGFR PACC mutations, demonstrating clinically meaningful progression-free survival, CNS complete responses, and a manageable safety profile [1].
In addition to the Phase 1b update, ArriVent is preparing to enroll the first patient in its global pivotal Phase 3 ALPACCA study in the second half of 2025. This study is designed to evaluate first-line firmonertinib monotherapy for the treatment of PACC mutant NSCLC with potential for both accelerated and full approval [1].
Further advancements in ArriVent's ADC pipeline include the dosing of the first patient in the Phase 1 study for ARR-217 (MRG007), a CDH17-targeted ADC in gastrointestinal tumors, by its partner Lepu Biopharma Co., Ltd. [1].
Top-line firmonertinib data from the global pivotal FURVENT Phase 3 study for first-line EGFR exon 20 insertion mutant NSCLC is projected to be available in early 2026. This study aims to assess the safety and efficacy of firmonertinib compared to platinum-based chemotherapy with pemetrexed [1].
As of June 30, 2025, ArriVent had cash and investments totaling $254.5 million. The company recently raised an additional $81.1 million in a public offering, which will fund its operating plan through mid-2027 [1].
References:
[1] https://www.globenewswire.com/news-release/2025/08/11/3130840/0/en/ArriVent-BioPharma-Reports-Second-Quarter-2025-Financial-Results.html
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