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NEWTOWN SQUARE, Pa. - ArriVent BioPharma, Inc. (NASDAQ:AVBP), a clinical-stage biopharmaceutical company with a market capitalization of $805 million, announced Monday that topline data from its global pivotal Phase 3 FURVENT study of firmonertinib in first-line EGFR exon20 insertion mutant non-small cell lung cancer (NSCLC) is expected in early 2026. Wall Street analysts maintain a strong buy consensus with price targets ranging from $33 to $45.
The company completed enrollment for the trial in the first quarter of 2025, with 398 patients recruited across sites in the United States, Europe, and parts of Asia including Japan and China.
The FURVENT study is evaluating firmonertinib, administered at either 160 mg or 240 mg once daily, compared to platinum-based chemotherapy with pemetrexed, which is the current first-line standard of care. The primary endpoint will assess progression-free survival by blinded independent central review.
Firmonertinib has received FDA Breakthrough Therapy Designation for the treatment of previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon20 insertion mutations. The drug was also granted Orphan Drug Designation for NSCLC with EGFR, HER2, or HER4 mutations.
The oral EGFR inhibitor is designed to target both classical and uncommon EGFR mutations. It was previously approved in China in March 2021 for first-line advanced NSCLC with certain EGFR mutations and for previously treated patients with EGFR T790M mutation.
EGFR exon20 insertion mutations constitute approximately 9% of all EGFR mutations in NSCLC patients, according to the press release statement. The company noted that patients with uncommon EGFR mutations have significantly lower life expectancy with available therapies.
ArriVent is also studying firmonertinib in a global Phase 3 trial for first-line NSCLC patients with EGFR PACC mutations and in a clinical combination study targeting advanced or metastatic NSCLC patients with EGFR classical mutations.
In other recent news, ArriVent BioPharma has announced a $75 million public offering of common stock and pre-funded warrants, with Goldman Sachs, Citigroup, and Guggenheim Securities serving as joint book-running managers. The proceeds are intended to support the development of firmonertinib and other pipeline programs. ArriVent also reported follow-up data from its Phase 1b FURTHER trial, demonstrating a 16-month median progression-free survival for patients treated with firmonertinib at a 240 mg dose in non-small cell lung cancer (NSCLC) with EGFR PACC mutations. The trial showed significant central nervous system activity, with a 41% complete response rate. Additionally, Goldman Sachs resumed coverage of ArriVent BioPharma with a Buy rating, citing a high probability of competitive clinical efficacy in its Phase 3 FURVENT trial. Clear Street maintained its Buy rating and $32 price target on ArriVent, despite the approval of a competitor’s drug. H.C. Wainwright also reiterated its Buy rating, highlighting strong trial data for firmonertinib. These developments underscore ArriVent’s ongoing efforts in advancing its cancer treatment pipeline.
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