AVBP

Topline global pivotal Phase 3 data for firmonertinib in first-line EGFR exon 20 insertion mutant NSCLC expected mid-2026 IND clearance of ARR-002, ArriVent’s dual-targeting MUC16/NaPi2b tetravalent ADC, advances into the clinic and plans to dose its first patient in 2H 2026, initially for ovarian and endometrial cancers ARR-002’s superior anti-tumor activity and favorable tolerability vs. single-target or bivalent approaches in preclinical ovarian cancer models presented at AACR Cash and investments of $326.4 million as of March 31, 2026 expected to fund operations into 4Q 2027 NEWTOWN SQUARE, Pa., May 11, 2026 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today reported financial results for the first quarter ended March 31, 2026, and highlighted recent Company progress. “Our two ongoing pivotal firmonertinib trials in uncommon EGFR-mutant non-small cell lung cancer (NSCLC) continue to advance, with topline monotherapy data for frontline EGFR exon 20 insertion mutations expected in mid-2026 and our global Phase 3 pivotal ALPACCA study continuing to enroll patients globally,” said Bing Yao, CEO of ArriVent. “At American Association for Cancer Research (AACR), we presented preclinical data highlighting the unique structural features of firmonertinib that improve binding and enhance activity against EGFR mutant proteins, further strengthening confidence in the broad activity of firmonertinib in EGFR-mutant NSCLC.” Dr. Yao continued, “We also presented preclinical data for our antibody-drug conjugate (ADC), ARR-002 at AACR. This novel MUC16/NaPi2b dual-targeting tetravalent ADC demonstrated synergistic anti-tumor activity compared to single-target and bivalent ADCs, along with a favorable tolerability profile, supporting its best-in-class potential. Following the recent clearance of our Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA), we plan to initially advance ARR-002 into the clinic for ovarian and endometrial cancers. Our balance sheet continues to be strong with projected cash runway into the fourth quarter of 2027, and we are focused on continued execution across our key registrational catalysts.” First Quarter 2026 and Recent Highlights Firmonertinib New pr...

Topline global pivotal Phase 3 data for firmonertinib in first-line EGFR exon 20 insertion mutant NSCLC expected mid-2026 Global pivotal Phase 3 first-line PACC mutant NSCLC study for firmonertinib enrollment underway ADC pipeline advancing with first ADC program, ARR-217, in Phase 1 clinical development Cash and investments of $312.8 million as of December 31, 2025 expected to fund operations into 3Q 2027 NEWTOWN SQUARE, Pa., March 05, 2026 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today reported financial results for the year ended December 31, 2025, and highlighted recent Company progress. “We are advancing firmonertinib toward potential registration, supported by two pivotal programs targeting uncommon EGFR mutations in non-small cell lung cancer (NSCLC), a high unmet need with limited treatment options,” said Bing Yao, CEO of ArriVent. “Our robust clinical data, including CNS activity, underscores the potential of firmonertinib to become a chemotherapy-free standard of care. We look forward to topline pivotal data for firmonertinib monotherapy in frontline EGFR exon 20 insertion mutant NSCLC expected in mid-2026. This is an event driven study, so we plan to continue sharpening our timeline as we look forward to sharing our data.” Dr. Yao continued, “Our antibody-drug conjugate (ADC) portfolio is also gaining momentum, led by ARR-217, a CDH17-targeted ADC currently in an ongoing Phase 1 trial, with best-in-class potential in gastrointestinal cancers. We expect additional ADC candidates to advance toward the clinic, broadening our pipeline beyond lung cancer into multiple additional solid tumor indications. Backed by a strong balance sheet and a projected cash runway into 3Q 2027, we are well positioned to deliver on our near-term catalysts.” Recent and Full Year 2025 Highlights Firmonertinib Dosed first in patient pivotal ALPACCA study. In December 2025, ArriVent announced dosing of the first patient in the global pivotal Phase 3 ALPACCA study evaluating firmonertinib monotherapy for first-line treatment of epidermal growth factor receptor (EGFR) PACC mutant non-small cell lung cancer (NSCLC) (NCT07185997). Positive final data in EGFR PACC mutant NSCLC. In September 2025, ArriVent presented posit...

Final Phase 1b results presented at World Lung Conference highlight the potential of firmonertinib to address unmet needs in EGFR PACC mutant NSCLC Received FDA IND clearance for ARR-217, a CDH-17 targeted ADC, with ongoing Phase 1 study in China Establised commercial leadership within excutive team with appointment of Brent S. Rice as Chief Commercial Officer Cash and investments of $305.4 million as of September 30, 2025 expected to fund operations into mid-2027 NEWTOWN SQUARE, Pa., Nov. 10, 2025 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (“Company” or “ArriVent”) (Nasdaq: “AVBP”), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today reported financial results for the third quarter ended September 30, 2025, and highlighted recent Company progress. “Our late-stage firmonertinib program continues to make strong progress across EGFR-mutant NSCLC populations, with two global Phase 3 pivotal studies being conducted in uncommon EGFR mutant non-small cell lung cancer (NSCLC). Backed by compelling data in both PACC and exon 20 insertion mutations, firmonertinib consistently shows the potential to address significant unmet needs in these underserved patient populations,” said Bing Yao, CEO of ArriVent. “Following our strong Phase 1b findings, we are advancing to pivotal development with enrollment of the first patient in our global pivotal Phase 3 trial for PACC mutant NSCLC expected in the fourth quarter of this year. Additionally, we project topline pivotal data from our global Phase 3 trial in exon 20 insertion mutant NSCLC in early 2026, a patient population for which firmonertinib received FDA Breakthrough Therapy Designation.” Dr. Yao continued, “Our antibody-drug conjugate (ADC) portfolio is also advancing with our lead candidate ARR-217, a CDH17-targeted ADC with best-in-class potential for the treatment of gastrointestinal cancers, in an ongoing Phase 1 trial. We expect additional ADC programs to progress toward the clinic, expanding our ADC portfolio across multiple solid tumor indications. With a strong balance sheet and projected cash runway into mid-2027, we believe we are well-positioned to deliver on multiple near-term catalysts.” Third Quarter 2025 and Recent Highlights Firmonertinib Final Phase 1b data in EGFR PACC mutant NSCLC. In September 2025, ArriVent presented final pr...

Positive interim Phase 1b update underscores firmonertinib’s potential in EGFR PACC mutant NSCLC; global pivotal Phase 3 ALPACCA study expected to enroll first patient in 2H 2025 Dosed the first patient in the Phase 1 Study for ARR-217 (MRG007), a CDH17 targeted ADC, in gastrointestinal tumors Top-line firmonertinib monotherapy data from global pivotal FURVENT Phase 3 study for first-line EGFR exon20 insertion mutant NSCLC projected to be in early 2026 Cash and investments of $254.5 million as of June 30, 2025, in addition to $81.1 million raised in the public offering in July 2025, expected to fund our operating plan to mid-2027 NEWTOWN SQUARE, Pa., Aug. 11, 2025 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today reported financial results for the second quarter ended June 30, 2025, and highlighted recent Company progress. “Firmonertinib continues to advance with strong momentum toward registration, demonstrating promise across all key EGFR-mutant NSCLC populations including underrepresented and difficult to treat patient types,” said Bing Yao, CEO of ArriVent. “The positive interim PACC Phase 1b data build on our clinical progress in Exon 20 insertion mutations and further validate the therapeutic potential of firmonertinib across EGFR mutations. We look forward to presenting final PACC Phase 1b data at the World Conference on Lung Cancer in September, and we anticipate enrolling the first patient in our global pivotal Phase 3 PACC study in the second half of 2025. Following completion of enrollment in our registrational Exon 20 insertion trial in Q1 2025, topline pivotal data is projected to be in early 2026.” Dr. Yao continued, “We believe our antibody-drug conjugate (ADC) pipeline is also making meaningful progress, led by ARR-217, a CDH17-targeted ADC with best-in-class potential for the treatment of gastrointestinal cancers. The first patient has been dosed, marking the first clinical entry from our ADC portfolio. Following our strengthened balance sheet and extended cash runway, we are well positioned to deliver on a series of important catalysts over the next twelve months.” Second Quarter 2025 and Recent Highlights Firmonertinib Positive interim update in EGFR PACC mutant NSCLC. In June 2025,...

ArriVent BioPharma (AVBP) said Monday that interim results from a global phase 1b study of firmonert

Completed enrollment in global pivotal Phase 3 study for firmonertinib monotherapy in first-line NSCLC harboring EGFR exon 20 insertion mutations Planned update for development of firmonertinib in first-line NSCLC PACC mutations in Q2 2025 First IND for ARR-217 (MRG007), an antibody drug conjugate (ADC) targeting CDH17, submitted in China Cash, cash equivalents and marketable securities of $205.5 million as of March 31, 2025 NEWTOWN SQUARE, Pa., May 12, 2025 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today reported financial results for the first quarter ended March 31, 2025, and highlighted recent Company progress. “We continued our strong execution across our oncology-focused pipeline and are preparing for several near-term milestones. Importantly, our late-stage firmonertinib program continues to show differentiated potential to address unmet needs across EGFR-mutant non-small cell lung cancer (NSCLC),” said Bing Yao, Chairman and Chief Executive Officer of ArriVent. “ARR-217 (MRG007), our recently acquired antibody drug conjugate (ADC) targeting the gastrointestinal marker CDH17 with best-in-class potential, is expected to be the first ADC from our pipeline to enter the clinic.” Dr. Yao continued, “In the year ahead, we plan to present updated data for firmonertinib in first line EGFR PACC mutant NSCLC, including Progression Free Survival (PFS) and duration of response, and provide our clinical development plan on the PACC program in the second quarter of 2025. We expect topline data in 2025 in our event-driven global pivotal Phase 3 study for firmonertinib monotherapy in first-line NSCLC harboring EGFR exon 20 insertion mutations.” First Quarter 2025 and Recent Highlights Firmonertinib Completed enrollment for pivotal trial. During the first quarter of 2025, we completed enrollment in the the global pivotal Phase 3 FURVENT study of firmonertinib monotherapy in first-line NSCLC EGFR exon 20 insertion mutations (NCT05607550). Firmonertinib, an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor, received FDA Breakthrough Therapy Designation in this patient population. Pipeline Expanded our pipeline to include ARR-217 (MRG007). In Jan...