firmonertinib

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ArriVent Announces Proposed $75 Million Public Offering of Common Stock and Pre-Funded Warrants
Globenewswire· 2025-07-01 20:05
NEWTOWN SQUARE, Pa., July 01, 2025 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (“ArriVent”) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced that it intends to offer and sell, subject to market and other conditions, $75 million of its shares of common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock, in an underwritten public offering. In ...
ArriVent BioPharma (AVBP) Earnings Call Presentation
2025-06-23 13:43
A Late-Stage Company With a Global Oncology Pipeline PACC Update June 23, 2025 Forward Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. These statements include, but are not limited to, implied and express statements about our strategy, business plans and objectives for our programs; plans and timelines for the preclinical and clinical development of our product candidates, i ...
ArriVent Announces Investor Event on Firmonertinib Path Forward for EGFR PACC Mutant NSCLC
Globenewswire· 2025-06-20 20:05
Company Overview - ArriVent BioPharma, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for cancer patients [2] - The company aims to leverage its team's extensive drug development experience to advance its lead candidate, firmonertinib, and a pipeline of novel therapeutics [2] Product Information - Firmonertinib is an oral, mutation-selective EGFR inhibitor effective against both classical and uncommon EGFR mutations, including PACC and exon 20 insertion mutations [3] - The drug was approved in China in March 2021 for first-line treatment of advanced NSCLC with specific EGFR mutations [3] Regulatory Designations - Firmonertinib received Breakthrough Therapy Designation from the U.S. FDA for treating previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations [4] - The drug also holds Orphan Drug Designation from the U.S. FDA for treating NSCLC with various EGFR mutations [4] Clinical Trials - Firmonertinib is currently undergoing a global Phase 3 trial for first-line NSCLC patients with EGFR exon 20 insertion mutations and a Phase 1b study for patients with EGFR PACC mutations [5] - The drug is also part of a clinical combination study targeting advanced or metastatic NSCLC patients with classical EGFR mutations, in collaboration with Beijing InnoCare Pharma Tech Co., Ltd. [5] Market Context - Lung cancer is the leading cause of cancer-related deaths globally, with NSCLC accounting for approximately 85% of all cases [6] - Uncommon EGFR mutations, such as exon 20 insertion and PACC mutations, represent significant unmet medical needs, with exon 20 mutations constituting about 9% and PACC mutations about 12% of all EGFR mutations [6]
ArriVent BioPharma Reports First Quarter 2025 Financial Results
Globenewswire· 2025-05-12 12:00
Core Insights - ArriVent BioPharma, Inc. reported financial results for Q1 2025, highlighting progress in its oncology pipeline and upcoming milestones [1][10]. Pipeline Developments - The firmonertinib program is advancing, with completed enrollment in the global pivotal Phase 3 FURVENT study for first-line NSCLC patients with EGFR exon 20 insertion mutations [3][7]. - ARR-217 (MRG007), a newly acquired antibody drug conjugate targeting CDH17, is expected to be the first ADC from ArriVent's pipeline to enter clinical trials [2][4]. Financial Performance - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $205.5 million, sufficient to fund operations into the second half of 2026 [7][16]. - Research and development expenses increased to $61.3 million in Q1 2025 from $17.0 million in Q1 2024, primarily due to a one-time upfront payment of $40 million to Lepu Biopharma [16][24]. - The net loss for Q1 2025 was $64.4 million, compared to a net loss of $17.4 million in Q1 2024 [16][24]. Upcoming Milestones - The company plans to present updated data for firmonertinib in first-line EGFR PACC mutant NSCLC in Q2 2025, including Progression Free Survival (PFS) and duration of response [2][8]. - Topline data from the pivotal Phase 3 study for firmonertinib is anticipated in 2025, with updates on timing expected in Q2 2025 [8][10]. Corporate Updates - Merdad Parsey, M.D., Ph.D., was appointed to the Board of Directors in April 2025, bringing extensive experience in global clinical development [9].
ArriVent BioPharma Appoints Merdad Parsey, M.D., Ph.D. to its Board of Directors
Globenewswire· 2025-04-28 12:00
Core Insights - ArriVent BioPharma, Inc. has appointed Dr. Merdad Parsey to its Board of Directors, bringing extensive experience in global clinical development from his previous role at Gilead Sciences, Inc. [1][2] - Dr. Parsey expressed enthusiasm about ArriVent's potential to transform cancer treatment with its lead candidate firmonertinib and its pipeline of next-generation antibody drug conjugates (ADCs) [2][3] - ArriVent is focused on developing differentiated medicines to meet unmet medical needs in cancer treatment, leveraging its team's drug development expertise [3] Company Overview - ArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development, and commercialization of innovative therapeutics for cancer patients [3] - The company aims to maximize the potential of its lead candidate firmonertinib and advance its ADC pipeline through approval and commercialization [3] Leadership Experience - Dr. Parsey has held significant roles in the biopharmaceutical industry, including Senior Vice President at Genentech and CEO of 3-V Biosciences, Inc. [2] - His academic background includes an M.D. and Ph.D. in immunology, with training at prestigious institutions such as Stanford University and the University of Colorado [2]