Ankündigung • May 12
ArriVent BioPharma, Inc. has filed a Follow-on Equity Offering in the amount of $250 million. ArriVent BioPharma, Inc. has filed a Follow-on Equity Offering in the amount of $250 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Live-Nachrichten • May 10
ArriVent Secures FDA Clearance to Advance Dual-Target ADC for Ovarian and Endometrial Cancer ArriVent BioPharma received FDA clearance of its Investigational New Drug (IND) application for ARR-002, a tetravalent antibody-drug conjugate targeting MUC16 and NaPi2b.
ARR-002 is initially aimed at treating ovarian and endometrial cancers, supported by preclinical data indicating dual-target binding, strong activity in animal models, and a favorable tolerability profile in monkeys.
The company plans to start a Phase 1 clinical trial for ARR-002 and dose the first patient in the second half of 2026.
For you as an investor, IND clearance is an important regulatory gate. It allows ArriVent to move ARR-002 from preclinical work into human studies, which is typically viewed as a key value inflection point in the drug development cycle. The dual-target approach to MUC16 and NaPi2b, together with the tetravalent design, is aimed at improving tumor targeting. The preclinical results provide the initial scientific rationale for advancing this candidate into the clinic.
The planned Phase 1 trial and the target to dose the first patient in the second half of 2026 provide a rough sense of the development timeline, including when early safety and pharmacology data might start to emerge. As with any early-stage oncology asset, investors will likely focus on how quickly the trial initiates, the quality of the initial safety profile, and whether the biological activity seen in animal models is reflected in signals observed in patients with ovarian and endometrial cancers. Ankündigung • May 09
Arrivent Biopharma, Inc. Announces IND Clearance for ARR-002 Targeting Ovarian and Endometrial Cancers ArriVent BioPharma, Inc. announced clearance of an investigational new drug (IND) application by the United States Food and Drug Administration (FDA) for ARR-002, a potential first-in-class MUC16/NaPi2b targeting tetravalent antibody-drug conjugate (ADC) with an initial focus in ovarian and endometrial cancers and broader therapeutic potential across solid tumors. Phase 1 initiation is expected in the second half of 2026. At AACR, compelling preclinical data was presented demonstrating ARR-002’s potential to improve safety and efficacy over conventional single-target and bivalent bispecific ADCs in ovarian and endometrial cancers. ARR-002’s dual-target approach is designed to improve delivery and reduce off-tumor toxicity to overcome key limitations of single-target ADCs, including limited internalization, suboptimal payload delivery, and heterogeneous target expression. MUC16 and NaPi2b are highly expressed on ovarian and endometrial cancers with limited expression in normal tissues, making them strong co-targets. Select preclinical data included in the IND submission of ARR-002 was presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting in a joint presentation with Aarvik Therapeutics demonstrating: Effective binding to individual targets, simultaneous engagement of both targets, and enhanced internalization vs. single-target antibody controls; Superior in vivo efficacy vs. single-target ADCs in the OVCAR-3 xenograft model; The potential for a wider therapeutic window based on a favorable tolerability profile in cynomolgus monkeys, consisting of reversible hematologic findings at a higher maximum tolerated single dose vs. other approaches in development. ARR-002 (also known as AV-P138-ADC) is a first-in-class, Mucin-16 (MUC16) and sodium-dependent phosphate transport protein 2b (NaPi2b) dual-target, tetravalent (2+2 format) ADC, with site-specific conjugation to vcMMAE at a drug-to-antibody ratio (DAR) of 4. Both these cell surface antigens are expressed in ovarian and endometrial cancers with limited expression in normal tissues, making them strong co-targets. Ankündigung • Apr 30
ArriVent BioPharma, Inc., Annual General Meeting, Jun 18, 2026 ArriVent BioPharma, Inc., Annual General Meeting, Jun 18, 2026. Ankündigung • Sep 23
ArriVent BioPharma, Inc. Appoints Brent S. Rice as Chief Commercial Officer ArriVent BioPharma, Inc. announced the appointment of Brent S. Rice as Chief Commercial Officer (CCO). Mr. Rice joins ArriVent with over 25 years of U.S. and global commercial experience in the biotechnology and pharmaceutical industry. Before joining ArriVent, Brent most recently served as the Senior Vice President and global Chief Commercial Officer, and Managing Director U.S. at Autolus Therapeutics Ltd. where he led global commercialization, commercial strategy and business portfolio management of their early and late-stage pipeline of next generation therapies. Under Brent's leadership, the company transitioned from a clinical stage development company to a commercial organization where he built the U.S. organization and led the successful introduction and launch of Autolus' first commercial product. An experienced executive leader, Brent brings cross-functional expertise in marketing, operations, and reimbursement, and building scalable commercial organizations, leading product launches, and negotiating high-value agreements that improve patient access. Prior to Autolus, Brent led Managed Markets at Juno Therapeutics, where he developed payer and reimbursement strategy capabilities. He spent 18 years at Amgen in roles of increasing responsibility, earning recognition as a strong cross-functional leader driving innovative partnerships and portfolio success. Ankündigung • Sep 09
Arrivent BioPharma, Inc. Presents the Final Analysis of Firmonertinib Monotherapy Data from Global Phase 1b Study in EGFR PACC Mutant Non-Small Cell Lung Cancer at the 2025 World Conference on Lung Cancer Arrivent BioPharma, Inc. presented positive final proof-of-concept data from the randomized global Phase 1b FURTHER trial for first-line firmonertinib monotherapy in patients with non-small cell lung cancer (NSCLC) harboring EGFR PACC mutations at the IASCLC 2025 annual World Conference on Lung Cancer (WCLC), in Barcelona, Spain. Firmonertinib was granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for the treatment of patients with previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations.irmonertinib was also granted U.S. FDA Orphan Drug Designation for the treatment of NSCLC with EGFR mutations or human epidermal growth factor receptor 2 (HER2) mutations or HER4 mutations. Ankündigung • Jul 22
Arrivent Biopharma, Inc.'S Topline Pivotal Phase 3 Furvent Data for Firmonertinib in First-Line Nsclc Egfr Exon20 Insertion Mutations Is Projected to Be Early 2026 ArriVent BioPharma, Inc. announced that topline firmonertinib monotherapy data from the global pivotal FURVENT Phase 3 (NCT05607550) study in first-line EGFR exon20 insertion mutant non-small cell lung cancer (NSCLC) is projected to be in early 2026. The primary endpoint will assess progression free survival (PFS) by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. In the first quarter of 2025, the study completed enrollment across global sites. The FURVENT is a global, pivotal 3 arm Phase 3 clinical trial of firmonertinib in first-line non-squamous locally advanced or metastatic NSCLC patients with exon 20 insertion mutations being conducted jointly with partner Allist. The FURVENT clinical trial is designed to assess the safety and efficacy of firmonertinib administered at either 160 mg or 240 mg, once-daily with each dose being compared to platinum-based chemotherapy withemetrexed, the current first-line standard of care. The primary endpoint of this study is PFS by BICR per RECIST 1.1. Secondary endpoints in patients with brain metastases at baseline include brain-specific CNS overall response rate (CNS-ORR) and CNS-PFS by modified RECIST (mRECIST). The study enrolled 398 patients globally, including from sites in the United States, Europe and certain Asian countries including Japan and China. Firmonertinib is an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor 2 (HER2) mutations or HER4 mutations. Firmonertinib was currently being studied in a global Phase 3 trial for first-line NSCLC patients with EGFR exon 20 insertion mutations (FURVENT; NCT05607550) and in a global Phase 3 study in first line NSCLC patients withEGFR PACC mutations (ALPACCA). Ankündigung • Jun 24
ArriVent Announces Positive Interim Firmonertinib Monotherapy Data from Global Phase 1B Study in EGFR PACC Mutant Non-Small Cell Lung Cancer and Plans to Advance into A Global Pivotal Study ArriVent BioPharma, Inc. announced encouraging additional follow up proof-of-concept data from the randomized global Phase 1b FURTHER trial for first-line firmonertinib monotherapy in patients with non-small cell lung cancer (NSCLC) harboring EGFR PACC mutations and a clinical development update for the firmonertinib program for the treatment of EGFR PACC mutant NSCLC. Ankündigung • Feb 04
ArriVent BioPharma, Inc. has filed a Follow-on Equity Offering in the amount of $250 million. ArriVent BioPharma, Inc. has filed a Follow-on Equity Offering in the amount of $250 million.
Security Name: Common Shares
Security Type: Common Stock
Transaction Features: At the Market Offering Ankündigung • Sep 10
ArriVent BioPharma, Inc. Announces Positive Proof-Of-Concept Global Phase 1B Interim Data for Firmonertinib Monotherapy in First-Line EGFR PACC Mutant Non-Small Cell Lung Cancer At the 2024 World Conference on Lung Cancer ArriVent BioPharma, Inc. announced positive proof-of-concept randomized global Phase 1b FURTHER interim data for first-line firmonertinib monotherapy in patients with non-small cell lung cancer (NSCLC) harboring EGFR PACC mutations at a Presidential Symposium Presentation at the IASCLC 2024 annual World Conference on Lung Cancer (WCLC), in San Diego, California. ArriVent plans to host a virtual webinar on September 9, 2024 at 4:30 pm ET. Presidential Symposium Presentation Highlights Current standards of care have improved outcomes for classical EGFR mutations but have been less effective against uncommon EGFR mutation types including PACC and exon 20 insertion mutations which represent approximately 12% and 9% of NSCLC EGFR mutations, respectively. Firmonertinib, an oral, once-daily, highly brain-penetrant EGFR inhibitor with broad activity across EGFR mutations, was evaluated for interim clinical proof-of-concept data in first-line EGFR PACC mutant NSCLC as part of the Phase 1b FURTHER trial. Select clinical activity and safety results from FURTHER interim data analysis include: First clinical dataset from an EGFR inhibitor being tested in a randomized defined population of EGFR PACC mutant NSCLC Robust systemic and central nervous system (CNS) responses across patients observed as of June 20, 2024 (data cut): 81.8% at 240mg and 47.8% at 160mg overall response rate (ORR) by blinded independent central review (BICR) 63.6% and 34.8% confirmed ORR by BICR at 240mg and 160mg dose levels, respectively. One unconfirmed partial response pending confirmation at each of the 160mg and 240mg dose levels. Median duration of response had not yet been reached; 90.9% (n = 20/22) patients with confirmed responses remain on study 46.2% (n = 6/13) CNS confirmed ORR by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by BICR in first-line patients with brain metastases at baseline Generally well-tolerated with a profile consistent with prior firmonertinib data Most frequent treatment-related adverse events (TRAEs) were diarrhea, rash, dry skin, stomatitis, and hepatic enzyme elevation No treatment discontinuation due to TRAEs was observed Firmonertinib showed promising dose-dependent activity in NSCLC patients across a broad range of EGFR PACC mutations in the first-line metastatic setting and includes CNS antitumor activity consistent with its high brain penetrance. Ankündigung • May 18
ArriVent BioPharma, Inc. Appoints John Hohneker as Board of Directors ArriVent BioPharma, Inc. announced the appointment of John Hohneker, M.D. to its board of directors. Dr. Hohneker brings over 30 years of experience in biopharmaceutical leadership and drug development, and currently serves on the Boards of public companies Carisma Therapeutics, Inc. and Curis, Inc., and private companies Sonata Therapeutics and Trishula Therapeutics. Most recently, Dr. Hohneker served as President and Chief Executive Officer of Anokion SA. Prior to this role, Dr. Hohneker was President of Research and Development at Forma Therapeutics, Inc., where he guided the company’s transition from a discovery-stage biotech to a clinical-stage company. Previously, Dr. Hohneker held various leadership roles during his 14 years at Novartis AG, including Senior Vice President and Global Head of Development, Immunology and Dermatology. During his tenure at Novartis, he played a key role in the development, approval and commercialization of several products. Dr. Hohneker earned his B.A. in chemistry from Gettysburg College and his M.D. from the University of Medicine and Dentistry of New Jersey at Rutgers Medical School. Ankündigung • Apr 24
ArriVent BioPharma, Inc. Appoints Kristine Peterson to Its Board of Directors ArriVent BioPharma, Inc. announced the appointment of Kristine Peterson to its Board of Directors. Ms. Peterson brings over 30 years of biopharmaceutical leadership experience, and currently serves on the Boards of public companies Immunocore, Inc. and Enanta Pharmaceuticals. Ms. Peterson has served as a Board Member for multiple companies, including ImmunoGen, Inc., Immunocore, Inc., Enanta Pharmaceuticals, Paratek Pharmaceuticals, Amarin Corporation and EyePoint Pharma. Most recently, she served as Chief Executive Officer for Valeritas, Inc., where she led the company’s development from early-stage R&D through to commercialization. Prior to Valeritas, Ms. Peterson held executive leadership roles at Johnson & Johnson, including Company Group Chair for their worldwide biotech and oncology groups, where she grew those businesses to more than $6 billion in sales, launched several new products, licensed new therapeutics, and rebuilt oncology R&D. Previously, she was also President and Senior Vice President, Commercial Operations for Biovail Corporation, where she oversaw the U.S. and Canadian business units. Earlier in her career, Ms. Peterson spent 20 years at Bristol-Myers Squibb in a variety of senior roles, including running their cardiovascular and metabolics business unit. She earned her B.S. and M.B. A from the University of Illinois at Urbana-Champaign. Board Change • Jan 27
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. No experienced directors. No highly experienced directors. Co-Founder, President of Research & Development and Director Stuart Lutzker is the most experienced director on the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.