ArriVent Announces IND Clearance for Novel Tetravalent MUC16/NaPi2b Targeting ADC ARR-002 with Initial Focus in Ovarian and Endometrial Cancers

ArriVent BioPharma received FDA IND clearance for ARR-002, a first-in-class dual-target antibody-drug conjugate targeting MUC16 and NaPi2b for ovarian and endometrial cancers. Preclinical data presented at AACR 2026 demonstrated superior efficacy and favorable tolerability compared to single-target ADCs. Phase 1 trial initiation is expected in the second half of 2026.

05/07/2026, 8:00 AM • GlobeNewswire

ArriVent to Present Two Preclinical Posters on the EGFR Inhibitor Firmonertinib and on the Novel dual-target MUC16/NaPi2b Tetravalent ADC ARR-002 at the 2026 AACR Annual Meeting

ArriVent BioPharma announced two preclinical poster presentations at the 2026 AACR Annual Meeting. The company will present data on firmonertinib, an EGFR inhibitor showing activity against classical and exon 20 insertion mutations with ongoing Phase 3 trials, and ARR-002, a dual-target MUC16/NaPi2b tetravalent ADC developed in partnership with Aarvik Therapeutics demonstrating superior anti-tumor activity in ovarian and endometrial cancer models.

03/17/2026, 5:00 PM • GlobeNewswire

$207B Market Shift: The Race for Fast Track Approval in Oncology

The FDA has accelerated oncology drug approvals with over 50 approvals in 2025 and increased expedited designations in 2026. Multiple biotech companies are advancing cancer treatments through Fast Track and Breakthrough Therapy designations, targeting high-unmet-need solid tumors. Key developments include Oncolytics' pelareorep showing significant survival benefits in colorectal cancer, Relay's zovegalisib receiving Breakthrough designation for breast cancer, MAIA's ateganosine advancing in lung cancer, Zai Lab's AUGTYRO approval in China, and Arrivent's firmonertinib entering pivotal Phase 3 trials for NSCLC.

02/05/2026, 9:35 AM • Benzinga

Fast-Tracking the $537B Cancer Cure: How Accelerated Approvals Reshaping Oncology in 2026

The oncology landscape is experiencing rapid regulatory advancement as precision medicine and genomics expand significantly. Multiple biotech companies are advancing cancer therapies toward accelerated FDA approvals in 2026, with the precision medicine market projected to grow from $138.67 billion in 2026 to $537.17 billion by 2035. Key developments include Oncolytics' pelareorep showing strong response rates in anal cancer, CG Oncology's Phase 3 trial ahead of schedule, Zentalis advancing azenosertib in ovarian cancer, ArriVent initiating a pivotal Phase 3 study for firmonertinib, and PDS Biotechnology gaining FDA alignment on trial endpoints.

01/12/2026, 10:35 AM • Benzinga

ArriVent Announces First Patient Dosed in Global Pivotal Phase 3 ALPACCA Trial Evaluating Firmonertinib for First-Line Treatment of EGFR PACC Mutant Non-Small Cell Lung Cancer

ArriVent BioPharma announced the first patient dosing in the Phase 3 ALPACCA pivotal trial evaluating firmonertinib for first-line treatment of EGFR PACC mutant NSCLC. The trial compares firmonertinib 240 mg once daily against osimertinib or afatinib, with primary endpoints of overall response rate and progression-free survival. The company estimates approximately 42,000 patients globally and 6,200 in the US annually with this mutation type.

12/22/2025, 8:00 AM • GlobeNewswire

Immunotherapy Breakthroughs Turn Cold GI Tumors Hot as Market Tops $443B

Emerging immunotherapy technologies are transforming treatment for gastrointestinal cancers, with companies developing novel combination strategies to activate immune responses in historically resistant tumors. The global cancer immunotherapy market is projected to reach $443.17 billion by 2030.

12/16/2025, 1:17 PM • Benzinga

ArriVent Posts Wider Loss in Fiscal Q2

ArriVent BioPharma reported a wider net loss in Q2 2025, with increased R&D expenses driven by clinical pipeline expansion and a strategic partnership. The company continues developing firmonertinib for non-small cell lung cancer and initiated a new antibody-drug conjugate program.

08/11/2025, 8:11 AM • The Motley Fool

ArriVent Announces Pricing of $75 Million Public Offering of Common Stock and Pre-Funded Warrants

ArriVent BioPharma announced a public offering of 2,482,692 common stock shares and pre-funded warrants, expecting to raise approximately $75 million to support its drug development programs, particularly firmonertinib.

07/01/2025, 11:15 PM • GlobeNewswire

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 announced positive interim data from a Phase 1b study of firmonertinib in EGFR PACC mutant non-small cell lung cancer, with plans to advance the drug into a global pivotal Phase 3 study.

06/23/2025, 7:00 AM • GlobeNewswire