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Recent Updates — ANL

September 8, 2026View Source ↗

On September 8, 2026, Adlai Nortye Group Ltd. announced the dosing of its first patient in Australia for AN4035, a first-in-class antibody-drug conjugate (ADC) targeting CEACAM5 armed with a pan-RAS(ON) inhibitor payload. This event initiates the global Phase I clinical trial for patients with CEACAM5-enriched RAS-addicted solid tumors. The company also received a 'Study-May-Proceed' letter from the U.S. FDA regarding its investigational new drug application, clearing the path to expand the trial into the United States. Management aims to report full Phase Ia data in the second half of 2027 and is concurrently filing an IND with China's NMPA. Adlai Nortye Group Ltd. operates as a clinical-stage biopharmaceutical company dedicated to developing innovative cancer therapies.

August 14, 2026View Source ↗

Adlai Nortye Ltd. reported unaudited first-half 2026 financial results and operational updates for the period ended June 30, 2026. The company raised $290 million through two private placement equity financings completed in February ($140 million) and April ($150 million). Cash and short-term investments increased to US$231.9 million from US$8.1 million at year-end 2025. Revenue rose to US$13.1 million, driven by license agreement milestones with Jiangsu Aosaikang Pharmaceutical Co., Ltd., while net loss narrowed by 70.9% to US$5.3 million. R&D expenses decreased slightly to US$14.6 million. Clinically, the company initiated enrollment in both once-daily and intermittent once-weekly arms of its global Phase I trial for pan-RAS(ON) inhibitor AN9025 and received regulatory approval in Australia for a Phase I trial of ADC AN4035. Adlai Nortye Ltd. is a clinical-stage biotechnology company focused on developing innovative cancer therapies.

August 3, 2026View Source ↗

Adlai Nortye Ltd. announced on August 3, 2026, that it has submitted a Clinical Trial Notification to Australia’s Therapeutic Goods Administration and received Human Research Ethics Committee approval to commence its Phase I clinical trial for AN4035. This first-in-class antibody drug conjugate targets CEACAM5-enriched RAS-addicted solid tumors using the company's proprietary RASiCA platform. Patient dosing is expected to begin in the second half of 2026, with investigational new drug applications also pending with the U.S. FDA and China NMPA. Adlai Nortye Ltd. operates as a clinical-stage biopharmaceutical company dedicated to developing innovative cancer therapies.

July 16, 2026View Source ↗

Adlai Nortye announced the first patient dosing in the intermittent weekly dosing arm of its global Phase 1 clinical trial for AN9025, a pan-RAS(ON) inhibitor. The trial is evaluating the safety, tolerability, pharmacokinetics, and anti-tumor activity of the drug in patients with advanced or metastatic solid tumors harboring RAS mutations. Both the daily (QD) and weekly (QW) dose escalation arms are currently enrolling. The company expects to share initial Phase 1 dose escalation data from the QD arm in the first half of 2027. Adlai Nortye is a clinical-stage biotechnology company developing innovative cancer therapies.