Adlai Nortye Group Ltd. ANL
Adlai Nortye Group Ltd. (Nasdaq: ANL) is an oncology drug developer. Its lead program, AN4035, is in Phase 1 for CEACAM5-enriched, RAS-addicted solid tumors (colorectal, pancreatic, lung). Its next catalyst on record is AN4035: Report full Phase Ia data (H2 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: AN4035 — Report full Phase Ia data (H2 2027). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Buparlisib (AN2025) | Recurrent/metastatic HNSCC after anti-PD-1/PD-L1 therapy | small molecule | Phase 3 |
| AN4035 (CEACAM5-targeting pan-RAS(ON) inhibitor ADC) | CEACAM5-enriched RAS-addicted solid tumors | antibody | Phase 1 |
| AN9025 (oral pan-RAS(ON) inhibitor) | RAS-driven cancers (not stated in supplied text) | small molecule | Phase 1 |
| AN8025 (multi-functional PD-1/L1 pathway fusion protein) | Solid tumors (not stated in supplied text) | protein/peptide | Phase 1 |
Recent results and decisions
- Aug 14, 2026positive Randomized Phase 2 ARTEMIS passed its futility analysis in March 2026; no efficacy data given.
The futility analysis of this Phase II study was successfully passed in March 2026, and the topline results are expected in the first half of 2027.
Filing - Aug 14, 2026discontinued Company will de-prioritize AN4005 as a monotherapy and remain open to collaboration for combination use.
we will de-prioritize the development of AN4005 as a monotherapy and remain open for collaboration to explore its potential as a combination partner.
Filing - Aug 3, 2026accepted Australian CTN submitted to TGA and HREC approval received to start the Phase 1 trial of AN4035 (ex-US regulatory action); US/China INDs in process.
today announced that it has submitted a Clinical Trial Notification (CTN) to Australia’s Therapeutic Goods Administration (TGA) and received approval from the Human Research Ethics Committee (HREC) to commence its phase I clinical trial evaluating AN4035
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 1 oncology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.