Adlai Nortye Doses First Patient in AN4035 Phase I Trial, Secures U.S. FDA IND Clearance
ANL has more than doubled off its 52-week low of $0.879.
Summary
Adlai Nortye dosed the first patient in its global Phase I trial of AN4035, a first-in-class pan-RAS(ON) inhibitor-based ADC, and received U.S. FDA IND clearance. Full Phase Ia data is expected in H2 2027.
Key Events · Product Development and Regulatory · ANL
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First Patient Dosed in AN4035 Phase I
First patient dosed in Australia, initiating the global Phase I trial in CEACAM5-enriched RAS-addicted solid tumors.
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U.S. FDA IND Clearance
Received 'Study-May-Proceed' letter from the U.S. FDA, clearing the path to expand the trial into the United States.
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China NMPA Filing Planned
Company is filing an IND application for AN4035 with the China National Medical Products Administration (NMPA).
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Data Readout Timeline
Full Phase Ia data expected in the second half of 2027.
Analysis · ANL · Life Sciences
Adlai Nortye has moved its first-in-class pan-RAS(ON) ADC, AN4035, into human testing — dosing the first patient in Australia and receiving a 'Study-May-Proceed' letter from the U.S. FDA. This is a meaningful de-risking event for the company's RASiCA platform: it validates the regulatory path in two major jurisdictions and starts the clock on clinical data. The company also disclosed plans to file an IND in China and guided to full Phase Ia data in the second half of 2027. For a clinical-stage biotech with $231.9M in cash as of H1 2026, advancing a novel ADC into the clinic is a core value driver, though the data readout remains roughly a year away.
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At the time of this filing, ANL was trading at $14.83 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $966.6M. The 52-week trading range was $0.88 to $17.25. This filing was assessed with positive market sentiment and an importance score of 7 out of 10.