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On Monday, H.C. Wainwright analysts downgraded Adlai Nortye Ltd. stock (NASDAQ:ANL) from Buy to Neutral. The stock, which has lost nearly 75% of its value over the past year according to InvestingPro data, currently trades at $1.80. The decision follows the release of topline results from the Phase 3 BURAN trial, which assessed the efficacy of buparlisib, a PI3K inhibitor, in combination with paclitaxel for treating advanced head and neck squamous cell carcinoma (HNSCC). The trial failed to meet its primary endpoint of improving overall survival compared to paclitaxel alone.
Following the trial results, Adlai Nortye announced plans to discontinue the buparlisib program. The company, with a market capitalization of $67.16 million, intends to make near-term adjustments to its operations, which may include a reduction in its workforce and pursuing strategic business development opportunities. InvestingPro analysis indicates the company is quickly burning through cash, though it maintains more cash than debt on its balance sheet. The final results of the study are anticipated to be presented at a major medical conference later this year, likely the European Society for Medical (TASE:BLWV) Oncology (ESMO).
In light of these developments, Adlai Nortye plans to shift focus towards advancing two preclinical assets: AN8025, a first-in-class, tri-specific immunotherapy designed as a T cell/APC modulator, and AN9025, an oral pan-RAS inhibitor. The company expects to file Investigational New Drug (IND) applications for both assets by the end of 2025.
The downgrade reflects the early-stage nature of Adlai Nortye’s remaining pipeline, as the company awaits further clinical updates. H.C. Wainwright analysts expressed disappointment with the trial outcome but will continue to monitor developments and reassess the situation as more information becomes available. InvestingPro subscribers have access to 13 additional investment tips and comprehensive financial metrics to better evaluate the company’s prospects.
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