HUTCHMED’s ESLIM-02 Phase 3 Trial Achieves 66.7% Response, Plans H1 2026 NDA
HUTCHMED shared positive Phase 3 ESLIM-02 data for sovleplenib in wAIHA, meeting the primary endpoint of hemoglobin response rate from weeks 5 to 24. The trial showed 43.8% vs 0% at week 8 and 66.7% at week 24, with the company planning a 2026 NDA submission to China’s NMPA.
1. Analysts Forecast 55.93% Upside for HUTCHMED
A recent compilation of Wall Street forecasts produces a consensus price target that implies a 55.93% upside for HUTCHMED (HCM). This estimate is derived from an average of 12 analyst models, with targets ranging from a low of 11.20 to a high of 25.00. Historical studies suggest that consensus price targets correctly predict only 52% of the time, yet HCM has seen four upward earnings estimate revisions in the past quarter versus one downward revision, indicating growing confidence in its near-term revenue outlook. Institutional ownership stands at 67%, and over the last three months, HCM’s short interest ratio has fallen from 4.8% to 3.2%, signaling reduced bearish sentiment among leveraged players.
2. Phase 3 Data Paves Way for wAIHA Filing in H1 2026
HUTCHMED announced that the Phase 3 registration portion of the ESLIM-02 trial for sovleplenib in adult warm antibody autoimmune hemolytic anemia (wAIHA) met its primary endpoint, achieving a durable hemoglobin response rate of 61% between weeks 5 and 24. In the earlier Phase 2 segment published in The Lancet Haematology, sovleplenib demonstrated an overall response rate of 43.8% at eight weeks versus 0% for placebo, rising to 66.7% over 24 weeks including crossover patients. wAIHA affects an estimated 17 adults per 100,000, with a mortality rate of up to 11%. HUTCHMED plans to file a New Drug Application for sovleplenib with China’s NMPA in the first half of 2026, alongside an NDA resubmission for second-line immune thrombocytopenia, where the drug has also shown promise in ongoing trials.