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On October 31, 2024, ESSA announced that it was ending its Phase 2 trial for a prostate cancer treatment which tested masofaniten with enzalutamide versus enzalutamide alone in patients with metastatic castration-resistant prostate cancer who had not yet used second-generation antiandrogens. According to the Company, the decision followed an interim review of safety, PK, and efficacy data. Specifically, results showed a higher PSA90 response rate in patients treated with enzalutamide alone than expected based on historical data and no clear benefit was seen with the masofaniten-enzalutamide combination over enzalutamide alone. Further, futility analysis showed a low likelihood of achieving the study’s primary endpoint. Finally, ESSA also said it will end other clinical studies on masofaniten, both as a monotherapy and in combination with other treatments, to focus resources.
Following this news, ESSA’s price fell over 73% on November 1, 2024.