林业发展局在审查了可靠的数据和安全信息后,为2025年后期第2/3阶段的试验清除了Neurizon的ALS药物。 FDA clears Neurizon’s ALS drug for late 2025 Phase 2/3 trial after reviewing strong data and safety info.

林业发展局解除了对Neurizon治疗药物NUZ-001的临床搁置。 Neurizon治疗药物NUZ-001是调查性ALS药物,在HEAY ALS平台试验中为第2/3阶段的测试清理了该药物,预计患者将于2025年底入学。 The FDA has lifted the clinical hold on Neurizon Therapeutics’ NUZ-001, an investigational ALS drug, clearing it for Phase 2/3 testing in the HEALEY ALS Platform Trial, with patient enrollment expected in late 2025. 该决定是在林业发展局批准Neurizon的IND应用之后作出的,其依据是强有力的临床初步数据、开放标签扩展研究带来的有希望的存活结果以及全面的安全和制造信息。 The decision follows FDA approval of Neurizon’s IND application, based on strong preclinical data, promising survival outcomes from an open-label extension study, and comprehensive safety and manufacturing information. 该公司与病人代言人、主要舆论领袖合作,并与Elanco签订许可证协议,以便取得进展。 The company credits collaboration with patient advocates, key opinion leaders, and a licensing agreement with Elanco for the progress. 以TDP-43病理学为目标的NUZ-001号仍在调查中,没有获准使用。 NUZ-001, which targets TDP-43 pathology, remains investigational and is not approved for any use.