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On Monday, Incyte Corporation INCY announced that it will pause enrollment in the ongoing Phase 2 study of MRGPRX2 (INCB000262) in chronic spontaneous urticaria (CSU).
周一,Incyte Corporation INCY宣布将暂停正在进行的慢性自发性荨麻疹(CSU)MRGPRX2(INCB000262)第二阶段研究的注册。
The decision was made following the observation of certain in vivo preclinical toxicology findings.
该决定是在观察某些体内临床前毒理学发现后做出的。
These data have been shared with the FDA, and Incyte will work closely with the FDA to determine the next steps.
这些数据已经与FDA共享,Incyte将与FDA密切合作,以确定下一步。
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Enrollment in the other INCB000262 proof-of-concept studies is complete. Data from all clinical studies will help inform its future development and guide the potential development of backup molecules.
其他INCB000262概念验证研究的注册已完成。来自所有临床研究的数据将有助于为其未来的发展提供信息,并指导备份分子的潜在发展。
In addition, data from the Phase 2 study evaluating MRGPRX4 (INCB000547) in cholestatic pruritus (CP) does not support further development.
此外,评估胆汁淤积性瘙痒症(CP)中MRGPRX4(INCB000547)的2期研究数据不支持进一步发展。
The company added the investigational drugs via the Escient Pharmaceuticals deal for $750 million.
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William Blair says the ‘update is clearly disappointing’ as the proof-of-concept data across all three indications was anticipated in the first quarter of 2025.
威廉·布莱尔(WilliamBlair)表示,这一更新显然令人失望,因为预计2025年第一季度将有三个指标的概念验证数据。
The analyst has not included estimates for the molecule in the model yet. However, William Blair previously projected it could launch in 2029 and bring substantial sales for Incyte in the 2030s, as it’s being tested for major market opportunities with the potential to become a blockbuster.
分析员还没有在模型中包括对分子的估计。然而,威廉·布莱尔(WilliamBlair)此前预计,它可能在2029年推出,并在2030年代为Incyte带来可观的销售额,因为它正在测试可能成为大片的主要市场机会。
“Although ‘547 was not the focus of the Escient acquisition, it is clearly negative to also see the discontinuation of the other clinical-stage program associated with the acquisition,” the analyst adds.
这位分析师补充道:“虽然547年不是Escient收购的重点,但与收购相关的其他临床阶段项目的中断显然是负面的。”。
William Blair writes that before more information is released about the toxicology findings and next steps for the ‘262 program, investors are likely to focus on other key pipeline updates expected in 2025.
威廉·布莱尔(WilliamBlair)写道,在有关毒理学发现和262计划下一步的更多信息发布之前,投资者可能会关注2025年其他关键管道更新。
These include Phase 3 results for povorcitinib in hidradenitis suppurativa, due in early 2025, and initial data on mutant-specific inhibitors (mCALR and JAK2V617F) for myeloproliferative neoplasms later in the year. These developments could significantly impact Incyte’s long-term outlook.
其中包括2025年初到期的化脓性汗腺炎中povorcitinib的3期结果,以及今年晚些时候骨髓增生性肿瘤突变特异性抑制剂(mCALR和JAK2V617F)的初步数据。这些发展可能会对Incyte的长期前景产生重大影响。
Price Action: INCY stock fell 11.35% at $68.28 during premarket session at the last check on Tuesday.
价格走势:在周二的最后一次检查中,INCY股票在上市前交易时段下跌11.35%至68.28美元。
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