Monday, the FDA lifted the partial clinical hold on studies of Zentalis Pharmaceuticals, Inc.’s ZNTL azenosertib, the company’s novel, selective, and orally bioavailable inhibitor of WEE1.

周一，FDA解除了Zentalis Pharmaceuticals，Inc.的ZNTL azenosertib研究的部分临床禁令，该公司的新型选择性口服生物可利用WEE1抑制剂。

The FDA has cleared the company to resume enrollment in all ongoing azenosertib clinical studies with no changes in the clinical development plan.

FDA已批准该公司恢复所有正在进行的阿泽诺西替尼临床研究的注册，临床开发计划没有变化。

Zentalis will be working with clinical trial investigators to resume study activities across the azenosertib development program as quickly as possible.

Zentalis将与临床试验研究人员合作，尽快恢复阿泽诺西替尼开发项目的研究活动。

Also Read: Zentalis Gears Up for Phase 3 Study of Azenosertib after Positive Phase 1b Outcomes.

另请阅读：Zentalis在积极的1b期结果后准备进行阿扎诺西替尼的3期研究。

“We are grateful to the FDA for their collaboration and review of our complete response package, which included a comprehensive safety assessment of the azenosertib program,” said Kimberly Blackwell, Chief Executive Officer.

首席执行官金伯利·布莱克威尔（KimberlyBlackwell）表示：“我们感谢FDA的合作和对我们完整的应对方案的审查，其中包括对阿泽诺西替尼项目的全面安全评估。”。

At a corporate event later this year, Zentalis will present azenosertib monotherapy data and provide additional updates to azenosertib clinical development and other data presentation timelines.

在今年晚些时候的一次企业活动上，Zentalis将展示阿折诺西替尼单药治疗数据，并提供阿折诺西替尼临床开发和其他数据展示时间表的更多更新。

The company remains on track to meet all previously disclosed data guidance for the remainder of 2024.

该公司在2024年剩余时间内仍有望达到之前披露的所有数据指导。

In June this year, the FDA issued a partial on three azenosertib studies for solid tumors, platinum-resistant ovarian cancer, and uterine serous carcinoma.

今年6月，美国食品和药物管理局（FDA）发布了针对实体瘤、铂类耐药卵巢癌和子宫浆液性癌的三项阿泽诺西替尼研究的部分报告。

The update followed two recent deaths due to presumed sepsis in the Phase 2 ZN-c3-005 DENALI study in platinum-resistant ovarian cancer.

在铂类耐药卵巢癌的2期ZN-c3-005 DENALI研究中，由于推测败血症，最近有两人死亡。

Price Action: ZNTL stock is up 41.7% at $4.59 during the premarket session at last check Monday.

价格走势：ZNTL股价在周一最后一次检查的上市前交易中上涨41.7%，至4.59美元。

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