Why Is Cancer-Focused Chimerix Stock Trading Higher On Tuesday?
Why Is Cancer-Focused Chimerix Stock Trading Higher On Tuesday?
The following recent program milestones and additional supportive data were extensively discussed with the FDA and will be included in the NDA:On Monday, Chimerix (NASDAQ:CMRX) announced that, following extensive dialogue with the FDA, the company plans to submit a complete New Drug Application (NDA) seeking accelerated approval for dordaviprone for recurrent H3 K27M-mutant diffuse glioma in the U.S. before year-end.
周一，Chimerix（纳斯达克：CMRX）宣布，在与FDA进行广泛对话后，公司计划在年底之前提交完整的新药申请（NDA），寻求对复发性H3 K2700万.mutant弥漫性胶质瘤的dordaviprone的加速审批。
A glioma is a tumor that originates in the glial cells of the brain or spinal cord and is the most common primary brain tumor.
胶质瘤是一种起源于大脑或脊髓的胶质细胞的肿瘤，是最常见的原发性脑肿瘤。
Chimerix stock is trading higher on a strong session volume of 4.31 million, compared to an average volume of 497.04K, as per data from Benzinga Pro.
根据Benzinga Pro的数据，Chimerix的股票在431万的强劲成交量下交易上涨，而平均成交量为49.704万。
The following recent program milestones and additional supportive data were extensively discussed with the FDA and will be included in the NDA:
最近的项目里程碑和其他支持性数据已与FDA进行了广泛讨论，将会包含在NDA中：
- Substantial enrollment of the Phase 3 ACTION study.
- Phase 2 objective response rate of the 50-patient primary efficacy analysis as the primary basis of efficacy in the NDA.
- Several response assessments, under which dordaviprone demonstrated an objective response rate of 28%, a median duration of response of 10.4 months, and a median time to response of 4.6 months.
- Additional clinical data sets and patient narratives supportive of the primary efficacy analysis.
- Clinical and nonclinical demonstration of dordaviprone-driven reversal of the central hallmark of H3 K27M-mutant glioma, H3K27 trimethyl loss.
- Comprehensive safety database of glioma patients and healthy volunteers that supports a favorable benefit/risk profile.
- Comprehensive clinical pharmacology and chemistry, manufacturing, and controls (CMC) studies.
- 第三阶段ACTION研究的大量入组。
- 第二阶段主要疗效分析中的50名患者的客观反应率作为NDA中的主要疗效依据。
- 在多个反应评估中，dordaviprone表现出28%的客观反应率，反应的中位持续时间为10.4个月，反应的中位时间为4.6个月。
- 额外的临床数据集和患者叙述支持主要疗效分析。
- 临床和非临床展示了dordaviprone驱动的H3 K2700万.mutant胶质瘤中央特征的逆转，即H3K27三甲基丢失。
- 全面的胶质瘤患者和健康志愿者安全数据库，支持良好的收益/风险特征。
- 全面的临床药理学和化学、制造业-半导体以及控制（CMC）研究。
Chimerix will request a Priority Review for the NDA. If granted, the resulting six-month FDA review period is expected to result in a potential initial Prescription Drug User Fee Act (PDUFA) action date in the third quarter of 2025.
Chimerix将请求对新药申请（NDA）进行优先审查。如果获得批准，预计六个月的FDA审查期将在2025年第三季度产生潜在的初步处方药用户费法案（PDUFA）行动日期。
Dordaviprone has received Rare Pediatric Disease Designation for H3 K27M-mutant glioma and is eligible to apply for a Rare Pediatric Disease Priority Review Voucher.
dordaviprone已获得H3 K2700万.mutant胶质瘤的罕见儿童疾病认定，并有资格申请罕见儿童疾病优先审查券。
"In anticipation of a potential approval, we have bolstered our commercial leadership team and will be ready for a U.S. launch as early as the third quarter of 2025, pending application acceptance and Priority Review, if granted," said Mike Andriole, CEO of Chimerix.
“为了迎接潜在的批准，我们已加强了商业领导团队，并将准备在2025年第三季度尽早在美国上市，前提是申请被接受并获得优先审查（如果获批），”Chimerix首席执行官Mike Andriole说。
Price Action: CMRX stock is up 153.20% at $2.19 at last check on Tuesday.
价格走势：CMRX股票在周二最后一次检查时上涨了153.20%，报2.19美元。
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