Penny Stock DBV Technologies通过FDA批准途径推进Viaskin花生过敏贴片-动脉网

Penny Stock DBV Technologies Advances Viaskin Peanut Allergy Patch With FDA Approval Pathway

benzinga 等信源发布 2024-10-23 14:15

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On Tuesday, DBV Technologies DBVT announced progress in its regulatory efforts for the Viaskin Peanut patch, aimed at treating peanut allergies in toddlers and children.

周二，DBV Technologies DBVT宣布其针对Viaskin花生贴片的监管工作取得了进展，该贴片旨在治疗幼儿和儿童的花生过敏。

The company has aligned with the FDA under the Accelerated Approval Program for toddlers aged 1–3.

根据1-3岁幼儿加速审批计划，该公司已与FDA达成一致。

DBV has agreed to the FDA’s guidance on key study components required for approval, including the COMFORT Toddlers safety study, which must be completed before the US marketing application submission, and a confirmatory study to demonstrate the patch’s effectiveness.

DBV已同意FDA关于批准所需关键研究组成部分的指导，包括必须在美国市场申请提交之前完成的舒适幼儿安全研究，以及证明该补丁有效性的验证性研究。

DBV plans to begin enrolling subjects in the COMFORT Toddlers study in the second quarter of 2025, with around 300–350 toddlers.

DBV计划在2025年第二季度开始招收舒适幼儿研究的受试者，约有300-350名幼儿。

DBV has also made headway on the Viaskin Peanut patch for older children. In September 2024, the company completed patient screening for the Phase 3 VITESSE trial, enrolling 654 children aged 4–7 years. Topline data are expected in the fourth quarter of 2025.

DBV还为年龄较大的儿童开发了Viaskin花生贴片。2024年9月，该公司完成了3期VITESSE试验的患者筛查，招募了654名4-7岁儿童。Topline数据预计将于2025年第四季度发布。

Discussions between DBV and the FDA have also addressed the patch’s adhesion issues. The company proposed a labeling solution that links adhesion data to the patch’s efficacy and safety.

DBV和FDA之间的讨论也解决了贴片的粘附问题。该公司提出了一种标签解决方案，将粘附数据与贴片的功效和安全性联系起来。

DBV also received scientific advice from the European Medicines Agency for a broader age range of 1–7 years in Europe.

DBV还获得了欧洲药品管理局的科学建议，在欧洲的年龄范围更广，为1-7岁。

In Europe, DBV has received scientific advice confirming that the EPITOPE study in 1–3-year-olds and positive results from the VITESSE study could support the European marketing application for the 1–7-year-old age group.

在欧洲，DBV收到了科学建议，证实1-3岁儿童的表位研究和VITESSE研究的阳性结果可以支持1-7岁年龄组的欧洲营销应用。

The company is planning a new safety study for toddlers with the modified patch to meet European requirements.

该公司正计划为学步儿童进行一项新的安全性研究，以满足欧洲的要求。

Despite its clinical progress, DBV’s financial situation raises concerns. The company reported cash and cash equivalents of $46.4 million as of September 30, 2024, and anticipates that this will fund operations only through the first quarter of 2025.

尽管取得了临床进展，但DBV的财务状况仍令人担忧。截至2024年9月30日，该公司报告的现金和现金等价物为4640万美元，预计这将仅为2025年第一季度的运营提供资金。

With ongoing operating losses, DBV has expressed uncertainty about its ability to continue operations without securing additional funding. The company is actively seeking new capital to support its research and potential product launch.

由于持续经营亏损，DBV表示不确定其在不获得额外资金的情况下继续经营的能力。该公司正在积极寻求新的资金来支持其研究和潜在的产品发布。

Price Action: DBVT stock is up 44.3% at $1.02 at last check Wednesday.

价格走势：DBVT股价周三上涨44.3%，至1.02美元。