The U.S. Food and Drug Administration granted on Tuesday Fast Track designation to

美国食品和药物管理局（FDA）于周二授予了快速通道资格认定

Johnson & Johnson’s

强生公司

JNJ

强生公司

investigational nipocalimab for moderate-to-severe

研究性nipocalimab用于中至重度

Sjögren’s disease (SjD)

干燥综合征 (SjD)

.

。

Last year, FDA granted Breakthrough Therapy designation (BTD) for

去年，FDA授予了突破性疗法认定（BTD）

the investigational therapy

研究性疗法

.

。

The Phase 2 DAHLIAS study,

第2阶段DAHLIAS研究，

presented last year

去年提交

, represented the first-ever positive results of an investigational FcRn blocker as a potential targeted therapy in SjD.

，代表了研究性FcRn阻断剂作为SjD潜在靶向治疗的首次取得积极结果。

The study

研究

achieved the primary endpoint in the 15 mg/kg Q2W nipocalimab group, showing a greater than 70% relative average improvement in systemic disease activity at Week 24 compared to placebo and IgG reductions of more than 77%.

在15 mg/kg Q2W nipocalimab组中达到了主要终点，显示在第24周时，与安慰剂相比，系统性疾病活动的相对平均改善超过70%，IgG降低超过77%。

Also Read:

另请阅读：

Cancer-Focused Nanobiotix Adjusts $2.7 Billion Johnson & Johnson Agreement To Strengthen Finances And Relieve Funding Burden

专注于癌症的纳米生物公司调整与强生公司的 27 亿美元协议以加强财务状况并减轻资金负担

Trends of improvement were similarly observed across multiple secondary endpoints. Safety and tolerability were consistent with other nipocalimab clinical studies.

在多个次要终点观察到类似的改善趋势。安全性和耐受性与其他nipocalimab临床研究一致。

Sjögren’s disease, also known as Sjögren’s syndrome, is a chronic autoimmune disorder that primarily affects the body’s exocrine glands (or moisture-producing glands), particularly those responsible for producing tears and saliva, leading to dry eyes and mouth.

干燥综合征，也称为舍格伦综合征，是一种慢性自身免疫性疾病，主要影响身体的外分泌腺（或产湿腺），特别是那些负责产生泪液和唾液的腺体，导致眼干和口干。

Earlier this month, Johnson & Johnson decided to discontinue the Phase 3 VENTURA development program evaluating aticaprant, a kappa opioid receptor (KOR) antagonist, as an adjunctive treatment for major depressive disorder (aMDD). The move follows insufficient efficacy in the target patient population.

本月初，强生公司决定终止评估 kappa 阿片受体 (KOR) 拮抗剂 aticaprant 作为重度抑郁症 (aMDD) 辅助治疗的 III 期 VENTURA 开发项目，原因是在目标患者群体中疗效不足。

The data confirmed aticaprant is safe and well-tolerated, and no new safety .

数据证实aticaprant是安全的且耐受性良好，没有新的安全性问题。

signals were identified

信号被识别

.

。

In February,

二月，

Sanofi SA

赛诺菲公司

SNY

索尼

and Johnson & Johnson discontinued the E.mbrace phase 3 study evaluating a vaccine candidate for extraintestinal pathogenic

强生公司停止了评估肠外致病性疫苗候选物的E.mbrace第三阶段研究

E. coli.

大肠杆菌。

The companies determined that the vaccine candidate was not sufficiently effective at preventing invasive E. coli disease (IED)

这些公司确定，该疫苗候选物在预防侵袭性大肠杆菌病（IED）方面效果不佳。

compared to placebo

与安慰剂相比

.

。

JNJ Price Action:

JNJ价格走势：

Johnson & Johnson stock is up 0.71% at $164 at publication Tuesday.

强生公司股票在周二发布时上涨了 0.71%，达到 164 美元。

Read Next:

接下来阅读：

Tesla Rival Zeekr To Provide Free Advanced Driver-Assistance Tech In China: Report

据报道，特斯拉的竞争对手极氪将在中国提供免费的高级驾驶辅助技术。

Photo: Gorodenkoff via Shutterstock

照片来源：Gorodenkoff 通过 Shutterstock

JNJ

强生公司

Johnson & Johnson

强生公司

$163.94

163.94美元

0.68

0.68

%

%

Stock Score Locked: Want to See it?

股票评分已锁定：想看看吗？

Benzinga Rankings give you vital metrics on any stock – anytime.

Benzinga排名为您提供任何股票的关键指标——随时。

Reveal Full Score

显示完整分数

Edge Rankings

边缘排名

Momentum

动量

51.67

51.67

Growth

增长

77.15

77.15

Quality

质量

20.19

20.19

Value

值

20.74

20.74

Price Trend

价格趋势

Short

短的

Medium

中等

Long

长

Overview

概述

SNY

索尼

Sanofi SA

赛诺菲集团

$59.00

59.00美元

0.14

0.14

%

%

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