The FDA has granted Fast Track designation to Cerecor Inc's (NASDAQ: CERC) CERC-002 to treat hospitalized patients with COVID-19.

FDA已授予Cerecor公司(NASDAQ: CERC) CERC-002快速通道指定，用于治疗COVID-19住院患者。

CERC-002 is a first-in-class fully human monoclonal antibody targeting LIGHT (tumor necrosis factor superfamily member 14, TNFSF14).

CERC-002是一类靶向LIGHT(肿瘤坏死因子超家族成员14,TNFSF14)的全人源单克隆抗体。

Fast Track designation provides an opportunity for more frequent interactions with the FDA review team throughout the development program.

快速通道指定提供了一个机会，在整个开发计划与FDA审查团队更频繁的互动。

Under Fast Track designation, a Biologic License Application (BLA) for CERC-002 is eligible for both rolling submission and priority review.1

在快速通道指定下，CERC-002的生物许可证申请(BLA)有资格滚动提交和优先审查

In March, the company announced final efficacy data from the Phase 2 trial evaluating CERC-002 for COVID-19 associated pneumonia and acute respiratory distress syndrome (ARDS).

今年3月，该公司公布了评估CERC-002治疗COVID-19相关肺炎和急性呼吸窘迫综合征(ARDS)的2期临床试验的最终疗效数据。

At both the 28-day and the 60-day final timepoints, an approximately 50% trend in mortality reduction (22.5% vs. 10.8%) was observed.

在28天和60天的最终时间点，观察到死亡率下降约50%的趋势(22.5%对10.8%)。

Price Action: CERC shares are up 15% at $2.92 during the premarket session on the last check Tuesday.

价格走势:在周二最后一次查盘前交易中，CERC股价上涨15%至2.92美元。