Benzinga | May 11, 2021 09:15AM EDT

Cerecor Shares Gain After FDA Fast Track Review Tag For CERC-002 In Hospitalized COVID-19 Patients

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

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

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

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

* 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).

* 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.

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