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 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.