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

05/11/2021 09:15
  • 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.