Lyra Therapeutics Stock Is Trading Higher After Positive FDA Meeting Outcome For Rhinosinusitis Program

  • Lyra Therapeutics Inc LYRA announced the successful outcome of an End-of-Phase 2 (EOP2) meeting with the FDA for LYR-210, its lead candidate for the treatment of chronic rhinosinusitis (CRS).
  • Lyra and the FDA established key elements of the Phase 3 program.
  • The single primary endpoint will evaluate improvement at week 24 using a composite score of three cardinal symptoms of CRS: nasal blockage, nasal discharge, and facial pain.
  • Based on the Agency's suggestion, Lyra will enroll approximately 350 subjects split into two replicate, largely concurrent Phase 3 clinical trials.
  • Both studies will evaluate a 7500µg dose of LYR-210, and additional key clinical aspects of the studies will also be the same.
  • The Phase 3 trial is expected to start by the end of 2021.
  • Related content: Benzinga's Full FDA Calendar.
  • Price Action: LYRA shares are up 19.4% at $9.4 during the premarket session on the last check Wednesday.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsHealth CareFDAGeneralBriefsRhinosinusitis
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!