Reviva: FDA Alignment on Brilaroxazine Clinical Trials for NDA in Schizophrenia

  FDA acceptance of 4-week global registrational Phase 3 RECOVER-2 study -

- Two positive 4-week studies plus a 12-month long-term safety study have potential to support a New Drug Application (NDA) for brilaroxazine in schizophrenia –

- Topline data from 1-year open-label extension (OLE) long-term safety trial expected in Q4 2024 -

https://www.globenewswire.com/news-release/2024/04/15/2862775/0/en/Reviva-Announces-FDA-Alignment-on-Brilaroxazine-Clinical-Trials-for-NDA-in-Schizophrenia.html