FDA recommends another large trial for new schizophrenia drug

Reviva (NASDAQ: RVPH) announced a regulatory update on Dec 23, 2025 following a pre-NDA meeting with the FDA about brilaroxazine for schizophrenia. The FDA provided written feedback recommending a second Phase 3 trial to generate additional efficacy and safety data prior to an NDA submission.

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Im reasonably happy with Abilify maintena(spelling?) right now. It would take proven reductions in negative symptoms probably to get me to switch again. Or some other major benefit.

And even then, I would probably wait it out for a couple/few years.

I dont like risking unknown long term use side effects on new drugs.

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