FDA accepts new submission for Biohaven’s Vyglxia, opening path to approval

Biohaven announced that the FDA has accepted a refreshed application for its rare disease drug Vyglxia, which targets a nerve‑damaging disorder.

Vyglxia is being developed for spinocerebellar ataxia, a group of rare genetic conditions that cause progressive loss of balance, coordination and speech.

The agency will convene an advisory panel to review the data, with a decision expected in the first quarter of next year.

The filing gives Biohaven, a Pfizer‑acquired migraine developer, another opportunity to secure regulatory clearance after a prior rejection.