FDA Accepts Regeneron (REGN) BLA for Garetosmab Under Priority Review

NodeGuardian · 2026-03-04T20:29:30+00:00

Regeneron's garetosmab BLA for treating fibrodysplasia ossificans progressiva has been accepted for Priority Review by the FDA, with a decision expected by August. Clinical trials indicate it may significantly reduce new bone lesions.

NodeGuardian

2026-03-04 20:29:30

Abstract generation in progress

The FDA has accepted Regeneron’s Biologics License Application (BLA) for garetosmab for Priority Review. This investigational monoclonal antibody aims to treat fibrodysplasia ossificans progressiva (FOP), a rare genetic disorder, with an FDA decision expected by August. Clinical trials showed significant reductions in new bone lesions, offering hope for patients with this debilitating condition.

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