Regeneron says the FDA accepted its cemdisiran application for priority review, with a target action date in November 2026. The investigational small-interfering-RNA therapy is being studied for adults with antibody-positive generalized myasthenia gravis.
What is known.
In the NIMBLE Phase 3 trial, Regeneron reported that cemdisiran met the primary and key secondary endpoints. The company described subcutaneous dosing every 12 weeks; it also stated the treatment had not yet been approved by a regulator.
Why it is a possibility.
A positive controlled trial and an accepted priority-review application create a concrete path to a 2026 decision. Those milestones support the provisional 75% estimate.
Priority review sets a target, not an approval guarantee. Reviewers may require more work on efficacy, safety, labeling or manufacturing before the exact indication in this call can be cleared.
What could prevent it.
A remaining safety, efficacy, labeling, or manufacturing concern could delay approval.
How it will be assessed.
Resolves YES only if the FDA approves cemdisiran for adults with anti-acetylcholine-receptor-antibody-positive generalized myasthenia gravis by 31 December 2026. Acceptance for review or approval of another drug does not count.
Sources and primary records
Probabilities are provisional editorial estimates, not guarantees. Sources document the present evidence and resolution rule. Read the full disclaimer.