Rapport Therapeutics, Inc. (RAPP) said the U.S. FDA has cleared the company to advance RAP-219 into registrational trials, allowing accelerated initiation of its Phase 3 program in focal onset seizures (FOS) during the second quarter of 2026.
The decision follows robust Phase 2a data and positions RAP-219 as a potential best-in-class therapy in epilepsy.
Focal onset seizures are among the most common forms of epilepsy, often presenting as recurrent episodes. Current therapies can be limited by tolerability and incomplete efficacy, leaving significant unmet need for patients.
RAP-219, a precision small-molecule therapy, is designed to selectively target receptor- associated proteins in the brain to improve seizure control.
The Phase 3 program will be a multicenter, randomized, double-blind trial enrolling adults with focal onset seizures. Participants will receive RAP-219 or placebo, with endpoints focused on seizure frequency reduction and long-term safety.
Rapport has also initiated an open-label extension study to allow patients from the Phase 2a trial to resume treatment, with initial data expected in the second half of 2026.
Building on the strength of its epilepsy program, Rapport is expanding development into primary generalized tonic-colonic seizures (PGTCS), the most common type of generalized seizure.
A Phase 3 trial in PGTCS is planned for the first half of 2027. The company is also progressing a Phase 2 trial of RAP-219 in bipolar mania, developing a long-acting injectable formulation, and advancing additional pipeline programs in chronic pain, migraine, and hearing disorders.
The company ended the third quarter with cash, cash equivalents and short-term investments of $531 million, sufficient to fund operations into the second half of 2029.
RAPT has traded between $5.66 and $42.39 over the past year. The stock closed yesterday's trading at $32.42, up 5.16%, and rose further in the after-hours to $32.90, up 1.48%.
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