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Rapport Therapeutics Announces Accelerated Initiation of RAP-219 Phase 3 Program, Expansion of Epilepsy Portfolio, and Continued Progress Across the Pipeline
U.S. Food and Drug Administration (FDA) allows advancement of RAP-219 into registrational trials for focal onset seizures (FOS); accelerated initiation of
About this update from Rapport Therapeutics, Inc.
[{"type":"text","content":"U.S. Food and Drug Administration (FDA) allows advancement of RAP-219 into registrational trials for focal onset seizures (FOS); accelerated initiation of Phase 3 program expected in the second quarter of 2026 On strength of RAP-219 Phase 2a FOS data, epilepsy portfolio expanded with new program in primary generalized tonic-clonic seizures (PGTCS) Phase 2 trial in bipolar mania, long-acting injectable, and other pipeline programs continuing to progress BOSTON and SAN DIEGO, Jan. 07, 2026 (GLOBE NEWSWIRE) -- Rapport Therapeutics, Inc. (Nasdaq: RAPP) (“Rapport” or the “Company”), a clinical-stage biotechnology company dedicated to the discovery and development of small molecule precision medicines for patients with neurological and psychiatric disorders, today announced plans to initiate its Phase 3 program for RAP-219 in FOS in the second quarter of 2026 and expand its epilepsy portfolio with a new program in PGTCS. Additionally, the Company announced progress across its pipeline, including its Phase 2 bipolar mania trial, long-acting injectable development, FDA’s removal of the clinical hold on its Phase 2 diabetic peripheral neuropathic pain (DPNP) trial, and advancement of additional pipeline programs. “Aligned with the FDA and supported by robust Phase 2a data in focal onset seizures, where we believe RAP-219 potentially represents a multi-billion-dollar market opportunity, we are initiating our Phase 3 trials in FOS ahead of plan,” said Abraham N. Ceesay, chief executive officer of Rapport. “We are excited to expand clinical development into primary generalized tonic-clonic seizures, reflecting our focus on building a growing epilepsy portfolio with a potential best-in-class profile in RAP-219 that will serve as a core strategic pillar for the Company. We are also advancing other important opportunities, including our Phase 2 trial in bipolar mania, long-acting injectable, and additional pipeline programs, applying our precision medicine approach to high unmet-need indications.” “We are focusing resources on the programs we believe are best positioned to drive impact and value creation. As we advance our strategy in pain, we plan to prioritize our promising α6β4 program in chronic pain and migraine and are deferring investment in the DPNP program for RAP-219 at this time. As we look to the new year ahead, we expect to build ...