Core Insights - The U.S. Food and Drug Administration (FDA) has allowed Rapport Therapeutics to advance RAP-219 into registrational trials for focal onset seizures (FOS), with Phase 3 program initiation expected in Q2 2026 [1][4] - The company is expanding its epilepsy portfolio to include primary generalized tonic-clonic seizures (PGTCS) based on strong Phase 2a data [1][4] - Other pipeline programs, including a Phase 2 trial in bipolar mania and long-acting injectable development, are progressing [1][11] Clinical and Pipeline Updates - Rapport is prioritizing programs with the greatest potential for patient impact and long-term value, aiming for a strong milestone cadence throughout 2026 and beyond [3] - The Phase 2a data in FOS supports a multi-billion dollar market opportunity, with estimates suggesting a greater than $2 billion commercial opportunity in the U.S. if approved [4] - An open-label long-term safety trial for RAP-219 has been initiated, with initial data expected in H2 2026 [4] - The company plans to initiate a Phase 3 trial for RAP-219 in PGTCS in the first half of 2027 [4] Business Updates - The company ended Q3 with $513 million in cash, expected to fund operations into the second half of 2029 [12] - The FDA has lifted the clinical hold on the diabetic peripheral neuropathic pain (DPNP) trial, but the company is deferring further investment in this program to focus on the α6β4 program for chronic pain and migraine [11][12] - Rapport will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026 [12]
Rapport Therapeutics Announces Accelerated Initiation of RAP-219 Phase 3 Program, Expansion of Epilepsy Portfolio, and Continued Progress Across the Pipeline