Rapport Therapeutics (RAPP) FDA Approvals $26.20 +1.14 (+4.55%) As of 03:05 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsInsider TradesNews and TrendsOptions ChainOwnershipSEC FilingsShort Interest Rapport Therapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Rapport Therapeutics (RAPP). Over the past two years, Rapport Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as RAP-219. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. RAP-219 FDA Regulatory Timeline and Events RAP-219 is a drug developed by Rapport Therapeutics for the following indication: For CNS Disorders. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Top-line results - October 20,2026Top-Line Results Phase 2Drug: RAP-219Announced Date: October 20, 2026Indication: For CNS DisordersAnnouncementRapport Therapeutics, Inc. announced positive topline results from its Phase 2 trial of RAP-219 in adults with acute bipolar mania.Read AnnouncementProvided Update - March 9,2026Provided Update Drug: RAP-219Announced Date: March 9, 2026Indication: For CNS DisordersAnnouncementRapport Therapeutics, Inc announced a collaboration granting Tenacia exclusive rights to develop and commercialize RAP-219 in Greater China, including in mainland China, Hong Kong, Macau and Taiwan.AI SummaryRapport Therapeutics announced a collaboration giving Tenacia Biotechnology exclusive rights to develop and commercialize RAP-219 in Greater China — defined as mainland China, Hong Kong, Macau and Taiwan. The agreement covers multiple indications, including focal onset seizures and bipolar mania, allowing Tenacia to lead local clinical development, regulatory filings and commercialization in those territories. Rapport said the partnership leverages Tenacia’s experience in central nervous system drug development and commercialization to help accelerate RAP-219’s U.S. and global development while Tenacia focuses on bringing the medicine to patients in Greater China. The deal aims to combine Rapport’s clinical program with Tenacia’s regional expertise and commercial capabilities. Financial terms include a $20 million upfront payment to Rapport, up to $308 million in potential development and commercial milestones, additional payments, and tiered royalties in the mid-single-digit to mid-teens range.Read AnnouncementStudy Initiation - January 7,2026Study Initiation Phase 3Drug: RAP-219Announced Date: January 7, 2026Target Action Date: Q2 2026Estimated Target Date Range: April 1, 2026 - June 30, 2026Indication: For CNS DisordersAnnouncementRapport Therapeutics, Inc 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.AI SummaryRapport Therapeutics plans to start a Phase 3 program for RAP-219 in focal onset seizures (FOS) in the second quarter of 2026, accelerating development after strong Phase 2a results that suggest a potential best-in-class profile and a multi‑billion dollar U.S. market opportunity if approved. The company has also opened an on‑label long‑term safety study to allow prior Phase 2a participants to resume RAP-219; initial data from that trial are expected in the second half of 2026. Building on the FOS data, Rapport is expanding its epilepsy program into primary generalized tonic‑clonic seizures (PGTCS) and plans to initiate a Phase 3 trial in PGTCS in the first half of 2027. The company is also advancing RAP-219’s long‑acting injectable formulation and continuing other clinical programs, keeping epilepsy as a core focus of its pipeline. Read AnnouncementNew Data - December 5,2025New Data Drug: RAP-219Announced Date: December 5, 2025Indication: For CNS DisordersAnnouncementRapport Therapeutics, Inc announced new data and post hoc analysis on clinical and patient reported benefits of RAP-219 in drug-resistant focal onset seizures (FOS), alongside topline efficacy and safety data from its recently reported Phase 2a FOS trial.AI SummaryRapport Therapeutics reported new data and a post-hoc analysis from its Phase 2a trial of RAP-219 in adults with drug‑resistant focal onset seizures. Presented at the American Epilepsy Society meeting, the results show early onset of action and steady clinical benefit across the full 8‑week treatment period. Median reductions in long episodes were about 71–75% across weeks 1–8, and median clinical seizure reductions were about 78% overall. RAP-219 showed consistent efficacy regardless of baseline disease severity: ≥30% long‑episode responder rates were ~85% whether baseline frequency was ≤48 or >48, and ≥50% clinical seizure responder rates were ~69–75% across lower and higher baseline seizure counts. Seizure freedom over 8 weeks occurred in about 24% of patients. Among patients with moderate or worse baseline impairment, RAP-219 improved seizure recovery time, thinking/concentration after seizures, interference with daily activities, and overall seizure intensity. The 30‑patient trial met its primary endpoint and RAP-219 was generally well tolerated, with mostly mild adverse events and a 10% discontinuation rate.Read AnnouncementResults - November 25,2025Results Phase 2Drug: RAP-219Announced Date: November 25, 2025Indication: For CNS DisordersAnnouncementRapport Therapeutics, Inc. announced that the Company will present the results of its Phase 2a trial of RAP-219 in focal onset seizures (FOS), along with new efficacy analysis, at the upcoming 2025 American Epilepsy Society (AES) Annual Meeting, taking place December 5–9, 2025, in Atlanta.AI SummaryRapport Therapeutics announced it will present results from its Phase 2a trial of RAP-219 for focal onset seizures at the 2025 American Epilepsy Society (AES) Annual Meeting, Dec. 5–9 in Atlanta. The company said it will share topline efficacy and safety findings, present new efficacy analyses during poster sessions, and host a dedicated Scientific Exhibit Room to highlight the RAP-219 clinical program. New data to be presented include RAP-219’s effect during the first month of treatment, consistency of efficacy across the treatment period, how baseline disease severity influences outcomes, and the drug’s impact on seizure severity and long episodes recorded by implanted RNS systems. Rapport will present posters on Dec. 7 (Poster 2.489) and Dec. 8 (Poster 3.355) and hold an exhibit room on Dec. 7; posters will be posted on the company’s website after the conference.Read AnnouncementClinical Trial - September 8,2025Clinical Trial Phase 2aDrug: RAP-219Announced Date: September 8, 2025Indication: For CNS DisordersAnnouncementRapport Therapeutics, Inc announced that the Phase 2a clinical trial of RAP-219 (RAP-219-FOS-201) in patients with drug-resistant focal onset seizures met its primary endpoint, demonstrating a statistically significant reduction in long episodes (LEs) – an objective electrographic biomarker for clinical seizure reduction – compared with baseline over the 8-week treatment period. In the trial, RAP-219 also demonstrated a statistically significant and clinically meaningful reduction in clinical seizures compared with baseline.AI SummaryRapport Therapeutics reported that its Phase 2a trial of RAP-219 in patients with drug-resistant focal onset seizures met the primary endpoint by achieving a statistically significant reduction in long episodes (LEs)—an electrographic biomarker tied to clinical seizure activity—over the eight-week treatment. In the modified intent-to-treat group, 85.2% of patients saw at least a 30% reduction in LEs (p<0.0001), with a median 71% drop from baseline (p=0.0001). RAP-219 also delivered a clinically meaningful cut in actual seizure events. Patients experienced a median 77.8% decrease in clinical seizures (p=0.01), 72% achieved at least a 50% reduction (p<0.0001), and 24% reached seizure freedom for the full eight weeks (p<0.0001). The medication was generally well tolerated, with mostly mild or moderate side effects and a low discontinuation rate. Based on these results, Rapport plans to initiate two Phase 3 registrational trials starting in the third quarter of 2026.Read AnnouncementPresentation - June 2,2025Presentation Drug: RAP-219Announced Date: June 2, 2025Indication: For CNS DisordersAnnouncementRapport Therapeutics, Inc today will host its inaugural Investor and Analyst Day, featuring presentations from Rapport's executive team on the Company's strategic priorities and updates from its clinical pipeline, including progress on the RAP-219 Phase 2a trial in focal epilepsy.AI SummaryRapport Therapeutics announced that it will host its inaugural Investor and Analyst Day, where the executive team will share the company’s strategic priorities and offer updates on its clinical pipeline. A key focus of the event is the progress on the RAP-219 Phase 2a trial in focal epilepsy. This trial, which is now fully enrolled, is designed to assess the potential of RAP-219 in treating refractory focal epilepsy using intracranial EEG data as a measure of its effect on long episodes that correlate with clinical seizures. The event will also feature a fireside chat with Dr. Jacqueline French, a leading epilepsy expert from NYU Langone, who will discuss the trial design and the unmet needs in focal epilepsy. Materials and a live stream will be available on the company website, providing investors and analysts with in-depth insights into the company’s developments.Read AnnouncementPoster Presentation - March 21,2025Poster Presentation Drug: RAP-219Announced Date: March 21, 2025Indication: For CNS DisordersAnnouncementRapport Therapeutics, Inc. announced two encore poster presentations at the 2025 American Academy of Neurology (AAN) Annual Meeting, taking place from April 5 to April 9, 2025, in San Diego, California. The data from these posters was originally presented at the American Epilepsy Society (AES) Annual Meeting in December 2024.AI SummaryRapport Therapeutics, Inc. announced two encore poster presentations at the 2025 American Academy of Neurology (AAN) Annual Meeting in San Diego, California, scheduled for April 5–9, 2025. These presentations revisit data first shared at the American Epilepsy Society Annual Meeting in December 2024 and focus on the company's ongoing research and development of RAP-219, an AMPA receptor negative allosteric modulator now in Phase 2 trials for refractory focal epilepsy. The first poster demonstrates that a 30% reduction in long episode frequency correlates with a clinically meaningful (≥50%) decrease in seizure activity. The second poster details how RAP-219 showed strong, dose-dependent antiseizure effects in preclinical models. These findings highlight the potential of RAP-219 as a precision treatment for epilepsy and underline Rapport Therapeutics’ commitment to advancing innovative therapies for neurological disorders.Read AnnouncementTop-line results - January 9,2025Top-Line Results Phase 2aDrug: RAP-219Announced Date: January 9, 2025Target Action Date: H1 2025Estimated Target Date Range: January 1, 2025 - June 30, 2025Indication: For CNS DisordersAnnouncementRapport Therapeutics, Inc Ongoing Phase 2a trial of RAP-219 in focal epilepsy is on track and topline data is expected in mid-2025AI SummaryRapport Therapeutics, Inc. announced promising updates from its trials for RAP-219, a treatment aimed at focal epilepsy. In the ongoing Phase 2a trial, RAP-219 is showing great promise with the current dosing regimen. Recent PET trial data confirmed that RAP-219 quickly reached and exceeded the target receptor occupancy needed for maximum efficacy within five days. This supports the approach used in the Phase 2a trial, and the drug was well tolerated by participants. The targeted action of RAP-219, focusing on TARP8 in key brain regions such as the hippocampus and cerebral cortex, suggests the potential for effective treatment with fewer side effects. Topline data from this trial is expected in mid-2025, marking an important milestone in developing a new option for patients struggling with refractory focal epilepsy.Read AnnouncementResults - January 9,2025Results Drug: RAP-219Announced Date: January 9, 2025Indication: For CNS DisordersAnnouncementRapport Therapeutics, Inc. announced results from its positron emission tomography (PET) trial and second multiple ascending dose (MAD-2) trial for RAP-219.AI SummaryRapport Therapeutics, Inc. announced promising results from two Phase 1 trials for RAP-219. In the positron emission tomography (PET) trial, RAP-219 reached and exceeded the target receptor occupancy needed for maximal efficacy within five days using the same dosing regimen as the current Phase 2a trial in focal epilepsy. The trial also confirmed that the targeted protein, TARP8, is mainly found in the hippocampus and cerebral cortex, with little expression in the cerebellum and brain stem. In the second multiple ascending dose (MAD-2) trial, RAP-219 was generally well tolerated even with faster dose titration and higher exposure levels compared to earlier studies. These results support the dosing strategy and highlight RAP-219’s broad therapeutic index, reinforcing its potential as a treatment in the ongoing clinical evaluation for focal epilepsy.Read Announcement Rapport Therapeutics FDA Events - Frequently Asked Questions Has Rapport Therapeutics received FDA approval? As of now, Rapport Therapeutics (RAPP) has not received any FDA approvals for its therapy in the last two years. What drugs has Rapport Therapeutics submitted to the FDA? In the past two years, Rapport Therapeutics (RAPP) has reported FDA regulatory activity for RAP-219. What is the most recent FDA event for Rapport Therapeutics? The most recent FDA-related event for Rapport Therapeutics occurred on October 20, 2026, involving RAP-219. The update was categorized as "Top-line results," with the company reporting: "Rapport Therapeutics, Inc. announced positive topline results from its Phase 2 trial of RAP-219 in adults with acute bipolar mania." What conditions do Rapport Therapeutics' current drugs treat? Currently, Rapport Therapeutics has one therapy (RAP-219) targeting the following condition: For CNS Disorders. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Arbutus Biopharma FDA EventsAcumen Pharmaceuticals FDA EventsCognition Therapeutics FDA EventsCorbus Pharmaceuticals FDA EventsDiaMedica Therapeutics FDA EventsGilead Sciences FDA EventsSCYNEXIS FDA EventsSciSparc FDA EventsAbbVie FDA EventsMedtronic FDA EventsTeleflex FDA EventsAchieve Life Sciences FDA EventsBioCryst Pharmaceuticals FDA EventsHeartBeam FDA EventsCardiff Oncology FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Veradermics FDA Events Definium Therapeutics FDA Events Organon & Co. 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Top-line results - October 20,2026Top-Line Results Phase 2Drug: RAP-219Announced Date: October 20, 2026Indication: For CNS DisordersAnnouncementRapport Therapeutics, Inc. announced positive topline results from its Phase 2 trial of RAP-219 in adults with acute bipolar mania.Read Announcement
Provided Update - March 9,2026Provided Update Drug: RAP-219Announced Date: March 9, 2026Indication: For CNS DisordersAnnouncementRapport Therapeutics, Inc announced a collaboration granting Tenacia exclusive rights to develop and commercialize RAP-219 in Greater China, including in mainland China, Hong Kong, Macau and Taiwan.AI SummaryRapport Therapeutics announced a collaboration giving Tenacia Biotechnology exclusive rights to develop and commercialize RAP-219 in Greater China — defined as mainland China, Hong Kong, Macau and Taiwan. The agreement covers multiple indications, including focal onset seizures and bipolar mania, allowing Tenacia to lead local clinical development, regulatory filings and commercialization in those territories. Rapport said the partnership leverages Tenacia’s experience in central nervous system drug development and commercialization to help accelerate RAP-219’s U.S. and global development while Tenacia focuses on bringing the medicine to patients in Greater China. The deal aims to combine Rapport’s clinical program with Tenacia’s regional expertise and commercial capabilities. Financial terms include a $20 million upfront payment to Rapport, up to $308 million in potential development and commercial milestones, additional payments, and tiered royalties in the mid-single-digit to mid-teens range.Read Announcement
Study Initiation - January 7,2026Study Initiation Phase 3Drug: RAP-219Announced Date: January 7, 2026Target Action Date: Q2 2026Estimated Target Date Range: April 1, 2026 - June 30, 2026Indication: For CNS DisordersAnnouncementRapport Therapeutics, Inc 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.AI SummaryRapport Therapeutics plans to start a Phase 3 program for RAP-219 in focal onset seizures (FOS) in the second quarter of 2026, accelerating development after strong Phase 2a results that suggest a potential best-in-class profile and a multi‑billion dollar U.S. market opportunity if approved. The company has also opened an on‑label long‑term safety study to allow prior Phase 2a participants to resume RAP-219; initial data from that trial are expected in the second half of 2026. Building on the FOS data, Rapport is expanding its epilepsy program into primary generalized tonic‑clonic seizures (PGTCS) and plans to initiate a Phase 3 trial in PGTCS in the first half of 2027. The company is also advancing RAP-219’s long‑acting injectable formulation and continuing other clinical programs, keeping epilepsy as a core focus of its pipeline. Read Announcement
New Data - December 5,2025New Data Drug: RAP-219Announced Date: December 5, 2025Indication: For CNS DisordersAnnouncementRapport Therapeutics, Inc announced new data and post hoc analysis on clinical and patient reported benefits of RAP-219 in drug-resistant focal onset seizures (FOS), alongside topline efficacy and safety data from its recently reported Phase 2a FOS trial.AI SummaryRapport Therapeutics reported new data and a post-hoc analysis from its Phase 2a trial of RAP-219 in adults with drug‑resistant focal onset seizures. Presented at the American Epilepsy Society meeting, the results show early onset of action and steady clinical benefit across the full 8‑week treatment period. Median reductions in long episodes were about 71–75% across weeks 1–8, and median clinical seizure reductions were about 78% overall. RAP-219 showed consistent efficacy regardless of baseline disease severity: ≥30% long‑episode responder rates were ~85% whether baseline frequency was ≤48 or >48, and ≥50% clinical seizure responder rates were ~69–75% across lower and higher baseline seizure counts. Seizure freedom over 8 weeks occurred in about 24% of patients. Among patients with moderate or worse baseline impairment, RAP-219 improved seizure recovery time, thinking/concentration after seizures, interference with daily activities, and overall seizure intensity. The 30‑patient trial met its primary endpoint and RAP-219 was generally well tolerated, with mostly mild adverse events and a 10% discontinuation rate.Read Announcement
Results - November 25,2025Results Phase 2Drug: RAP-219Announced Date: November 25, 2025Indication: For CNS DisordersAnnouncementRapport Therapeutics, Inc. announced that the Company will present the results of its Phase 2a trial of RAP-219 in focal onset seizures (FOS), along with new efficacy analysis, at the upcoming 2025 American Epilepsy Society (AES) Annual Meeting, taking place December 5–9, 2025, in Atlanta.AI SummaryRapport Therapeutics announced it will present results from its Phase 2a trial of RAP-219 for focal onset seizures at the 2025 American Epilepsy Society (AES) Annual Meeting, Dec. 5–9 in Atlanta. The company said it will share topline efficacy and safety findings, present new efficacy analyses during poster sessions, and host a dedicated Scientific Exhibit Room to highlight the RAP-219 clinical program. New data to be presented include RAP-219’s effect during the first month of treatment, consistency of efficacy across the treatment period, how baseline disease severity influences outcomes, and the drug’s impact on seizure severity and long episodes recorded by implanted RNS systems. Rapport will present posters on Dec. 7 (Poster 2.489) and Dec. 8 (Poster 3.355) and hold an exhibit room on Dec. 7; posters will be posted on the company’s website after the conference.Read Announcement
Clinical Trial - September 8,2025Clinical Trial Phase 2aDrug: RAP-219Announced Date: September 8, 2025Indication: For CNS DisordersAnnouncementRapport Therapeutics, Inc announced that the Phase 2a clinical trial of RAP-219 (RAP-219-FOS-201) in patients with drug-resistant focal onset seizures met its primary endpoint, demonstrating a statistically significant reduction in long episodes (LEs) – an objective electrographic biomarker for clinical seizure reduction – compared with baseline over the 8-week treatment period. In the trial, RAP-219 also demonstrated a statistically significant and clinically meaningful reduction in clinical seizures compared with baseline.AI SummaryRapport Therapeutics reported that its Phase 2a trial of RAP-219 in patients with drug-resistant focal onset seizures met the primary endpoint by achieving a statistically significant reduction in long episodes (LEs)—an electrographic biomarker tied to clinical seizure activity—over the eight-week treatment. In the modified intent-to-treat group, 85.2% of patients saw at least a 30% reduction in LEs (p<0.0001), with a median 71% drop from baseline (p=0.0001). RAP-219 also delivered a clinically meaningful cut in actual seizure events. Patients experienced a median 77.8% decrease in clinical seizures (p=0.01), 72% achieved at least a 50% reduction (p<0.0001), and 24% reached seizure freedom for the full eight weeks (p<0.0001). The medication was generally well tolerated, with mostly mild or moderate side effects and a low discontinuation rate. Based on these results, Rapport plans to initiate two Phase 3 registrational trials starting in the third quarter of 2026.Read Announcement
Presentation - June 2,2025Presentation Drug: RAP-219Announced Date: June 2, 2025Indication: For CNS DisordersAnnouncementRapport Therapeutics, Inc today will host its inaugural Investor and Analyst Day, featuring presentations from Rapport's executive team on the Company's strategic priorities and updates from its clinical pipeline, including progress on the RAP-219 Phase 2a trial in focal epilepsy.AI SummaryRapport Therapeutics announced that it will host its inaugural Investor and Analyst Day, where the executive team will share the company’s strategic priorities and offer updates on its clinical pipeline. A key focus of the event is the progress on the RAP-219 Phase 2a trial in focal epilepsy. This trial, which is now fully enrolled, is designed to assess the potential of RAP-219 in treating refractory focal epilepsy using intracranial EEG data as a measure of its effect on long episodes that correlate with clinical seizures. The event will also feature a fireside chat with Dr. Jacqueline French, a leading epilepsy expert from NYU Langone, who will discuss the trial design and the unmet needs in focal epilepsy. Materials and a live stream will be available on the company website, providing investors and analysts with in-depth insights into the company’s developments.Read Announcement
Poster Presentation - March 21,2025Poster Presentation Drug: RAP-219Announced Date: March 21, 2025Indication: For CNS DisordersAnnouncementRapport Therapeutics, Inc. announced two encore poster presentations at the 2025 American Academy of Neurology (AAN) Annual Meeting, taking place from April 5 to April 9, 2025, in San Diego, California. The data from these posters was originally presented at the American Epilepsy Society (AES) Annual Meeting in December 2024.AI SummaryRapport Therapeutics, Inc. announced two encore poster presentations at the 2025 American Academy of Neurology (AAN) Annual Meeting in San Diego, California, scheduled for April 5–9, 2025. These presentations revisit data first shared at the American Epilepsy Society Annual Meeting in December 2024 and focus on the company's ongoing research and development of RAP-219, an AMPA receptor negative allosteric modulator now in Phase 2 trials for refractory focal epilepsy. The first poster demonstrates that a 30% reduction in long episode frequency correlates with a clinically meaningful (≥50%) decrease in seizure activity. The second poster details how RAP-219 showed strong, dose-dependent antiseizure effects in preclinical models. These findings highlight the potential of RAP-219 as a precision treatment for epilepsy and underline Rapport Therapeutics’ commitment to advancing innovative therapies for neurological disorders.Read Announcement
Top-line results - January 9,2025Top-Line Results Phase 2aDrug: RAP-219Announced Date: January 9, 2025Target Action Date: H1 2025Estimated Target Date Range: January 1, 2025 - June 30, 2025Indication: For CNS DisordersAnnouncementRapport Therapeutics, Inc Ongoing Phase 2a trial of RAP-219 in focal epilepsy is on track and topline data is expected in mid-2025AI SummaryRapport Therapeutics, Inc. announced promising updates from its trials for RAP-219, a treatment aimed at focal epilepsy. In the ongoing Phase 2a trial, RAP-219 is showing great promise with the current dosing regimen. Recent PET trial data confirmed that RAP-219 quickly reached and exceeded the target receptor occupancy needed for maximum efficacy within five days. This supports the approach used in the Phase 2a trial, and the drug was well tolerated by participants. The targeted action of RAP-219, focusing on TARP8 in key brain regions such as the hippocampus and cerebral cortex, suggests the potential for effective treatment with fewer side effects. Topline data from this trial is expected in mid-2025, marking an important milestone in developing a new option for patients struggling with refractory focal epilepsy.Read Announcement
Results - January 9,2025Results Drug: RAP-219Announced Date: January 9, 2025Indication: For CNS DisordersAnnouncementRapport Therapeutics, Inc. announced results from its positron emission tomography (PET) trial and second multiple ascending dose (MAD-2) trial for RAP-219.AI SummaryRapport Therapeutics, Inc. announced promising results from two Phase 1 trials for RAP-219. In the positron emission tomography (PET) trial, RAP-219 reached and exceeded the target receptor occupancy needed for maximal efficacy within five days using the same dosing regimen as the current Phase 2a trial in focal epilepsy. The trial also confirmed that the targeted protein, TARP8, is mainly found in the hippocampus and cerebral cortex, with little expression in the cerebellum and brain stem. In the second multiple ascending dose (MAD-2) trial, RAP-219 was generally well tolerated even with faster dose titration and higher exposure levels compared to earlier studies. These results support the dosing strategy and highlight RAP-219’s broad therapeutic index, reinforcing its potential as a treatment in the ongoing clinical evaluation for focal epilepsy.Read Announcement
