RAPP (Rapport Therapeutics, Inc.) PDUFA Date | FDA Catalyst & Approval Status

May 20, 2026

Rapport Therapeutics to Participate in the Jefferies Global Healthcare Conference and Goldman Sachs 47th Annual Global Healthcare Conference

Rapport Therapeutics Reports First Quarter 2026 Financials and Provides Business Update

Rapport Therapeutics reported positive Phase 2a data for RAP-219, showing a 90% median reduction in focal onset seizures. The company anticipates topline results for its bipolar mania trial in Q4 2026, ahead of previous guidance. With a strong cash position of $476.8 million, Rapport is well-positioned for continued development, including a Phase 3 program in focal onset seizures set to begin in Q2 2026.

Apr 21, 2026

Efficacy and Tolerability of RAP-219, a Potential First-in-Class Negative Allosteric Modulator of γ8 TARP: Impact on RNS Long Episodes and Clinical Seizures

The article discusses RAP-219, a potential first-in-class negative allosteric modulator targeting α3 TARP. It highlights the drug's efficacy and tolerability in addressing RNS long episodes and clinical seizures. The research involves a team of experts in the field, suggesting a comprehensive approach to evaluating the treatment's potential.

Apr 21, 2026

Rapport Therapeutics Presents RAP-219 Focal Onset Seizure Phase 2a Follow-up Period Results Demonstrating Sustained Seizure Reduction at the 2026 American Academy of Neurology Annual Meeting Clinically meaningful efficac

Rapport Therapeutics recently presented encouraging follow-up results from its Phase 2a trial of RAP-219 for focal onset seizures at the American Academy of Neurology Annual Meeting. The data indicated a significant median reduction in clinical seizures, including a 90% reduction in the first four weeks post-treatment. RAP-219 exhibited a long half-life of approximately 22 days, allowing for maintained therapeutic levels. The drug was generally well tolerated throughout the trial, setting the stage for upcoming pivotal Phase 3 studies slated to begin in the second quarter of 2026.

Apr 1, 2026

Rapport Therapeutics to Present New Phase 2 Treatment Follow-Up Data for RAP-219 in Focal Onset Seizures at the 2026 American Academy of Neurology Annual Meeting

Rapport Therapeutics will present new follow-up data from its Phase 2a trial of RAP-219 for focal onset seizures at the 2026 American Academy of Neurology Annual Meeting. The presentation will highlight the efficacy and tolerability of RAP-219, a potential first-in-class negative allosteric modulator. The meeting is scheduled for April 18-22, 2026, in Chicago.

Mar 10, 2026

Rapport Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update • RAP-219's lead program demonstrated robust and consistent activity in patients with focal onset seizu

Rapport Therapeutics reported positive financial results for Q4 and full year 2025, highlighting robust Phase 2a trial outcomes for its lead product RAP-219 in focal onset seizures. The company plans to initiate a Phase 3 program for RAP-219 in mid-2026 and has expanded its epilepsy portfolio to include primary generalized tonic-clonic seizures. Despite a net loss increase for the year, Rapport remains financially strong with substantial cash reserves expected to sustain operations until 2029. A strategic collaboration with Tenacia Biotechnology aims to boost RAP-219 development efforts in Greater China.

Mar 9, 2026

Rapport Therapeutics and Tenacia Biotechnology Announce Strategic Collaboration for the Development and Commercialization of RAP-219 in Greater China

Rapport Therapeutics has entered a strategic collaboration with Tenacia Biotechnology for the development and commercialization of RAP-219 in Greater China. Tenacia will handle the drug's development in regions including mainland China, Hong Kong, Macau, and Taiwan, while Rapport retains global rights. The partnership includes a $20 million upfront payment and potential milestone payments totaling up to $308 million.

Feb 25, 2026

Rapport Therapeutics to Participate in Upcoming March 2026 Investor Conferences

Rapport Therapeutics, a clinical-stage biotechnology firm, has announced its participation in several investor conferences in March 2026. These events include presentations and fireside chats at notable conferences in Boston and Miami. The company focuses on developing small molecule precision medicines for neurological and psychiatric disorders, highlighting its innovative RAP technology platform.

Feb 24, 2026

Rapport Therapeutics to Participate in Upcoming Investor Conferences

Rapport Therapeutics Announces Accelerated Initiation of RAP-219 Phase 3 Program, Expansion of Epilepsy Portfolio, and Continued Progress Across the Pipeline

Rapport Therapeutics has announced the accelerated initiation of its Phase 3 program for RAP-219 targeting focal onset seizures, expected to begin in Q2 2026. The company is also expanding its epilepsy portfolio with a new program for primary generalized tonic-clonic seizures. Additionally, Rapport is making progress in other areas, including bipolar mania and long-acting injectables.

Dec 18, 2025

Rapport Therapeutics to Present at the 44th Annual J.P. Morgan Healthcare Conference

Dec 8, 2025

Rapport Therapeutics Announces New Data and Post Hoc Analysis Demonstrating the Magnitude and Consistency of RAP-219’s Clinical Response in Patients with Focal Onset Seizures

Rapport Therapeutics announced promising post hoc analysis results for RAP-219, demonstrating its early efficacy and consistent response in patients with drug-resistant focal onset seizures. The Phase 2a trial showed a significant reduction in seizure frequency and improvements in patient-reported outcomes. The company plans to advance RAP-219 into pivotal Phase 3 trials following a meeting with the FDA.

Dec 5, 2025

Efficacy and Tolerability of RAP-219, a Potential First-in-Class Negative Allosteric Modulator of γ8 Transmembrane AMPA Receptor Regulatory Protein (TARPγ8): Impact on RNS Long Episodes and Focal Seizures

The article discusses RAP-219, a novel negative allosteric modulator targeting TARPγ8, which may provide efficacy in treating RNS long episodes and focal seizures. The research is led by a team of experienced medical professionals, highlighting the potential of this first-in-class therapy. The implications for seizure management could be significant.

Nov 25, 2025

Rapport Therapeutics to Present New Phase 2a Data Analysis Further Characterizing RAP-219 in Focal Onset Seizures at 2025 American Epilepsy Society Annual Meeting

Rapport Therapeutics announced it will present new Phase 2a data for RAP-219, targeting focal onset seizures, at the 2025 American Epilepsy Society Annual Meeting. The presentation will include efficacy analysis and safety data, highlighting RAP-219's potential as a novel treatment. The event is scheduled for December 5-9, 2025, in Atlanta.

Nov 6, 2025

Rapport Therapeutics Reports Third Quarter 2025 Financials and Provides Business Update

Rapport Therapeutics reported positive financial results for Q3 2025, highlighting the success of RAP-219 in Phase 2a trials for focal onset seizures. The company achieved a significant median reduction in seizures and plans to advance to Phase 3 trials. With a strong financial position post-public offering, Rapport aims to continue its development in bipolar disorder and diabetic peripheral neuropathic pain.

Sep 11, 2025

Rapport Therapeutics to Participate in TD Cowen's 5th Annual Novel Mechanisms in Neuropsychiatry & Epilepsy Summit

Rapport Therapeutics will participate in TD Cowen's 5th Annual Novel Mechanisms in Neuropsychiatry & Epilepsy Summit on September 17, 2025. The company, known for its precision medicine approach, is developing RAP-219 for conditions like drug-resistant focal onset seizures and bipolar mania. The event will feature a fireside chat accessible via the company's website.

Sep 10, 2025

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Rapport Announces Pricing of Public Offering of Common Stock

Rapport Therapeutics has announced the pricing of a public offering of 9,615,385 shares of common stock at $26.00 per share, aiming to raise around $250 million. The offering is set to close on September 11, 2025, pending customary conditions. Rapport is focused on developing precision medicines for neurological and psychiatric disorders.

Sep 8, 2025

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Rapport Announces Proposed Public Offering of Common Stock

Rapport Therapeutics has announced a proposed public offering of $250 million in common stock to support its clinical-stage programs targeting neurological and psychiatric disorders. The offering includes an option for underwriters to purchase an additional $37.5 million in shares. The completion of the offering is contingent on market conditions.

Sep 8, 2025

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Rapport Announces Positive Topline Results from Phase 2a Clinical Trial of RAP-219 in Patients with Focal Onset Seizures

Rapport Therapeutics announced positive topline results from its Phase 2a clinical trial of RAP-219, which showed a significant reduction in long episodes and clinical seizures in patients with drug-resistant focal onset seizures. The trial demonstrated high efficacy, with 85.2% of patients achieving a 30% reduction in long episodes and 72.0% achieving a 50% reduction in clinical seizures. The company plans to advance RAP-219 into Phase 3 trials in 2026.

Sep 5, 2025

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Rapport Therapeutics to Announce Topline Results for RAP-219 Phase 2a Trial in Focal Onset Seizures on Monday, September 8, 2025

Rapport Therapeutics Reports Second Quarter 2025 Financials and Provides Business Update • RAP-219 Phase 2a trial in patients with drug-resistant focal onset seizures is fully enrolled and on track for topline res

Rapport Therapeutics has reported its financial results for the second quarter of 2025, alongside updates on its clinical trials. The Phase 2a trial of RAP-219 for drug-resistant focal onset seizures is fully enrolled and expected to yield topline results by September 2025. Additionally, the company has initiated a new Phase 2 trial of RAP-219 targeting bipolar mania, with results anticipated in early 2027. Despite a net loss of $26.7 million, the firm maintains a robust cash position to support its operations through the end of 2026.

Jun 2, 2025

Rapport Therapeutics Hosts Investor and Analyst Day; Provides Corporate Updates

Rapport Therapeutics hosted its inaugural Investor and Analyst Day, highlighting updates on its clinical pipeline, particularly the fully enrolled RAP-219 Phase 2a trial for focal epilepsy. CEO Abraham N. Ceesay emphasized the trial's potential to demonstrate the efficacy of their precision neuroscience approach. The event included expert insights from Dr. Jacqueline French, reinforcing the significance of the trial.

Jun 2, 2025

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Investor & Analyst Day

At the Investor & Analyst Day held on June 2, 2025, Rapport presented an update on its drug candidate RAP-219, which aims to address refractory focal epilepsy, bipolar mania, and diabetic peripheral neuropathic pain. The company highlighted its robust financial position, expecting to fund operations through the end of 2026 with $285.4 million in cash. The agenda included discussions of the clinical trials, potential first-in-class opportunities, and the innovative RAP technology platform used for drug discovery. However, concerns were raised regarding the current FDA hold on RAP-219 and the dependency on third-party collaborators for clinical development.

May 27, 2025

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Rapport Therapeutics to Participate in the Jefferies Global Healthcare Conference and Goldman Sachs 46th Annual Global Healthcare Conference

Rapport Therapeutics, a clinical-stage biotech firm, will participate in two significant investor conferences: the Jefferies Global Healthcare Conference on June 4, 2025, and the Goldman Sachs 46th Annual Global Healthcare Conference on June 9, 2025. The company focuses on developing precision medicines for neurological and psychiatric disorders, with its lead drug candidate, RAP-219, targeting specific brain regions. Webcasts of the events will be available on their website.

May 21, 2025

Rapport Therapeutics to Host 2025 Investor and Analyst Day

May 8, 2025

Rapport Therapeutics Reports First Quarter 2025 Financials and Provides Business Update • RAP-219 Phase 2a trial in patients with refractory focal epilepsy remains on track with topline results expected in the thi

Rapport Therapeutics reported its financial results for Q1 2025, highlighting advancements in its clinical trials, particularly for RAP-219 in refractory focal epilepsy. The Phase 2a trial remains on schedule, with topline results anticipated in Q3 2025, while another trial for bipolar mania is set to commence shortly after. The company maintains a strong financial position with $285.4 million in cash. However, it also reported an increased net loss and higher R&D expenses compared to the previous year.

Mar 21, 2025

Rapport Therapeutics to Present Data at the 2025 American Academy of Neurology Annual Meeting

Mar 11, 2025

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Rapport Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update • Results of positron emission tomography (PET) trial and second multiple ascending dose (MAD-2) trial

Rapport Therapeutics has reported its financial results for the fourth quarter and full year 2024, showcasing significant advancements in its drug development pipeline, particularly for RAP-219. The company is experiencing positive momentum in its ongoing Phase 2a trials for epilepsy and plans to initiate additional trials for conditions such as bipolar mania. Despite a rise in overall net losses and increased research and development expenses, the company maintains a robust cash position expected to support its operations through the end of 2026. Furthermore, positive results from recent trials bolster their confidence in RAP-219's potential as a transformative treatment for central nervous system disorders.

Corporate overview March 2025 Disclaimer This presentation contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, eac

Rapport has outlined its corporate overview aimed at advancing its clinical programs, notably the development of RAP-219 for treating drug-resistant focal epilepsy, bipolar disorder, and peripheral neuropathic pain. The company has highlighted the significant cash reserves expected to sustain operations through 2026 and the potential to emerge as a leader in precision neuroscience. However, risks related to regulatory approvals, reliance on third parties for clinical trials, and the need for additional funding could impact the company's progression.

Rapport Therapeutics Announces Appointment of Dr. Jeffrey Sevigny as Chief Medical Officer to Drive Clinical Strategy and Precision Medicine Development

Rapport Therapeutics Announces New Phase 1 Data, Further Supporting RAP-219 s Transformative Potential for CNS Disorders In the PET trial, RAP-219 achieved and exceeded target receptor occupancy, increasing support for t

Rapport Therapeutics announced promising Phase 1 data for its drug RAP-219, which has achieved and surpassed target receptor occupancy, suggesting its efficacy for central nervous system disorders. The drug was found to be generally well tolerated during trials, and its Phase 2a trial in focal epilepsy is progressing well, with results expected in mid-2025. However, the company also disclosed that their CMO has resigned, potentially impacting the company's clinical operations. The data reinforces the belief in RAP-219's transformative potential for patients suffering from conditions requiring precise pharmacological interventions.

CORRECTION -- Rapport Therapeutics Announces New Phase 1 Data, Further Supporting RAP-219's Transformative Potential for CNS Disorders

Dec 6, 2024

Rapport Therapeutics Presents Data Demonstrating Consistent Association Between Decreases in RNS Measured Long Episodes and Meaningful Reductions in Clinical Seizures

Nov 14, 2024

Rapport Therapeutics to Present Data at American Epilepsy Society Annual Meeting

Nov 7, 2024

Rapport Therapeutics Reports Third Quarter Financials and Provides Business Update • Biotech industry leaders added to the Board of Directors, bringing deep expertise in drug discovery, neuro

Rapport Therapeutics reported its third-quarter financials, highlighting a strong cash position of $320.7 million and the ongoing clinical trials for its lead candidate RAP-219. The company has added several experienced biotech leaders to its Board of Directors to support further growth. Current trials, including one for focal epilepsy, are on track, with topline data expected in mid-2025. However, an Investigational New Drug Application for RAP-219 targeting diabetic peripheral neuropathic pain is currently on hold as they address FDA feedback.

Nov 7, 2024

Rapport Therapeutics Reports Third Quarter Financials and Provides Business Update

Nov 4, 2024

Rapport Therapeutics to Present at Stifel Healthcare Conference and Jefferies London Healthcare Conference in November

Sep 5, 2024

Rapport Therapeutics to Present at Upcoming Epilepsy Medical Conferences

Aug 29, 2024

Rapport Therapeutics to Present at 22nd Annual Morgan Stanley Global Healthcare Conference and TD Cowen’s 4th Annual Novel Mechanisms in Neuropsychiatry Summit

Aug 8, 2024

Rapport Therapeutics Reports Second Quarter Financials and Provides Business Update • Completed initial public offering, raising $174.4 million in gross proceeds, including full exercise of the underwriters' optio

Rapport Therapeutics announced its Q2 2024 financial results, highlighting a successful IPO that raised $174.4 million. The company is advancing its lead product candidate, RAP-219, with a Phase 2a trial in focal epilepsy set to begin in Q3 2024. Additional trials are planned for RAP-219 in conditions such as peripheral neuropathic pain and bipolar disorder. Despite a net loss reported for the quarter, the company maintains a strong cash position to support its pipeline through at least 2026.

Jul 29, 2024

Rapport Therapeutics to Present Data for TARPγ8 AMPAR Negative Modulator at IASP 2024 World Congress on Pain

Jun 12, 2024

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Rapport Therapeutics Announces Closing of $174 Million Initial Public Offering, Including Full Exercise of Underwriters’ Option to Purchase Additional Shares and Concurrent Private Placement

Jun 6, 2024

Rapport Therapeutics Announces Pricing of Initial Public Offering

Mar 19, 2024

Rapport Therapeutics Appoints Pioneering Industry Leader John Maraganore to Board of Directors

Feb 28, 2024

Rapport Therapeutics Appoints Chief People Officer

Jan 16, 2024

Rapport Therapeutics Appoints Terry-Ann Burrell to Board of Directors

Jan 3, 2024

Rapport Therapeutics to Present at the 42nd Annual J.P. Morgan Healthcare Conference

Oct 30, 2023

Rapport Therapeutics Appoints Chief Financial Officer

Sep 7, 2023

Rapport Therapeutics Appoints Chief Operating Officer and Scientific Advisory Board Member

Aug 23, 2023

Rapport Therapeutics Raises $150 Million in Series B Funding Round and Announces Key Board Appointments to Further Advance Precision Neuromedicine Platform

Jun 29, 2023

Rapport Therapeutics Names Scientific Advisory Board

Mar 7, 2023