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Rapport Therapeutics (RAPP) FDA Events

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FDA Events for Rapport Therapeutics (RAPP)

This 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 and RTX-1738. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Rapport Therapeutics' Drugs in FDA Review

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.

RTX-1738 - FDA Regulatory Timeline and Events

RTX-1738 is a drug developed by Rapport Therapeutics for the following indication: Lead product candidate RAP-219, across a variety of acute and chronic pain. 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.

Rapport Therapeutics FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Rapport Therapeutics (RAPP) has reported FDA regulatory activity for the following drugs: RAP-219 and RTX-1738.

The most recent FDA-related event for Rapport Therapeutics occurred on June 2, 2025, involving RAP-219. The update was categorized as "Presentation," with the company reporting: "Rapport 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."

Current therapies from Rapport Therapeutics in review with the FDA target conditions such as:

  • For CNS Disorders - RAP-219
  • Lead product candidate RAP-219, across a variety of acute and chronic pain - RTX-1738

More FDA Event Resources from MarketBeat

  • 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

This page (NASDAQ:RAPP) was last updated on 7/11/2025 by MarketBeat.com Staff
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