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Leap Therapeutics (LPTX) FDA Events

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FDA Events for Leap Therapeutics (LPTX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Leap Therapeutics (LPTX). Over the past two years, Leap Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as DKN-01 and FL-501. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Leap Therapeutics' Drugs in FDA Review

DKN-01 - FDA Regulatory Timeline and Events

DKN-01 is a drug developed by Leap Therapeutics for the following indication: Advanced gynecological malignancies. 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.

FL-501 - FDA Regulatory Timeline and Events

FL-501 is a drug developed by Leap Therapeutics for the following indication: Novel GDF-15 Neutralizing Antibody. 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.

Leap 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, Leap Therapeutics (LPTX) has reported FDA regulatory activity for the following drugs: DKN-01 and FL-501.

The most recent FDA-related event for Leap Therapeutics occurred on June 23, 2025, involving DKN-01. The update was categorized as "updated results," with the company reporting: "Leap Therapeutics, Inc. today reported updated results from Part B of the DeFianCe study (NCT05480306), a Phase 2 study of sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in combination with bevacizumab and chemotherapy (Sirexatamab Arm) compared to bevacizumab and chemotherapy (Control Arm) in patients with advanced microsatellite stable (MSS) colorectal cancer (CRC) who have received one prior systemic therapy for advanced disease."

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

  • Advanced gynecological malignancies - DKN-01
  • Novel GDF-15 Neutralizing Antibody - FL-501

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:LPTX) was last updated on 7/10/2025 by MarketBeat.com Staff
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