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Silexion Therapeutics (SLXN) FDA Events

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FDA Events for Silexion Therapeutics (SLXN)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Silexion Therapeutics (SLXN). Over the past two years, Silexion Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as LODER, SIL204, and SIL-204. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Silexion Therapeutics' Drugs in FDA Review

LODER - FDA Regulatory Timeline and Events

LODER is a drug developed by Silexion Therapeutics for the following indication: In patients with non-resectable locally advanced pancreatic cancer. 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.

SIL204 - FDA Regulatory Timeline and Events

SIL204 is a drug developed by Silexion Therapeutics for the following indication: Across Multiple Cancer Types Beyond Pancreatic Cancer. 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.

SIL-204 - FDA Regulatory Timeline and Events

SIL-204 is a drug developed by Silexion Therapeutics for the following indication: In advanced pancreatic cancer. 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.

Silexion Therapeutics FDA Events - Frequently Asked Questions

In the past two years, Silexion Therapeutics (SLXN) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, Silexion Therapeutics (SLXN) has reported FDA regulatory activity for the following drugs: SIL-204, SIL204 and LODER.

The most recent FDA-related event for Silexion Therapeutics occurred on July 9, 2025, involving SIL204. The update was categorized as "Positive Data," with the company reporting: "Silexion Therapeutics Corp. announced new positive preclinical data demonstrating SIL204's significant efficacy in human lung cancer cell lines."

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

  • In advanced pancreatic cancer - SIL-204
  • Across Multiple Cancer Types Beyond Pancreatic Cancer - SIL204
  • In patients with non-resectable locally advanced pancreatic cancer - LODER

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:SLXN) was last updated on 7/11/2025 by MarketBeat.com Staff
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