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Salarius Pharmaceuticals (SLRX) FDA Events

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FDA Events for Salarius Pharmaceuticals (SLRX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Salarius Pharmaceuticals (SLRX). Over the past two years, Salarius Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as azacitidine and Seclidemstat. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Salarius Pharmaceuticals' Drugs in FDA Review

azacitidine - FDA Regulatory Timeline and Events

azacitidine is a drug developed by Salarius Pharmaceuticals for the following indication: For Hematologic Cancers. 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.

Seclidemstat - FDA Regulatory Timeline and Events

Seclidemstat is a drug developed by Salarius Pharmaceuticals for the following indication: Relapsed and refractory (R/R) Ewing sarcoma and Ewing-related sarcomas. 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.

Salarius Pharmaceuticals FDA Events - Frequently Asked Questions

In the past two years, Salarius Pharmaceuticals (SLRX) 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, Salarius Pharmaceuticals (SLRX) has reported FDA regulatory activity for the following drugs: Seclidemstat and azacitidine.

The most recent FDA-related event for Salarius Pharmaceuticals occurred on July 9, 2025, involving Seclidemstat. The update was categorized as "Publication," with the company reporting: "Salarius Pharmaceuticals, Inc. announces that two animal studies recently published in peer-reviewed journals provide additional insight into the role of inhibiting lysine-demethylase 1 (LSD1 or KDM1A), a well-validated target in hematologic and solid tumors."

Current therapies from Salarius Pharmaceuticals in review with the FDA target conditions such as:

  • Relapsed and refractory (R/R) Ewing sarcoma and Ewing-related sarcomas - Seclidemstat
  • For Hematologic Cancers - azacitidine

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