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SELLAS Life Sciences Group (SLS) FDA Events

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FDA Events for SELLAS Life Sciences Group (SLS)

This section highlights FDA-related milestones and regulatory updates for drugs developed by SELLAS Life Sciences Group (SLS). Over the past two years, SELLAS Life Sciences Group has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as galinpepimut-S and SLS009. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

SELLAS Life Sciences Group's Drugs in FDA Review

galinpepimut-S (GPS) - FDA Regulatory Timeline and Events

galinpepimut-S (GPS) is a drug developed by SELLAS Life Sciences Group for the following indication: Targets the WT1 protein, which is present in an array of tumor types. 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.

SLS009 - FDA Regulatory Timeline and Events

SLS009 is a drug developed by SELLAS Life Sciences Group for the following indication: For Treatment of Acute Myeloid Leukemia. 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.

SELLAS Life Sciences Group FDA Events - Frequently Asked Questions

In the past two years, SELLAS Life Sciences Group (SLS) 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, SELLAS Life Sciences Group (SLS) has reported FDA regulatory activity for the following drugs: SLS009 and galinpepimut-S (GPS).

The most recent FDA-related event for SELLAS Life Sciences Group occurred on June 2, 2025, involving SLS009. The update was categorized as "Efficacy Data," with the company reporting: "SELLAS Life Sciences Group, announced preclinical efficacy of SLS009 (tambiciclib) in ASXL1 mutated colorectal cancer lines."

Current therapies from SELLAS Life Sciences Group in review with the FDA target conditions such as:

  • For Treatment of Acute Myeloid Leukemia - SLS009
  • Targets the WT1 protein, which is present in an array of tumor types. - galinpepimut-S (GPS)

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