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Geron (GERN) FDA Events

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FDA Events for Geron (GERN)

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

Imetelstat - FDA Regulatory Timeline and Events

Imetelstat is a drug developed by Geron for the following indication: Telomerase inhibitor exclusively owned by Geron and being developed in hematologic 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.

Geron FDA Events - Frequently Asked Questions

As of now, Geron (GERN) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Geron (GERN) has reported FDA regulatory activity for Imetelstat.

The most recent FDA-related event for Geron occurred on May 28, 2025, involving Imetelstat. The update was categorized as "Presentation," with the company reporting: "Geron Corporation announced presentations on RYTELO®(imetelstat) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2025 Congress."

Currently, Geron has one therapy (Imetelstat) targeting the following condition: Telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies..

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