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.
- Drug:
- Imetelstat
- Announced Date:
- May 28, 2025
- Indication:
- Telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies.
Announcement
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.
AI Summary
Geron Corporation has announced that it will present new data on its drug RYTELO® (imetelstat) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) Congress. The presentations will focus on post-hoc analyses from the Phase 3 IMerge trial, which examined RYTELO in patients with lower-risk myelodysplastic syndromes (LR-MDS) who have transfusion-dependent anemia. The new analyses demonstrate that RYTELO may offer clinical benefits regardless of a patient’s ring sideroblast status, baseline serum erythropoietin levels, or prior treatment history.
These findings further support the potential of RYTELO to provide more time without transfusion reliance and improve patient outcomes, reinforcing its role as a valuable second-line option. Geron’s presentations at ASCO and EHA emphasize the commitment to advancing telomerase inhibition as a transformative treatment strategy for blood cancer.
Read Announcement - Drug:
- Imetelstat
- Announced Date:
- March 11, 2025
- Indication:
- Telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies.
Announcement
Geron Corporation announced that the European Commission (EC) has granted marketing authorization for RYTELO® (imetelstat) as a monotherapy for the treatment of adult patients with transfusion-dependent (TD) anemia due to very low, low or intermediate risk myelodysplastic syndromes (lower-risk MDS or LR-MDS) without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (ESAs).
AI Summary
Geron Corporation announced that the European Commission has granted marketing authorization for RYTELO® (imetelstat) as a monotherapy for adult patients with transfusion-dependent anemia due to very low, low, or intermediate risk myelodysplastic syndromes (LR-MDS) who lack an isolated deletion 5q abnormality. This approval is for patients who have had an unsatisfactory response to, or are ineligible for, erythropoietin-based therapy (ESAs). LR-MDS is a type of blood cancer where patients often depend on frequent red blood cell transfusions, leading to serious health issues and decreased quality of life. RYTELO is the first telomerase inhibitor of its kind approved in the European Union and is expected to significantly reduce transfusion needs. The decision is supported by positive clinical trial results and represents a breakthrough option for patients with limited treatment alternatives.
Read Announcement- Drug:
- Imetelstat
- Announced Date:
- December 13, 2024
- Indication:
- Telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies.
Announcement
Geron Corporation announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of RYTELO (imetelstat) for the treatment of adult patients with transfusion-dependent (TD) anemia due to very low, low or intermediate risk myelodysplastic syndromes (LR-MDS) without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.
AI Summary
Geron Corporation announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending the approval of RYTELO (imetelstat). RYTELO is aimed at adult patients with transfusion-dependent anemia caused by very low, low, or intermediate risk myelodysplastic syndromes (LR-MDS) with a non-del 5q abnormality, especially in those who have not had a good response to or cannot use erythropoietin-based therapy.
The recommendation followed findings from the pivotal IMerge Phase 3 trial, which showed that RYTELO reduced the need for red blood cell transfusions during the first 24 weeks compared to placebo. The European Commission is expected to review the CHMP’s recommendation and make a final decision in the coming months, which could mark the introduction of Europe’s first telomerase inhibitor for LR-MDS treatment.
Read Announcement- Drug:
- Imetelstat
- Announced Date:
- December 10, 2024
- Indication:
- Telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies.
Announcement
Geron Corporation announced new analyses presented at the 66th American Society of Hematology (ASH) Annual Meeting from the IMerge clinical trial in patients with lower-risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia suggesting clinical activity of first-in-class telomerase inhibitor RYTELO™ (imetelstat) regardless of type or number of prior therapies, as well as favorable patient-reported outcomes (PROs).
AI Summary
Geron Corporation presented new analyses at the 66th American Society of Hematology Annual Meeting from its IMerge clinical trial in patients with lower-risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia. The findings suggest that their first-in-class telomerase inhibitor, RYTELO™ (imetelstat), demonstrates clinical activity regardless of the type or number of prior therapies a patient has received. This is promising news as it indicates that RYTELO may benefit a broader range of patients who have not responded to or become refractory to other treatments.
Additionally, the study showed favorable patient-reported outcomes (PROs), highlighting potential improvements in symptoms and overall quality of life. These encouraging results support further development and exploration of RYTELO as a novel treatment option for patients with LR-MDS, reinforcing Geron’s commitment to advancing therapies in hematologic cancer care.
Read Announcement- Drug:
- Imetelstat
- Announced Date:
- July 26, 2024
- Indication:
- Telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies.
Announcement
Geron Corporation announced that the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology (NCCN Guidelines) for the treatment of Myelodysplastic Syndromes (MDS) to recommend RYTELO™ (imetelstat) as a Category 1 and 2A treatment of symptomatic anemia in patients with lower-risk MDS. Treatments are classified as Category 1 and 2A when there is uniform NCCN consensus ≥85% that the intervention is appropriate.
AI Summary
Geron Corporation announced that the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology for treating myelodysplastic syndromes (MDS). The guidelines now recommend RYTELO™ (imetelstat) as a Category 1 and 2A treatment for symptomatic anemia in patients with lower‐risk MDS.
Category 1 and 2A classifications are based on a uniform consensus of 85% or more among NCCN experts, showing strong support for RYTELO in these patient groups. Under these updates, RYTELO is recommended as a second-line treatment (Category 1) for patients with serum EPO ≤500 mU/mL and as a first-line treatment (Category 2A) for those with serum EPO >500 mU/mL who are ineligible for erythropoiesis-stimulating agents. This significant guideline update underscores RYTELO’s emerging role as a compelling treatment option for lower-risk MDS patients battling transfusion-dependent anemia.
Read Announcement- Drug:
- Imetelstat
- Announced Date:
- June 7, 2024
- Indication:
- Telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies.
Announcement
MAIA Biotechnology, Inc announced the validation of clinical and regulatory pathways for viable therapies leveraging the cell's telomeric functions as evidenced by the U.S. Food and Drug Administration (FDA) approval of imetelstat, a treatment for low- to intermediate-risk hematologic malignancies (myelodysplastic syndromes) from Geron Corporation.
AI Summary
MAIA Biotechnology, Inc. recently announced that its approach of targeting telomere functions for cancer treatment has been validated by a significant FDA milestone. This validation is based on the FDA approval of imetelstat—a treatment for low- to intermediate-risk hematologic malignancies (myelodysplastic syndromes) developed by Geron Corporation. The FDA’s decision underscores the potential of therapies that harness telomeric mechanisms, confirming that interfering with telomerase activity can be an effective strategy against cancer. MAIA, a pioneer in telomere-targeting immunotherapies, sees this regulatory endorsement as a strong indication that its own research and clinical programs are on the right path. The company is encouraged by this precedent as it continues to develop innovative treatments aimed at disrupting telomere maintenance in cancer cells, opening new avenues for improving patient outcomes in cases where traditional therapies have failed.
Read Announcement
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
FDA Event Stage Terminology & Abbreviation Guide
- 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
