Imetelstat

Geron Announces Data Presentations from IMerge Phase 3 Evaluating Imetelstat in Lower Risk MDS at Society of Hematologic Oncology Annual Meeting

Retrieved on: 
Thursday, September 7, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Society, European Hematology Association, SOHO, Publication, MDS, Imetelstat, Corporation, Geron Corporation, Patient, Risk, System, Fatigue, Pharmaceutical industry

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced poster presentations of data from IMerge, the Company’s Phase 3 clinical trial evaluating its first-in-class investigational telomerase inhibitor imetelstat vs. placebo in patients with lower risk myelodysplastic syndromes (MDS) at the eleventh annual Society of Hematologic Oncology Annual Meeting (SOHO) held in Houston, Texas and virtually.

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced poster presentations of data from IMerge, the Company’s Phase 3 clinical trial evaluating its first-in-class investigational telomerase inhibitor imetelstat vs. placebo in patients with lower risk myelodysplastic syndromes (MDS) at the eleventh annual Society of Hematologic Oncology Annual Meeting (SOHO) held in Houston, Texas and virtually.
  • Statistically significant and clinically meaningful efficacy results were achieved across key MDS subgroups irrespective of ring sideroblast (RS) status, baseline transfusion burden and IPSS risk category.
  • Patient-reported outcomes (PRO) data reported a sustained meaningful improvement in fatigue for imetelstat-treated patients vs. placebo.
  • Consistent with prior imetelstat clinical experience, the most common serious adverse events were primarily short-lived, manageable cytopenias.

Geron Announces PDUFA Date for Imetelstat NDA in Lower Risk MDS

Retrieved on: 
Tuesday, August 22, 2023
Biotechnology, Pharmaceutical, Health, FDA, Medical Devices, Hospitals, Clinical Trials, Other Health, PDUFA, MDS, NDA, Imetelstat, Corporation, Geron Corporation, Patient, Transfusion-dependent anemia, Pharmaceutical industry

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has assigned a standard review and a Prescription Drug User Fee Act (PDUFA) action date of June 16, 2024 for Geron’s New Drug Application (NDA) for imetelstat for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes (MDS).

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has assigned a standard review and a Prescription Drug User Fee Act (PDUFA) action date of June 16, 2024 for Geron’s New Drug Application (NDA) for imetelstat for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes (MDS).
  • In addition, the FDA informed the Company that it is currently planning to hold an advisory committee meeting as part of the NDA review.
  • “We look forward to working with the FDA to complete the NDA review process on a timely basis,” said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer.
  • “With the PDUFA date now set, we continue to expect an imetelstat launch in the United States by the end of the first half of 2024, subject to FDA approval.”

Geron Announces FDA Acceptance of New Drug Application for Imetelstat for the Treatment of Lower Risk MDS

Retrieved on: 
Monday, August 21, 2023
Research, Hospitals, FDA, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Telomerase, New Drug Application, NDA, Cancer, MDS, Imetelstat, Corporation, Geron Corporation, Patient, Risk, Transfusion-dependent anemia, Pharmaceutical industry

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has accepted the filing of Geron’s New Drug Application (NDA) for imetelstat, its first-in-class telomerase inhibitor, for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes (MDS).

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has accepted the filing of Geron’s New Drug Application (NDA) for imetelstat, its first-in-class telomerase inhibitor, for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes (MDS).
  • “The FDA’s acceptance of our New Drug Application is an important landmark along our steadfast journey to bring telomerase inhibition with imetelstat to the market,” said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer.
  • Statistically significant and clinically meaningful efficacy results were achieved across key MDS subgroups irrespective of ring sideroblast (RS) status, baseline transfusion burden and IPSS risk category.
  • Additionally, Geron expects to submit a Marketing Authorization Application (MAA) in the European Union (EU) in the fourth quarter of 2023.

Geron Corporation Reports Business Highlights and Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 3, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Ruxolitinib, Employment, EAP, General counsel, Amgen, BeiGene, New Drug Application, Clinical trial, GAAP, MF, ASCO, MDS, Imetelstat, Corporation, Geron Corporation, Patient, Risk, Celgene, EHA, Webcast, Depreciation, FDA, IMPRESS, Fatigue, Novartis, Pharmaceutical industry, Cryptocurrency, Rare-earth element

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported business highlights and financial results for the second quarter of 2023.

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported business highlights and financial results for the second quarter of 2023.
  • Initiated Expanded Access Protocol (EAP) in June 2023, making imetelstat available to clinicians and patients prior to potential FDA approval.
  • In the second quarter of 2023, the Company received $17.8 million upon the cash exercise of outstanding warrants.
  • ET on Thursday, August 3, 2023 to discuss business updates, and second quarter financial results.

Geron Announces U.S. Expanded Access Protocol for Imetelstat in Lower Risk MDS

Retrieved on: 
Thursday, June 29, 2023
FDA, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, EAP, Red blood cell, Majesty of the Seas, Lenalidomide, NDA, MDS, Imetelstat, Corporation, Geron Corporation, Microsoft Access, Patient, Physician, Risk, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Pharmaceutical industry

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that an Expanded Access Protocol (EAP) is available for imetelstat, the Company’s first-in-class telomerase inhibitor.

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that an Expanded Access Protocol (EAP) is available for imetelstat, the Company’s first-in-class telomerase inhibitor.
  • In that trial, the primary endpoint of 8-week transfusion independence (TI) was significantly higher with imetelstat vs. placebo (P
  • Mean hemoglobin levels in imetelstat-treated patients increased significantly (P
  • Further, statistically significant and clinically meaningful efficacy results were achieved across key MDS subgroups: ring sideroblast (RS) status, baseline transfusion burden and IPSS risk category.

Geron Announces Submission of New Drug Application to FDA for First-in-Class Telomerase Inhibitor Imetelstat

Retrieved on: 
Tuesday, June 20, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, MDS, New Drug Application, Imetelstat, NDA, Corporation, Geron Corporation, Telomerase, Patient, Risk, Transfusion-dependent anemia, TI, Pharmaceutical industry

“This pioneering achievement to submit the first New Drug Application to the FDA for a telomerase inhibitor reflects the dedication, commitment and teamwork of so many people who believed targeting telomerase could make a significant difference for patients,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer.

Key Points: 
  • “This pioneering achievement to submit the first New Drug Application to the FDA for a telomerase inhibitor reflects the dedication, commitment and teamwork of so many people who believed targeting telomerase could make a significant difference for patients,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer.
  • As allowed under imetelstat’s Fast Track designation in lower risk MDS, Geron has requested that the FDA grant Priority Review of the NDA.
  • Under standard practice, Geron expects FDA communication in 60 days whether the NDA was accepted for review and the timeline of such review (i.e., priority or standard).
  • Additionally, based on IMerge Phase 3, Geron expects to submit a Marketing Authorization Application (MAA) in the EU in the second half of 2023.

Geron Announces First Patient Dosed in Investigator-Led Phase 2 IMpress Trial Evaluating Imetelstat in Patients with Relapsed/Refractory AML or Higher Risk MDS

Retrieved on: 
Tuesday, June 13, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Telomerase, Majesty of the Seas, Clinical trial, Acute myeloid leukemia, MDS, Imetelstat, AML, Publication, Corporation, Geron Corporation, Patient, Risk, Therapy, AM, Principal, IMPRESS, Pharmaceutical industry

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that the first patient has been dosed in the investigator-led Phase 2 IMpress clinical trial evaluating imetelstat, the Company’s first-in-class telomerase inhibitor, in patients with acute myeloid leukemia (AM)L, or higher risk myelodysplastic syndromes (MDS), who are relapsed/refractory/intolerant to hypomethylating agents (HMAs).

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that the first patient has been dosed in the investigator-led Phase 2 IMpress clinical trial evaluating imetelstat, the Company’s first-in-class telomerase inhibitor, in patients with acute myeloid leukemia (AM)L, or higher risk myelodysplastic syndromes (MDS), who are relapsed/refractory/intolerant to hypomethylating agents (HMAs).
  • “This trial is based on multiple preclinical publications that describe the role of telomerase in AML, which have reported that inhibiting telomerase in both mouse and human AML models targets and potentially depletes leukemic stem cells and impairs their leukemic progression,” said Faye Feller, M.D., Executive Vice President, Chief Medical Officer of Geron.
  • “We are delighted that the first patient has been dosed in the investigator-led IMpress Phase 2 study, an important first step to understanding the potential impact of imetelstat in relapsed/refractory AML and higher risk MDS.”
    “Despite some recent advances in the treatment of AML and higher risk MDS, there is still a tremendous unmet need for new agents, especially in the relapsed/refractory setting,” said Uwe Platzbecker, M.D., Department of Hematology, Cellular Therapy and Hemostaseology, Leipzig University Hospital, Leipzig, Germany, and Principal Investigator of IMpress.
  • “With the first patient dosed and several in screening, we are pleased that IMpress Phase 2 is underway and look forward to understanding more about the potential efficacy of imetelstat in this rather frail and elderly patient population.”

Geron Announces New Data and Analyses from IMerge Phase 3 Presented at EHA Reporting Robust Durability of Transfusion Independence, Evidence of Disease-Modifying Activity and Favorable Fatigue PRO in Imetelstat-Treated Lower Risk MDS Patients

Retrieved on: 
Monday, June 12, 2023
Biotechnology, FDA, Other Health, Health, Pharmaceutical, Oncology, Other Science, Research, Hospitals, Science, Clinical Trials, Neutropenia, FACIT, RBC, TET2, University, MOA, Telomerase, ESA, Reverse transcriptase, TI, Erythropoiesis-stimulating agent, Chromosome, Bone marrow, Neuropsychological test, Mutation, TA, Publication, MF, VAF, MDS, ASXL1, Patient, Risk, Anemia, EHA, Therapy, Biology, University of Florence, Cochran–Mantel–Haenszel statistics, Gene, Thrombocytopenia, News, IPSS, Fatigue, Disease, Silviculture, Medical device, Pharmaceutical industry, Nursing, DNMT3A, SF3B1, Imetelstat

This is the first Phase 3 trial we know of to show an improvement in fatigue in lower risk MDS patients,” stated Dr. Platzbecker.

Key Points: 
  • This is the first Phase 3 trial we know of to show an improvement in fatigue in lower risk MDS patients,” stated Dr. Platzbecker.
  • For patients treated with imetelstat, there was a numerically higher percentage of patients reporting any episode of sustained meaningful improvement in fatigue.
  • Further, patients receiving imetelstat experienced a shorter median time to first sustained clinically meaningful improvement in fatigue vs placebo (28.3 vs 65.0 weeks).
  • In addition to these IMerge Phase 3 presentations, Geron collaborators presented a translational analysis from a subset of IMerge Phase 2 patients, as well as imetelstat myelofibrosis (MF) pre-clinical results.

Geron to Host Virtual Investor Event on June 14, 2023

Retrieved on: 
Tuesday, June 6, 2023
Biotechnology, FDA, Other Health, Health, Pharmaceutical, Oncology, Other Science, Research, Hospitals, Science, Clinical Trials, Ruxolitinib, Clinic, European Hematology Association, Hematology, Cell therapy, American Society of Clinical Oncology, H. Lee Moffitt Cancer Center & Research Institute, Teaching hospital, Acute myeloid leukemia, ASCO, MDS, Imetelstat, Corporation, Geron Corporation, Risk, EHA, Annual general meeting, Webcast, Society, Pharmaceutical industry

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, will host a virtual investor event on Wednesday, June 14, 2023 at 8:00 a.m. Eastern Time.

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, will host a virtual investor event on Wednesday, June 14, 2023 at 8:00 a.m. Eastern Time.
  • Topics to be covered at the event include:
    Summary of new IMerge Phase 3 data in lower risk myelodysplastic syndromes (MDS) featured in 2023 medical meetings.
  • This includes presentation of data at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 2, 2023 and upcoming presentations at the European Hematology Association (EHA) Annual Meeting taking place from June 8-11, 2023.
  • An archive of the webcast will be available on the Company’s website for 30 days.

Geron Announces ASCO Presentation Reporting Durable Continuous Transfusion Independence with Imetelstat in IMerge Phase 3 Lower Risk MDS Patients

Retrieved on: 
Friday, June 2, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Red blood cell, ESA, TI, American Society of Clinical Oncology, ASCO, MDS, Imetelstat, Corporation, Geron Corporation, Patient, Risk, Annual general meeting, Society, Pharmaceutical industry

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, announced a presentation reporting durable continuous transfusion independence with imetelstat, the Company’s first-in-class telomerase inhibitor, in IMerge Phase 3 lower risk MDS patients.

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, announced a presentation reporting durable continuous transfusion independence with imetelstat, the Company’s first-in-class telomerase inhibitor, in IMerge Phase 3 lower risk MDS patients.
  • The ASCO presentation reported IMerge Phase 3 results with a data cut-off of October 2022, the same for top-line results reported in January 2023.
  • The primary endpoint of 8-week transfusion independence (TI) was met with high statistical significance (P
  • Imetelstat-treated patients also experienced a statistically significant (P=0.042) and clinically meaningful mean reduction in RBC transfusion units compared to placebo.