Imetelstat

Geron Announces FDA Oncologic Drugs Advisory Committee Votes in Favor of the Clinical Benefit/Risk Profile of Imetelstat for the Treatment of Transfusion-Dependent Anemia in Patients with Lower-Risk MDS

Retrieved on: 
Thursday, March 14, 2024
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“We are pleased with the Committee’s decision to recognize the positive clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS.

Key Points: 
  • “We are pleased with the Committee’s decision to recognize the positive clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS.
  • Additionally, a sustained increase in mean hemoglobin levels in imetelstat-treated patients was observed over time compared to placebo patients.
  • The ODAC provides the FDA with independent opinions and recommendations from outside medical experts, patients and caregivers, though the recommendations are not binding.
  • Geron plans to commercially launch imetelstat in the U.S. upon potential FDA approval.

Geron Corporation Reports Business Highlights and Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Wednesday, February 28, 2024
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Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing investigational first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported business highlights and financial results for the fourth quarter and full year 2023.

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing investigational first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported business highlights and financial results for the fourth quarter and full year 2023.
  • The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of June 16, 2024 to the NDA.
  • In September 2023, the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for imetelstat in the same proposed indication as the NDA.
  • Geron will host a conference call at 8:00 am ET on Wednesday, February 28, 2024, to discuss business updates and fourth quarter and full year 2023 financial results.

Geron Announces IMerge Phase 3 Presentations at ASH Highlighting Significant Durability of Transfusion Independence and Breadth of Effect Across MDS Subgroups with Imetelstat in Lower Risk MDS

Retrieved on: 
Monday, December 11, 2023
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The results showed that imetelstat consistently had higher RBC-TI response rates than placebo across these different risk subgroups.

Key Points: 
  • The results showed that imetelstat consistently had higher RBC-TI response rates than placebo across these different risk subgroups.
  • Overall, durable 24-week and 1-year RBC-TI responses were observed with imetelstat in all lower- and higher-risk subgroups.
  • This analysis suggests clinical benefit of imetelstat across different molecularly defined subgroups and independent of the underlying molecular mutation pattern.
  • This analysis indicates that achievement of RBC-TI was associated with improved survival, suggesting that transfusion dependence is a modifiable predictor of clinical outcomes in lower risk MDS.

Geron Announces Fifty Percent Enrollment in the Phase 3 IMpactMF Clinical Trial Evaluating Imetelstat in Patients with Relapsed/Refractory Myelofibrosis

Retrieved on: 
Wednesday, December 6, 2023
Health, Stem Cells, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Safety, JAK, BAT, Gold, Corporation, Patient, Pharmacokinetics, Jaki, Survival, Imetelstat, Geron Corporation, Ruxolitinib, MF, Bone marrow, Pharmaceutical industry, Medicine

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced achievement of fifty percent enrollment in the Phase 3 IMpactMF clinical trial investigating the Company’s first-in-class telomerase inhibitor, imetelstat, versus best available therapy (BAT) in patients with relapsed/refractory myelofibrosis (MF).

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced achievement of fifty percent enrollment in the Phase 3 IMpactMF clinical trial investigating the Company’s first-in-class telomerase inhibitor, imetelstat, versus best available therapy (BAT) in patients with relapsed/refractory myelofibrosis (MF).
  • “This is the first Phase 3 trial to evaluate overall survival as a primary endpoint in relapsed/refractory MF and is also the first Phase 3 trial investigating a telomerase inhibitor in this patient population.
  • “There is therefore a very pressing need for treatments that can improve survival in relapsed/refractory MF.
  • A median OS of 29.9 months in imetelstat 9.4 mg/kg arm was observed in IMbark Phase 2, compared to 14-16 months median OS for historical controls for these JAKi relapsed/refractory MF patients.

Geron Announces Publication in The Lancet of Results from the IMerge Phase 3 Clinical Trial Evaluating Imetelstat in Lower Risk MDS

Retrieved on: 
Monday, December 4, 2023
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Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced publication in The Lancet of results from the IMerge Phase 3 trial investigating imetelstat versus placebo in patients with lower risk myelodysplastic syndromes (MDS) relapsed/refractory or ineligible for erythropoiesis stimulating agents (ESAs).

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced publication in The Lancet of results from the IMerge Phase 3 trial investigating imetelstat versus placebo in patients with lower risk myelodysplastic syndromes (MDS) relapsed/refractory or ineligible for erythropoiesis stimulating agents (ESAs).
  • “With regards to the safety results, neutropenia and thrombocytopenia were predictable and manageable, with little to no significant clinical consequences.
  • 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.
  • Consistent with prior imetelstat clinical experience, the most common adverse events were thrombocytopenia and neutropenia that were manageable and of short duration.

Geron Corporation Reports Business Highlights and Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 2, 2023
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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 third 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 third quarter of 2023.
  • Ms. Robertson brings to Geron over 30 years of financial and commercial operations experience.
  • In the third quarter of 2023, the Company received $28.3 million upon the cash exercise of outstanding warrants.
  • Geron will host a conference call at 9:00 am ET on Thursday, November 2, 2023 to discuss business updates and third quarter 2023 financial results.

Geron IMerge Phase 3 Presentations at Upcoming ASH Annual Meeting Reinforce Significant Durability and Breadth of Effect of Imetelstat in Lower Risk MDS

Retrieved on: 
Thursday, November 2, 2023
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Four abstracts have been accepted for presentation at the 65th American Society of Hematology (ASH) Annual Meeting taking place from December 9-12 in San Diego, California and virtually.

Key Points: 
  • Four abstracts have been accepted for presentation at the 65th American Society of Hematology (ASH) Annual Meeting taking place from December 9-12 in San Diego, California and virtually.
  • “Additionally, our abstract showcasing a real-world data population level analysis of over 5,000 lower risk MDS patients adds to the significant literature suggesting a correlation between TI and improvement in survival.
  • This analysis suggests imetelstat has clinical activity in lower risk MDS patients independent of risk categories.
  • Achievement of durable TI was associated with improved survival, supporting the clinical benefit of achieving transfusion independence in lower risk MDS.

Geron Announces EMA Validation of Marketing Authorization Application for Imetelstat for the Treatment of Lower Risk MDS

Retrieved on: 
Friday, September 29, 2023
Research, Hospitals, FDA, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, European Medicines Agency, Committee on Herbal Medicinal Products, Marketing, EMA, MDS, Imetelstat, Corporation, Geron Corporation, Patient, Risk, Transfusion-dependent anemia, Anemia, MAA, CHMP, Medical device, EU

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for imetelstat, a first-in-class investigational 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 European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for imetelstat, a first-in-class investigational telomerase inhibitor, for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes (MDS).
  • “The EMA validation of the marketing authorization application for imetelstat brings us one step closer to potentially offering this first-in-class therapeutic to lower risk MDS patients in the EU suffering from anemia,” 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.
  • Consistent with prior imetelstat clinical experience, the most common serious adverse events were primarily short-lived, manageable cytopenias.

Geron Announces Appointment of Michelle Robertson as Executive Vice President, Chief Financial Officer and Treasurer, and the Retirement of Olivia Bloom, Geron's Long-Time Chief Financial Officer

Retrieved on: 
Monday, September 11, 2023
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Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced the appointment of Michelle Robertson as Executive Vice President, Chief Financial Officer (CFO) and Treasurer, effective September 25, 2023.

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced the appointment of Michelle Robertson as Executive Vice President, Chief Financial Officer (CFO) and Treasurer, effective September 25, 2023.
  • Ms. Robertson's appointment follows the retirement of Olivia Bloom, Geron's incumbent CFO, also effective September 25, 2023.
  • Olivia’s strategic vision, financial prowess and inspiring dedication have been foundational in making Geron what we are today,” said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer.
  • “In the same breath, I am also thrilled to welcome Michelle Robertson to the Geron executive management team at this important moment in our history.

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.