Recurrent Myelofibrosis

Geron’s blood disorder drug imetelstat is forecast to generate $1.2bn in sales in 2029, according to GlobalData. Credit: MacroEcon via Shutterstock. Advisers to the US Food and Drug Administration (FDA) on 14 March defended Geron ‘s blood disorder drug, saying the benefits outweighed the risks associated with the treatment, based on data from a Phase III trial. The FDA’s Oncologic Drugs Advisory Committee voted 12 to two in favour of the clinical benefit / risk profile of imetelstat based on results from the IMerge Phase III clinical trial (NCT02598661), to treat transfusion-dependent anaemia in patients with a group of blood cancers called myelodysplastic syndromes (MDS). The Phase III IMerge trial enrolled 178 patients across North America, Europe, the Middle East, and Asia. Imetelstat, a telomerase inhibitor, showed significantly higher red blood cell transfusion independence (RBC-TI) rates for at least eight consecutive weeks, compared to placebo, meeting its primary endpoint. Additionally, 28% of imetelstat-treated patients achieved a statistically significant improvement in the key secondary endpoint of RBC-TI at 24 weeks, compared to 3% on placebo. The concerns leading up to the FDA’s advisory panel meeting were surrounding the high rate of cytopenias (low red blood cell counts) in patients treated with the drug, but the committee ultimately backed the drug’s efficacy and safety. See Also: With FDA greenlight, BMS Breyanzi brings CAR-T cell therapy to CLL and SLL FDA approves Madrigal’s Rezdiffra as the first NASH therapy The regulatory agency will now provide a decision on the approval of the treatment by 16 June 2024 under the Prescription Drug User Fee Act. If approved, imetelstat will be competing with Bristol Myers Squibb ‘s Reblozyl (luspatercept). The drug generated $1bn last year, as per BMS’ annual report. GlobalData expects the drug to continue its upward sales trajectory and pull in $3.4bn in global sales in 2030. The FDA expanded Reblozyl’s label in August 2023 to treat the same indication. According to GlobalData’s Pharma Intelligence Center, imetelstat is forecast to generate $1.2bn in sales in 2029. GlobalData is the parent company of Pharmaceutical Technology. The drug is also being investigated in a Phase III IMpactMF (NCT04576156) open-label, controlled trial to treat patients with relapsed/refractory myelofibrosis (MF). Approximately 320 subjects with intermediate-2 or high-risk MF who are relapsed after or refractory to previous JAK inhibitor treatment will be randomised to receive either imetelstat or the best available therapy (BAT). In the announcement accompanying the backing, Geron CEO Faye Feller said: “We are pleased with the committee’s decision to recognise the positive clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anaemia in adult patients with lower-risk MDS. “There are few treatment options and significant unmet medical need remains for these patients, particularly among those with difficult-to-treat subtypes of this blood cancer.”

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today reported that it has granted non-statutory stock options to purchase an aggregate of 397,010 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company. The stock options were granted on February 21, 2024, at an exercise price of $1.93 per share, which is equal to the closing price of Geron common stock on the date of grant. Stock options representing an aggregate of 388,440 shares have a 10-year term and vest over four years, with 12.5% of the shares underlying the options vesting on the six-month anniversary of commencement of employment for the respective employees and the remaining shares vesting over the following 42 months in equal installments of whole shares, subject to continued employment with Geron through the applicable vesting dates. Stock options representing an aggregate of 8,570 shares have a 10- year term and vest in full upon achievement of a certain regulatory milestone, subject to continued employment with Geron through the applicable vesting date. All of the stock options were granted as material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of the stock option agreements covering the grants and Geron’s 2018 Inducement Award Plan, which was adopted December 14, 2018, and provides for the granting of stock options to new employees. About Geron Geron is a late-stage clinical biopharmaceutical company pursuing therapies with the potential to extend and enrich the lives of patients living with hematologic malignancies. Our first-in-class investigational telomerase inhibitor, imetelstat, harnesses Nobel Prize-winning science in a treatment that may alter the underlying drivers of disease. The New Drug Application (NDA) for imetelstat for the treatment of transfusion dependent anemia in adult patients with lower risk myelodysplastic syndromes (LR MDS) who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs), based on the results from the Phase 3 IMerge clinical trial, is currently under review by the United States Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 16, 2024. In addition, an MAA is under review in the European Union for the same proposed indication. Furthermore, Geron currently has an ongoing pivotal Phase 3 clinical trial evaluating imetelstat in relapsed/refractory myelofibrosis (MF). To learn more, visit or follow us on LinkedIn. View source version on businesswire.com: Contacts Aron Feingold Vice President, Investor Relations and Corporate Communications Kristen Kelleher Senior Manager, Investor Relations investor@geron.com media@geron.com Source: Geron Corporation View this news release online at:

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today reported that it has granted non-statutory stock options to purchase an aggregate of 895,930 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company. The stock options were granted on January 17, 2024, at an exercise price of $1.92 per share, which is equal to the closing price of Geron common stock on the date of grant. Stock options representing an aggregate of 873,000 shares have a 10-year term and vest over four years, with 12.5% of the shares underlying the options vesting on the six-month anniversary of commencement of employment for the respective employees and the remaining shares vesting over the following 42 months in equal installments of whole shares, subject to continued employment with Geron through the applicable vesting dates. Stock options representing an aggregate of 22,930 shares have a 10-year term and vest in full upon achievement of a certain regulatory milestone, subject to continued employment with Geron through the applicable vesting date. All of the stock options were granted as material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of the stock option agreements covering the grants and Geron’s 2018 Inducement Award Plan, which was adopted December 14, 2018, and provides for the granting of stock options to new employees. About Geron Geron is a late-stage clinical biopharmaceutical company pursuing therapies with the potential to extend and enrich the lives of patients living with hematologic malignancies. Our first-in-class investigational telomerase inhibitor, imetelstat, harnesses Nobel Prize-winning science in a treatment that may alter the underlying drivers of disease. The New Drug Application (NDA) for imetelstat for the treatment of transfusion dependent anemia in adult patients with lower risk myelodysplastic syndromes (LR MDS) who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs), based on the results from the Phase 3 IMerge clinical trial, is currently under review by the United States Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 16, 2024. In addition, an MAA is under review in the European Union for the same proposed indication. Furthermore, Geron currently has an ongoing pivotal Phase 3 clinical trial evaluating imetelstat in relapsed/refractory myelofibrosis (MF). To learn more, visit or follow us on LinkedIn. View source version on businesswire.com: Contacts Aron Feingold Vice President, Investor Relations and Corporate Communications Kristen Kelleher Senior Manager, Investor Relations investor@geron.com media@geron.com Source: Geron Corporation View this news release online at: