Geron Corporation (NASDAQ: GERN) is engaged as a late-stage biopharmaceutical company, which is focused on the research and development of treatments for patients suffering from hematologic malignancies. Shares of the late-stage biopharma company are rallying 37% through early trading on Wednesday, January 4, 2023. Over the past three months, Geron has seen average daily volume of 3.99 million shares. However, volume of 94.41 million shares or dollar volume of around $311.55 million, has already exchanged hands through early trading.
Shares of Geron are gaining after the company reported positive top-line and secondary endpoint results from its IMerge Phase 3 clinical trial of Imetelstat for the treatment of lower risk myelodysplastic syndromes (MDS) who have relapsed, refractory or are not eligible for erythropoiesis stimulating agents (ESAs).
The IMerge Phase 3 trial was a double-blind, 2:1 randomized, placebo-controlled clinical trial. During the trial’s first 8 weeks, patients treated with Imetelstat saw very statistically significant improvements compared to the placebo group. After eight weeks, Imetelstat patients saw a transfusion independence (TI) reading of 47 compared to 9 in the placebo group. This met the primary endpoints for the Phase 3 trial. Over a 24-week period, Imetelstat patients saw a TI reading of 33, compared to the placebo group’s 2 result.
This shows that Imetelstat-treated patients were able to achieve transfusion independent broadly among lower risk MDS subtypes. Average hemoglobin levels in Imetelstat patients saw a robust increase over time compared to the placebo group. In additional, test groups saw clinically-meaningful average reduction in RBC transfusion units compared to the placebo group.
Imetelstat maintained a very strong safety profile throughout the clinical trial. Treatment emergent adverse events (TEAEs) that were seen in the IMerge Phase 3 trial were consistent with the known potential safety risks of the treatment. No new safety issues were found.
Moving forward, Geron Corporation says it plans to submit a New Drug Application with the U.S. Food and Drug Administration, as well as a Marketing Authorization Application (MAA) with EU regulators during the second half of 2023. Geron estimates commcerical launch of Imetelstat to take place sometime during the first half of 2024 in the U.S. and by the end of 2024 in the EU.
“Today is a great day for lower risk MDS patients who are living with the burden of transfusions. The results from the IMerge Phase 3 study were resoundingly positive, presenting compelling durability of transfusion independence, delivering on the promise of imetelstat and telomerase inhibition for these patients,” said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer. “This milestone is the first of many upcoming catalysts for Geron, with planned U.S. and EU regulatory submissions in 2023, as well as preparations for a potential U.S. commercial launch. In addition, in 2024, we expect an interim analysis of the IMpactMF Phase 3 trial of imetelstat in relapsed/refractory myelofibrosis.”
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