Geron Corporation GERN announced positive top-line data from the phase III IMerge study evaluating its lead pipeline candidate, imetelstat in lower risk myelodysplastic syndromes (MDS) patients who are relapsed, refractory or ineligible for erythropoiesis stimulating agents (ESAs).
The randomized, placebo-controlled IMerge study evaluated imetelstat in patients with IPSS low or intermediate-1 risk (lower risk) transfusion dependent MDS who relapsed after, were refractory to, or ineligible for ESA treatment.
The study met its primary efficacy endpoint of 8-week transfusion independence (TI) and a key secondary endpoint of 24-week TI while demonstrating highly statistically significant and clinically meaningful improvements following treatment with imetelstat in the given patient population.
Shares of Geron were up 32.9% following the announcement of the news on Wednesday. The stock has rallied 165.8% in the past year against the industry’s decline of 17.7%.
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Safety data from the study were similar to prior imetelstat clinical data with no new safety signals reported either in the study.
Based on the positive data from the IMerge study, along with data from earlier clinical studies, GERN plans to file a new drug application in mid-2023 in the United States. A marketing authorization application is expected to be filed in the second half of 2023 in the European Union or EU.
Upon potential approval, Geron is planning to launch imetelstat in lower risk MDS in the United States in the first half of 2024 and the EU by the end of 2024.
Apart from lower risk MDS, GERN is evaluating imetelstat for treating patients with JAK inhibitor relapsed/refractory myelofibrosis (MF).
The randomized, controlled phase III IMpactMF is evaluating imetelstat in patients with intermediate-2 or high-risk MF who are relapsed after or refractory to prior treatment with a JAK inhibitor, also referred to as relapsed/refractory MF.
The primary endpoint of the IMpactMF study is to check the overall survival. Enrollment in the study is currently ongoing.
The company is also looking to develop imetelstat in additional hematologic myeloid malignancies.
Zacks Rank & Stocks to Consider
Geron currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Syndax Pharmaceuticals, Inc. SNDX, Celularity Inc. CELU and Repare Therapeutics Inc. RPTX, all sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
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