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Geron (GERN) Begins Phase III Myelofibrosis Study on Imetelstat

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Zacks Equity Research
·4 min read
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Geron Corporation GERN announced the initiation of the long-awaited phase III study — IMpactMF — to evaluate its lead pipeline candidate, imetelstat, in patients with refractory myelofibrosis (“MF”). The company expects to report interim data and final data from the study in 2024 and 2025, respectively.

The study is targeting a patient population with a significant unmet medical need to improve overall survival (“OS”) in MF patients who are refractory or unresponsive to treatment with JAK inhibitors. It will compare imetelstat with the best available therapy for refractory MF patients for the study’s primary endpoint of improvement in OS.

The study is designed to enroll approximately 320 patients with intermediate-2 or high-risk MF. The final analysis of OS will be triggered when 50% or 160 patients enrolled in the study die. The interim analysis of the study has been planned when 70% of 160 patients die.

Please note that the company has completed the mid-stage IMbark study evaluating imtelestat in MF patients before 2019. Updated median overall survival data, announced in December 2018, suggest a meaningful survival outcome. The company has been in discussion with the FDA for future steps of the development of the candidate in this indication for nearly a year.

Shares of Geron closed at 0.7% higher on Apr 13, followed by an increase of 2.8% during after-hours trading on the same day. However, the stock has lost 10.1% so far this year compared with the industry’s 5.1% decline.

Apart from MF, the company is developing imetelstat for treating myelodysplastic syndromes (“MDS”). A phase III study, IMerge, is evaluating the candidate in patients with lower-risk MDS. The company expects to complete enrollment in the second half of 2021 and the top-line data from the study between the end of 2022 and the first half of 2023. In December 2020, the Independent Data Monitoring Committee for the study recommended the continuation of the study without modifications.

Anticipated timelines for both enrollment and top-line data readout have been delayed by at least six months so far due to COVID-19-related disruptions. However, the company expects study activities to normalize over the next few months amid vaccination and declining COVID-19 infection cases in the United States.

The company is also planning to develop imetelstat in additional hematologic myeloid malignancies.

Geron Corporation Price

Geron Corporation Price
Geron Corporation Price

Geron Corporation price | Geron Corporation Quote

Zacks Rank & Stocks to Consider

Geron currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks from the biotech sector are Moderna MRNA, Avid Bioservices CDMO and Atea Pharmaceuticals AVIR, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Moderna’s earnings estimates have moved up from $12.72 to $22.72 for 2021 in the past 60 days. Share price of the company has increased 43.3% so far this year.

Avid’s earnings estimates have moved up from 2 cents to 9 cents for 2021 in the past 60 days. The company delivered an earnings surprise in three of the trailing four quarters, the average beat being 100.42%. Share price of the company has increased 66.7% so far this year.

Atea’s earnings estimates have moved up from $3.70 to $8.34 for 2021 in the past 60 days. Share price of the company has increased 36.9% so far this year.

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