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Geron Stock Rises after Positive Interim Update on Imetelstat
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Shares of Geron Corporation (GERN - Free Report) increased almost 20% on Monday after it provided a positive update on two late-stage studies for imetelstat, its lead pipeline candidate.
So far this year, Geron’s shares have outperformed the Zacks classified Medical - Biomedical and Genetics industry. The stock rose 23.7% during the period while the industry witnessed a gain of 2.9%.
Telomerase inhibitor, imetelstat, is being developed for the treatment of hematologic myeloid malignancies like myelofibrosis (MF) and myelodysplastic syndromes (MDS).
Geron informed that partner Johnson & Johnson’s (JNJ - Free Report) subsidiary Janssen has completed the second internal data review of two studies, IMbark (phase II for the treatment of MF) and IMerge (phase II/III for the treatment of MDS), on imetelstat.
We remind investors that in September last year, Janssen had announced unfavorable findings from the planned internal reviews of initial data from IMbark and IMerge. As a result of the analysis, Janssen had then said that clinical activity of imetelstat, in the 4.7 mg/kg dosing arm, in the IMbark study did not warrant any further investigation and that it will no longer enrol new patients.
In March this year, Geron informed that the treatment of patients remaining on study in IMbark and IMerge is ongoing to obtain additional and more mature data. However, new patient enrollment in both trials was suspended until completion of the second internal data reviews by Janssen.
Following the second internal review, for IMerge, Janssen said that the benefit/risk profile of imetelstat in the treated patients supports continued development in lower risk MDS indication. The companies plan to provide a data package and proposed trial design refinements to the FDA. Geron mentioned that if Janssen decides to proceed to Part 2 of IMerge (a larger, 170 patient, Phase III portion), patient enrollment will begin in the fourth quarter of this year.
For IMbark, the recent results suggest that the clinical benefit and a potential overall survival benefit observed supports continuation of the trial without modifications. The trial that assesses the safety and efficacy of imetelstat treatment in relapsed or refractory MDS will also include an assessment of overall survival. Also, the data suggest that 9.4 mg/kg is an appropriate starting dose in the study.
We remind investors that in Nov 2014 Geron entered into a license and collaboration agreement with Janssen, granting the latter exclusive worldwide rights to develop and commercialize imetelstat for all human therapeutic uses, including hematologic myeloid malignancies.
Other stocks in the health care sector worth considering include Sanofi (SNY - Free Report) and Roche Holding AG (RHHBY - Free Report) . While Roche sports a Zacks Rank #1, Sanofi has a Zacks Rank #2.
Shares of Roche have risen 11% this year so far while earnings estimates for 2017 went up almost 12% in the past 30 days.
Shares of Sanofi have risen 10.2% this year so far while earnings estimates for 2017 went up almost 2% in the past 60 days.
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Geron Stock Rises after Positive Interim Update on Imetelstat
Shares of Geron Corporation (GERN - Free Report) increased almost 20% on Monday after it provided a positive update on two late-stage studies for imetelstat, its lead pipeline candidate.
So far this year, Geron’s shares have outperformed the Zacks classified Medical - Biomedical and Genetics industry. The stock rose 23.7% during the period while the industry witnessed a gain of 2.9%.
Telomerase inhibitor, imetelstat, is being developed for the treatment of hematologic myeloid malignancies like myelofibrosis (MF) and myelodysplastic syndromes (MDS).
Geron informed that partner Johnson & Johnson’s (JNJ - Free Report) subsidiary Janssen has completed the second internal data review of two studies, IMbark (phase II for the treatment of MF) and IMerge (phase II/III for the treatment of MDS), on imetelstat.
We remind investors that in September last year, Janssen had announced unfavorable findings from the planned internal reviews of initial data from IMbark and IMerge. As a result of the analysis, Janssen had then said that clinical activity of imetelstat, in the 4.7 mg/kg dosing arm, in the IMbark study did not warrant any further investigation and that it will no longer enrol new patients.
In March this year, Geron informed that the treatment of patients remaining on study in IMbark and IMerge is ongoing to obtain additional and more mature data. However, new patient enrollment in both trials was suspended until completion of the second internal data reviews by Janssen.
Following the second internal review, for IMerge, Janssen said that the benefit/risk profile of imetelstat in the treated patients supports continued development in lower risk MDS indication. The companies plan to provide a data package and proposed trial design refinements to the FDA. Geron mentioned that if Janssen decides to proceed to Part 2 of IMerge (a larger, 170 patient, Phase III portion), patient enrollment will begin in the fourth quarter of this year.
For IMbark, the recent results suggest that the clinical benefit and a potential overall survival benefit observed supports continuation of the trial without modifications. The trial that assesses the safety and efficacy of imetelstat treatment in relapsed or refractory MDS will also include an assessment of overall survival. Also, the data suggest that 9.4 mg/kg is an appropriate starting dose in the study.
We remind investors that in Nov 2014 Geron entered into a license and collaboration agreement with Janssen, granting the latter exclusive worldwide rights to develop and commercialize imetelstat for all human therapeutic uses, including hematologic myeloid malignancies.
Geron currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Other stocks in the health care sector worth considering include Sanofi (SNY - Free Report) and Roche Holding AG (RHHBY - Free Report) . While Roche sports a Zacks Rank #1, Sanofi has a Zacks Rank #2.
Shares of Roche have risen 11% this year so far while earnings estimates for 2017 went up almost 12% in the past 30 days.
Shares of Sanofi have risen 10.2% this year so far while earnings estimates for 2017 went up almost 2% in the past 60 days.
Looking for Ideas with Even Greater Upside?
Today's investment ideas are short-term, directly based on our proven 1 to 3 month indicator. In addition, I invite you to consider our long-term opportunities. These rare trades look to start fast with strong Zacks Ranks, but carry through with double and triple-digit profit potential. Starting now, you can look inside our home run, value, and stocks under $10 portfolios, plus more. Click here for a peek at this private information >>