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Geron's Growth Depends on Continuation of Imetelstat Studies
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On Aug 14, we issued an updated research report on Geron Corporation (GERN - Free Report) . This developmental stage biopharmaceutical company, based in Cambridge, MA, is focused on the development of first-in-class therapeutic products with its patented core technology, telomerase, for the treatment of cancer.
In the last six months, Geron’s shares have returned 63.9% against a decline of 5.1% for the industry.
Imetelstat in Focus
Geron has no approved products in its portfolio and generates revenues in the form of license fees and royalties. The company is developing its sole pipeline candidate, imetelstat, in collaboration with Johnson & Johnson (JNJ - Free Report) in mid-stage studies for treatment of hematologic myeloid malignancies like myelofibrosis (“MF”) and myelodysplastic syndromes (“MDS”). The candidate enjoys orphan drug designation for both the indications. The phase II IMbark study is evaluating imetelstat in MF while the candidate is being evaluated for MDS in phase II/III IMerge study.
J&J, through its subsidiary Janssen, is conducting both the studies. In March 2018, Janssen stopped enrolling patients in the IMbark study. During the second quarter of 2018, Janssen initiated a protocol-specified analysis of the study to reach a decision on continuation of the study. The decision is expected in the third quarter.
The IMerge study enrolled 25 more patients in a refined MDS indication as an expansion of part I of the study. Janssen will seek confirmation of the clinical benefit and safety observed in preliminary analysis in these additional patients.
We note that in December 2017, Geron presented preliminary data from the study. Data showed that 54% of the patients treated with imetelstat achieved RBC transfusion-independence (reduced or no requirement of RBC transfusion over a certain interval).
Investors are solely banking on the continuation and success of these two studies. However, Acceleron Pharma Inc. and its partner Celgene Corporation are developing their candidate, luspatercept, in patients with lower risk of MDS. The companies are planning to file regulatory applications in the United States and Europe seeking approval of luspatercept in the first half of 2019. The candidate’s approval will likely increase competition for imetelstat going forward.
With no approved product and no other pipeline candidates, the accelerated development of imetelstat is necessary for Geron’s growth.
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Geron's Growth Depends on Continuation of Imetelstat Studies
On Aug 14, we issued an updated research report on Geron Corporation (GERN - Free Report) . This developmental stage biopharmaceutical company, based in Cambridge, MA, is focused on the development of first-in-class therapeutic products with its patented core technology, telomerase, for the treatment of cancer.
In the last six months, Geron’s shares have returned 63.9% against a decline of 5.1% for the industry.
Imetelstat in Focus
Geron has no approved products in its portfolio and generates revenues in the form of license fees and royalties. The company is developing its sole pipeline candidate, imetelstat, in collaboration with Johnson & Johnson (JNJ - Free Report) in mid-stage studies for treatment of hematologic myeloid malignancies like myelofibrosis (“MF”) and myelodysplastic syndromes (“MDS”). The candidate enjoys orphan drug designation for both the indications. The phase II IMbark study is evaluating imetelstat in MF while the candidate is being evaluated for MDS in phase II/III IMerge study.
J&J, through its subsidiary Janssen, is conducting both the studies. In March 2018, Janssen stopped enrolling patients in the IMbark study. During the second quarter of 2018, Janssen initiated a protocol-specified analysis of the study to reach a decision on continuation of the study. The decision is expected in the third quarter.
The IMerge study enrolled 25 more patients in a refined MDS indication as an expansion of part I of the study. Janssen will seek confirmation of the clinical benefit and safety observed in preliminary analysis in these additional patients.
We note that in December 2017, Geron presented preliminary data from the study. Data showed that 54% of the patients treated with imetelstat achieved RBC transfusion-independence (reduced or no requirement of RBC transfusion over a certain interval).
Investors are solely banking on the continuation and success of these two studies. However, Acceleron Pharma Inc. and its partner Celgene Corporation are developing their candidate, luspatercept, in patients with lower risk of MDS. The companies are planning to file regulatory applications in the United States and Europe seeking approval of luspatercept in the first half of 2019. The candidate’s approval will likely increase competition for imetelstat going forward.
With no approved product and no other pipeline candidates, the accelerated development of imetelstat is necessary for Geron’s growth.
Geron Corporation Price
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