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Geron (GERN) at 52-Week Low on Imetelstat Study Update
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Geron Corporation (GERN - Free Report) provided an update from two of the ongoing studies on its lead compound, imetelstat.
The stock lost 19.6% on the news, touching a new 52-week low of $2.06 on Sep 12 before eventually closing a little higher at $2.30.
The company announced that its partner, Janssen Biotech, a Johnson & Johnson (JNJ - Free Report) company, has completed the planned internal reviews of initial data from the two studies – IMbark (phase II) for the treatment of myelofibrosis and IMerge (phase II/III) for the treatment of myelodysplastic syndromes.
Janssen concluded that clinical activity of imetelstat, in the 4.7 mg/kg dosing arm, in the IMbark study did not warrant any further investigation, and will be closed to new patient enrollment. The company, however, plans to continue evaluating imetelstat in the 9.4 mg/kg dosing arm, which is currently on hold. Additional internal data reviews will be conducted in the second quarter of 2017 to include a longer follow-up of patients at 24 weeks and resume enrollment in the 9.4 mg/kg dosing arm.
On the other hand, an internal review of the part 1 of the IMerge study on imetelstat showed similar safety and efficacy data as the pilot study conducted on the candidate at the Mayo Clinic. Further assessment of data from the study is expected in the second quarter of 2017. Based on this data, Janssen will decide on whether or not it will move ahead with the planned phase III study, which is expected to begin patient enrollment in mid 2017.
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.
The decision to stop evaluating the 4.7 mg/kg dose of imetelstat in the IMbark study is a huge setback for Geron as it puts the company’s prospects into the hands of the 9.4 mg/kg group, clearly raising Geron's risk profile. Note that the company is highly dependent on imetelstat for growth.
Going ahead, we expect investor focus to remain on further details pertaining to the 9.4 mg/kg group in the IMerge study and additional internal review data from the part 1 of the IMerge study.
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Geron (GERN) at 52-Week Low on Imetelstat Study Update
Geron Corporation (GERN - Free Report) provided an update from two of the ongoing studies on its lead compound, imetelstat.
The stock lost 19.6% on the news, touching a new 52-week low of $2.06 on Sep 12 before eventually closing a little higher at $2.30.
The company announced that its partner, Janssen Biotech, a Johnson & Johnson (JNJ - Free Report) company, has completed the planned internal reviews of initial data from the two studies – IMbark (phase II) for the treatment of myelofibrosis and IMerge (phase II/III) for the treatment of myelodysplastic syndromes.
Janssen concluded that clinical activity of imetelstat, in the 4.7 mg/kg dosing arm, in the IMbark study did not warrant any further investigation, and will be closed to new patient enrollment. The company, however, plans to continue evaluating imetelstat in the 9.4 mg/kg dosing arm, which is currently on hold. Additional internal data reviews will be conducted in the second quarter of 2017 to include a longer follow-up of patients at 24 weeks and resume enrollment in the 9.4 mg/kg dosing arm.
On the other hand, an internal review of the part 1 of the IMerge study on imetelstat showed similar safety and efficacy data as the pilot study conducted on the candidate at the Mayo Clinic. Further assessment of data from the study is expected in the second quarter of 2017. Based on this data, Janssen will decide on whether or not it will move ahead with the planned phase III study, which is expected to begin patient enrollment in mid 2017.
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.
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The decision to stop evaluating the 4.7 mg/kg dose of imetelstat in the IMbark study is a huge setback for Geron as it puts the company’s prospects into the hands of the 9.4 mg/kg group, clearly raising Geron's risk profile. Note that the company is highly dependent on imetelstat for growth.
Going ahead, we expect investor focus to remain on further details pertaining to the 9.4 mg/kg group in the IMerge study and additional internal review data from the part 1 of the IMerge study.
Geron is a Zacks Rank #1 (Strong Buy) stock. A couple of equally ranked stocks in the health care sector are Corcept Therapeutics Incorporated (CORT - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . You can see the complete list of today’s Zacks #1 Rank stocks here.
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Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>