BTIG Maintains 'Neutral' Rating on Geron (GERN) Following Imetelstat Update
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BTIG affirms Geron Corp. (Nasdaq: GERN) with a Neutral rating following an update on the ongoing imetelstat Phase II IMbark trial in MF and Phase II/III trial in MDS.
Analyst Ling Wang noted the following key points late Monday:
- Imetelstat showed consistent safety profile in both trials. Safety profile of imetelstat was consistent with prior observations and no new AEs were observed, which is positive in our view.
- Update on IMbark. The decision to close the 4.7 mg/kg arm is not surprising, since IMbark is a dose-refining trial. Although it is slightly disappointing that the 9.4 mg/kg arm did not meet the pre-specified criteria (details not disclosed), we understand the IMbark patients (relapsed/refractory MF population, a true unmet need) are more treatment-experienced than in the prior pilot study, which may require longer follow-up and/or additional dose-refining to ascertain the efficacy in this patient population. Additional interim analysis is expected in 2Q17, which Janssen believes should have a sufficient number of patients and follow-up to inform the future development plan of this dose.
- IMerge trial continues unmodified. Safety and efficacy of imetelstat are consistent with a prior pilot study in MDS patients. Additional assessment will occur in 2Q17 as well. A go-no-go decision will be made based on the benefit/risk analysis of these patients.
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