Shares of Geron Corporation (NASDAQ:GERN) ended Monday session in rd green amid volatile trading. The shares closed up +0.20 points or 9.76% at $2.25 with 3.62 million shares getting traded. Post opening the session at $2.09, the shares hit an intraday low of $2.08 and an intraday high of $2.26 and the price vacillated in this range throughout the day. The company has a market cap of $367.01 million and the numbers of outstanding shares have been calculated to be 159.14 million shares.
Geron Corporation (GERN) on Sept. 12, 2016 provided updates on the clinical trials being conducted by Janssen Research & Development, LLC, of the telomerase inhibitor imetelstat. Planned internal reviews of initial data from both trials have been completed by Janssen, and both trials are continuing in order to evaluate additional and more mature data.
IMergeTM (NCT02598661) is a Phase 2/3 clinical trial evaluating imetelstat in transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS) who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The clinical trial is in two parts: Part 1 is a Phase 2, open-label, single-arm design in approximately 30 patients and Part 2 is a Phase 3, randomized, double-blind, placebo-controlled design in approximately 170 patients. The primary efficacy endpoint is the rate of red blood cell transfusion-independence lasting at least 8 weeks. Part 1 of the trial is fully enrolled.
Janssen has conducted an initial internal review of efficacy, safety and pharmacokinetic data from a subset of patients from Part 1 of IMergeTM and this review indicated that emerging safety and efficacy in IMergeTM is consistent with data reported from the pilot study conducted at Mayo Clinic in MDS patients. IMergeTM will continue unmodified at this time.
Further assessment of data from IMergeTM is expected to occur in the second quarter of 2017 to include longer follow-up of all patients enrolled in Part 1. A decision on whether to move forward to Part 2 of IMergeTM will be based on an assessment of the benefit/risk profile of imetelstat in these patients. If Janssen decides to move forward with Part 2, the Phase 3 clinical trial is expected to be open for patient enrollment in mid-2017.
Shares of Galena Biopharma Inc (NASDAQ:GALE) ended Monday session in red amid volatile trading. The shares closed down -0.026 points or -6.91% at $0.356 with 4.92 million shares getting traded. Post opening the session at $0.38, the shares hit an intraday low of $0.34 and an intraday high of $0.39 and the price vacillated in this range throughout the day. The company has a market cap of $90.38 million and the numbers of outstanding shares have been calculated to be 213.97 million shares.
Galena Biopharma Inc (GALE) announced that Mark W. Schwartz, Ph.D., President and Chief Executive Officer will present a corporate update at the Sachs Associates 16th Annual Biotech in Europe Forum. The presentation will take place on Wednesday, September 28, 2016 at 10:15 a.m. local time at the Congress Center Basel in Basel, Switzerland.
The presentation will be webcast and available on the Investors section of the Company’s website at http://investors.galenabiopharma.com/events.cfm.