Has Geron Undersold Itself To Janssen?
Kanak Kanti De • 252 Comments
Kanak Kanti De • 252 Comments
Geron: Still Standing
Robert Lawton • 375 Comments
Robert Lawton • 375 Comments
Thu, May 5, 4:16 PM
Wed, May 4, 5:35 PM
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Thu, Feb. 25, 7:27 PM
- Geron (GERN -3%) is up 3.1% in after-hours trading following an in-line loss for its fourth quarter earnings on $220K in revenue.
- In the full year, the company eked out a profit of $46,000 vs. 2014's net loss of $35.7M. Revenues came to $36.4M, including full recognition of a $35M upfront payment from Janssen received in December 2014.
- Geron said the FDA granted orphan drug designation to imetelstat for the treatment of MF and for the treatment of MDS, and that the European Medicine Agency granted orphan drug designation to imetelstat for the treatment of MF.
- R&D expenses for 2015 were $17.8M vs. the prior year's $20.7M, mainly due to organizational resizing and lower costs to make imetelstat. G&A costs were $17.8M.
- Press Release
Thu, Feb. 25, 4:12 PM
Wed, Feb. 24, 5:35 PM
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Dec. 7, 2015, 9:19 AM| Dec. 7, 2015, 9:19 AM | 714 Comments
Nov. 30, 2015, 12:49 PM
Nov. 25, 2015, 5:38 PM
Nov. 6, 2015, 9:29 AM
Nov. 5, 2015, 4:10 PM
- Geron (NASDAQ:GERN): Q3 EPS of $0.17 beats by $0.06.
- Revenue of $35.4M beats by $14.05M.
Nov. 4, 2015, 5:35 PM
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Sep. 16, 2015, 8:32 AM
- The first patient has been dosed in a Phase 2 clinical trial, called IMbark, evaluating imetelstat in patients with myelofibrosis, a bone marrow disorder characterized by scarring (fibrosis) in the bone marrow which leads to severe anemia, weakness, fatigue and an enlarged spleen and liver. The study is being conducted by Janssen Biotech (NYSE:JNJ) under the terms of its November 2014 exclusive global imetelstat license from discoverer Geron (NASDAQ:GERN).
- The mid-stage trial will assess two doses (9.4 mg/kg every three weeks or 4.7 mg/kg every three weeks) of imetelstat as monotherapy in ~200 high risk MF patients who have relapsed or failed to adequately respond to Janus Kinase (JAK) inhibitor treatment [Novartis' (NYSE:NVS) Jakafi (ruxolitinib)]. An interim review of the data will be done after ~20 subjects in each arm have been dosed and followed for at least 12 weeks. The review will be the basis for any modifications going forward.
- The co-primary endpoints are spleen response rate, determined by the percentage of patients who achieve at least a 35% reduction in spleen volume from baseline at week 24, and symptom response rate, determined by the percentage of patients who experience at least a 50% reduction in Total Symptom Scores from baseline at week 24.
- According to clinicaltrials.gov, the final data collection date for the primary endpoints is March 2017. The estimated study completion date is March 2018.
- Imetelstat inhibits an enzyme called telomerase by binding to its RNA template. Most cancers have a high level of telomerase activity and relatively short telemeres (caps at the end of each strand of DNA) compared to normal cells. Inhibiting telomerase inhibits the proliferation of malignant progenitor cells.
Sep. 4, 2015, 12:39 PM
- Thinly traded nano cap KaloBios Pharmaceuticals (KBIO +43.9%) jumps again in early trading on robust volume. Shares have more than doubled over the past two trading sessions.
- A possible driver of the bullish action may be Geron's (GERN -3.5%) interest in acquiring an early-stage oncology asset via licensing or outright purchase of a company. In the company's Q4 earnings call in March, CEO Chip Scarlett said the due diligence process to assess potential candidates was underway.
- Kalabios' two lead product candidates are KB004, a monoclonal antibody currently in Stage 2 development for myelofibrosis or myelodysplastic syndrome and KB003, a monoclonal antibody in Phase 1 development for chronic myelomonocytic leukemia.
Sep. 3, 2015, 9:12 AM
Sep. 2, 2015, 6:04 PM
- Geron (NASDAQ:GERN) +20.4% AH on news that the New England Journal of Medicine would publish two papers showing positive results for GERN's flagship drug imetelstat, an inhibitor of the telomerase cancer cell enzyme.
- In two mid-stage clinical trials, GERN said the use of imetelstat suggested it works against malignant cells that cause essential thrombocythemia, a disease in which the body produces too many blood platelets, and against myelofibrosis, a bone marrow disease that disrupts the body's production of blood cells.
Aug. 5, 2015, 5:27 PM
- Geron (NASDAQ:GERN): Q2 EPS of -$0.06 in-line.
- Revenue of $0.3M (-11.8% Y/Y) misses by $0.1M.
Geron Corp. discovers and develops therapeutic products for cancer. It is a clinical stage biopharmaceutical company developing a telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. The company's imetelstat, their sole product candidate, is a potent and specific inhibitor of... More
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