Has Geron Undersold Itself To Janssen?
Kanak Kanti De • 252 Comments
Kanak Kanti De • 252 Comments
Mon, Oct. 3, 9:22 AM
Mon, Sep. 19, 10:41 AM
- Geron (GERN +6.4%) heads north on increased volume in response to its announcement of a license deal with Janssen Pharmaceuticals (JNJ +0.2%). The company has granted Janssen exclusive global rights to develop and commercialize products based on Geron's specialized oligonucleotide backbone chemistry in addition to RNA interference candidates for the treatment of all human disorders except blood and bone marrow cancers and exclusive of telomerase inhibitors.
- Geron has also granted Janssen a non-exclusive global license to develop and commercialize oligonucleotides based on Geron's patents covering the synthesis of monomers (building blocks of oligonucleotides). Janssen Biotech has non-exclusive rights to the same intellectual property under their November 2014 imetelstat agreement.
- Under the terms of the deal, Geron will receive an upfront payment of $5M, up to $75M in milestones and low-single-digit royalties on global net sales of each licensed product.
Mon, Sep. 12, 12:47 PM
Mon, Sep. 12, 11:00 AM
Mon, Sep. 12, 9:23 AM
- Geron (NASDAQ:GERN) is down 27% premarket on robust volume in response to its update on two clinical trials being conducted by collaboration partner and licensee Janssen Research & Development, LLC, (NYSE:JNJ) assessing imetelstat in certain blood disorders. Investors were apparently expecting good news but will have to wait since both studies will continue in order to generate more data. In other words, proof of efficacy ain't there yet.
- The first trial, IMbark, is a Phase 2 study assessing two dosages of imetelstat (4.7 mg/kg and 9.4 mg/kg) in ~200 patients with intermediate/high risk myelofibrosis (MF) who have relapsed or did not respond to prior treatment with a JAK inhibitor. To date, over 90 subjects have been enrolled in the two arms. The 4.7 mg/kg dose has not demonstrated an acceptable amount of activity so the arm will be closed to further enrollment. Enrollment in the 9.4 mg/kg arm will continue. The minimum number of patients needed for the Week 12 analysis was not met so the analysis will be done on 24-week data instead. Janssen will conduct an additional internal data review in Q2 2017.
- The second trial, IMerge, evaluating imetelstat in patients with low/intermediate risk myelodysplastic syndromes who have relapsed or failed to respond to an erythropoiesis stimulating agent, will continue unmodified. Janssen will conduct another assessment in Q2 2017.
- 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.
Mon, Sep. 12, 9:15 AM
Wed, Aug. 3, 4:09 PM
Tue, Aug. 2, 5:35 PM
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Thu, May 5, 4:16 PM
- Geron (NASDAQ:GERN): Q1 EPS of -$0.06 in-line.
- Revenue of $0.75M (+38.9% Y/Y) beats by $0.56M.
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.
Thu, Feb. 25, 4:12 PM
- Geron (NASDAQ:GERN): Q4 EPS of -$0.05 in-line.
- Revenue of $0.22M (+22.2% Y/Y) misses by $0.1M.
Wed, Feb. 24, 5:35 PM
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Dec. 7, 2015, 9:19 AM| Dec. 7, 2015, 9:19 AM | 714 Comments
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