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Geron Corporation (GERN)
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by Charles Bankhead, Senior Editor, MedPage TodaySeptember 14, 2020
A first-in-class telomerase inhibitor, single-agent imetelstat achieved an SVR35 response rate in 10% of patients with relapsed or refractory myelofibrosis in a phase II trial. Overall, 37% of patients had at least a 10% improvement in spleen volume at 24 weeks. Patients treated with the higher of two doses evaluated in the trial had a median overall survival (OS) of 29.9 months, which compared favorably with historical data for patients with relapsed/refractory myelofibrosis, said Verstovsek.
The results led to a phase III trial to compare single-agent imetelstat and best available therapy (excluding a JAK inhibitor) in 320 patients with relapsed/refractory myelofibrosis. The trial has a primary endpoint of OS and has the statistical power to detect a 40% reduction in the survival hazard for the imetelstat arm. Enrollment is expected to begin during the first quarter of 2021.
"This is a really important new development," said Verstovsek. "Not only are we talking about patients who are refractory to JAK inhibitors, but we are talking about upping the bar. This is a moment in drug development when we are going from anemia as the endpoint ... to talking about for the first time ever a randomized trial of treatment to prolong survival."
Imetelstat - Orphan - EMEA-001910-PIP03-20
Geron Corporation; Treatment of acute myeloid leukaemia (AML) / Treatment of myelodysplastic syndromes (MDS), including juvenile myelomonocytic leukaemia (JMML) / Treatment of paediatric patients with relapsed or refractory AML or MDS, including JMML, from 1 year to less than 18 years of age
Day 60 discussion Action:
For discussion Oncology
Update posted September 21, 2020
Imetelstat Given Intravenously Alone and With Standard 13-Cis-Retinoic Acid in Children With Neuroblastoma
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01916187
Recruitment Status : Withdrawn (drug company withdrew support following re-examination of benefit-risk assessment for the investigational use of imetelstat in this population)
First Posted : August 5, 2013
Last Update Posted : September 21, 2020
Seems like after 60 Day Discussion period( July 16, 2020), the Sponsor Upgraded the Neuroblastoma clinical trial. This is more what Janssen does than Geron because of the Staff required.
Getting Interesting moving forward
I’ve been saying for a while that the pps should bleed upwards during the Phase III - now we are almost a year into the *first Phase III and just 2 years or so until final data is compiled.
That seems like a long time, but not for a hedge fund looking to get 10x or better on an investment. Maybe just maybe last week was the start of the upwards march... obviously not sure, but one thing I am sure of... if the Phase III progresses, it will not be at $2 when it is a few months away from that final data compilation.
Good times to come, for longs at least, Cheers!
As a current patient with MDS and now close to full remission I have some very specific feelings about TI. My treatment was with Aza and Ventoclav. I have finished 4 cycles. Until about 5 weeks ago I was receiving transfusions twice a week. For those who doubt that TI is not such a big deal I can only say you are absolutely wrong. I was not eligible for participateion in a Imetelstat trial. I only hope that when Aza stops working some time in the future that Imetelstat will be available to me. I have been a shareholder for about 20 years and have seen the ups and dows with this stock. I hold a very large position and am looking to cash in on it when either a buyer takes us out or the market recognize the value of Geron's drug. If their is a buy out I believe it will be somewhere north of 20 billion dollars.
Imetelstat is universally recognized as a needed now, safe, effective medicine (EMA "positive opinions" as an example) for numerous blood cancers on numerous levels. ASH is coming with continuing good news. New approvals are a certainty. Cancer combinations of all sorts are the future.
I've had a sneaking suspicion that there's a "leak" from under the Geron roof which leads directly to short interest. If that's the case and a good deal of Fridays late afternoon action was covering then something big could actually be coming down the pike quite soon. 22-23 million shares wouldn't explain option experations... that's a lot of unaccounted volume and AH makes it that much more suspicious. Just a thought?
With overall survival for MF at 29’.9 months Vs 12 months
We should be approved on that alone
GERN Latest Real Time Trades
Check out those 999,000 and other LARGE trades on Nasdaq on Friday Closing
Manipulator would not be doing this unless he was expecting something soon
Reply from investor relations reference Sienna Diagnostics/Bard1 and Geron
I will say they did reply promptly and with detail..
"Information was disclosed in our Q2 2020 10-Q on page 15,
, which was filed with the SEC and posted to our website on August 6. We expect to provide an additional update in our Q3 2020 10-Q as well.
Taken from the Geron Q2 2020 10-Q (but not in its entirety):
In December 2007, we received 13,842,625 ordinary shares in Sienna Cancer Diagnostics Limited, or Sienna, in connection with a license we granted to Sienna for our hTERT technology for use in human diagnostics.
As of June 30, 2020, the fair value of our shares in Sienna was $668,000.
In April 2020, Sienna announced the merger of its company with BARD1 Life Sciences Limited, or BARD1, subject to approval by Sienna’s shareholders, whereby BARD1 will acquire all of Sienna’s ordinary shares. Sienna shareholders will receive 13 BARD1 shares for every five Sienna shares held. On July 15, 2020, Sienna shareholders approved the merger. On July 20, 2020, the Federal Court of Australia approved the merger, and since that time, trading for Sienna ordinary shares on the Australian stock exchange has been suspended. Effective August 3, 2020, the exchange of Sienna ordinary shares for BARD1 shares was complete. BARD1 shares trade on the Australian stock exchange under the ticker symbol BD1.
Geron Investor Relations
Geron Corporation - Investors - SEC Filings - SEC Filings Details
Fan / Martin - what does it mean to “lend your shares out” ? Just want to make sure of what was meant in the last thread you guys had so I don’t make the mistake. I bought my shares in my fidelity brokerage and that was it. I didn’t do anything else. Making sure I am good lol
I was so disappointed at last Monday's conference that I reduced 47500 shares from 107500 shares I had. I have 60,000 shares now, but I regret selling 4,7500 shares on Friday. I don't know what will happen on Monday, but I think I should increase my position back to 80,000 shares. Good or bad things will happen sooner. My heart is beating fast again after a long time. I can't wait for Monday.
Over the last 10 minutes of trading the price was actually quite volatile over a 15 cent range or so. Some parties exited the position, some new parties entered. Fact is price held up (increased), selling pressure will be suppressed going forward, new positions added in 1.90 range for support, and shorts will need to cover at a more rapid pace. A little bit of news (it's out there because the volume says so) and we jump!
Good luck longs!
Let’s say it is a sad day in our country to lose an irreplaceable ICON, RBG
Fan, you are right the 23+ volume was short covering. The stock trading pattern chart of Gern on Friday 9/18/20 is similar to any other day, controlled by market makers who are preventing sp from advancing on certain point, as you see it in multiples of horizontal lines every day. The exception was bizarre last minute or immediately in after hour dumping of 14 million shares or trading 550k shares with significant swing 1.965 to 1.84 at 3:51. This is in contrast to any other stock, just look at aapl, srne, fb, cost or any other. This is in addition to options players in coordination with MMs and mainly Geron competitive, INCY, who block share price. They limited gain at 12 cents to clean all options. We all more or less know how to read the chart, but perhaps if someone knows a professional at higher level or has been market maker to explain this clearly and once for all we learn what is going on. We must believe that this will come to an end soon and they will be exposed and prosecuted.
Salt N Pepper
We all know the volume but thing that is surprising is the PPS, why is the needle struck at $2.01 for 35M volume?
One Day Technical Analysis
Check the last 1/2 hr of trading. This is not all Options Trading more like Short Covering
Geron Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
Download this Press Release PDF Format (opens in new window)
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN) today reported that it has granted a non-statutory stock option to purchase an aggregate of 80,000 shares of Geron common stock as an inducement to a newly-hired employee in connection with commencement of employment with the Company.
I think this for real. I have not seen Donkey pull for GERN since I have own Geron.
Lets see where this goes
JS did 2 CC that were not done in the prior year, Wainwright & BTIG
Form 4 Director Buy August 21, 2020
This feels like September to Remember
ARWR up ~50% after promising Phase II data...
GERN pps was nothing but hammered as it continually delivered promising Phase II data (breakthrough efficacy w safety in an unmet need).
Now Imetelstat is well underway with one Phase III with yet another Phase III queuing up -
Soon, and almost certainly, Geron will be unveiling knockout Phase III data as these large scale trials will reflect the safety and efficacy experienced in early stage trials —
And that is why keep calling this stock a near ground floor opportunity. Just look at the pps.
We have Janssen (for paying for the Phase II trials) and short sellers who beat up the stock price all throughout and after Phase II trials, and are still making up a substantial portion of total shares outstanding, to thank for this groundfloor opportunity.
Keep a Keen Eye on this sight. Todays action only reveals that some action is about to be taken. Nasdaq as reported by George had 35M Volume for today. This is not only a quarter ending options day but something that about to happen.
Ken/AF are here because they want your stock.
September might the month
Almost 4million shares traded the last hour.......interesting. Thoughts....options? Partnership? EMA approval recommendations?......67 day rule? - end of September.....?
Volume proceeds price is an old rule to always remember. Today Extremely high volume coupled with a good move in price. I would say we are about to witness a very good move up. Will we hit the target price of $7 soon? Or could other factors be in play now. We will see next week won’t we.
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