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Geron Corporation (GERN)

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1.6800-0.1200 (-6.67%)
At close: 4:00PM EDT

1.7000 +0.02 (1.19%)
After hours: 6:09PM EDT

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  • P
    PEDMAC2000
    I got a response from Geron to a change in the one of the trials... that Fan pointed out

    Thank you for your interest in Geron.

    While the two seem inter-related, it’s really a matter of closing out a previous study in neuroblastoma, and ongoing dialogue with the European Medicines Agency’s Pediatric Committee (PDCO). As I am sure you are aware, both the EMA and the U.S. Food and Drug Administration require that a pediatric plan outlining a strategy for investigation of the new medicinal product in the pediatric population be agreed upon with each agency prior to submitting an application for marketing approval of a new drug. It is referred to as a pediatric investigation plan (PIP) for the EMA and a initial pediatric study plan (iPSP) for the FDA.

    Sincerely
    Geron Investor Relations
  • g
    gerncures
    News!!!
    GERN's Imetelstat
    "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."

    by Charles Bankhead, Senior Editor, MedPage TodaySeptember 14, 2020 See whole article below!

    Imetelstat

    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."
  • K
    Kangar
    by Charles Bankhead, Senior Editor, MedPage TodaySeptember 14, 2020

    Imetelstat

    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."
  • F
    Fan
    Form 4 Filed by Directors in June 2020 Insider Transactions

    Take some time to review the transactions in June 2020 by Directors. Print the first 3 pages to Review these filings.

    Something might take place in September 2020

    https://sec.report/CIK/0000886744/Insider-Trades
  • R
    Ryan W
    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!
  • S
    Shareholder101
    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.
  • L
    Lazarus
    Interesting enough the EMA CHMP (Committee for Medicinal Products for Human Use) met last week Sept. 13-17, according to rccola335 over on Imetelchat. Kmall had pointed out back in July that there is a 67day period from EMA ODD to possible recommendation for approval......if I'm not mistaken Sept. 24th would be that day.......could be the reason for the MASSIVE spike in volume on Friday. 10x the average daily is NOT simply options related or "day" traders as one Einstein here suggested. Should be an interesting week. -Laz
  • e
    early retirement
    GERN stock call buying is up 10,000% for December 2020 calls. What does that mean?
  • T
    Toyoda
    I don't own many shares currently, but am going to put in a buy for a good amount from this back pull. Looking forward to the continued up trend.
  • D
    Donkey
    Novartis ?

    Hey guys, did this patent and Novartis hit a dead end, or is there still some useful working going on?? Too bad the article should be dated 2003 instead of time stamped 2020! All pretty old articles from 2003.

    The patent (No. 6,610,839) was granted by the U.S. Patent and Trademark Office for claims surrounding the promoter of the human telomerase reverse transcriptase gene (hTERT). Geron had licensed the hTERT promoter to Novartis subsidiary Genetic Therapy, Inc., to develop viruses for targeting cancer cells. Cell Genesys, Inc. recently acquired rights to GTI products including the hTERT promoter, prompting a milestone payment to Geron.

    h://www.bio-itworld.com/columns/new-news/geron-receives-telomerase-promoter-patent--2003-08-26t000000-2-3150/

    hps://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(03)00051-0

    GTI seems bullish on the clinical potential of their oncolytic viruses. One GTI virus, OVA001, makes use of the E2F-1 promoter to drive the essential E1A gene, restricting viral replication to Rb-defective tumor cells—present in about 85 percent of tumors. Trying to push selectivity even further, GTI researchers have put E4 genes under the control of the human telomerase reverse transcriptase (hTERT) promoter—also reported to be selectively active in tumor cells— in combination with E2F-1 controlled E1A. A third vector uses E2F-1 to drive E1A, and incorporates the gene for macrophage colony-stimulating factor (GM-CSF) with the aim of inducing local inflammatory and systemic anti-tumor responses.
    Geron Corp. has been granted a US patent covering the promoter of human telomerase, the enzyme that helps repair the ends of chromosomes and has been studied intensively as a potential anti-cancer therapeutic.
    Geron Corp. has been granted a US patent covering the promoter of human telomerase, the enzyme that helps repair the ends of chromosomes and has been studied intensively as a potential anti-cancer therapeutic.
    www.bio-itworld.com
  • N
    NYCStreetsmart
    Call buying slowly picking up volume.
    At 2:10 PM
    839 calls purchased vs 103 puts sold.
    Most notable trade:
    200 Jan 15, 2021 10 dollar calls purchased at .05 having implied volatility of 167%
    Nice trade for someone; boat drinks if they get in the money.
  • P
    PEDMAC2000
    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, https://ir.geron.com/investors/sec-filings/sec-filings-details/default.aspx?FilingId=14316058, 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.

    Sincerely
    Geron Investor Relations
    "
    Geron Corporation - Investors - SEC Filings - SEC Filings Details
    ir.geron.com
  • K
    Kira
    WHAT HAVE WE LEARNED ABOUT GERN?
    GERN is now in FDA phase 3 drug trials with a Nobel Prize winning technology that the FDA has given Fast-Track status for that is the only drug that returns cancerous bone marrow to normal that H.C.Wainwright just gave GERN stock a $7 - 12 month price target price that is 400% above today's price.
    Shorts bash GERN 24/7 here because the shorts are caught with 34 million shorted GERN shares that the short have to buy back now at higher prices.
    Just GERN's cash in the bank is worth around a $1 a share of GERN's current stock price.
    Google money cnn gern and see why the experts just gave GERN a $7 dollar 12 month target price.
  • B
    BLACKMARANGO
    Let's all thank our dear leader, king chippy, for all he has done for investors!!!

    He's swell.

    He's the greatest.

    He has investors' best interests as his top objectives.

    Now, if you really believe that, let me sell you some GERN!

    Of course, IMO.
  • L
    Lazarus
    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?
  • K
    Kangar
    I can only hope the higher lows mean more investors are understanding the science. Investors just are not scientists. So much FUD and panic came out of the JNJ discontinuation, it scared everyone away, but there's nothing for it. Big milestone payment for underbaked data? That looks like a bad deal for any company. Can't say I would make a different decision given that set of facts. I disagree with AF that it was "flimsy" data, but it was certainly premature. Anyways, water under the bridge. All we can do is ignore the noise and keep our attention on THE DATA. What investors still do not realize is that this company's prospects and ownership of the drug are dramatically higher than they were under the partnership with JNJ. The PII data are brilliant and Geron owns 100% of Imetelstat. I imagine investors all over the country slowly, cautiously, a bit confused, a bit unsure if they are seeing it right, "uh...why aren't we buying this $GERN...? why isn't this thing $10 a share if it modifies disease...? why did JNJ walk? what am I missing...?" Give 'em time.
  • K
    Kira
    $GERN conversation
    FOR THE FIRST TIME GERN IS IN PHASE 3 TRAILS AND WITH FDA FAST-TRACK. GERN'S FUTURE IS VERY BRIGHT NOW. SEE BELOW.
    1. Everyday GERN is worth more money because everyday GERN is 1 day closer to FDA approval and GERN is already up 40% for 2020.
    2. H.C. Wainwright global investment just rated GERN a strong buy with a $7 target with the next 12 months.
    3. Just GERN's cash in the bank is worth around $1 a share of GERN's current stock price.
    4. If we are looking for a stock to buy with huge capital gains of 10,000% or more GERN is it, much like PCYC that went up 45,000% before being bought out and IMMU up over 10,000% before being bought out.
    5. Hedge funds still need to buy up 34 million GERN shares to balance their books.
    6. GERN could be the mother of all short squeezes with more up side then Tesla in percentage of stock gains.
    7. GERN is up over 100% from GERN's lows in December 2018.
    8. GERN insiders are buying GERN stock.
    9. Google money cnn GERN and see what the analyst are saying about GERN.
    10. Google bay bridge bio drug valuation and see why GERN stock is more valuable everyday.
  • L
    Lazarus
    Eric Mueller - GERON - Director of Manufacturing - 2019-Present

    ......fairly recent hire.
  • T
    Toyoda
    Lots of bad mouthing this company going on here. I've done my research. I believe the science and not these what looks like shorts trying to drive down the price. Talk to the hand.
  • S
    Short
    The facts are the facts:

    No Products
    No Profits
    No Partners
    No Potential buyout
    No Paid Dividends
    No Pharma Labs
    No Phase III success
    No Primary Endpoint success
    No Program for Stock buyback
    No Pharma Pipeline

    Welcome to the best place on Earth...... welcome to Baggieville!!!!😂😂😂