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Geron Corporation (GERN)

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1.3800+0.0200 (+1.47%)
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  • k
    kmall
    Here's a Novartis employee who's been with Novartis since 2015.....in between she worked for Geron for 4 months to help facilitate meetings with the FDA and then back to Novartis....hmmm???
    Sometimes the little clues lead to treasure. Has Omar been right all along?? ......I love the title in her job description...... :)

    Jennifer Z.
    High Performing Team Player Ready for Adventure and Take Off!

    1- Executive Assistant
    Novartis
    Jan 2020 - Present1 yr 9 mos
    East Hanover, NJ
    Prepare agendas, coordinate and run global leadership team meetings
    Prepare and disseminate communications and announcements on behalf of senior leadership
    Global calendar management for executives with fast changing priorities
    Plan and coordinate large scale virtual meetings with multiple time zones including US, UK, Switzerland, China, Japan, India; attend and record meetings as needed
    Create, develop and maintain SharePoint site
    Onboard new colleagues; assist with facilities and IT needs
    Domestic and international travel planning and coordination for multiple executives including visa processing, vaccine coordination, maintaining up to date information on border crossing and embassy requirements
    Expense report processing with currency conversions

    2- Executive Assistant
    Geron Corporation
    Oct 2019 - Jan 20204 mos
    Parsippany, NJ
    Support to C-Level executives (Chief Medical Officer, Chief Business Officer, Chief Commercial Officer) at biotechnology company
    Coordinate logistics for Board of Directors meetings including all hotel, transportation and catering arrangements
    Coordinate travel logistics and compile all necessary information required for onsite FDA meetings in Silver Spring, MD
    Domestic and international travel arrangements, expense report processing

    3 - Executive Assistant
    Novartis
    Aug 2015 - Oct 20194 yrs 3 mos
    East Hanover, NJ
    Extensive calendar management, expense report processing and domestic and international travel coordination for global heads/executives in Global Drug Development
    Provide executive level support to numerous international executives visiting the US from Switzerland and India (including Global Head of Drug Development & Chief Medical Officer)
    Coordinate large Town Halls and webcasts with multiple global locations including logistics and technical requirements; facilitate Q&A sessions using Pigeon Hole and other applications
    Event planning for 100-1000 people including celebrations and lunch & learn events
    Meeting planning and logistics for Leadership Team including internal and offsite meetings held in US, Europe and Asia; attend offsite events to support Leadership Team
    Lead administrator for department with 100 US based colleagues, 3 US based administrative assistants and 3 EU administrative assistants
    Maintain the utmost confidentiality when handling complex human resource issues and classified business information
    Led archive project to archive 25 years’ worth of clinical trial documents
    Acted as coordinator for move of 100 department colleagues across campus

    ***Could be something ???

    Could be nothing ???

    Could an Executive Assistant give us one of the biggest clues we've been waiting/looking for ???......-Kmall
  • L
    Louis
    @kmall---"2. Nov 2021 - "Investor Day": Announcement for Imetelstat 2.0 and additional indications, ATM allocation announced, Manufacturing update - possible explanation for $75mil 3 part tranche loan (Banwol, Korea facility expansion?), ASH 2021 abstract submissions (?), possible partnership announcement"
    ----------------------------------------------------------------------------------------------------------
    With phase 2 successes, and confirming phase 3 trials ongoing, and with manufacturing upgrades, I believe that new partners are very likely. Geron/Imetelstat needs some reputation building in the investment community. The proper new partner would do that, bringing financial stability for the longer term and deep pockets for the development of IMET 2.0 and combinations.
  • J
    John
    UPDATED:AUG 13, 2021 ORIGINAL:JAN 24, 2021

    Imetelstat for Myelofibrosis

    Imetelstat for patients with myelofibrosis failing Jakafi

    DR. C.H. WEAVER M.D.
    Executive Editor Charles H. Weaver, MD, is a medical oncologist who received his medical training at the Hospital of the University of Pennsylvania, National Institutes of Health and Fred Hutchinson Cancer Research Center

    About Imetelstat

    Imetelstat is a telomerase inhibitor being evaluated in the IMBARK™ clinical trial that has generated substantial enthusiasm, and a pivotal phase clinical 3 trial is currently underway. Imetelstat was first studied in a small, pilot study at the Mayo Clinic, and led to complete and partial remissions in 7 of 33 patients (21%), unusual in MF clinical studies.4

    Overall MF patients treated at the higher dose experienced an average survival of 30 months, and greater than 40% of patients experienced improvements in bone marrow fibrosis. The reduction in bone marrow fibrosis was correlated with the improvement and overall survival. Imetelstat appeared to particularly benefit patients with “triple negative” disease, a known poor-prognosis subgroup. In these patients the median overall survival was 35.9 months.

    https://news.cancerconnect.com/myeloproliferative-neoplasms-mpn/imetelstat-for-myelofibrosis

    *************************************************

    Very Positive Article. If you look at EMA docs this is what they were seeking.
  • O
    Omar
    Novartis November. thanks small. it was Novartis all along. don't forget steesma is with Novartis too. gonna be a great acquisition.
  • k
    kmall
    Here's how it's going down......

    1. Any day now: P3 IMerge 100% enrollment announcement.

    2. Nov 2021 - "Investor Day": Announcement for Imetelstat 2.0 and additional indications, ATM allocation announced, Manufacturing update - possible explanation for $75mil 3 part tranche loan (Banwol, Korea facility expansion?), ASH 2021 abstract submissions (?), possible partnership announcement

    3. Q1 - Q2 2022: P3 IMpact (MF) 50% enrollment announcement

    3. Q3 - Q4 2022: P3 IMerge Clinical Trial complete.

    4. Q1 - Q2 2023: P3 IMerge Clinical Trial top-line data readout.

    5. Q2 2023: FDA & EMA - NDA & BLA submission

    6. Q2 2023: EHA Abstracts review (P3 IMerge data)

    7. Q3 - Q4 2023: FDA & EMA* Approval for Imetelstat in LR MDS

    *Approval in EMA grants Geron 10YRS of Marketing exclusivity in LR MDS in EU

    8. Global Commercialization of Imetelstat in EU, US, UK, Japan, Australia, India, South America, Israel, Taiwan, China

    **Of course at anytime a BO or Partnership could be announced. Hope this clarifies some confusion out there with those of you who seem to have a difficult time acknowledging how these things proceed. I won't name any names, of course. IMO -Kmall
  • B
    BooHoo
    The kmall fantasy that Novartis planted an executive assistant at Geron to set the stage for a buyout and then pulled her back is one of the more outlandish things I've seen here. And that says a lot.
  • J
    John
    History of Changes for Study: NCT01731951

    Imetelstat Sodium in Treating Participants With Primary or Secondary Myelofibrosis

    Latest version (submitted August 24, 2021) on ClinicalTrials.gov

    https://clinicaltrials.gov/ct2/history/NCT01731951?A=17&B=18&C=merged#StudyPageTop

    *********************************************

    Mayo Clinic Results posted September 21, 2021
  • p
    pablo
    Maybe time for Scarlett to buy some shares in the open market ? To show confidence to the share holders
    We have been in low 1 for a long time now
  • D
    DDD
    Geron's quarterly options expiration today. There will be strange/high volume around the close and after the close of the regular trading session. Do not take this to mean that "somebody knows something"
  • W
    WildBill
    GERN holding up well. China and the delta variant are driving the market. This sums it up: “The big surprise of the pandemic—the one thing that nobody saw coming—was the resistance to the vaccines. This was a failure of imagination. No one imagined that 30 percent of the country could watch 674,000 of their neighbors die and still refuse to take a free, life-saving vaccine.” “No one fully understood the power of negative polarity. Understood that one tribe of Americans hates their neighbors literally unto death. Hates them so much that they would rather risk their own lives than be perceived as doing what ‘the elites’ tell them.
  • S
    Serkan
    If Geron is seriously interested in new indications and/or IMET 2.0, partnership is inevitable.

    I think that Dr.JS's reference to November investor meeting is an indication that he is continuing to work on a partnership.
  • A
    Away
    As of June 30, 2021, $GERN had $239.1 million in cash on hand. Accord to the CFO, that is enough to fund operations until end of 1Q2023. Which is also when top-line results of the MDS trial will be available. They will receive $25 million in non-dilutive funding from the second tranche of that $75 million loan they took out last year. There is no ATM dilution on the horizon.
  • D
    Donald
    Conclusions: Imetelstat was found to be active in patients with myelofibrosis but also had the potential to cause clinically significant myelosuppression. (Funded by Geron; ClinicalTrials.gov number, NCT01731951.).

    https://pubmed.ncbi.nlm.nih.gov/26332545/?dopt=Abstract
  • A
    Andrew
    NOVartis is the Swiss word for NOVember
  • w
    walkerbill76
    kmall 10 hours ago
    Here's a Novartis employee who's been with Novartis since 2015.....in between she worked for Geron for 4 months to help facilitate meetings with the FDA and then back to Novartis....hmmm???
    ---------------------------------------------------------------------------------------------------------

    So you're saying that because a GERN executive's secretary worked for Novartis, Novartis MUST be thinking about losing a couple billion buying Geron?

    Run us through the reasoning here, please ;)
  • J
    JC
    Accumulate before November. Won’t matter much if GERN is at $1.30 or $1.50. Chances are, it’ll be much higher by end of the year and significantly higher next year.

    Comparing where Geron is today compared to anytime in recent past, risk-reward heavily favors reward side. With Jakafi’s failure, Imetelstat is destined to replace it soon enough. It’s a superior drug all around, so any verification of superior efficacy during phase III, even using double blind testing, will trigger expedited approval process. Note that even during a double blind testing, results are known to those in charge of the trial (not to patients and doctors administering the drug).

    Institutions are in no hurry to load up just yet, but make no mistake that they are accumulating slowly but surely. Sooner or later, they’ll be buying in droves as we near the completion of P3 trial. You can either get in now or later. Your choice.
  • J
    John
    Guidance Documents

    EudraVigilance eXtend Medicinal product Dictionary(XEVMPD) authorisation procedures (XLS/96KB)

    Last updated: 14/09/2021

    Legal effective date: 13/09/2021

    ************************************************

    This comes from EMA files. When words like "Legal effective date" some Event is taking Shape. If you go through Guidance docs many updates.

    Geron for the first time is holding 3 healthcare CC in one month(September) and November Showcase. Very Unusual for this Company at this time period.
  • h
    hunter
    My post was deleted…..
    Highlights from this mornings conference,

    Greater then 3 billion market potential for just LR MDS and refractory MF,
    239mill in cash end of q2,
    Very strong evidence that Imet is disease modifying,
    Emphasizing unmet needs and OS data (hinting at early approval?),
    55 sites open for MF with 180 expected in 30 countries,
    Imet is better then luspatercept in all key categories with specific slide comparing the two,
    Very meaning full TI rates,
    Imet is expected to be part of the standard of care in LR MDS,
  • S
    Serkan
    I understand the logic behind very lofty valuation like 80, 90 or even 140 ..

    Well what I don’t get is how come the SP does not discount this very bright future?

    Shorting GERN stock is not a good and/or satisfactory explanation for that. Right??
  • k
    kmall
    With 91%+ enrollment of P3 IMerge, Geron is quickly entering the 87% success rate of ultimate approval. Had the DSMB had safety issues with Imetelstat at this point, this trial most likely would have been halted before reaching 91% enrollment.

    "The success rate of each drug discovery stage in academia was 31.8% for preclinical, 75.1% for phase I, 50.0% for phase II, 58.6% for phase III, and 87.5% for NDA and BLA. The LOA from phase I to approval was 19.3% (Figure 1)" -Kmall