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   Biotech / MedicalGeron Corp.


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To: Savant who wrote (3505)10/6/2019 7:26:46 AM
From: cycleupcycledown
   of 3519
 
Fantastic news....added more....oh ya!!!

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To: tktrimbath who wrote (3506)10/6/2019 7:29:12 PM
From: cycleupcycledown
   of 3519
 
I guess there's an outside chance geron has tweaked the dosage or have found a good combo to enhance the efficacy.

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From: cycleupcycledown10/25/2019 2:35:33 PM
   of 3519
 
Wedge break out, oh ya!

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From: cycleupcycledown12/7/2019 12:24:07 PM
   of 3519
 
My plan....I bought thousands of shares around $1.5, one lump sum....Going to dollar cost average out over 4 years, selling same amount of shares every month...should do pretty good, outside chance of hitting the mother lode.

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From: tktrimbath12/31/2019 4:34:47 PM
   of 3519
 
My end of year review of GERN

INTRO Here's my semi-annual exercise to see if I remember why I own the stocks I own, and so I can check back and see if their stories have changed. I post in case it helps others too.

Geron

GERN (market cap is $0.272B was $0.263B)

Geron is an advanced biotech company primarily (solely?) developing a treatment for cancer based on managing telomeres, molecules at the end of chromosomes that manage cell life. Good luck deciphering oncological jargon, but as I understand it, the company is concentrating their efforts on applicable blood disorders.

While the company is proceeding through Phase 2 and 3 clinical trials, the results haven’t generated much enthusiasm within the investing community. Except for a few spikes, the stock has steadily been declining for several years. The downside with biotechs is understandably near zero. The upside with GERN is significantly higher than treating blood disorders. Controlling cell life potentially impacts disorders that involve cells that forget to die (e.g. cancers) or cells that die too readily (e.g. auto-immune disorders). A proof of the technology, particularly FDA approval for even one disorder, would probably dramatically improve the stock price, and the lives of many patients (which is the more important success criterion.)

I continue to hold, partly out of habit, partly because they are in Phase 3 (which usually decreases risk) and at a low stock price (which suggests a significant reward).

DISCLOSURE LTBH since 1999 and continuing to hold. I might consider buying more, but will probably wait for substantial, quantitative results are made public - which would spark a spike that might price me out of the sale. Stay tuned.

(I've also collected links to the other discussion boards and my other stocks over on my blog trimbathcreative.wordpress.com )

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From: tktrimbath5/15/2020 2:43:23 PM
1 Recommendation   of 3519
 

"Geron believes imetelstat's addressable population could include 85% of lower-risk MDS patients, resulting in potential revenue of $500 million per year."


&


"investors might want to remain cautious"


https://www.fool.com/investing/2020/05/15/why-gerons-soaring-163.aspx

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From: Savant5/19/2020 12:11:41 AM
   of 3519
 
GERN, another bump on Monday

fool.com

After four abstracts were released highlighting the latest data on its lead drug candidate, imetelstat, shares of Geron ( NASDAQ:GERN) were trading 23.4% higher as of 1:21 p.m. EST on Friday.

So whatPreviously, Geron's prospects were dealt a significant blow when former imetelstat co-developer Johnson & Johnson decided against advancing the drug into phase 3 studies following lackluster mid-stage trial results in myelodysplastic syndromes (MDS) and myelofibrosis. After Geron received the rights to imetelstat back from J&J, it initiated a phase 3 study in MDS and paused development in MF.

At the upcoming European Hematology Association Congress, which will be held virtually from June 11 through June 14, researchers will provide updated mid-stage data regarding imetelstat's effectiveness against MDS in an oral presentation. They will highlight that 32% of patients in the study (12 patients) achieved 24-week independence from red blood cell transfusions, and 29% of them (11 patients), were transfusion free for at least one year, including one patient who was transfusion free for 2.7 years.

Poster presentations at the event will also offer new insights into imetelstat's phase 2 trial in MF. One poster highlights a dose-dependent trend toward longer overall survival in patients who responded to imetelstat. Another poster highlights improved overall survival in triple negative MF patients who are relapsed or refractory to Janus Kinase (JAK) inhibitors, including Incyte's Jakafi, a blockbuster treatment with expected sales of over $1.88 billion in 2020.

Now whatThe oral abstract is encouraging because it suggests Geron's ongoing phase 3 MDS trial could pan out. If it does, Geron believes imetelstat's addressable population could include 85% of lower-risk MDS patients, resulting in potential revenue of $500 million per year.

The poster presentations also offer encouragement because they could tilt the odds in favor of Geron restarting development of the drug as a treatment for MF. Management plans to sit down with the Food and Drug Administration soon to discuss its options in MF, and then make a decision on whether or not to start a phase 3 study.

Although these presentations are sparking optimism, investors might want to remain cautious given J&J's decision to abandon development of imetelstat and Geron's inability to attract a suitor or another collaborator. Until definitive late-stage data becomes available, it may be wiser to focus on other biotech companies with clearer pathways to drug approvals.

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From: tktrimbath6/30/2020 6:56:33 PM
   of 3519
 
My mid year review of GERN

INTRO Here's my semi-annual exercise to see if I remember why I own the stocks I own, and so I can check back and see if their stories have changed. I post in case it helps others too.

Geron

GERN (market cap is $0.677B was $0.272B)

Geron is a leading edge biotech developing treatments for blood disorders by managing telomeres. The specific application may suffice to make the company profitable, if the treatment is approved; but the more general application could extend to other cancers and illnesses caused by improper cell death or growth. If proven, that opens the market to treating auto-immune disorders as well as cancers. Some treatments are in variations of Phase Three clinical trials, but approval and profitability can be years away.

Perhaps the better description is that Geron was, rather than is, a leading edge biotech. While their technologies are advanced, their development has taken decades during which competition has developed, the company's earlier suite of technologies has reduced to one, and the company's financial situation continues to rely on limited income.

I continue to hold because the company has made progress, and because selling now does not generate much cash. The fate and fortune of the company will probably be determined within the next few years. I've waited a long time. I can wait some more.

DISCLOSURE LTBH since 1999 and continuing to hold. I might consider buying more, but will probably wait for substantial, quantitative results to be made public - which would spark a spike that might price me out of the sale. Stay tuned.

(I've also collected links to the other discussion boards and my other stocks over on my blog trimbathcreative.net )

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From: Savant7/1/2020 5:35:32 PM
1 Recommendation   of 3519
 
Geron Receives Positive Opinion from the EMA Committee for Orphan Medicinal Products for Orphan Drug Designation in the European Union for Imetelstat to Treat Myelodysplastic Syndromes -- Designation would provide 10-year period of marketing exclusivity in the European Union after product approval -- Patients are currently enrolling in a Geron-sponsored Phase 3 clinical trial in lower risk myelodysplastic syndromes MENLO PARK, Calif., July 01, 2020 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion on the Company's application for orphan drug designation of its first-in-class telomerase inhibitor, imetelstat, as a potential treatment for myelodysplastic syndromes (MDS). The Company expects that the European Commission, based on this positive opinion of the COMP, will formally grant the orphan drug designation for the European Union (EU) by the end of July. Imetelstat has already been granted orphan drug designation by the United States Food and Drug Administration as a potential treatment for MDS. "The positive opinion from the COMP acknowledges the compelling clinical data from our Phase 2 clinical trial that imetelstat has the potential to provide a clinically relevant advantage to lower risk MDS patients who are transfusion dependent and have failed to respond to treatment with erythropoiesis stimulating agents," said John A. Scarlett, Chairman and Chief Executive Officer. "Our ongoing IMerge Phase 3 clinical trial in lower risk MDS is being conducted at multiple sites around the world, and data from this trial are intended to support global regulatory filings." To qualify for orphan drug designation in the EU, an investigational medicine must be intended to treat a seriously debilitating or life-threatening condition that affects fewer than five in 10,000 people in the EU, and there must be sufficient non-clinical or clinical data to suggest the investigational medicine may produce clinically relevant outcomes. EMA orphan drug designation provides companies with certain benefits and incentives, including clinical protocol assistance, differentiated evaluation procedures for Health Technology Assessments in certain countries, access to a centralized marketing authorization procedure valid in all EU member states, reduced regulatory fees and ten years of market exclusivity. Ongoing IMerge Phase 3 Clinical Trial The IMerge Phase 3 clinical trial is a double-blind, randomized, placebo-controlled clinical trial with registration intent. The trial is designed to enroll approximately 170 patients with lower risk transfusion dependent MDS who are relapsed or refractory to an ESA, have not received prior treatment with either a hypomethylating agent (HMA) or lenalidomide and who are non-del(5q). Geron expects to complete patient enrollment by the end of the first quarter of 2021 and top-line results to be available in the second half of 2022. About Myelodysplastic Syndromes MDS is a group of blood disorders in which the proliferation of malignant progenitor cells produces multiple malignant cell clones in the bone marrow resulting in disordered and ineffective production of the myeloid lineage, which includes red blood cells, white blood cells and platelets. Chronic anemia is the predominant clinical problem in patients who have lower risk MDS. Many of these patients become dependent on red blood cell transfusions due to low hemoglobin. Serial red blood cell transfusions can lead to elevated levels of iron in the blood and other tissues, which the body has no normal way to eliminate. Iron overload is a potentially dangerous condition. Studies in patients with MDS have shown that iron overload resulting from regular red blood cell transfusions is associated with lower quality of life, shorter overall survival and a higher risk of developing acute myeloid leukemia. About Imetelstat Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the apoptosis of malignant stem and progenitor cells, which allows potential recovery of normal hematopoiesis. Geron's imetelstat development program includes two ongoing or planned registration-enabling studies, IMerge, an ongoing Phase 2/3 clinical trial in lower risk myelodysplastic syndromes (MDS), and a planned Phase 3 clinical trial in refractory myelofibrosis (MF) expected to be open for patient screening and enrollment in the first quarter of 2021. Imetelstat has been granted Fast Track designation by the U.S. Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment. About Geron Geron is a late-stage clinical biopharmaceutical company focused on the development and potential commercialization of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.

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From: tktrimbath12/31/2020 7:30:30 PM
1 Recommendation   of 3519
 
My End Of Year Review of GERN

INTRO Here's my semi-annual exercise to see if I remember why I own the stocks I own, and so I can check back and see if their stories have changed. I post in case it helps others too.

Geron

GERN (market cap is $0.494B was $0.677B)

Geron is a biotech directed to gerontology issues. Originally they were pursuing several technologies but over the decades they've had to sell them off to financially sustain the remainder of the company. Currently, the prime technology is directed at telomere management, particularly for blood disorders. If successful, the technology should be applicable to other disorders like autoimmune diseases as well as cancers.

The good news is that the company has made it to Phase 3. A hurdle ahead of them is the FDA's tendency to require additional efforts from innovative technologies. (See Dendreon's history with Provenge for prostate cancer.) Their current trial plan may suffice. Their current trial plan still requires years of effort, then the approval process, then implementation, then adoption by the medical community, then hopefully getting paid sufficiently to make the company profitable. Hence, high risk. The ability to expand to other treatments is also the potential for high reward financially and in a humane sense.

I continue to hold, but have sold off most of my shares to concentrate on more near-term opportunities. I haven't sold off all, though, as I feel clinical trial news can be surprisingly positive without warning and the investment community's response can be more rapid than mine.

DISCLOSURE LTBH since 1999 and continuing to hold. I might consider buying more, but will probably wait for substantial, quantitative results to be made public - which would spark a spike that might price me out of the sale. Stay tuned.

(I've also collected links to the other discussion boards and my other stocks over on my blog trimbathcreative.net )

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