Buy gern stock

Posted: PapaCarlo Date of post: 06.07.2017

Recent patient information suggests substantial efficacy in MF and now a third MPN disease after ET, MDS-RARS. Many positive catalysts could occur at any time. Sitting on sidelines risks missing those events. For many Geron NASDAQ: GERN followers, the story is well known: Target telomerase and inhibit the enzyme that cancer cells require to multiply, and watch the cancer fade away.

The drug that does just that, GERN's Imetelstat, has had some very exciting results. The drug is succeeding against multiple, challenging cancers by sending patients into remission, something never done before in these myeloproliferative disorders.

Now a little blurb about my background, I'm not a Bio analyst or a forensic accountant scrutinizing COGS and margins. I was a floor specialist, market maker of NASDAQ stocks and ran a fairly large trading desk over my 25 years in the industry. This experience has taught me to look for special situations where fear or greed has unbalanced the market.

While those events are harder and harder to find, we now have such a situation with GERN. I rarely push my ideas forward into articles, however with GERN there is now such a large disconnect between the huge potential and low price that this opportunity warrants an article. Three of the five went into complete remission, meaning the fibrosis in the marrow cleared, blood cleared and blood counts reverted to normal.

It was as if these patients were getting the benefits of stem cell replacements but in a much faster time-frame, and without the life-threatening risks. It was also the first time in this disease that a drug produced partial responses PRs and complete responses CRs. The FDA's hold in March sent the stock tumbling and has created a wonderful buying opportunity. Many investors, make that most investors, originally thought the FDA's hold was meant to stop the new MF trial from proceeding, when in fact the hold was directed solely at the company's ET study.

Importantly, MF, while related to ET, is much more life threatening and has unmet medical needs advanced MF patients have life expectancies [LEs] of just 1.

As most are aware, the Mayo Clinic's IND was also temporarily placed on a partial hold, not because there was anything wrong, but simply because Geron's ET trial had shown slightly elevated but persistent LFTs mind you, these levels were similar to what you get after drinking a martini or two, and these elevated levels have no clinical significance that I could find.

Ironically, the hold was a blessing in disguise for investors as we learned two important things. These 33 patients with MF 23 AML 1 and MDS RARS 9 have very short life expectancies LEs. The AML patient has a five month LE or less and while we don't have specifics on the MDS patients, we know that all nine remain in the study.

GERN Stock Price - Geron Corp. Stock Quote (U.S.: Nasdaq) - MarketWatch

All these patients were enrolled prior to Jan , some as early as the beginning of If you watch this video of Dr. Snyder is not running the Mayo IST, this is fairly exciting detective work that shows we have 33 remissions in the Mayo trial. And even if he misspoke, there certainly are a number of remissions accompanied by strong CIs. Snyder's presentation I firmly believe we will get confirmation of these facts at ASH in early December, and this event could cause price eruption pun intended.

We have strong, yet anecdotal evidence that the drug works. It appears that many investors and analysts are waiting on the sidelines as GERN gathers the requested FDA data on ET patients. In order to get released from their hold, the company must track the LFTs to baseline, and because the patients had been on Imetelstat for years, this could easily take another months to get complete data.

The number one concern for investors is that while it appears the drug works, and works wonders against MF and other MPN diseases , Geron can't legally move forward with a multi-center PHII trials while its IND is on hold by the FDA.

So, until they collect this data and report back to the FDA, their hold prevents the company from taking a step forward. Up until August 4th there was no other option for GERN other than to wait for their LFT data to be collected, then submit it in a package to the FDA. On August 5th GERN made the critical announcement that they were taking over control of the Mayo Clinic's authorization to run trials IND and their independent study IST, and all the data that comes with it.

There are three very important points here. GERN has already received data from the IST and "The company plans to use the transferred data and information from the Myelofibrosis IST to inform the design of Geron's planned Phase 2 clinical trial in MF".

Having the complete data set, as well as data going forward will dramatically help GERN understand their drug and inform them for the new Phase II trials.

It would also seem logical that this move was not just to collect data something that could have been done in a simple agreement , but also to allow Geron a path forward in order to initiate their PHII MF trials as soon as 1Q , which continues to be CEO Chip Scarlet's planned timeframe.

buy gern stock

One other news item worthy of consideration is the recent August 25th paper from a working group which was "comprised of members from European LeukemiaNet NYSE: ELN and International Working Group for MPN Research and Treatment IWG-MRT. New drugs should be tested for preventing disease progression in MF patients with early disease in randomized studies, and a time to event, like progression-free or event-free survival should be the primary endpoint.

Here is specific wording that is also very important and not fully understood by the market or investors. According to the last GERN press release, "Geron has committed to the U. Food and Drug Administration FDA that the company will not initiate any new clinical studies under the transferred IND from Mayo Clinic until Geron has had further communication with the FDA regarding the company's IND and development plans for Imetelstat. The foremost goal for GERN is to start their new multi-center trials, and at the end of September they will have the means to do so.

The company needs a CLEAN IND in order to start a new trial in MF, and this newly acquired IND will give them the legal means to move forward into MF. That is by far the company's top priority. There are a number of potential positive catalysts that may occur at any time during the next six months, and sitting on the sidelines risks missing these events. The transfer of the Mayo Clinic's IND should go through and Geron will present a package to the FDA 1.

Efficacy data on the MF patients and the planned PHII multi-center study. While the FDA may or may not grant a partial release of the Geron IND hold, it won't matter as the company can proceed into MF studies under Mayo's IND.

The ASH abstracts will be announced in early November, then there could be excellent, if not blockbuster, data presented at ASH in December. If Geron eventually gets BTD for their drug, I find it realistic that we may see the stock price in double digits as that would mean the FDA has verified that the efficacy is a noticeable improvement over all competitors.

Recall, Imetelstat has been shown to be the only drug to induce remissions in MF. Obviously there are risks associated with this biotech stock. The company has one drug, and that drug is on full clinical hold which might not be released. We haven't seen much in terms of adverse effects, but the reader should go back over the presentations and look at past SAEs.

The company has cash in the bank, but probably needs more money or a partner to complete Phase III trials. While there are risks with every stock, the drug's potential efficacy should allay concerns. This drug may be 3 for 3 in the Myloproliferative diseases: Investors recall that prior to Imetelstat, nobody had ever seen partial or complete remissions in Myelofibrosis. With respect to the AML patient who was infused sometime before Jan and probably had a LE of five months or less.

Jakafi is FDA approved and has helped shrink the spleen in MF patients, but according to research, "does nothing to modify the disease of MF " and its use has never resulted in a CR or PR.

Hydroxurea is another option, but again, doesn't affect the disease, it just helps symptoms. From my research and in speaking to patients and friends with MF and having conversations with their doctors, both patients and doctors want access to Imetelstat and would certainly want the drug as their first option- if available. This seems to be more critical information not yet absorbed by the market.

It would be interesting to see an analyst do a direct comparison between INCY and GERN and a comparison of the side effects and efficacy of their two main drugs, Jakafi and Imetelstat. Fundamentally driven value assessments are difficult to determine in biotech drugs, especially with drugs not yet FDA approved, so I will leave the fundamental analysis to another writer. We don't know if Imetelstat will be approved or not and if so, for how many diseases?

However, it does appear that GERN's drug is working on a number of myeloproliferative disorders and sending patients into remission.

My opinion is that the FDA will certainly value remissions over manageable side-effects, and they will move this drug forward. One final point regarding a true possibility- Breakthrough Therapy Designation BTD , which is the gold standard for fast FDA approvals. The following bullet points are from the FDA website. This appears to describe Imetelstat. Regarding the second bullet point, the FDA site later offers a suggestion of what substantial improvement might be, specifically it states if a drug offers CRs when other drugs have only recorded PRs, that might prove sufficient.

buy gern stock

In the case of Imetelstat, it has demonstrated both PRs and CRs and no other drug has ever demonstrated either response in MF. More from their site All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and FDA will either grant or deny the request. It isn't often you get a chance to buy a potential cancer cure at such a cheap price.

Yes there is still substantial risk as Imetelstat is GERN's only drug, but the reward seems so improbably high and the results seem that they will be so improbably good. These catalysts appear on the horizon, it's just a matter of when they occur.

Those investors who sit on the sidelines and wait might miss out by waking up to a much higher stock price. We simply don't know exactly when news will hit, but it seems highly improbable that the FDA won't allow a life-saving drug to get to market.

Investors were confused by the FDA's action, but we now have a better opportunity to buy a company and its drug. Imetelstat appears to be working effectively on numerous cancers and it has been suggested that it might also work in very challenging cancers such as pancreatic cancer and other cancers with active telomerase.

I like investing in a drug that saves lives and I love the potential of this drug. How many potential upgrades are possibly awaiting? There are 25 Million shorts- just substantial fuel for the fire. This reminds me of that investment and potential. As always, do your own due-diligence.

buy gern stock

The author wrote this article themselves, and it expresses their own opinions. The author is not receiving compensation for it other than from Seeking Alpha.

The author has no business relationship with any company whose stock is mentioned in this article. This is my largest holding. Long Ideas Short Ideas Cramer's Picks IPOs Quick Picks Sectors Editor's Picks. The Best Buy In The Market Sep. Summary Geron has the largest potential upside of any stock I follow. Acquiring the Mayo Clinic's data and IND is a critical step to move the company forward.

GERN : Summary for Geron Corporation - Yahoo Finance

Some History Now a little blurb about my background, I'm not a Bio analyst or a forensic accountant scrutinizing COGS and margins. Investing Ideas , Long Ideas , Healthcare , Biotechnology. Want to share your opinion on this article?

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