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Geron Corporation (GERN)
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“ Safety data from the Phase 2 IMbark and IMerge trials were further analyzed to understand the characteristics of hematologic and non-hematologic adverse events. These analyses highlighted that the imetelstat-related cytopenias are short, reversable and with limited clinical consequence when managed with the dose modification guidelines in the protocols. These data are further evidence for the on-target effect of imetelstat based on the selective reduction of malignant cells in the bone marrow through telomerase inhibition resulting in the observed meaningful clinical benefits for patients in the Phase 2 trials.”
Safety, overall survival, with the rep big pharma has garnered over the years, geron not only is a target for the revenue they can generate but the positive pr they can bring to whomever is involved. Imagine that, a cancer research company excited about the challenge of setting overall survival as a endpoint and not just some spleen size reduction bs.
“The current presentation reported clinical responses across different cytogenetic and molecularly defined categories whereby responses were independent of mutation status or number of mutations. These data support the unique telomerase inhibition mechanism of action of imetelstat and the potential to target the malignant stem and progenitor cells of the underlying disease.” Geron today.
My efficacy data post was deleted?
Ooooh-K. Whatever, the poster is on Geron's website.
Cliff's Notes - Efficacy is "profound & durable" ;)
“These data support the unique telomerase inhibition mechanism of action of imetelstat and the potential to target the malignant stem and progenitor cells of the underlying disease.” Geron today. Sums it up.
I kind of don't want a buyout because Geron can stand on its own and move up to the $200-plus range. I"m not claiming that'll happen tomorrow -- don't want to exaggerate -- but in two to three years; however, if there is a buyout before all the trials complete -- as there was with Kite Pharma, which didn't have one approved drug when it was bought out for $175 a share four years ago -- I would reasonably think that Geron could command around $125 to $175 within the year, 2021 to early 2022.
expect Geron to be fast tracked as a "New Molecular Enitiy "
If it is it could mean approval for both trials...A 2 for one approval..
The different worlds of Imetelstat (IMET):
1. The IMET world of scientific and medical successes in a variety of blood cancers (ET, PV, MF, MDS), that is compelling, remarkable, durable, potent, and specific, with very successful phase 2's and ongoing confirming phase 3's. This is the world of Dr. Rizo (Chief Medical Officer).
2. The Geron world of manipulated stock prices, hedge funds, and computer control.
3. The world of potential partners or a buyout. This is JS's (CEO) world as he sits on information that only he and a handful of insiders know for sure. The rest of us can only speculate as investors.
4. The world of the patient whose needs come first & now, as IMET's OS (time of survival), TI (transfusion improvement), disease modification (bone marrow), and a good safety profile all are very positive.
5. The world of approval agencies including the FDA, EMA, India, Japan, others. This is the world of orphan status, fast-tracks, and ultimately full approvals.
6. The world of conferences, such as EHA and ASH, that are subjects of discussion and interpretation.
EHA 2021 Posters
July 1, 2020.......last year right after EHA :
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
Could this years abstracts be a "prerequisite" for AA by the EMA ?
Speaking if partnerships. What companies have the most to lose if Gern gets approval
Number 1 is BMY (revlimid)
Number 2. Is INCY (i mean the cream is good and all)
Who else? Any company using JAK inhibitors?
These shorts/bashers are all the same, day after day to year after year: It's always the same nonsense, on how the CEO is blameworthy or how the share price will never rise -- they gleefully taunt. If, however, you're invested in a company with solid science, such as Geron, you just have to be patient. I was invested in Regeneron for a decade and the stock didn't budge, basically stayed around $20 the whole time, and the shorts/bashers sang the same song: It'll never go up, that's what it's worth, Wall Street assigns Regeneron $20 forever! Well ... Regeneron was over $650 per share in 2020 and now it's around $550. There are tons of volatile biotech stories like that: look at Novavax, which was $4 per share in 2019 and is now over $200. Shorts/bashers also ladled the nonsense thick on Novavax's board.
Orphan Drug Designation* in the European Union for Imetelstat to Treat Myelodysplastic Syndromes......7/1/2020
* Designation would provide 10-year period of marketing exclusivity in the European Union after product approval
After Hours Volume 416,459
1 Large Transaction
16:02:07 $1.45 395,182
With EMA Updates, EMA may have an impact
EFFICACY OF IMETELSTAT IS INDEPENDENT OF MOLECULAR SUBTYPES IN HEAVILY TRANSFUSED NON-DEL(5Q) LOWER RISK MDS (LR-MDS) RELAPSED/REFRACTORY (R/R) TO ERYTHROPOIESIS STIMULATING AGENTS (ESA)
Of 34/38 pts with baseline cytogenetic results, 28 (82.4%) pts had very good/good and 6 (17.6%) pts had intermediate (int)/poor cytogenetic risk (n=3 trisomy 8, n=1 for del(7q), inv(3)/t(3q) and complex karyotype). Though pts with int/poor risk had higher TI and HI-E response rates compared with pts with very good/good risk pts, no statistically significant difference was observed: 83.3% (5/6) vs 35.7% (10/28) had ≥8-w TI; 50% (3/6) vs 32.1% (9/28) had ≥24-w TI; and 50% (3/6) vs 25% (7/28) had ≥1-y TI; 100% (6/6) of pts with int/poor risk group vs 60.7% (17/28) achieved HI-E response (Fig. A).
Of 31/38 pts with baseline mutation data, 28 (90.3%) pts had at least one mutation, among which 15 (53.6%), 8 (28.6%) and 5 (17.9%) pts had 1, 2 and ≥3 mutations, respectively. The ≥8-w TI rate was 60%, 50% and 20% respectively, ≥1-y TI rate was 46.7%, 37.5% and 20% respectively, and HI-E response rate was 93.3%, 50% and 60%, respectively (Fig. B). Three pts (9.7%) had no mutation detected, of which 1 pt had 8-w TI and HI-E response. The most frequently mutated gene was SF3B1 (87.1%, n=27), consistent with the predominance of ring sideroblast phenotypes (n=23); followed by DNMT3A (19.4%), KIT (16.1%) and RUNX1 (6.4%), all coexisting with SF3B1 mutation. Among pts with SF3B1 mutation, hot spot mutations were detected: 3 (11.1%) E622D, 3 (11.1%) R625C/L, 4 (14.8%) H662Q, 4 (14.8%) K666R, 12 (44.4%) K700E and 1 (3.7%%) G740E, respectively. Durable TI was observed in pts with these hot spot mutations except K666R, and HI-E response was seen in pts with all hot spot mutations (Fig. C). Analysis of clinical responses across the mutation defined subgroups on genes involved in different biological functions, including splicing process, epigenetic regulation, or receptors/kinases, were performed and ≥8-w TI was 50.0%, 42.9% and 25.0%; ≥24-w TI was 42.9%, 42.9% and 25.0%; ≥1-y TI was 39.3%, 28.6% and 25.0%, and HI-E responses were 75.0%, 71.4% and 50.0%, respectively (Fig. D).
Imetelstat demonstrated clinical efficacy across different molecularly defined subgroups including in pts with poor prognosis in heavily transfused LR-MDS ESA-R/R, who have limited treatment options. Phase 3 of IMerge, a placebo-controlled trial of imetelstat, is ongoing to further confirm the efficacy, safety, and biomarker results.
.........confirming efficacy as we speak.
Nasdaq says GERN going to $5 soon. See below.
WASHINGTON, June 7 (Reuters) - The Financial Industry Regulatory Authority (FINRA), Wall Street's self-regulatory body, has proposed changes to its short-interest reporting requirements in a bid to make information more useful.
The proposed changes to Rule 4560 would increase the frequency of short-interest reports from twice a month to weekly or even daily. The change would require clearing firms to report synthetic short exposure - bets made against shares via derivatives - in firm and customer accounts.
The move highlights intensifying scrutiny of short-selling, betting against shares to profit if they fall, amid ongoing volatility in "meme stocks." These are driven by retail investors banding together to squeeze hedge funds that bet against GameStop AMC Entertainment Holdings Inc and other stocks.
The changes would also require clearing firms to report to FINRA certain information on the stock loans that facilitate short bets "for regulatory purposes, but with an eye toward eventual public dissemination," amid other changes, said the watchdog. The proposal was released late Friday.
"These potential changes could improve the usefulness of short sale-related information to FINRA, other regulators, investors and other market participants," FINRA said.
FINRA is an industry-financed self-regulatory organization overseen by the U.S. Securities and Exchange Commission (SEC).
The proposed changes, which are subject to public consultation, would likely increase the burden on clearing firms and prime brokers, who bear the primary responsibility for short interest reporting under the current requirements, FINRA said.
The agency currently collects and publish this data but it is not easy for many investors to access. This proposal seeks to address that. (Reporting by Katanga Johnson; Editing by Michelle Price and Cynthia Osterman)
It wouldn’t surprise me if they try to push the stock lower tomorrow with today’s good press release.
H. C. Wainwright says GERN will be $7 a share in the next six months and here is why below.
Johnson and Johnson employees who are insiders are leaving Johnson and Johnson for GERN because GERN's future was very very bright.
There is a reason why all these Johnson and Johnson employees are quitting Johnson and Johnson to join the GERN team! You would not leave a company like Johnson and Johnson that supports you and your family to join a failing company. No and GERN is pure Gold. Just ask the ex Johnson and Johnson employee who have moved over to the GERN team.
Let’s take a level headed approach here.
Let’s say that in 2 years GERN is only at $2 a share (an ultra conservative figure). That’s a 35% increase or 17.5%
Per year return. If any positive results come from the phase 3 trial then $50 - $100 per share is likely as Geron controls the whole thing. This is a no brainer. Personally I hope the short bashers artificially push the price down within the next 7 days as I’m moving more cash over to buy. Shorts are walking a fine line here. They think they have until the clinical trials end to manipulate the share price. Any positive results from the trials will most definitely put them in a short squeeze. When that happens I’m going to sit back and enjoy the ride.
It would appear bleak for GERN investors if chippy is going to "sequester" all Phase 3 results for another couple of years!
After all, he's milked the Phase 2 results for all their worth and, perhaps, then some.
So, No News for another 2 years?
What about a buyout?
Of course, IMO.
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