Geron mit Hammernews!! - Die letzten 30 Beiträge

[Magnetfeldfredy]

Geron

Gerons Imetelstat = Gamechanger in Blutkrebsbehandlung:

https://stkt.co/FSDYcipe

[Magnetfeldfredy]

Gern

Goldman Sachs lifts Geron stock target to $5 on FDA panel support
EditorAhmed Abdulazez AbdulkadirStock Markets
Published Mar 15, 2024 07:00AM ET

Goldman Sachs lifts Geron stock target to $5 on FDA panel support © Reuters.

GERN
0.00%

On Friday, Goldman Sachs, a leading investment banking firm, raised its price target for Geron (NASDAQ:GERN) Corporation (NASDAQ:GERN) shares from $4.00 to $5.00, while retaining a Buy rating. This adjustment follows the favorable outcome of a recent FDA Advisory Committee vote regarding Geron's drug, imetelstat.

The FDA's Advisory Committee voted 12-2 in favor of the benefit/risk profile of imetelstat for patients with lower-risk myelodysplastic syndrome (LR-MDS) who are either ineligible for, or have relapsed or are refractory to, erythropoiesis-stimulating agents (ESAs). The committee's physicians expressed strong support for the clinical benefits of the drug, despite recognizing the safety risks identified by the FDA.

The hematologists on the panel highlighted that the management of cytopenias, a potential side effect, could be incorporated into standard clinical practices. This positive reception has led analysts to anticipate the approval of Geron's New Drug Application (NDA) for imetelstat by or before the Prescription Drug User Fee Act (PDUFA) date of June 16, 2024.

The drug's commercial launch is also looked upon favorably due to the significant unmet need within the LR-MDS patient population. Key Opinion Leaders (KOLs) and discussions during the committee meeting underscored the enthusiasm for imetelstat. Consequently, the firm has adjusted its model to reflect a 95% probability of approval for imetelstat in treating LR-MDS, up from the previous 90%.

In light of these developments, Goldman Sachs has updated its M&A rank for Geron to 2 from the previous rank of 3.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

[Sugar2000]

Antwort auf Beitrag Nr.: 75.458.556 von Kopflaus am 15.03.24 08:22:03

Ob sich J&J den Fehler von damals eingesteht? Bei 20-30 USD wäre ich auch bereit abzugeben...

[Kopflaus]

Antwort auf Beitrag Nr.: 75.458.049 von Magnetfeldfredy am 15.03.24 07:10:38

Hm, 5 Dollar, das könnte sein. Aber den Wert von Geron schätze ich nun durchaus im Berreich von 10 bis 30 Dollar ein
Das Jahreshoch war bei 3,7 Dollar und da war noch alles ungewiss.
Insyte als Vergleichswert hat eine MK von 12 Milliarden Dollar, Geron bei 12 Milliarden MK ein Wert von 20 Dollar je Aktie.
Und dies halte ich bei entgültiger Zulassung für gerechtfertigt.
Johnson&Johnson möchte ich noch als Interessenten an Geron in den Raum werfen.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 75.457.254 von Sugar2000 am 14.03.24 22:06:31

Gern

Ja, heute könnte ein Monster short squeeeeeeeeeeeeezzzzzzzzzzzzzzzeeeeeeeeeeeeeee die Aktie auf US Dollar 5 bringen.........

[Sugar2000]

Antwort auf Beitrag Nr.: 75.456.744 von Magnetfeldfredy am 14.03.24 21:01:33

Yes, hoffentlich läuft es weiter. Meine Teile liegen seit über 20 Jahren im depot ;-)

[Magnetfeldfredy]

Geron

Sieg:

Geron Announces FDA Oncologic Drugs Advisory Committee Votes in Favor of the Clinical Benefit/Risk Profile of Imetelstat for the Treatment of Transfusion-Dependent Anemia in Patients with Lower-Risk MDS
March 14, 2024
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FDA Oncologic Drugs Advisory Committee voted 12 to 2 in favor of the clinical benefit/risk profile of imetelstat based on results from the IMerge Phase 3 clinical trial
There are significant unmet needs across key TD LR-MDS patient populations, including difficult-to-treat subgroups that are underserved by currently available treatment options
June 16, 2024 PDUFA target action date for imetelstat NDA for the treatment of TD anemia in adult patients with LR-MDS


FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing investigational first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to 2 in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent (TD) anemia in adult patients with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS) who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs).

“We are pleased with the Committee’s decision to recognize the positive clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS. There are few treatment options and significant unmet medical need remains for these patients, particularly among those with difficult-to-treat subtypes of this blood cancer,” said Faye Feller, M.D., Geron’s Executive Vice President, Chief Medical Officer. “We believe that imetelstat has the potential to be an important new medicine for patients and look forward to continuing our collaboration with the FDA as they complete their review of our New Drug Application.”

The ODAC reviewed the results from the IMerge Phase 3 clinical trial. The primary endpoint of red blood cell transfusion independence (RBC-TI) for at least eight consecutive weeks was significantly higher with imetelstat vs. placebo (p<0.001), with median RBC-TI duration approaching one year for imetelstat ≥8-week RBC-TI responders. In addition, 28% of imetelstat-treated patients compared to 3% on placebo obtained a statistically significant improvement in the key secondary endpoint of at least 24-week RBC-TI. For those patients achieving ≥24-week RBC-TI, the median duration was 80 weeks. Clinically meaningful RBC-TI was achieved across key MDS subgroups irrespective of ring sideroblast (RS) status, baseline transfusion burden and International Prognostic Scoring (IPSS) risk category. Additionally, a sustained increase in mean hemoglobin levels in imetelstat-treated patients was observed over time compared to placebo patients. Consistent with prior imetelstat clinical experience, the most common Grade 3-4 adverse events were thrombocytopenia (62%) and neutropenia (68%) that were generally manageable and of short duration.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 16, 2024 for Geron’s New Drug Application (NDA) for imetelstat for the treatment of TD anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes, who have failed to respond, or have lost response to, or are ineligible for ESAs. The ODAC provides the FDA with independent opinions and recommendations from outside medical experts, patients and caregivers, though the recommendations are not binding. Geron plans to commercially launch imetelstat in the U.S. upon potential FDA approval.

About IMerge Phase 3

The Phase 3 portion of the IMerge Phase 2/3 trial is a double-blind, 2:1 randomized, placebo-controlled clinical trial to evaluate imetelstat in patients with IPSS Low or Intermediate-1 risk (lower-risk) transfusion-dependent MDS who were relapsed after, refractory to, or ineligible for, erythropoiesis stimulating agent (ESA) treatment, had not received prior treatment with either a hypomethylating agent or lenalidomide and were non-del(5q). To be eligible for IMerge Phase 3, patients were required to be transfusion-dependent, defined as requiring at least four units of packed red blood cells (RBCs), over an eight-week period during the 16 weeks prior to entry into the trial. The primary efficacy endpoint of IMerge Phase 3 is the rate of red blood cell transfusion independence (RBC-TI) lasting at least eight weeks, defined as the proportion of patients without any RBC transfusion for at least eight consecutive weeks since entry to the trial (8-week RBC-TI). Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks (24-week RBC-TI), the duration of RBC-TI and the rate of hematologic improvement erythroid (HI-E), which is defined under 2006 IWG criteria as a rise in hemoglobin of at least 1.5 g/dL above the pretreatment level for at least eight weeks or a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden. A total of 178 patients were enrolled in IMerge Phase 3 across North America, Europe, the Middle East and Asia.

About Imetelstat

Imetelstat is a novel, first-in-class investigational telomerase inhibitor exclusively owned by Geron and being developed by Geron in hematologic malignancies. Data from non-clinical studies and clinical trials of imetelstat provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies, resulting in malignant cell apoptosis. Imetelstat has been granted Fast Track designation by the U.S. Food and Drug Administration for both the treatment of adult patients with transfusion-dependent anemia due to Low or Intermediate-1 risk MDS that is not associated with del(5q) who are refractory or resistant to an erythropoiesis stimulating agent, and for adult patients with Intermediate-2 or High-risk myelofibrosis (MF) whose disease has relapsed after or is refractory to Janus kinase (JAK) inhibitor treatment. Imetelstat is currently not approved by any regulatory authority.

[Magnetfeldfredy]

Gern

The FDA’s Oncologic Drugs Advisory Committee will meet virtually on March 14, 2024, to review Geron Corporation’s (NASDAQ:GERN) imetelstat application seeking approval for transfusion-dependent anemia in adult patients with lower-risk Myelodysplastic Syndromes (MDS).

June 16, 2024, is the PDUFA date for imetelstat NDA for transfusion-dependent anemia in adult patients with lower-risk MDS.

The injectable drug imetelstat was being studied in patients with lower-risk myelodysplastic syndromes, a type of blood cancer that requires frequent blood transfusions for managing anemia.

On Tuesday, FDA’s staff flagged concerns related to its Phase 3 trial, according to the FDA briefing documents.

“FDA acknowledges that the results of Study MDS3001-Phase 3 met the statistical goals for the primary endpoint of 8-week red blood cell – transfusion independence (RBC-TI) and key secondary endpoint of 24-week RBC-TI, but the following:

It is not clear that the magnitude and durability of RBC-TI outweigh the risks of treatment with imetelstat for patients with lower-risk MDS.
The HI-E, CR, PR, and OS results are not supportive of a disease-modifying treatment effect.
The patient-reported outcomes are not supportive of a treatment effect.”

The document notes that the clinical meaningfulness of an 8-week RBC-TI period in the context of lower-risk MDS is uncertain.

“FDA requires collection and submission of OS data in oncology clinical trials to assess clinical benefit. Furthermore, one argument for therapeutically targeting transfusion-dependent anemia in subjects with lower-risk MDS is that higher RBC transfusion density has been reported to correlate with decreased overall survival,” the FDA staff noted.

According to Needham’s expert analysis, there is around 80-85% likelihood of a favorable AdComm vote for imetelstat due to its risk/benefit profile.

The analyst highlights that if the vote is positive, the FDA will likely grant full approval by the PDUFA date.

Citing the expert, Needham notes that the long duration of transfusion independence in responders and disease-modifying characteristics of imetelstat are particularly compelling.

Price Action: GERN shares are down 18.50% at $1.745 on the last check Tuesday.

Photo via Shutterstock

[Magnetfeldfredy]

Gern

share97
22m
$GERN what did you idiots expect the FDA to write? That there is clear benefit and they are requesting discussion for the fun of it? Get your heads out of your rear ends.

20% 24 week TI in RS- patients who received imetelstat vs 0% in those who didn’t. That is all you need to know! Bullish
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[Sugar2000]

Antwort auf Beitrag Nr.: 73.021.547 von Sugar2000 am 04.01.23 13:36:11

Und direkt das Momentum wieder raus...
https://seekingalpha.com/news/3922125-geron-dips-85-on-175m-…

News genutzt um Aktien zu platzieren...

[nicolani]

die amis sagen uns gleich was hier geht und was nicht! naja wer hat hier fast 4€ bezahlt!

[Sugar2000]

Yes, sieht gut aus!

Geron Announces Positive Top-Line Results from IMerge Phase 3 Trial of Imetelstat in Lower Risk MDS

https://ir.geron.com/investors/press-releases/press-release-…

https://s201.q4cdn.com/710325604/files/doc_news/Geron-Announ…

[Sugar2000]

Heute wirds spannend...

https://ir.geron.com/investors/press-releases/press-release-…

[bundi007]

Warum der Anstieg? Weiß wer mehr?

[optschraub]

Mal sehen, im Januar ist ja wieder so ein binäres Ereignis (Ergebnisse P 3 MDS),
diesmal habe ich die Shortrate im Blick..
die war 2018 beim Absturz extrem hoch.
Da müssen ja einige Insider gewusst haben das J&J einen Rückzieher macht.
Hatte mich kalt erwischt damals.

[Sugar2000]

Antwort auf Beitrag Nr.: 72.370.550 von optschraub am 09.09.22 16:21:31

Ja, ich habe noch welche von vor der Steuerreform im depot... wenn es mal irgendwann fliegt, Abgeltungsteuerfrei ;-)

[optschraub]

Bin schon länger dabei

[Sugar2000]

Still und heimlich gehts bei Geron aufwärts... noch jemand dabei?

[Malecon]

Geron Corp (GERN) Announces Publication of IMbark Phase 2 Data in Journal of Clinical Oncology

https://www.streetinsider.com/dr/news.php?id=18574943&gfv=1

[Wandfarbentester]

.... bald 1 Jahr rum und es bricht nicht aus.

[Wandfarbentester]

Ausbruch in welche Richtung?

[Stoxtrayder]

Heute deutlich über 2$ mit hohem Volumen, dürfte der endgültige Ausbruch sein! 👌

Neue Präsi von letzter Woche:

https://s24.q4cdn.com/668523011/files/doc_presentations/2020…

[Stoxtrayder]

https://mobile.twitter.com/VJHemOnc/status/12731861583364464…

[Stoxtrayder]

https://www.globenewswire.com/news-release/2020/06/12/204743…

Nächster Versuch gerade die 2$-Marke zu durchbrechen...

[sharepicker321]

Antwort auf Beitrag Nr.: 63.724.705 von Stoxtrayder am 18.05.20 17:17:21

da hat es eine kleine Fahnenstangenhause gegeben bis 2€, aber immerhin auch ein neuer kleiner Impuls wieder nach oben?!

[Stoxtrayder]

Per Ende April noch 32 Mio. Aktien leerverkauft, daher wohl gerade das kleine Shortie-Feuerchen 🔥

[Stoxtrayder]

Schöne Daten, die da gestern präsentiert wurden...👌

Genügend Cash, aussichtsreiches Medi...könnte was werden in naher Zukunft, daß ich wieder meinen EK sehe...

[Stoxtrayder]

Totgesagte leben länger...🥴

Einer meiner (wenigen) Depotleichen zuckt mal wieder...noch viel Platz bis zu meinem 3,50$ EK...

[optschraub]

Antwort auf Beitrag Nr.: 63.085.399 von geldspender am 21.03.20 11:33:20

Die Wahrscheinlichkeit der Genehmigung einer Phase 3 Studie beträgt ca 63%.
Also so in 2 bis 3 Jahren eine Vervielfachung des Kurses zu 63%.

[geldspender]

Wer hat eine Meinung zu dieser Aktie, neben Corona gibt es sicher noch andere Probleme, die später
wieder in den Vordergrund treten, gehört diese Aktie dann u den Gewinnern??