NicOx.... in attesa di.....
- Creatore Discussione DickSIM
- Data di Inizio
viralic
Forumer storico
Devono fare un ak se pagano in cash, oppure possono dare loro azioni in concambio....basta che si quotino in un mercato Euronext.
viralic
Forumer storico
non so....mi pare che abbia già scontato nel prezzo molto della prossima approvazione....la possibilità di rialzo in caso positivo lo vedo limitato, mentre in caso negativo sarebbe un crollo di almeno il 50%. Andava comprata prima dei dati della fase 3 a giugno scorso quando quotava poco più di 1 dollaro. Non dico che sia un cattivo investimento ma troppo spesso ultimamente ho visto scendere azioni subito dopo approvazioni scontate a causa di mancanza di nuovi eventi binari.
Jazalde
Forumer storico
Ok grazie
viralic
Forumer storico
Qui i dati di fase 3 presentati oggi.......in breve : efficacia ok ma molti abbandoni tra i pazienti per l'alta tossicità !...Riuscirà a superare la FDA ?....
Geron Announces ASCO Presentation Reporting Durable Continuous Transfusion Independence with Imetelstat in IMerge Phase 3 Lower Risk MDS Patients
02/06/2023 21:30 - RSF
For best results when printing this announcement, please click on link below: http://newsfile.refinitiv.com/getne...rs.com:20230602:nBw9cPQKfa&default-theme=true
Geron Announces ASCO Presentation Reporting Durable Continuous Transfusion Independence with Imetelstat in IMerge Phase 3 Lower Risk MDS Patients
* Primary endpoint of 8-week transfusion independence (TI) significantly higher with imetelstat vs. placebo (P
* Statistically significant and clinically meaningful efficacy results achieved across key MDS subgroups: ring sideroblast (RS) status, baseline transfusion burden and IPSS risk category
* Safety results consistent with prior imetelstat clinical experience
* Reduction in variant allele frequency (VAF) of genes commonly mutated in MDS and their correlation with clinical endpoints support disease-modifying potential of imetelstat
* Data support NDA submission which is on track for June 2023 to support potential U.S. commercial launch in first half of 2024
Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, announced a presentation reporting durable continuous transfusion independence with imetelstat, the Company’s first-in-class telomerase inhibitor, in IMerge Phase 3 lower risk MDS patients. These data were presented today at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.
“The presentation at ASCO of our IMerge Phase 3 data highlighted the meaningful longer-term duration of transfusion independence with imetelstat compared to placebo, as well as significantly higher rates of TI across MDS subgroups, greater reductions in transfusion units and sustained increases in hemoglobin levels,” said Faye Feller, M.D., Executive Vice President, Chief Medical Officer of Geron. “With our U.S. New Drug Application based on these data on track to be submitted to the FDA this month, I look forward to the day when imetelstat could be available for lower risk MDS patients in the first half of 2024.”
IMerge Phase 3 enrolled lower risk MDS patients who were relapsed after, refractory to, or ineligible for erythropoiesis stimulating agent (ESA) treatment and were transfusion dependent, defined as requiring at least four units of packed red blood cells (RBCs) over an eight-week period. The ASCO presentation reported IMerge Phase 3 results with a data cut-off of October 2022, the same for top-line results reported in January 2023. The primary endpoint of 8-week transfusion independence (TI) was met with high statistical significance (P
Mean hemoglobin levels in imetelstat-treated patients increased significantly (P
Significantly higher 8-week TI rates were observed with imetelstat vs. placebo across key lower risk MDS subgroups, including ring sideroblast (RS) status, baseline transfusion burden and IPSS risk category, with similar 8-week TI responses seen for imetelstat within each subgroup category.
“The IMerge Phase 3 results are especially encouraging because of the significant unmet need in lower risk MDS patients with symptomatic anemia needing regular red blood cell transfusions, especially with less than half of such patients responding to frontline ESA therapy, and most of those who do respond losing that response in less than two years,” said Amer Methqal Zeidan, MBBS MHS, Associate Professor of Internal Medicine (Hematology) and director of hematology Early Therapy Research at Yale School of Medicine and Yale Cancer Center, who presented the data at ASCO and is an IMerge lead investigator. “Based on the IMerge trial results, I believe imetelstat represents an important and novel option for patients with lower risk MDS after ESA failure, particularly in terms of the high response rate, durability of response, significant and sustained hemoglobin increase in responders, the preliminary evidence of disease modification across the mutational spectrum of the disease and considering the manageable and reversible adverse event profile. This potential treatment option is especially important for patients with high transfusion burden and those without ring sideroblasts who have high unmet need.”
The safety profile observed with imetelstat in IMerge Phase 3 was consistent with prior clinical experience with no new safety signals. Non-hematologic adverse events (AEs) were generally low grade. No cases of Hy’s Law or drug-induced liver injury were observed, and the incidence of grade 3 liver function test laboratory abnormalities was similar between imetelstat and placebo groups. Grade 3-4 thrombocytopenia and neutropenia were the most frequently reported hematologic AEs and were most often reported during Cycles 1-3. These cytopenias resolved within two weeks, and over 80% of events were reversible to grade 2 or lower within 4 weeks. There were no fatal hematologic AEs or cytopenic events. Clinical consequences of grade 3-4 infection and bleeding were low and similar between imetelstat and placebo groups.
Most AEs leading to dose modifications were grade 3-4 neutropenia and thrombocytopenia. Although approximately 75% of patients treated with imetelstat had dose modifications due to AEs, less than 15% of patients discontinued treatment due to treatment-emergent adverse events (TEAE).
Discontinuation of imetelstat treatment in these patients due to a TEAE generally occurred late in treatment, with a median time to treatment discontinuation of 21.1 weeks (range 2.3 to 44.0 weeks).
Reductions in variant allele frequency (VAF) of genes frequently mutated in MDS were greater for imetelstat-treated patients vs. placebo: SF3B1 (P
The presentation slides are available on the Publications section of Geron’s website: Studies on telomerase inhibition and imetelstat | Geron (Studies on telomerase inhibition and imetelstat | Geron) .
About IMerge Phase 3
The Phase 3 portion of the IMerge Phase 2/3 study 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 HMA 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 TI). Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks (24-week TI), the duration of 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, Middle East and Asia.
Geron Announces ASCO Presentation Reporting Durable Continuous Transfusion Independence with Imetelstat in IMerge Phase 3 Lower Risk MDS Patients
02/06/2023 21:30 - RSF
For best results when printing this announcement, please click on link below: http://newsfile.refinitiv.com/getne...rs.com:20230602:nBw9cPQKfa&default-theme=true
Geron Announces ASCO Presentation Reporting Durable Continuous Transfusion Independence with Imetelstat in IMerge Phase 3 Lower Risk MDS Patients
* Primary endpoint of 8-week transfusion independence (TI) significantly higher with imetelstat vs. placebo (P
* Statistically significant and clinically meaningful efficacy results achieved across key MDS subgroups: ring sideroblast (RS) status, baseline transfusion burden and IPSS risk category
* Safety results consistent with prior imetelstat clinical experience
* Reduction in variant allele frequency (VAF) of genes commonly mutated in MDS and their correlation with clinical endpoints support disease-modifying potential of imetelstat
* Data support NDA submission which is on track for June 2023 to support potential U.S. commercial launch in first half of 2024
Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, announced a presentation reporting durable continuous transfusion independence with imetelstat, the Company’s first-in-class telomerase inhibitor, in IMerge Phase 3 lower risk MDS patients. These data were presented today at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.
“The presentation at ASCO of our IMerge Phase 3 data highlighted the meaningful longer-term duration of transfusion independence with imetelstat compared to placebo, as well as significantly higher rates of TI across MDS subgroups, greater reductions in transfusion units and sustained increases in hemoglobin levels,” said Faye Feller, M.D., Executive Vice President, Chief Medical Officer of Geron. “With our U.S. New Drug Application based on these data on track to be submitted to the FDA this month, I look forward to the day when imetelstat could be available for lower risk MDS patients in the first half of 2024.”
IMerge Phase 3 enrolled lower risk MDS patients who were relapsed after, refractory to, or ineligible for erythropoiesis stimulating agent (ESA) treatment and were transfusion dependent, defined as requiring at least four units of packed red blood cells (RBCs) over an eight-week period. The ASCO presentation reported IMerge Phase 3 results with a data cut-off of October 2022, the same for top-line results reported in January 2023. The primary endpoint of 8-week transfusion independence (TI) was met with high statistical significance (P
Mean hemoglobin levels in imetelstat-treated patients increased significantly (P
Significantly higher 8-week TI rates were observed with imetelstat vs. placebo across key lower risk MDS subgroups, including ring sideroblast (RS) status, baseline transfusion burden and IPSS risk category, with similar 8-week TI responses seen for imetelstat within each subgroup category.
“The IMerge Phase 3 results are especially encouraging because of the significant unmet need in lower risk MDS patients with symptomatic anemia needing regular red blood cell transfusions, especially with less than half of such patients responding to frontline ESA therapy, and most of those who do respond losing that response in less than two years,” said Amer Methqal Zeidan, MBBS MHS, Associate Professor of Internal Medicine (Hematology) and director of hematology Early Therapy Research at Yale School of Medicine and Yale Cancer Center, who presented the data at ASCO and is an IMerge lead investigator. “Based on the IMerge trial results, I believe imetelstat represents an important and novel option for patients with lower risk MDS after ESA failure, particularly in terms of the high response rate, durability of response, significant and sustained hemoglobin increase in responders, the preliminary evidence of disease modification across the mutational spectrum of the disease and considering the manageable and reversible adverse event profile. This potential treatment option is especially important for patients with high transfusion burden and those without ring sideroblasts who have high unmet need.”
The safety profile observed with imetelstat in IMerge Phase 3 was consistent with prior clinical experience with no new safety signals. Non-hematologic adverse events (AEs) were generally low grade. No cases of Hy’s Law or drug-induced liver injury were observed, and the incidence of grade 3 liver function test laboratory abnormalities was similar between imetelstat and placebo groups. Grade 3-4 thrombocytopenia and neutropenia were the most frequently reported hematologic AEs and were most often reported during Cycles 1-3. These cytopenias resolved within two weeks, and over 80% of events were reversible to grade 2 or lower within 4 weeks. There were no fatal hematologic AEs or cytopenic events. Clinical consequences of grade 3-4 infection and bleeding were low and similar between imetelstat and placebo groups.
Most AEs leading to dose modifications were grade 3-4 neutropenia and thrombocytopenia. Although approximately 75% of patients treated with imetelstat had dose modifications due to AEs, less than 15% of patients discontinued treatment due to treatment-emergent adverse events (TEAE).
Discontinuation of imetelstat treatment in these patients due to a TEAE generally occurred late in treatment, with a median time to treatment discontinuation of 21.1 weeks (range 2.3 to 44.0 weeks).
Reductions in variant allele frequency (VAF) of genes frequently mutated in MDS were greater for imetelstat-treated patients vs. placebo: SF3B1 (P
The presentation slides are available on the Publications section of Geron’s website: Studies on telomerase inhibition and imetelstat | Geron (Studies on telomerase inhibition and imetelstat | Geron) .
About IMerge Phase 3
The Phase 3 portion of the IMerge Phase 2/3 study 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 HMA 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 TI). Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks (24-week TI), the duration of 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, Middle East and Asia.
viralic
Forumer storico
Questo è il loro punto debole....naturalmente non particolarmente sottolineato dalla dirigenza ma esiste ..
"La maggior parte degli eventi avversi che hanno portato a modifiche della dose sono stati neutropenia e trombocitopenia di grado 3-4. Sebbene circa il 75% dei pazienti trattati con imetelstat abbia avuto modifiche della dose a causa di eventi avversi, meno del 15% dei pazienti ha interrotto il trattamento a causa di eventi avversi emergenti dal trattamento (TEAE).
L'interruzione del trattamento con imetelstat in questi pazienti a causa di un TEAE si è generalmente verificata in una fase avanzata del trattamento, con un tempo mediano all'interruzione del trattamento di 21,1 settimane (intervallo da 2,3 a 44,0 settimane).
Le riduzioni della frequenza allelica variante (VAF) dei geni frequentemente mutati nella MDS erano maggiori per i pazienti trattati con imetelstat rispetto al placebo: SF3B1 ("
"La maggior parte degli eventi avversi che hanno portato a modifiche della dose sono stati neutropenia e trombocitopenia di grado 3-4. Sebbene circa il 75% dei pazienti trattati con imetelstat abbia avuto modifiche della dose a causa di eventi avversi, meno del 15% dei pazienti ha interrotto il trattamento a causa di eventi avversi emergenti dal trattamento (TEAE).
L'interruzione del trattamento con imetelstat in questi pazienti a causa di un TEAE si è generalmente verificata in una fase avanzata del trattamento, con un tempo mediano all'interruzione del trattamento di 21,1 settimane (intervallo da 2,3 a 44,0 settimane).
Le riduzioni della frequenza allelica variante (VAF) dei geni frequentemente mutati nella MDS erano maggiori per i pazienti trattati con imetelstat rispetto al placebo: SF3B1 ("
Nicox2003
Nuovo forumer
Cher Monsieur Labbé,
Je suis actionnaire de Nicox depuis près de deux décennies. Je connais en conséquence très bien la société. Je suis par ailleurs en contact avec plusieurs dizaines d'actionnaires de Nicox de longue date comme moi. Si je me permets de vous écrire aujourd'hui, c'est pour vous informer de notre grande inquiétude dans la récente évolution de Nicox, depuis que M. Segerros en est CEO.
Sur la période septembre 2022-mai 2023, nous avons constaté qu'il n'y a plus d'actions significatives de Nicox. La société semble s'être complètement arrêtée depuis cette période.
La lettre aux actionnaires nous a tous beaucoup inquiété, parce qu'il n'y a pas de ligne directrice claire, qu'elle précise des plans qui nous apparaissent extrêmement couteux, aléatoires et auxquels par ailleurs nous avons déjà goûté. Par ailleurs, comment lever autant d'argent avec un cours aussi bas, cours divisé par 4 depuis l'arrivée de M. Segerros ? Enfin, vous aurez remarqué qu'il n'est pas fait mention des développements internes de Nicox, notamment du NCX470, laissant penser qu'on repartirait d'une feuille blanche, ce qui n'est pas envisageable.
Je souhaiterais que vous mesureriez les risques que vous faites prendre à Nicox, en laissant cet individu à ce poste. Nous perdons du temps précieux, et nous nous mettons de plus en plus dans une situation compliquée, avec une action qui ne cesse de baisser.
Enfin, travaillant aussi dans l'inductrie pharmaceutique, j'ai pu mener mon enquête sur M. Segerros et le moins qu'on puisse dire c'est que les avis ne sont pas positifs.
En espérant que nous pourrons être entendus, Cordialement.
Je suis actionnaire de Nicox depuis près de deux décennies. Je connais en conséquence très bien la société. Je suis par ailleurs en contact avec plusieurs dizaines d'actionnaires de Nicox de longue date comme moi. Si je me permets de vous écrire aujourd'hui, c'est pour vous informer de notre grande inquiétude dans la récente évolution de Nicox, depuis que M. Segerros en est CEO.
Sur la période septembre 2022-mai 2023, nous avons constaté qu'il n'y a plus d'actions significatives de Nicox. La société semble s'être complètement arrêtée depuis cette période.
La lettre aux actionnaires nous a tous beaucoup inquiété, parce qu'il n'y a pas de ligne directrice claire, qu'elle précise des plans qui nous apparaissent extrêmement couteux, aléatoires et auxquels par ailleurs nous avons déjà goûté. Par ailleurs, comment lever autant d'argent avec un cours aussi bas, cours divisé par 4 depuis l'arrivée de M. Segerros ? Enfin, vous aurez remarqué qu'il n'est pas fait mention des développements internes de Nicox, notamment du NCX470, laissant penser qu'on repartirait d'une feuille blanche, ce qui n'est pas envisageable.
Je souhaiterais que vous mesureriez les risques que vous faites prendre à Nicox, en laissant cet individu à ce poste. Nous perdons du temps précieux, et nous nous mettons de plus en plus dans une situation compliquée, avec une action qui ne cesse de baisser.
Enfin, travaillant aussi dans l'inductrie pharmaceutique, j'ai pu mener mon enquête sur M. Segerros et le moins qu'on puisse dire c'est que les avis ne sont pas positifs.
En espérant que nous pourrons être entendus, Cordialement.
Jazalde
Forumer storico
Ho letto e ti ringrazio per il post che mi fa capire la situazione e difatti il titolo ha avuto si una reazione positiva ma poi ho notato sul finale molti volumi in vendita e quindi sto con gli occhi aperti anche se ne ho solo 500 e ci sto per ora guadagnando poco (l
e ho prese a 3 dollari) e quindi ora vedo lunedi e magari esco perche' pure a me non convince la situazione descritta-
anche se i casi avversi neutropenia etc) dicono si siano poi risolti nel giro di qualche settimana e la fda potrebbe approvare il farmaco vista la indipendenza trasfusionale che da grossi benefici in termini sia economici che strutturali (zero trasfusioni e quindi meno sangue da usare in queste situazioni) ,quindi chissa? vedo come va l'andamento prima della presentazione della domanda e poi decido,anche perche' ho letto che il 31 maggio ci sono stati acquisti a mercato,anchge se non capisco bene il significato di : (stock options right to buy)di 500.000 azioni da parte dei dirigenti a 3,27 e questo mi sembra un segnale positivo anche se non sono molte
Ultima modifica:
Jazalde
Forumer storico
Ma mi domando come abbia fatto il management a prendere questo ceo? Ma dove vivono? o forse dormono o hanno fatto finta di dormire se questa poersona non aveva un buon nome penso che lo sapevano e allora?e mi meraviglio che Garufi essendo pure azionista abbia accettato questa situazione,
non lo capisco e sinceramente fa pure venire cattive idee anche pure per il fatto che lo abbiano messo su un diverso mercato.
faccio queste riflessioni anche se per il momento sono fuori e quindi mi interessa relativamente pero' ci ho rimesso in passato e quindi mi girano lo stesso le .....