Gern (Geron Corp)
-
beurssukkel
- Forum actieveling
- Berichten: 467
- Lid geworden op: 03 nov 2015 16:17
- waarderingen: 118
Laatste artikelen op Beursig.com
Beleggen in bitcoin en ethereum op Euronext beurs
Wild west taferelen bij aandelen, crypto valuta en ...
Volg Beursig.com
-
€JantjePetertje€
- Forum verkenner
- Berichten: 45
- Lid geworden op: 01 jul 2021 17:13
- waarderingen: 0
Re: Gern (Geron Corp)
Dit aandeel heeft een flinke duik in 2020 genomen. In 2021 schijnt het zich langzaamaan te herstellen. Het is verstandig nu nog in te stappen, want ik denk dat hij weer mooi zal stijgen...
Re: Gern (Geron Corp)
nabeurs was het eventjes feest
GERN After-Hours $1.75 + 0.28 + 19.04%
Geron Enters New Innovative Licensing and Access Pathway in the United Kingdom for Imetelstat
Mon, October 25, 2021
Innovation Passport Designation Awarded to Imetelstat for the Treatment of Lower Risk Myelodysplastic Syndromes
Pathway Intended to Expedite Regulatory Review Process
FOSTER CITY, Calif., October 25, 2021--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, today announced that imetelstat, the Company’s first in class telomerase inhibitor, has been granted an Innovation Passport, which is the first prescribed entry point to the Innovative Licensing and Access Pathway (ILAP) launched in the United Kingdom (UK) by the Medicines and Healthcare products Regulatory Agency (MHRA) in January 2021, post-Brexit. The objective of this new licensing and access pathway is to reduce the time to market for innovative medicines. Key benefits of being within ILAP include a 150-day accelerated assessment and rolling review of a Marketing Authorization Application (MAA), as well as opportunities for frequent interactions with the review staff at the MHRA and its partner agencies, including the National Institute for Health and Care Excellence (NICE), to discuss imetelstat’s development, regulatory plans and reimbursement plans.
"We are pleased to participate in this new expedited review pathway established by MHRA and look forward to working with them and their partner agencies as we collaborate to bring imetelstat to UK patients," said Sharon McBain, Geron’s Vice President, Global Regulatory Affairs. "We are pleased imetelstat met the three qualifying criteria for the Innovation Passport and believe that because of the durable transfusion independence across different patient subgroups and strong evidence of disease-modifying activity observed in our IMerge Phase 2 study, imetelstat’s novel telomerase inhibitor approach has the potential to be an important drug in this patient population."
Patients from the IMerge Phase 2 clinical trial achieved durable transfusion independence with imetelstat treatment, including transfusion-free periods greater than one year, irrespective of the disease subgroup, such as ringed sideroblast positive or ringed sideroblast negative. Such durability provides significant and meaningful clinical benefit to lower risk MDS patients given their chronic anemia and the debilitating impact of serial blood transfusions. In addition, depletion of cytogenetic abnormalities and reductions in key driver mutations associated with lower risk MDS were observed, and these results were also correlated with transfusion independence. Taken together, the durability, molecular and cytogenetic data from IMerge Phase 2 provide strong evidence for disease-modifying activity of imetelstat which has the potential to differentiate it from other currently approved and investigational treatments in lower risk MDS today.
Imetelstat is currently being studied in two Phase 3 clinical trials, IMerge Phase 3 in lower risk MDS and IMpactMF in refractory myelofibrosis. Based upon current planning assumptions, Geron expects top-line results for the IMerge Phase 3 clinical trial to be available at the beginning of January 2023.
About ILAP and Innovation Passport
The Innovation Passport is awarded by the UK’s Innovation Licensing and Access Pathway Steering Group, which consists of representatives from MHRA, NICE, the Scottish Medicines Consortium (SMC) and the National Health Service (NHS) England. To enter ILAP and receive an Innovation Passport, an experimental drug needs to meet the following public health and/or patient-centric criteria: (1) the condition is life-threatening or seriously debilitating; (2) the program fulfills at least one of the following: innovative medicine, clinically significant new indication or, it is intended for a special population; and (3) the medicine has the potential to offer benefits to patients. The ILAP aims to accelerate the time to market and facilitate patient access to medicines through the development of a target development profile (TDP) that outlines a unique product-specific roadmap for regulatory and development milestones. Other benefits provided by ILAP include the potential for a 150-day accelerated assessment of a Marketing Authorization Application (MAA) and rolling review. The ILAP also provides opportunities for frequent interactions with the review staff at the MHRA and its partner agencies to discuss the drug’s development and regulatory plans, as well as reimbursement.
About IMerge Phase 3
IMerge Phase 3 is a double-blind, randomized, placebo-controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 170 transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS), also referred to as lower risk MDS, who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The primary endpoint is the rate of red blood cell (RBC) transfusion independence (TI) for any consecutive period of eight weeks or longer, or 8-week RBC-TI rate. Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks, or 24-week RBC-TI rate, and the rate of hematologic improvement-erythroid (HI-E), defined as a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden.
IMerge Phase 3 is fully enrolled and patient enrollment has been closed. For additional information about IMerge Phase 3, visit ClinicalTrials.gov/NCT02598661.
About Myelodysplastic Syndromes
Myelodysplastic syndromes are a group of diverse blood disorders that develop because bone marrow cells do not mature into healthy blood cells. Many patients develop chronic anemia, the predominant clinical problem in lower risk MDS, and become dependent on red blood cell transfusions which leads to iron overload, heart and kidney complications, decreases in quality of life and shorter overall survival. Approximately 70% of MDS patients are categorized in the lower risk groups at diagnosis, according to the International Prognostic Scoring System that assigns relative risk of progression to acute myelogenous leukemia and overall survival by taking into account the presence of a number of disease factors, such as cytopenias and cytogenetics.
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in myeloid hematologic malignancies. Data from Phase 2 clinical trials 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 and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States 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 associated 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 myeloid hematologic malignancies. The Company currently is conducting two Phase 3 clinical trials: IMerge in lower risk myelodysplastic syndromes and IMpactMF in refractory myelofibrosis. For more information about Geron, visit www.geron.com.
GERN After-Hours $1.75 + 0.28 + 19.04%
Geron Enters New Innovative Licensing and Access Pathway in the United Kingdom for Imetelstat
Mon, October 25, 2021
Innovation Passport Designation Awarded to Imetelstat for the Treatment of Lower Risk Myelodysplastic Syndromes
Pathway Intended to Expedite Regulatory Review Process
FOSTER CITY, Calif., October 25, 2021--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, today announced that imetelstat, the Company’s first in class telomerase inhibitor, has been granted an Innovation Passport, which is the first prescribed entry point to the Innovative Licensing and Access Pathway (ILAP) launched in the United Kingdom (UK) by the Medicines and Healthcare products Regulatory Agency (MHRA) in January 2021, post-Brexit. The objective of this new licensing and access pathway is to reduce the time to market for innovative medicines. Key benefits of being within ILAP include a 150-day accelerated assessment and rolling review of a Marketing Authorization Application (MAA), as well as opportunities for frequent interactions with the review staff at the MHRA and its partner agencies, including the National Institute for Health and Care Excellence (NICE), to discuss imetelstat’s development, regulatory plans and reimbursement plans.
"We are pleased to participate in this new expedited review pathway established by MHRA and look forward to working with them and their partner agencies as we collaborate to bring imetelstat to UK patients," said Sharon McBain, Geron’s Vice President, Global Regulatory Affairs. "We are pleased imetelstat met the three qualifying criteria for the Innovation Passport and believe that because of the durable transfusion independence across different patient subgroups and strong evidence of disease-modifying activity observed in our IMerge Phase 2 study, imetelstat’s novel telomerase inhibitor approach has the potential to be an important drug in this patient population."
Patients from the IMerge Phase 2 clinical trial achieved durable transfusion independence with imetelstat treatment, including transfusion-free periods greater than one year, irrespective of the disease subgroup, such as ringed sideroblast positive or ringed sideroblast negative. Such durability provides significant and meaningful clinical benefit to lower risk MDS patients given their chronic anemia and the debilitating impact of serial blood transfusions. In addition, depletion of cytogenetic abnormalities and reductions in key driver mutations associated with lower risk MDS were observed, and these results were also correlated with transfusion independence. Taken together, the durability, molecular and cytogenetic data from IMerge Phase 2 provide strong evidence for disease-modifying activity of imetelstat which has the potential to differentiate it from other currently approved and investigational treatments in lower risk MDS today.
Imetelstat is currently being studied in two Phase 3 clinical trials, IMerge Phase 3 in lower risk MDS and IMpactMF in refractory myelofibrosis. Based upon current planning assumptions, Geron expects top-line results for the IMerge Phase 3 clinical trial to be available at the beginning of January 2023.
About ILAP and Innovation Passport
The Innovation Passport is awarded by the UK’s Innovation Licensing and Access Pathway Steering Group, which consists of representatives from MHRA, NICE, the Scottish Medicines Consortium (SMC) and the National Health Service (NHS) England. To enter ILAP and receive an Innovation Passport, an experimental drug needs to meet the following public health and/or patient-centric criteria: (1) the condition is life-threatening or seriously debilitating; (2) the program fulfills at least one of the following: innovative medicine, clinically significant new indication or, it is intended for a special population; and (3) the medicine has the potential to offer benefits to patients. The ILAP aims to accelerate the time to market and facilitate patient access to medicines through the development of a target development profile (TDP) that outlines a unique product-specific roadmap for regulatory and development milestones. Other benefits provided by ILAP include the potential for a 150-day accelerated assessment of a Marketing Authorization Application (MAA) and rolling review. The ILAP also provides opportunities for frequent interactions with the review staff at the MHRA and its partner agencies to discuss the drug’s development and regulatory plans, as well as reimbursement.
About IMerge Phase 3
IMerge Phase 3 is a double-blind, randomized, placebo-controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 170 transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS), also referred to as lower risk MDS, who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The primary endpoint is the rate of red blood cell (RBC) transfusion independence (TI) for any consecutive period of eight weeks or longer, or 8-week RBC-TI rate. Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks, or 24-week RBC-TI rate, and the rate of hematologic improvement-erythroid (HI-E), defined as a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden.
IMerge Phase 3 is fully enrolled and patient enrollment has been closed. For additional information about IMerge Phase 3, visit ClinicalTrials.gov/NCT02598661.
About Myelodysplastic Syndromes
Myelodysplastic syndromes are a group of diverse blood disorders that develop because bone marrow cells do not mature into healthy blood cells. Many patients develop chronic anemia, the predominant clinical problem in lower risk MDS, and become dependent on red blood cell transfusions which leads to iron overload, heart and kidney complications, decreases in quality of life and shorter overall survival. Approximately 70% of MDS patients are categorized in the lower risk groups at diagnosis, according to the International Prognostic Scoring System that assigns relative risk of progression to acute myelogenous leukemia and overall survival by taking into account the presence of a number of disease factors, such as cytopenias and cytogenetics.
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in myeloid hematologic malignancies. Data from Phase 2 clinical trials 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 and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States 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 associated 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 myeloid hematologic malignancies. The Company currently is conducting two Phase 3 clinical trials: IMerge in lower risk myelodysplastic syndromes and IMpactMF in refractory myelofibrosis. For more information about Geron, visit www.geron.com.
Re: Gern (Geron Corp)
van het yahooforum
1. GERN zei 10 maart 2022, ze (GERN) praten nu met Big Pharma over partnerschappen! Dit is ENORM!
2. Big Pharma zegt dat ze $ 1,75 BILJOEN ja BILJOEN beschikbaar hebben voor het maken van deals biotechbedrijven. Dit is ENORM!
3. Het Verenigd Koninkrijk zou het medicijn van GERN nu elke dag kunnen goedkeuren. Dit is ENORM!
4. Johnson en Johnson insiders stoppen met JNJ en rennen naar GERN voor werk. Ja JNJ insiders. Dit is ENORM!
5. GERN's medicijn is het enige medicijn dat kankerachtig beenmerg weer normaal maakt. Dit is ENORM!
6. GERN's medicijn is het enige medicijn dat levensjaren toevoegt aan de ziekste bloedkankerpatiënten. Dit is ENORM!
7.M.D. Anderson en vele anderen prijzen gern's drug online in video's. Dit is ENORM!
8.M.D. Anderson zegt dat het medicijn van GERN de lat enorm heeft verhoogd en voor de eerste keer ooit M.A. Anderson kan praten over het verhogen van de algehele overleving (meer jaren te leven) van deze bloedkankerpatiënten. Dit is ENORM!
9. PCYC steeg met 45.000% van deze lage niveaus. Gern's technologie blaast PCYC-medicijn weg. Als GERN vanaf hier maar 20.000% omhoog gaat is het nog steeds 1 van de beste buys van het decennium. Dit is ENORM!
10. Op 11 maart zetten drie aandelenanalisten sterke aankopen op GERN-aandelen nadat ze GERN hadden horen zeggen dat ze in gesprek zijn met big pharma in de GERN-conference call van 10 maart. Dit is ENORM!
11. 5 aandelenanalisten hebben nu sterke aankopen op GERN zonder analistenbeoordeling GERN-aandelen een verkoop. Dit is ENORM.
12. 11 maart 2022 H.C. Wainwright-analist zette een koersdoel van $ 7 dollar 12 maand op GERN-aandelen na het horen van de GERN-presentatie van 10 maart.
13. De short sellers shorten elke dag 330.000 meer GERN-aandelen om de aandelenkoers van GERN laag te houden, maar deze gaan niet werken. Dit windt gern's voorraad nog strakker voor de komende GERN run in de tieners. GERN $10 tot $20 per aandeel binnenkort!
14. H.C. Wainright zegt dat GERN-aandelen de komende 12 maanden met 600% zullen stijgen. Dit is ENORM!
15. U kunt nu GERN-aandelen kopen en ENORM veel geld verdienen of u kunt naar de short sellers luisteren en het in de shorts nemen.
Mistral liked last!
1. GERN zei 10 maart 2022, ze (GERN) praten nu met Big Pharma over partnerschappen! Dit is ENORM!
2. Big Pharma zegt dat ze $ 1,75 BILJOEN ja BILJOEN beschikbaar hebben voor het maken van deals biotechbedrijven. Dit is ENORM!
3. Het Verenigd Koninkrijk zou het medicijn van GERN nu elke dag kunnen goedkeuren. Dit is ENORM!
4. Johnson en Johnson insiders stoppen met JNJ en rennen naar GERN voor werk. Ja JNJ insiders. Dit is ENORM!
5. GERN's medicijn is het enige medicijn dat kankerachtig beenmerg weer normaal maakt. Dit is ENORM!
6. GERN's medicijn is het enige medicijn dat levensjaren toevoegt aan de ziekste bloedkankerpatiënten. Dit is ENORM!
7.M.D. Anderson en vele anderen prijzen gern's drug online in video's. Dit is ENORM!
8.M.D. Anderson zegt dat het medicijn van GERN de lat enorm heeft verhoogd en voor de eerste keer ooit M.A. Anderson kan praten over het verhogen van de algehele overleving (meer jaren te leven) van deze bloedkankerpatiënten. Dit is ENORM!
9. PCYC steeg met 45.000% van deze lage niveaus. Gern's technologie blaast PCYC-medicijn weg. Als GERN vanaf hier maar 20.000% omhoog gaat is het nog steeds 1 van de beste buys van het decennium. Dit is ENORM!
10. Op 11 maart zetten drie aandelenanalisten sterke aankopen op GERN-aandelen nadat ze GERN hadden horen zeggen dat ze in gesprek zijn met big pharma in de GERN-conference call van 10 maart. Dit is ENORM!
11. 5 aandelenanalisten hebben nu sterke aankopen op GERN zonder analistenbeoordeling GERN-aandelen een verkoop. Dit is ENORM.
12. 11 maart 2022 H.C. Wainwright-analist zette een koersdoel van $ 7 dollar 12 maand op GERN-aandelen na het horen van de GERN-presentatie van 10 maart.
13. De short sellers shorten elke dag 330.000 meer GERN-aandelen om de aandelenkoers van GERN laag te houden, maar deze gaan niet werken. Dit windt gern's voorraad nog strakker voor de komende GERN run in de tieners. GERN $10 tot $20 per aandeel binnenkort!
14. H.C. Wainright zegt dat GERN-aandelen de komende 12 maanden met 600% zullen stijgen. Dit is ENORM!
15. U kunt nu GERN-aandelen kopen en ENORM veel geld verdienen of u kunt naar de short sellers luisteren en het in de shorts nemen.
Re: Gern (Geron Corp)
Het enigste nadeel dat ik nu zie is: geen noemenswaardig verkoopsteam.
Vandaar partnership nodig.
Vandaar partnership nodig.
Re: Gern (Geron Corp)
Afgelopen week een KV aan 1,05. Koers steeg 20% op dit nieuws ipv te dalen.
Ik heb 25% van mijn positie verkocht met groot verlies in de hoop deze stukken lager weer in te kopen.
Average 3.5 USD momenteel.
Spannende tijden!
Ik heb 25% van mijn positie verkocht met groot verlies in de hoop deze stukken lager weer in te kopen.
Average 3.5 USD momenteel.
Spannende tijden!
-
koenvhaver
- Forum actieveling
- Berichten: 889
- Lid geworden op: 11 jan 2012 16:40
- waarderingen: 163
Re: Gern (Geron Corp)
Ah, ze bestaan nog: andere beleggers van Geron. Heb dit al jaren in portefeuille. Al enkele keren aan- en verkocht. Nu gemiddeld erin aan 1,40. Heb geduld want dit jaar zal er net als vorig jaar niet veel speciaals zijn. Pas in 2023 wordt het echt spannend.
De 400% is bereikt geweest
Re: Gern (Geron Corp)
Zit er nu bijna 5 jaar in denk ik. Af en toe eens een kleine trade, maar grootste positie altijd behouden. Net voor het JNJ debacle gemiddelde nog hard verhoogdkoenvhaver schreef: ↑03 apr 2022 11:52Ah, ze bestaan nog: andere beleggers van Geron. Heb dit al jaren in portefeuille. Al enkele keren aan- en verkocht. Nu gemiddeld erin aan 1,40. Heb geduld want dit jaar zal er net als vorig jaar niet veel speciaals zijn. Pas in 2023 wordt het echt spannend.
-
beurssukkel
- Forum actieveling
- Berichten: 467
- Lid geworden op: 03 nov 2015 16:17
- waarderingen: 118
Re: Gern (Geron Corp)
Wss zijn jullie BB volgers. In 2023 zal het MOETEN gebeuren. Ondertussen zijn we nog niet aan de vroege patatten. Ik verwacht na de zomer nog een zware financiële crisis. Europa piept en kraakt, Oekraïne, stikstof, inflatie. Er is niet veel nodig voor een Europese lente en we weten ondertussen hoe de Arabische lente geëvolueerd is. Hopelijk blijft Geron (US-beurs) hier van gespaard, anders wordt het nog een centjes aandeel.Naz-T schreef: ↑03 apr 2022 12:39Zit er nu bijna 5 jaar in denk ik. Af en toe eens een kleine trade, maar grootste positie altijd behouden. Net voor het JNJ debacle gemiddelde nog hard verhoogdkoenvhaver schreef: ↑03 apr 2022 11:52Ah, ze bestaan nog: andere beleggers van Geron. Heb dit al jaren in portefeuille. Al enkele keren aan- en verkocht. Nu gemiddeld erin aan 1,40. Heb geduld want dit jaar zal er net als vorig jaar niet veel speciaals zijn. Pas in 2023 wordt het echt spannend.
-
koenvhaver
- Forum actieveling
- Berichten: 889
- Lid geworden op: 11 jan 2012 16:40
- waarderingen: 163
Re: Gern (Geron Corp)
De spanning blijft zich opbouwen naar 2023. De topvrouw heeft wel een stap opzij gezet dus dat is minder goed nieuws maar voor de rest blijf ik geduld hebben. Dit aandeel staat ook volledig los van de algemene marktcondities.
De 400% is bereikt geweest
