Yeji

$GERN

GERON CORP

Runway:3 mo
NasdaqMarket cap: —CIK 0000886744

Upcoming catalysts

1 surfaced
AdComDate TBD
$GERNGERON CORP
imetelstat · transfusion-dependent 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 erythropoiesis-stimulating agents
“the FDA informed the Company that it is currently planning to hold an advisory committee meeting as part of the NDA review”

Drug pipeline

rytelo
imetelstat
transfusion-dependent 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 erythropoiesis-stimulating agents
Imetelstat Sodium (GRN163L)
Lung Cancer
Imetelstat 4.7 mg/kg
Myelofibrosis
Imetelstat sodium
Locally Recurrent or Metastatic Breast Cancer
GRN163L
Chronic Lymphoproliferative Diseases
Imetelstat (7.5 mg/kg)
Multiple Myeloma

Recent & active trials

NCTDrugPhaseStatusPrimary completion
NCT04576156imetelstatPhase 3Active Not Recruiting2028-06-30
NCT05371964Imetelstat sodiumPhase 1Recruiting2027-02-01
NCT02598661Imetelstat sodiumPhase 3Active Not Recruiting2023-10-13
NCT01731951imetelstatPhase 2Completed2018-05-24
NCT02426086Imetelstat 4.7 mg/kgPhase 2Completed2018-04-26
NCT01242930imetelstatPhase 2Completed2014-11-01
NCT01243073imetelstatPhase 2Completed2013-10-01
NCT01137968imetelstatPhase 2Completed2013-09-01
NCT00310895Imetelstat sodiumPhase 1Completed2013-03-01
NCT00124189GRN163LPhase 1Completed2013-03-01
NCT01256762Imetelstat sodiumPhase 2Completed2012-10-01
NCT00718601Imetelstat sodiumPhase 1Completed2011-10-01
NCT00732056GRN163LPhase 1Completed2011-09-01
NCT00594126Imetelstat sodiumPhase 1Completed2011-07-01
NCT00510445Imetelstat sodiumPhase 1Completed2011-04-01
NCT05937568imetelstat—Approved For Marketing—

Recent catalysts

PDUFAJun 16, 2024· 720d ago· unknown
$GERNGERON CORP
imetelstat · transfusion-dependent 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 erythropoiesis-stimulating agents
“its New Drug Application ("NDA") for the use of imetelstat for the treatment of transfusion-dependent 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 erythropoiesis-stimulating agents, was accepted by the United States Food and Drug Administration ("FDA") for review and assigned a Prescription Drug User Fee Act ("PDUFA") action date of June 16, 2024.”
FDA approvalJun 6, 2024· 730d ago· success
$GERNGERON CORP
rytelo
“openFDA ORIG (TYPE 1) approval of RYTELO — application NDA217779”
AdComMar 14, 2024· 814d ago
$GERNGERON CORP
imetelstat · transfusion-dependent 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 erythropoiesis-stimulating agents
“announcing the results of the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee, virtually held on March 14, 2024, in connection with the Company's New Drug Application for imetelstat for the treatment of transfusion-dependent 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 erythropoiesis-stimulating agents”
NDA/BLA filedAug 21, 2023· 1020d ago· unknown
$GERNGERON CORP
imetelstat · transfusion-dependent 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 erythropoiesis-stimulating agents
“On August 21, 2023, Geron Corporation announced that its New Drug Application ("NDA") for the use of imetelstat for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes has been accepted for filing by the U.S. Food and Drug Administration ("FDA").”