15.03.2024 02:42:12 - dpa-AFX: Geron Gets Favorable Votes From FDA Panel For Imetelstat In Treating Transfusion-Dependent Anemia

WASHINGTON (dpa-AFX) - Geron Corp. (GERN) said Thursday that the U.S. Food
and Drug Administration Oncologic Drugs Advisory Committee or ODAC voted 12 to 2
in favor of the clinical benefit/risk profile of imetelstat for the treatment of
transfusion-dependent anemia in adult patients with low-to-intermediate-1 risk
myelodysplastic syndromes or LR-MDS who have not responded to or have lost
response to or are ineligible for erythropoiesis-stimulating agents or ESAs.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of
June 16, 2024 for Geron'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 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.

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Copyright RTT News/dpa-AFX
Name WKN Börse Kurs Datum/Zeit Diff. Diff. % Geld Brief Erster Schluss
GERON CORP. (DEL.) DL-001 902213 Frankfurt 4,184 28.06.24 14:39:45 +0,090 +2,20% 0,000 0,000 4,087 4,184

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