Geron Corp (NASDAQ:GERN) shares are soaring in Thursday’s after-hours session after the company announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia.
What Happened: After the market close on Thursday, Geron announced that ODAC voted 12 to two 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. The patients must have either not responded to or lost response to or be ineligible for erythropoiesis-stimulating agents.
Imetelstat is a novel, first-in-class investigational telomerase inhibitor exclusively owned by Geron and being developed by Geron in hematologic malignancies.
The ODAC reviewed results from the late-stage clinical biopharmaceutical company’s Merge Phase 3 trial and found that the primary endpoint of red blood cell transfusion independence (RBC-TI) for at least eight consecutive weeks was significantly higher with imetelstat versus placebo.
“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, executive vice president and chief medical officer of Geron.
“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 FDA has assigned a Prescription Drug User Fee Act target action date of June 16, 2024 for Geron’s New Drug Application for imetelstat.
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GERN Price Action: Earlier this week, Geron shares traded lower on reports FDA staff reviewers had raised multiple safety concerns over Geron’s anemia drug.
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