Geron Corp’s Stock Still Soaring
Geron Corp’s (NASDAQ:GERN) stock is experiencing a significant surge since yesterday’s after-hours trading and holds steady after the breaking news of the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) giving a favorable vote for the clinical benefit/risk profile of imetelstat in treating transfusion-dependent anemia.
Key Details: Geron announced post-market close on Thursday that the ODAC had cast a dominant vote of 12 to 2 supporting imetelstat’s clinical benefit/risk profile in the treatment of transfusion-dependent anemia in adult patients identified with low-to-intermediate-1 risk myelodysplastic syndromes. This applies primarily to patients who’ve either shown no response, lost response, or are ineligible for erythropoiesis-stimulating agents.
Imetelstat, a pioneering, first-in-class investigational telomerase inhibitor, is exclusively owned and developed by Geron for hematologic malignancies.
The ODAC extensively reviewed results from Geron’s late-stage Merge Phase 3 trial, determining that the primary goal of achieving red blood cell transfusion independence for a minimum of eight weeks was significantly more attainable with imetelstat in comparison to a placebo.
“Given the limited treatment options and extensive unmet medical need for these patients, particularly those dealing with challenging variations of this blood cancer, we strongly believe in the potential of imetelstat to be a game-changing new medicine,” commented Faye Feller, Geron’s Executive Vice President and Chief Medical Officer.
Geron is eager to continue its cooperative efforts with the FDA as they advance their review of the New Drug Application.
The FDA has allocated a target action date of June 16, 2024, under the Prescription Drug User Fee Act for the New Drug Application for imetelstat by Geron.
