GERN - Geron: FDA PDUFA Review With Continued Imetelstat Advancement

2024-05-01 16:23:58 ET

Summary

• Geron Corporation has a PDUFA date of June 16th of 2024 for the FDA to decide upon whether imetelstat should be approved for patients with low-risk myelodysplastic syndrome.
• The FDA Oncologic Drugs Advisory Committee already voted in favor of imetelstat 12 to 2 for patients with low-risk myelodysplastic syndrome.
• The European Commission has already accepted the MAA for review of imetelstat for low-risk myelodysplastic syndrome; European approval is possible in 2025.
• Imetelstat is also being evaluated in the ongoing phase 3 IMpactMF study for the treatment of patients of relapsed/refractory MF; Interim analysis expected in the 1st half of 2025 and final data expected in the 1st half of 2026.

Geron Corporation ( GERN ) is gearing up for a major milestone as a biotech company. It has a PDUFA date set for June 16th of 2024, which is the date by which the FDA will decide whether imetelstat should be approved for the treatment of patients with low-risk myelodysplastic syndrome [LR-MDS]. These are patients who have failed to respond, lost response to or ineligible for Erythropoiesis-stimulating agents [ESAs]. An FDA advisory panel already voted in favor of imetelstat for this LR-MDS patient population, recommending that the risk-benefit profile is ideal for regulatory approval of it....

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