FDA Accepts Geron's NDA For Imetelstat For Treatment Of Lower Risk Myelodysplastic Syndromes

(RTTNews) - The United States Food and Drug Administration has accepted the filing of Geron Corp.'s (GERN) New Drug Application (NDA) for imetelstat, its first-in-class telomerase inhibitor, for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes or MDS, the company said in a statement on Monday.

In Monday pre-market trade, GERN was trading at $2.80 up $0.19 or 7.27%.

The company noted that the NDA submission was based on results from IMerge Phase 3, in which the primary endpoint of 8-week transfusion independence (TI) was significantly higher with imetelstat compared to. placebo, with median transfusion independence duration approaching one year for imetelstat 8-week TI responders.

As per the rule, the FDA has up to 74 days from the NDA submission date to notify Geron of the Prescription Drug User Fee Act (PDUFA) action date for the NDA. Upon receipt of this notification, Geron plans to disclose the timeline for the NDA review.

Additionally, Geron expects to submit a Marketing Authorization Application in the European Union in the fourth quarter of 2023.

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