Geron Imetelstat Trial In Lower Risk MDS Meets Primary Efficacy Goal; Stock Climbs In Pre-market

(RTTNews) - Geron Corp. (GERN), a late-stage clinical biopharmaceutical company, announced Wednesday positive top-line results from its IMerge Phase 3 clinical trial evaluating imetelstat in lower risk myelodysplastic syndromes or MDS patients.

Imetelstat is a novel, first-in-class telomerase inhibitor, being developed in hematologic malignancies.

The company noted that IMerge Phase 3, a double-blind, 2:1 randomized, placebo-controlled clinical trial to evaluate imetelstat, met its primary efficacy endpoint in MDS patients who are relapsed, refractory or ineligible for erythropoiesis stimulating agents or ESAs.

In light of the positive top-line results from IMerge Phase 3, combined with data from earlier clinical trials, the company plans to submit an NDA in the U.S. in mid-2023 and a Marketing Authorization Application or MAA in the EU in the second half of 2023.

With Fast Track designation for imetelstat from the U.S. Food and Drug Administration to treat adult patients with transfusion dependent anemia due to Low or Intermediate-1 risk MDS that is not associated with del(5q) who are refractory or resistant to an ESA, a request for rolling submission of the NDA was submitted and has been granted.

John Scarlett, Geron's Chairman and Chief Executive Officer, said, "The results from the IMerge Phase 3 study were resoundingly positive, presenting compelling durability of transfusion independence, delivering on the promise of imetelstat and telomerase inhibition for these patients. This milestone is the first of many upcoming catalysts for Geron, with planned U.S. and EU regulatory submissions in 2023, as well as preparations for a potential U.S. commercial launch."

In addition, in 2024, the company expects an interim analysis of the IMpactMF Phase 3 trial of imetelstat in relapsed/refractory myelofibrosis.

Geron is preparing to commercially launch imetelstat in lower risk MDS in the first half of 2024 in the U.S. and by the end of 2024 in the EU, assuming regulatory approvals are granted.

In pre-market activity on Nasdaq, Geron shares were gaining around 66 percent to trade at $3.99.

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