Geron gains after submitting marketing application for blood cancer therapy

• Shares of Geron Corporation (NASDAQ:GERN) gained for the first time in six sessions on Tuesday after the biotech announced the submission of its New Drug Application (NDA) for blood cancer therapy imetelstat to the FDA.
• The NDA seeks FDA approval of imetelstat for transfusion-dependent anemia in certain low- to intermediate-1-risk adults with myelodysplastic syndromes (MDS).
• Given imetelstat’s Fast Track designation for imetelstat in lower-risk MDS, the company expects FDA to issue Priority Review for the NDA. A decision on review is anticipated within 60 days.
• The NDA is backed by data from the IMerge Phase 3 in which imetelstat achieved the primary endpoint of 8-week transfusion independence (TI) compared to placebo (P<0.001) with statistical significance.
• Geron (GERN) expects to use the same data in a planned Marketing Authorization Application (MAA) for imetelstat in the EU in H2 2023.

More on Geron

• Geron hits three-month low as Goldman Sachs issues Neutral rating
• Geron: Ready To Face The Competition With Imetelstat In Lower Risk MDS