Myelodysplastic syndrome, which refers to a group of blood disorders, affects an estimated 60,000 people in the U.S. The abnormal or malignant precursor cells in the bone marrow proliferates resulting in a disordered and ineffective production of the myeloid lineage, which includes red blood cells, white blood cells and platelets in patients with myelodysplastic syndrome (MDS). Reblozyl, Inqovi, Vidaza, Dacogen, and Revlimid are some of the FDA-approved treatments for MDS.
The stock we are bringing to your attention is that of a late-stage clinical biopharmaceutical company developing a drug for lower risk myelodysplastic syndromes – Geron Corp. (GERN).
The drug candidate in focus is Imetelstat, a potent and specific inhibitor of an enzyme called telomerase, under a phase III trial in lower risk MDS, dubbed IMerge.
The IMerge phase III trial is evaluating an improvement in the rate of red blood cell transfusion independence (RBC-TI) of participants treated with Imetelstat compared to placebo. The study completed enrollment of approximately 170 patients with lower risk MDS last October.
Geron expects top-line results from IMerge phase III study in early January 2023.
If all goes well, the company expects to submit a New Drug Application seeking approval for Imetelstat in lower risk MDS in the U.S. in the first half of 2023 and Marketing Authorization Application in the EU in the second half of 2023.
The other ongoing trials with Imetelstat are:
— A phase III trial of Imetelstat as a single agent in relapsed/refractory myelofibrosis patients, dubbed IMpactMF.
— A phase I trial of Imetelstat in combination with Ruxolitinib in patients with frontline myelofibrosis, dubbed IMproveMF.
Planned trials with Imetelstat are:
— An investigator-led phase II study of single-agent Imetelstat in relapsed/refractory (R/R) acute myeloid leukemia (AML) and higher risk MDS, dubbed IMpress, is expected to start in the second half of 2022.
— An investigator-led phase I/II study of Imetelstat in combination with hypomethylating agents (HMAs) or Venetoclax in R/R AML, dubbed TELOMERE, is expected to start in the second half of 2022.
As of June 30, 2022, the company had approximately $220 million in cash and marketable securities.
GERN has traded in a range of $0.99 to $2.79 in the last 1 year. The stock closed Friday’s trading at $2.66, down 0.75%.
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