(Reuters) – Geron Corp said on Wednesday its experimental drug helped more patients with a difficult-to-treat blood cancer achieve independence from routine transfusions in a late-stage trial, sending shares of the drug developer nearly 50% higher.
The drug, ejemplos actos humanos eticos imetelstat, was being studied in patients with types of lower risk myelodysplastic syndromes (MDS), which requires frequent blood transfusions for patients to manage their anemia, the company said.
The drug, if approved, will enter into a market that already has players such as Bristol Myers Squibb’s Reblozyl, which has been approved by the U.S. Food and Drug Administration to treat forms of the disease.
Geron anticipates a peak market potential of $1.2 billion in the United States and some key EU countries by 2030, Chief Executive Officer John Scarlett told Reuters.
Nearly 40% of the 118 patients who were on the drug showed independence from transfusion for eight weeks, compared with 15% of the 60 patients on placebo, the company said in a statement.
The data appears to be a “better/best case scenario” for the drug’s chances at approval, said Stifel analyst Stephen Willey.
Adverse effects observed during the late-stage trial were consistent with previous trials, with low count of platelets and white blood cells among the most common, the company said.
Geron said these adverse effects were not uncommon, adding “the side effects are short lived and reversible, and do not have an increased risk of bleeding or infections.”
The company plans to file an application for U.S. approval in mid-2023.
Geron is also testing the drug for myelofibrosis, a rare type of bone marrow cancer, and expects data from an interim analysis in 2024. If approved, the drug would compete with Incyte Corp’s myelofibrosis drug, Jakafi.
Shares of California-based Geron rose 50% to $3.61 in morning trade.
(Reporting by Sriparna Roy and Leroy Leo in Bengaluru; Editing by Saumyadeb Chakrabarty and Shinjini Ganguli)
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