Updated 6:39 a.m. EST: Adds latest stock price movements.
Geron (NASDAQ:Gern) stock ~17% added The company’s lead drug, imetelstat, was launched premarket Friday after the U.S. Food and Drug Administration approved it as a late-stage option for a type of blood cancer called myelodysplastic syndrome (MDS).
Accordingly, the company announced in a statement Thursday that imetelstat, a telomerase inhibitor, will be launched in the United States under the name Rytelo for adults with low- to intermediate-risk MDS who develop anemia requiring transfusions. I did.
This treatment will be indicated for people who do not respond to or are not eligible to receive a class of drugs called erythropoiesis-stimulating agents.
The approval puts Geron ( GERN ) in competition with Bristol Myers ( BMY ) and Merck ( MRK ), which sell Reblozyl, another MDS treatment approved for low-risk patients.
The approval comes after an FDA advisory committee voted 12 to 2 in favor of imetelstat in March. The company has scheduled a conference call for 8 a.m. Friday to discuss the regulatory victory.