LONDON: Shares in biopharmaceutical company Geron surged more than 16 per cent before market open on Friday, a day after the company received its first approval from the US Food and Drug Administration for a drug. blood disorder medicine Rytelo,
The injectable drug will compete with: Bristol Myers Squibb’S ReblozilWhich was given the green signal for label expansion by the regulator last year for the same disease indication.
California-based Geron said it would discuss pricing and availability of the new drug in a conference call with investors later today.
Ritelo is approved to treat the following: transfusion-dependent anemia In adults with low-risk myelodysplastic syndromes — a group of blood cancers where blood cells in the bone marrow do not mature or cannot make healthy blood cells, Geron said in a statement Thursday.
The approval was based on a late-stage study in which about 40 percent of patients taking the drug showed freedom from blood transfusions by eight weeks, compared with 15 percent of patients taking a placebo.
In January last year, Geron CEO John Scarlett told Reuters that the company estimated a market potential of $1.2 billion for the treatment in the United States and some key European Union countries by 2030.
In March, independent advisers to the FDA backed the drug’s benefits, saying they outweighed its risks.
Geron Shares They rose 16.7 per cent to $4.54 in pre-bell trading.
(Reporting by Sriparna Roy, Christy Santosh and Pratik Jain in Bengaluru; Editing by Nivedita Bhattacharya)
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